導(dao)語：中藥(yao)治療緊張(zhang)性頭(tou)痛(tong)的臨床研究一文來源于網友上傳(chuan)，不代表本站觀點，若需要原創文章可咨(zi)詢(xun)客(ke)服老師，歡迎(ying)參考。

摘要：系統收集中藥治療緊張性頭痛（ＴＴＨ）臨床研究的(de)現(xian)(xian)有(you)證(zheng)(zheng)據(ju)(ju)(ju)，評價(jia)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治療(liao)緊(jin)(jin)張(zhang)性(xing)頭(tou)痛(tong)(tong)(tong)(tong)臨(lin)(lin)床(chuang)研(yan)(yan)究(jiu)的(de)現(xian)(xian)狀。方法：計算機檢索國(guo)(guo)家知識基(ji)礎設施(shi)數(shu)(shu)(shu)據(ju)(ju)(ju)庫(ku)（ＣＮＫＩ）、中(zhong)(zhong)(zhong)國(guo)(guo)學(xue)(xue)(xue)術期(qi)(qi)刊(kan)數(shu)(shu)(shu)據(ju)(ju)(ju)庫(ku)（ＣＳＰＤ）、中(zhong)(zhong)(zhong)文科技(ji)期(qi)(qi)刊(kan)數(shu)(shu)(shu)據(ju)(ju)(ju)庫(ku)（ＣＣＤ）、中(zhong)(zhong)(zhong)國(guo)(guo)生物醫學(xue)(xue)(xue)文獻數(shu)(shu)(shu)據(ju)(ju)(ju)庫(ku)（ＣＢＭｄｉｓｃ）、ＥＭｂａｓｅ、ＰｕｂＭｅｄ、ＣｏｃｈｒａｎｅＬｉｂｒａｒｙ、Ｗｅｂｏｆｓｃｉｅｎｃｅ、ＣｌｉｎｉｃａｌＴｒｉａｌｓｇｏｖ和中(zhong)(zhong)(zhong)國(guo)(guo)臨(lin)(lin)床(chuang)試(shi)驗注(zhu)冊中(zhong)(zhong)(zhong)心共１０個數(shu)(shu)(shu)據(ju)(ju)(ju)庫(ku)，檢索時限(xian)為建庫(ku)至２０２０年１０月，納入有(you)關(guan)(guan)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治療(liao)ＴＴＨ的(de)臨(lin)(lin)床(chuang)研(yan)(yan)究(jiu)，采用證(zheng)(zheng)據(ju)(ju)(ju)圖方法呈(cheng)現(xian)(xian)臨(lin)(lin)床(chuang)研(yan)(yan)究(jiu)的(de)證(zheng)(zheng)據(ju)(ju)(ju)分布情況。結(jie)果：共納入４７１項(xiang)(xiang)(xiang)臨(lin)(lin)床(chuang)研(yan)(yan)究(jiu)，其中(zhong)(zhong)(zhong)隨(sui)機對(dui)照試(shi)驗３７８項(xiang)(xiang)(xiang)，非隨(sui)機對(dui)照試(shi)驗４１項(xiang)(xiang)(xiang)，隊列研(yan)(yan)究(jiu)１項(xiang)(xiang)(xiang)，病例系列研(yan)(yan)究(jiu)５１項(xiang)(xiang)(xiang)，文獻總發(fa)表(biao)數(shu)(shu)(shu)量在總體上隨(sui)時間變化呈(cheng)增(zeng)長趨勢，但(dan)呈(cheng)“鋸(ju)齒狀”波動；方法學(xue)(xue)(xue)質(zhi)量評價(jia)結(jie)果顯示(shi)目前中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治療(liao)緊(jin)(jin)張(zhang)性(xing)頭(tou)痛(tong)(tong)(tong)(tong)的(de)臨(lin)(lin)床(chuang)研(yan)(yan)究(jiu)質(zhi)量較(jiao)低(di)；中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治療(liao)緊(jin)(jin)張(zhang)性(xing)頭(tou)痛(tong)(tong)(tong)(tong)對(dui)總有(you)效(xiao)率(lv)、安全性(xing)事件、頭(tou)痛(tong)(tong)(tong)(tong)持續時間、頭(tou)痛(tong)(tong)(tong)(tong)強度、頭(tou)痛(tong)(tong)(tong)(tong)發(fa)作(zuo)頻率(lv)、焦慮抑郁量表(biao)關(guan)(guan)注(zhu)度較(jiao)高，對(dui)經濟學(xue)(xue)(xue)指標(biao)及遠期(qi)(qi)預后指標(biao)關(guan)(guan)注(zhu)較(jiao)低(di)。療(liao)程集中(zhong)(zhong)(zhong)在１５～３０ｄ。結(jie)論：目前中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治療(liao)ＴＴＨ的(de)臨(lin)(lin)床(chuang)研(yan)(yan)究(jiu)質(zhi)量較(jiao)低(di)，未(wei)來需要開展更多高質(zhi)量的(de)臨(lin)(lin)床(chuang)研(yan)(yan)究(jiu)為中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治療(liao)ＴＴＨ提(ti)供更充分的(de)證(zheng)(zheng)據(ju)(ju)(ju)。

關鍵詞　緊張性頭痛；中(zhong)醫；中(zhong)藥；證據圖；臨床研究；研究現狀(zhuang)；質量評價

緊張性頭痛（ＴｅｎｓｉｏｎｔｙｐｅＨｅａｄａｃｈｅ，ＴＴＨ）主要表現為頭部兩側的輕度、中度的壓迫性、緊箍樣疼痛，日常活動如走路或爬樓梯一般不加重頭痛，常無惡心、嘔吐，可伴隨畏光或者畏聲。ＴＴＨ是最常見的原發性頭痛，在ＧＢＤ２０１６（ＴｈｅＧｌｏｂａｌＢｕｒｄｅｎｏｆＤｉｓｅａｓｅｓ，Ｉｎｊｕｒｉｅｓ，ａｎｄＲｉｓｋＦａｃｔｏｒｓＳｔｕｄｙ２０１６）調查的３２８種疾病中，ＴＴＨ是僅次于齲齒和潛伏性結核感染的第三大常見疾病，全球的患病率為２３６％～２９０％［１］。ＴＴＨ降低患者的生命質量，減少出勤天數，造成較大的經濟負擔［１３］。ＴＴＨ對情緒、睡眠、精神等影響極大，ＴＴＨ患者伴有焦慮或抑郁情緒比非頭痛患者更為普遍，持續不緩解的ＴＴＨ使得中年以上人群并發心腦血管的風險增加［４６］。中藥治療ＴＴＨ具有一定的優勢，隨著近年來對ＴＴＨ的關注度增加，中藥治療ＴＴＨ的臨床研究逐漸增多，但尚無對該領域現有證據的梳理和總結。證據圖是以表格或圖形為主要呈現形式的一種新型證據綜合研究方法，通過系統收集相關研究領域的現有證據進行深入分析，全面展示研究領域取得的證據、進展及存在的問題［７８］。本研究采用證據圖方法，較為直觀地呈現中藥治療ＴＴＨ的臨床研究的證據分布，為下一步臨床研究的開展提供方向。
1.資料與方法

1.1文(wen)(wen)(wen)獻來(lai)源　本(ben)研(yan)究所依托課(ke)題(ti)為中醫(yi)藥(yao)循證醫(yi)學(xue)項目“腦病中醫(yi)藥(yao)優先主(zhu)題(ti)設(she)(she)置與循證研(yan)究實施(shi)方案設(she)(she)計”（ＺＺ１３０２４３）。基于該(gai)課(ke)題(ti)，通過計算(suan)機檢索國(guo)(guo)家(jia)知識(shi)基礎設(she)(she)施(shi)數(shu)(shu)(shu)據(ju)庫(ku)（ＣｈｉｎａＮａｔｉｏｎａｌＫｎｏｗｌｅｄｇｅＩｎｆｒａｓｔｒｕｃｔｕｒｅ，ＣＮＫＩ）、中國(guo)(guo)學(xue)術期刊數(shu)(shu)(shu)據(ju)庫(ku)（ＣｈｉｎａＳｃｉｅｎｃｅＰｅｒｉｏｄｉｃａｌＤａｔａｂａｓｅ，ＣＳＰＤ）、中文(wen)(wen)(wen)科技(ji)期刊數(shu)(shu)(shu)據(ju)庫(ku)（ＣｈｉｎｅｓｅＣｉｔａｔｉｏｎＤａｔａｂａｓｅ，ＣＣＤ）、中國(guo)(guo)生物(wu)醫(yi)學(xue)文(wen)(wen)(wen)獻數(shu)(shu)(shu)據(ju)庫(ku)（ＣｈｉｎａＢｉｏｌｏｇｙＭｅｄｉｃｉｎｅ，ＣＢＭ）、ＥＭｂａｓｅ、ＰｕｂＭｅｄ、ＣｏｃｈｒａｎｅＬｉｂｒａｒｙ、ｗｅｂｏｆｓｃｉｅｎｃｅ數(shu)(shu)(shu)據(ju)庫(ku)，并查(cha)詢ＣｌｉｎｉｃａｌＴｒｉａｌｓｇｏｖ和中國(guo)(guo)臨(lin)床試驗注冊中心（ＣｈｉｎｅｓｅＣｌｉｎｉｃａｌＴｒｉａｌＲｅｇｉｓｔｒｙ，ＣｈｉＣＴＲ）兩大(da)臨(lin)床試驗注冊系統，搜集中醫(yi)藥(yao)治療ＴＴＨ的中英文(wen)(wen)(wen)文(wen)(wen)(wen)獻，建立了(le)中醫(yi)藥(yao)治療ＴＴＨ數(shu)(shu)(shu)據(ju)庫(ku)。檢索時(shi)限均從建庫(ku)至２０２０年１０月(yue)。

1.2檢(jian)索(suo)策略　檢(jian)索(suo)采用主題(ti)詞(ci)(ci)與自(zi)由詞(ci)(ci)結(jie)合的方式，中(zhong)文(wen)檢(jian)索(suo)詞(ci)(ci)包括：“緊張(zhang)性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“肌收縮性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“心(xin)因性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“壓力性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“應(ying)激性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“心(xin)理肌源性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“普通頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“原(yuan)發性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“特(te)發性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)”“中(zhong)醫藥(yao)(yao)”“中(zhong)醫”“中(zhong)藥(yao)(yao)”“中(zhong)成藥(yao)(yao)”“中(zhong)草(cao)藥(yao)(yao)”“草(cao)藥(yao)(yao)”“方藥(yao)(yao)”等(deng)。英文(wen)檢(jian)索(suo)檢(jian)索(suo)詞(ci)(ci)包括：“ＴｅｎｓｉｏｎＴｙｐｅＨｅａｄａｃｈｅ”“ｔｅｎｓｉｏｎｈｅａｄａｃｈｅ”“ｔｅｎｓｉｏｎｔｙｐｅｈｅａｄａｃｈｅ”“ＴｅｎｓｉｏｎＶａｓｃｕｌａｒＨｅａｄａｃｈｅ”“ｐｓｙｃｈｏｇｅｎｉｃＨｅａｄａｃｈｅｓ”“Ｍｅｄｉｃｉｎｅ，ＣｈｉｎｅｓｅＴｒａｄｉｔｉｏｎａｌ”“ｔｒａｄｉｔｉｏｎａｌｃｈｉｎｅｓｅｍｅｄｉｃｉｎｅ”“ｈｅｒｂａｌｍｅｄｉｃｉｎｅ”“Ｃｈｉｎｅｓｅｄｒｕｇ”“Ｃｈｉｎｅｓｅｈｅｒｂａｌｍｅｄｉｃｉｎｅ”等(deng)。該(gai)數(shu)據庫按(an)照(zhao)研究(jiu)類型及干預(yu)措(cuo)施等(deng)對文(wen)獻(xian)進行系統分(fen)類。本研究(jiu)納入(ru)的文(wen)獻(xian)均(jun)直接來(lai)源于(yu)以(yi)上建立的中(zhong)醫藥(yao)(yao)治療緊張(zhang)性(xing)頭(tou)(tou)(tou)痛(tong)(tong)(tong)數(shu)據庫。

1.3納入標準　納入中藥(yao)(yao)制劑（包(bao)括中藥(yao)(yao)湯劑、中藥(yao)(yao)單(dan)藥(yao)(yao)、中藥(yao)(yao)提取物、中成(cheng)藥(yao)(yao)等(deng)，藥(yao)(yao)物使用(yong)方式不限，口(kou)服(fu)、注射、外用(yong)等(deng)均可）治療ＴＴＨ相關臨(lin)床研究，包(bao)括隨(sui)機對照試驗、非隨(sui)機對照試驗、隊列(lie)研究、病例(li)對照研究、病例(li)系列(lie)研究、橫(heng)斷面研究。

1.4排除(chu)標準(zhun)　重復發(fa)表的文(wen)獻；會議(yi)摘要；無法獲取全文(wen)的文(wen)獻。

1.5文獻篩選及數據提取　成立ＴＴＨ文獻梳理小組，共有７名研究成員，分為２個小組獨立進行文獻的篩選及數據提取，遇到分歧通過討論或者咨詢第三方研究員協助判斷。將初檢的文獻導入ＮｏｔｅＥｘｐｒｅｓｓ３２０軟件進行匯總，排除重復的文獻、閱讀文獻題目和摘要剔除不符合納入標準的文獻，對可能符合納入標準的文獻進行全文閱讀，確定最終納入的文獻，建立數據提取表。數據提取表內容包括：作者信息、發表年份、發表雜志、研究類型、研究對象、疾病西醫診斷標準、中醫證候、總樣本例數、干預類型、干預類型及具體干預措施、療程、結局指標名稱及測量方法、不良反應、不良事件、隨訪情況、脫落及失訪情況。
1.6文(wen)(wen)獻質量(liang)(liang)(liang)評(ping)(ping)價(jia)(jia)(jia)ＴＴＨ文(wen)(wen)獻梳理(li)小組的(de)(de)７名研究(jiu)成員分為２個小組獨立進(jin)行(xing)文(wen)(wen)獻的(de)(de)質量(liang)(liang)(liang)評(ping)(ping)價(jia)(jia)(jia)，遇到分歧通過討(tao)論或者(zhe)咨詢第三方研究(jiu)員協助判(pan)斷(duan)。按照研究(jiu)類型的(de)(de)不同采用相應(ying)的(de)(de)文(wen)(wen)獻質量(liang)(liang)(liang)評(ping)(ping)價(jia)(jia)(jia)方法進(jin)行(xing)質量(liang)(liang)(liang)評(ping)(ping)價(jia)(jia)(jia)。

1.6.1隨(sui)機(ji)對(dui)(dui)照試(shi)驗　采用Ｃｏｃｈｒａｎｅ偏倚(yi)風(feng)(feng)險(xian)(xian)評(ping)估(gu)工具對(dui)(dui)納入的(de)文(wen)獻進行方法(fa)質量(liang)學評(ping)價，主要包(bao)括：１）隨(sui)機(ji)序列產生；２）分(fen)配隱藏(zang)；３）對(dui)(dui)研究(jiu)者(zhe)(zhe)和受(shou)試(shi)者(zhe)(zhe)實施盲法(fa)；４）研究(jiu)結(jie)(jie)局盲法(fa)評(ping)定；５）結(jie)(jie)局數據的(de)完(wan)整性(xing)；６）選(xuan)擇性(xing)報(bao)告研究(jiu)結(jie)(jie)果；７）其他潛在偏倚(yi)。對(dui)(dui)納入的(de)研究(jiu)進行以(yi)上(shang)７個條目的(de)評(ping)價，做出(chu)高風(feng)(feng)險(xian)(xian)、偏倚(yi)風(feng)(feng)險(xian)(xian)不確定和低風(feng)(feng)險(xian)(xian)的(de)判斷。

1.6.2非(fei)隨機對照(zhao)試驗　采用(yong)非(fei)隨機對照(zhao)方(fang)法學(xue)評價指標，共有１２個(ge)評價項(xiang)目，每個(ge)項(xiang)目評分(fen)范圍為０～２分(fen)，０分(fen)表示文(wen)獻中(zhong)沒有報告，１分(fen)表示文(wen)獻報告過(guo)但不充分(fen)，２分(fen)表示文(wen)獻報道(dao)較(jiao)為充分(fen)［９１０］。

1.6.3隊(dui)列研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)及病(bing)(bing)(bing)例(li)對(dui)(dui)照研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)　使用紐卡(ka)斯(si)爾渥(wo)太華量表(biao)(biao)進行文獻(xian)質(zhi)(zhi)量評(ping)價(jia)(jia)［１１］。該(gai)量表(biao)(biao)包括(kuo)３個(ge)維度，８個(ge)條(tiao)(tiao)目(mu)(mu)，從(cong)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)人(ren)群(qun)選擇、組間(jian)可比(bi)性、結果／暴(bao)露因(yin)素(su)測量３個(ge)維度進行評(ping)價(jia)(jia)，使用☆代(dai)表(biao)(biao)分(fen)值，其中組間(jian)可比(bi)性對(dui)(dui)應(ying)的(de)條(tiao)(tiao)目(mu)(mu)２顆(ke)☆，其余每個(ge)條(tiao)(tiao)目(mu)(mu)１顆(ke)☆，滿分(fen)為９顆(ke)☆，５～９顆(ke)☆為相(xiang)對(dui)(dui)高質(zhi)(zhi)量的(de)文章。１６４　病(bing)(bing)(bing)例(li)系(xi)列研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)　目(mu)(mu)前(qian)尚(shang)無公(gong)認的(de)評(ping)價(jia)(jia)病(bing)(bing)(bing)例(li)系(xi)列研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)的(de)質(zhi)(zhi)量評(ping)價(jia)(jia)工具。本研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)采用加(jia)拿大衛生經(jing)濟研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)所(suo)（ＩｎｓｔｉｔｕｔｅｏｆＨｅａｌｔｈＥｃｏｎｏｍｉｃｓ，ＩＨＥ）病(bing)(bing)(bing)例(li)系(xi)列研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)的(de)質(zhi)(zhi)量評(ping)估清(qing)單進行質(zhi)(zhi)量評(ping)價(jia)(jia)，該(gai)清(qing)單包括(kuo)８個(ge)領域，２０個(ge)條(tiao)(tiao)目(mu)(mu)，研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)者(zhe)主要(yao)從(cong)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)目(mu)(mu)的(de)、研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)類型(xing)，研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)人(ren)群(qun)、干預(yu)與聯合干預(yu)、結果測量、統計分(fen)析(xi)、結果與結論、利益(yi)沖突和資(zi)金(jin)來源(yuan)８個(ge)領域進行評(ping)價(jia)(jia)，做出“是”“不清(qing)楚”“否(fou)”的(de)判斷(duan)［１２１３］。

1.7證據分(fen)(fen)布(bu)結果(guo)分(fen)(fen)析　使用ＭｉｃｒｏｓｏｆｔＥｘｃｅｌ２０１６軟件(jian)對納入文(wen)獻進行(xing)統(tong)計分(fen)(fen)析。應(ying)用圖表(biao)(biao)結合(he)文(wen)字方式(shi)描述研究數(shu)量及特征。使用折(zhe)線圖表(biao)(biao)示(shi)文(wen)獻的(de)年度發表(biao)(biao)趨勢，餅圖、條(tiao)形圖及百分(fen)(fen)條(tiao)圖表(biao)(biao)示(shi)各類別的(de)比例(li)分(fen)(fen)布(bu)情況，氣泡圖展示(shi)證據分(fen)(fen)布(bu)情況。

2.結果

2.1文獻檢(jian)索結果　共檢(jian)索到(dao)１９０４２篇(pian)文獻，去除重復(fu)后得(de)到(dao)１０９６８篇(pian)，閱讀題目(mu)和(he)摘要(yao)后得(de)到(dao)１４０８篇(pian)文獻，閱讀全(quan)文后最(zui)終納入(ru)合格文獻４７１篇(pian)。文獻篩選流程見(jian)圖１。

2.2臨(lin)床研(yan)究(jiu)(jiu)(jiu)基本信(xin)息及年(nian)度(du)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)趨勢(shi)　本研(yan)究(jiu)(jiu)(jiu)共納入４７１篇文(wen)(wen)獻(xian)，包括４７１項臨(lin)床研(yan)究(jiu)(jiu)(jiu)，其(qi)(qi)中隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗３７８項，非隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗４１項，隊(dui)列研(yan)究(jiu)(jiu)(jiu)１項，病(bing)例系列研(yan)究(jiu)(jiu)(jiu)５１項，其(qi)(qi)中隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗為(wei)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)數(shu)(shu)量最(zui)(zui)多的(de)研(yan)究(jiu)(jiu)(jiu)類(lei)型(xing)，其(qi)(qi)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)數(shu)(shu)量遠遠高于(yu)其(qi)(qi)他研(yan)究(jiu)(jiu)(jiu)類(lei)型(xing)。納入文(wen)(wen)獻(xian)的(de)主要(yao)來源為(wei)期(qi)刊論文(wen)(wen)，達４０８篇，其(qi)(qi)次為(wei)學(xue)位論文(wen)(wen)５１篇，會議論文(wen)(wen)１２篇。見圖２。中藥治療ＴＴＨ的(de)臨(lin)床研(yan)究(jiu)(jiu)(jiu)總(zong)(zong)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)數(shu)(shu)量在(zai)總(zong)(zong)體上隨(sui)(sui)時(shi)間(jian)變化(hua)呈(cheng)增長(chang)趨勢(shi)，但呈(cheng)“鋸(ju)齒狀”波(bo)動(dong)，文(wen)(wen)獻(xian)最(zui)(zui)早發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)于(yu)１９８６年(nian)，１９８６—１９９９年(nian)文(wen)(wen)獻(xian)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)數(shu)(shu)量較少，２０１０—２０１６年(nian)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)文(wen)(wen)獻(xian)較多，其(qi)(qi)中２０１６年(nian)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)文(wen)(wen)獻(xian)最(zui)(zui)多，達４５篇。隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗的(de)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)趨勢(shi)與(yu)臨(lin)床研(yan)究(jiu)(jiu)(jiu)文(wen)(wen)獻(xian)總(zong)(zong)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)數(shu)(shu)量大(da)致相同，呈(cheng)波(bo)動(dong)性增長(chang)趨勢(shi)，隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗最(zui)(zui)早發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)于(yu)１９９２年(nian)；非隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗及病(bing)例系列研(yan)究(jiu)(jiu)(jiu)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)數(shu)(shu)量相對(dui)較少，非隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)數(shu)(shu)量較為(wei)平穩；病(bing)例系列研(yan)究(jiu)(jiu)(jiu)隨(sui)(sui)時(shi)間(jian)變化(hua)有(you)小范圍的(de)波(bo)動(dong)，但大(da)致呈(cheng)增長(chang)趨勢(shi)。見圖３。圖３　中藥治療ＴＴＨ的(de)文(wen)(wen)獻(xian)年(nian)度(du)發(fa)(fa)(fa)(fa)表(biao)(biao)(biao)趨勢(shi)　　注：ＲＣＴ為(wei)隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗；ＣＣＴ為(wei)非隨(sui)(sui)機對(dui)照(zhao)(zhao)試(shi)驗；ＣＳ為(wei)病(bing)例系列研(yan)究(jiu)(jiu)(jiu)

2.3納入(ru)(ru)的(de)(de)臨(lin)床研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)方(fang)(fang)(fang)(fang)法(fa)(fa)學質(zhi)量(liang)評(ping)(ping)價(jia)(jia)(jia)(jia)　對(dui)(dui)納入(ru)(ru)的(de)(de)３７８項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)隨(sui)(sui)機(ji)(ji)對(dui)(dui)照(zhao)(zhao)試驗進(jin)行(xing)方(fang)(fang)(fang)(fang)法(fa)(fa)學質(zhi)量(liang)評(ping)(ping)價(jia)(jia)(jia)(jia)：１）在(zai)(zai)(zai)隨(sui)(sui)機(ji)(ji)序列(lie)產(chan)(chan)生(sheng)上(shang)(shang)(shang)，９６項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（２５４０％）評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)低偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險，其(qi)中８４項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)采用隨(sui)(sui)機(ji)(ji)數字(zi)表，９項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)采用計(ji)(ji)算(suan)機(ji)(ji)軟件(jian)產(chan)(chan)生(sheng)隨(sui)(sui)機(ji)(ji)序列(lie)，３項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)使用抽簽法(fa)(fa)；４０項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（１０５８％）評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)高風(feng)(feng)(feng)(feng)(feng)險偏(pian)(pian)(pian)(pian)倚(yi)(yi)，其(qi)中３５項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)采用就(jiu)診順(shun)序，２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)根據(ju)患(huan)(huan)者(zhe)意愿進(jin)行(xing)分(fen)(fen)(fen)(fen)(fen)組(zu)(zu)(zu)，３項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)按照(zhao)(zhao)住(zhu)院號(hao)或(huo)門(men)診號(hao)；２４２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（６４０２％）僅(jin)提(ti)及(ji)(ji)(ji)“隨(sui)(sui)機(ji)(ji)”字(zi)樣，未(wei)(wei)(wei)(wei)(wei)(wei)(wei)具(ju)體描(miao)(miao)(miao)述(shu)隨(sui)(sui)機(ji)(ji)序列(lie)產(chan)(chan)生(sheng)方(fang)(fang)(fang)(fang)法(fa)(fa)，評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險不(bu)明確(que)。２）關于(yu)(yu)分(fen)(fen)(fen)(fen)(fen)配隱藏，３項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（０７９％）按照(zhao)(zhao)住(zhu)院號(hao)或(huo)門(men)診號(hao)分(fen)(fen)(fen)(fen)(fen)組(zu)(zu)(zu)，評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)高風(feng)(feng)(feng)(feng)(feng)險偏(pian)(pian)(pian)(pian)倚(yi)(yi)；３７５項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９９２１％）未(wei)(wei)(wei)(wei)(wei)(wei)(wei)提(ti)及(ji)(ji)(ji)分(fen)(fen)(fen)(fen)(fen)配隱藏，評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險不(bu)明確(que)。３）關于(yu)(yu)盲法(fa)(fa)，所(suo)有(you)(you)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)均(jun)(jun)(jun)評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險不(bu)明確(que)，其(qi)中１５項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)僅(jin)提(ti)及(ji)(ji)(ji)“盲法(fa)(fa)”字(zi)樣，未(wei)(wei)(wei)(wei)(wei)(wei)(wei)具(ju)體描(miao)(miao)(miao)述(shu)實(shi)(shi)施(shi)方(fang)(fang)(fang)(fang)式；３７６項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)均(jun)(jun)(jun)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)提(ti)及(ji)(ji)(ji)盲法(fa)(fa)。４）關于(yu)(yu)數據(ju)完(wan)整性(xing)，３３項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（８７３％）評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)低偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險，其(qi)中１５項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)無失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)病(bing)例(li)，１８項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)了(le)(le)(le)病(bing)例(li)失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)情(qing)(qing)(qing)況(kuang)及(ji)(ji)(ji)失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)原因；其(qi)余(yu)３４５項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９１２７％）未(wei)(wei)(wei)(wei)(wei)(wei)(wei)具(ju)體報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)病(bing)例(li)失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)脫落情(qing)(qing)(qing)況(kuang)，評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險不(bu)明確(que)。５）在(zai)(zai)(zai)選擇性(xing)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)結(jie)(jie)(jie)果上(shang)(shang)(shang)，９２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（２４３４％）未(wei)(wei)(wei)(wei)(wei)(wei)(wei)在(zai)(zai)(zai)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)結(jie)(jie)(jie)果中報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)方(fang)(fang)(fang)(fang)法(fa)(fa)中列(lie)出的(de)(de)結(jie)(jie)(jie)局(ju)(ju)(ju)評(ping)(ping)價(jia)(jia)(jia)(jia)指(zhi)標(biao)，評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)高風(feng)(feng)(feng)(feng)(feng)險偏(pian)(pian)(pian)(pian)倚(yi)(yi)；因所(suo)有(you)(you)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)均(jun)(jun)(jun)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)進(jin)行(xing)臨(lin)床研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)方(fang)(fang)(fang)(fang)案注冊，余(yu)２８６項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)臨(lin)床研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（７５６６％）均(jun)(jun)(jun)評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險不(bu)明確(que)。其(qi)他(ta)偏(pian)(pian)(pian)(pian)倚(yi)(yi)來源不(bu)清(qing)楚，評(ping)(ping)價(jia)(jia)(jia)(jia)為(wei)(wei)(wei)(wei)(wei)偏(pian)(pian)(pian)(pian)倚(yi)(yi)風(feng)(feng)(feng)(feng)(feng)險不(bu)明確(que)。見(jian)圖４。　在(zai)(zai)(zai)納入(ru)(ru)的(de)(de)４１項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)非隨(sui)(sui)機(ji)(ji)對(dui)(dui)照(zhao)(zhao)試驗中，所(suo)有(you)(you)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)均(jun)(jun)(jun)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)對(dui)(dui)納入(ru)(ru)患(huan)(huan)者(zhe)的(de)(de)連貫(guan)性(xing)、終點指(zhi)標(biao)客觀(guan)(guan)性(xing)、預(yu)期數據(ju)的(de)(de)收(shou)集、樣本(ben)量(liang)估算(suan)進(jin)行(xing)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)。１）對(dui)(dui)于(yu)(yu)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)目的(de)(de)，２６項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（６３４１％）報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)較為(wei)(wei)(wei)(wei)(wei)充分(fen)(fen)(fen)(fen)(fen)；２）關于(yu)(yu)終點指(zhi)標(biao)的(de)(de)選擇，１７項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（４１４６％）報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)的(de)(de)結(jie)(jie)(jie)局(ju)(ju)(ju)指(zhi)標(biao)較能恰當(dang)地(di)反映(ying)結(jie)(jie)(jie)局(ju)(ju)(ju)指(zhi)標(biao)；３）對(dui)(dui)于(yu)(yu)隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)時(shi)間(jian)，４項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９７６％）在(zai)(zai)(zai)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)方(fang)(fang)(fang)(fang)法(fa)(fa)中報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)時(shi)間(jian)，但未(wei)(wei)(wei)(wei)(wei)(wei)(wei)給出隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)時(shi)的(de)(de)數據(ju)，余(yu)３７項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９０２４％）均(jun)(jun)(jun)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)情(qing)(qing)(qing)況(kuang)；４）在(zai)(zai)(zai)失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)率(lv)上(shang)(shang)(shang)，１項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（２４４％）失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)率(lv)低于(yu)(yu)５％，余(yu)４０項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９７５６％）均(jun)(jun)(jun)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)情(qing)(qing)(qing)況(kuang)；５）在(zai)(zai)(zai)觀(guan)(guan)察(cha)組(zu)(zu)(zu)與對(dui)(dui)照(zhao)(zhao)組(zu)(zu)(zu)是(shi)否同步(bu)的(de)(de)評(ping)(ping)價(jia)(jia)(jia)(jia)上(shang)(shang)(shang)，２９項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（７０７３％）的(de)(de)２組(zu)(zu)(zu)是(shi)同期進(jin)行(xing)的(de)(de)，１２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（２９２７％）未(wei)(wei)(wei)(wei)(wei)(wei)(wei)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)該條(tiao)目；６）對(dui)(dui)于(yu)(yu)組(zu)(zu)(zu)間(jian)基(ji)(ji)線，３２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（７８０５％）報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)對(dui)(dui)照(zhao)(zhao)組(zu)(zu)(zu)和(he)觀(guan)(guan)察(cha)組(zu)(zu)(zu)基(ji)(ji)線可(ke)(ke)比，９項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（２１９５％）未(wei)(wei)(wei)(wei)(wei)(wei)(wei)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)；７）在(zai)(zai)(zai)統計(ji)(ji)分(fen)(fen)(fen)(fen)(fen)析(xi)上(shang)(shang)(shang)，２３項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（５６１０％）根據(ju)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)類型進(jin)行(xing)正(zheng)確(que)的(de)(de)統計(ji)(ji)分(fen)(fen)(fen)(fen)(fen)析(xi)，１８項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（４３９０％）對(dui)(dui)統計(ji)(ji)分(fen)(fen)(fen)(fen)(fen)析(xi)方(fang)(fang)(fang)(fang)法(fa)(fa)的(de)(de)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)不(bu)充分(fen)(fen)(fen)(fen)(fen)。見(jian)圖５。本(ben)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)僅(jin)納入(ru)(ru)１項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)隊列(lie)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)［１４］，在(zai)(zai)(zai)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)人(ren)群的(de)(de)選擇上(shang)(shang)(shang)，受(shou)試者(zhe)均(jun)(jun)(jun)來源于(yu)(yu)門(men)診病(bing)例(li)，暴露(lu)因素的(de)(de)確(que)定(ding)方(fang)(fang)(fang)(fang)法(fa)(fa)采用固定(ding)的(de)(de)檔(dang)案記錄，研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)開始前(qian)尚(shang)無預(yu)期事件(jian)發生(sheng)；研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)在(zai)(zai)(zai)設計(ji)(ji)和(he)統計(ji)(ji)分(fen)(fen)(fen)(fen)(fen)析(xi)時(shi)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)考慮２組(zu)(zu)(zu)間(jian)的(de)(de)可(ke)(ke)比性(xing)；對(dui)(dui)于(yu)(yu)結(jie)(jie)(jie)果測(ce)(ce)量(liang)，研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)者(zhe)在(zai)(zai)(zai)評(ping)(ping)價(jia)(jia)(jia)(jia)前(qian)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)規定(ding)隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)時(shi)間(jian)，未(wei)(wei)(wei)(wei)(wei)(wei)(wei)具(ju)體描(miao)(miao)(miao)述(shu)受(shou)試者(zhe)的(de)(de)失(shi)(shi)訪(fang)(fang)(fang)(fang)(fang)(fang)情(qing)(qing)(qing)況(kuang)。最終評(ping)(ping)價(jia)(jia)(jia)(jia)結(jie)(jie)(jie)果為(wei)(wei)(wei)(wei)(wei)３顆☆，質(zhi)量(liang)較低。對(dui)(dui)納入(ru)(ru)５１項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)病(bing)例(li)系列(lie)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)進(jin)行(xing)方(fang)(fang)(fang)(fang)法(fa)(fa)學質(zhi)量(liang)評(ping)(ping)價(jia)(jia)(jia)(jia)：１）對(dui)(dui)于(yu)(yu)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)目的(de)(de)，２７項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（５２９４％）報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)清(qing)楚；２）對(dui)(dui)于(yu)(yu)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)類型，２５項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（４９０２％）有(you)(you)計(ji)(ji)劃前(qian)瞻(zhan)性(xing)地(di)收(shou)集病(bing)例(li)，僅(jin)有(you)(you)１項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（１９６％）為(wei)(wei)(wei)(wei)(wei)多中心病(bing)例(li)收(shou)集，１項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（１９６％）連續性(xing)納入(ru)(ru)患(huan)(huan)者(zhe)；３）在(zai)(zai)(zai)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)人(ren)群的(de)(de)選擇上(shang)(shang)(shang)，４９項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９６０８％）較為(wei)(wei)(wei)(wei)(wei)清(qing)楚地(di)描(miao)(miao)(miao)述(shu)了(le)(le)(le)患(huan)(huan)者(zhe)的(de)(de)特(te)點，１２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（２３５３％）明確(que)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)了(le)(le)(le)納入(ru)(ru)與排除標(biao)準，僅(jin)有(you)(you)２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（３９２％）對(dui)(dui)納入(ru)(ru)患(huan)(huan)者(zhe)的(de)(de)病(bing)情(qing)(qing)(qing)進(jin)行(xing)闡述(shu)；４）在(zai)(zai)(zai)干預(yu)措施(shi)上(shang)(shang)(shang)，５０項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９８０４％）較為(wei)(wei)(wei)(wei)(wei)清(qing)楚地(di)描(miao)(miao)(miao)述(shu)了(le)(le)(le)干預(yu)措施(shi)，８項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（１５６９％）描(miao)(miao)(miao)述(shu)了(le)(le)(le)聯合(he)(he)干預(yu)措施(shi)；５）對(dui)(dui)于(yu)(yu)結(jie)(jie)(jie)局(ju)(ju)(ju)測(ce)(ce)量(liang)，３９項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（７６４７％）事先確(que)定(ding)結(jie)(jie)(jie)局(ju)(ju)(ju)指(zhi)標(biao)及(ji)(ji)(ji)標(biao)準，２０項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（３９２２％）較為(wei)(wei)(wei)(wei)(wei)合(he)(he)理地(di)測(ce)(ce)量(liang)了(le)(le)(le)結(jie)(jie)(jie)局(ju)(ju)(ju)指(zhi)標(biao)，１９項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（３７２５％）在(zai)(zai)(zai)干預(yu)前(qian)后測(ce)(ce)量(liang)了(le)(le)(le)結(jie)(jie)(jie)局(ju)(ju)(ju)指(zhi)標(biao)，所(suo)有(you)(you)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)均(jun)(jun)(jun)未(wei)(wei)(wei)(wei)(wei)(wei)(wei)報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)對(dui)(dui)結(jie)(jie)(jie)局(ju)(ju)(ju)評(ping)(ping)價(jia)(jia)(jia)(jia)人(ren)員實(shi)(shi)施(shi)盲法(fa)(fa)情(qing)(qing)(qing)況(kuang)；６）在(zai)(zai)(zai)統計(ji)(ji)學檢驗應用上(shang)(shang)(shang)，僅(jin)１６項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（３１３７％）較為(wei)(wei)(wei)(wei)(wei)詳細地(di)描(miao)(miao)(miao)述(shu)了(le)(le)(le)統計(ji)(ji)學檢驗且應用合(he)(he)理；７）在(zai)(zai)(zai)結(jie)(jie)(jie)果與結(jie)(jie)(jie)論上(shang)(shang)(shang)，只有(you)(you)５項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（９８０％）描(miao)(miao)(miao)述(shu)了(le)(le)(le)隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)時(shi)間(jian)及(ji)(ji)(ji)隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)數據(ju)，２項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（３９２％）報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)了(le)(le)(le)隨(sui)(sui)訪(fang)(fang)(fang)(fang)(fang)(fang)情(qing)(qing)(qing)況(kuang)，９項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（１７６５％）報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)了(le)(le)(le)不(bu)良事件(jian)發生(sheng)；８）對(dui)(dui)于(yu)(yu)利(li)益(yi)沖(chong)突(tu)和(he)資(zi)金來源，只有(you)(you)１項(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)(xiang)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)(jiu)（１９６％）報(bao)(bao)(bao)(bao)告(gao)(gao)(gao)(gao)(gao)了(le)(le)(le)利(li)益(yi)沖(chong)突(tu)和(he)資(zi)金來源。見(jian)圖６。

2.4研(yan)(yan)(yan)究人群類型及并(bing)發癥研(yan)(yan)(yan)究　納(na)入(ru)的(de)４７１項(xiang)臨(lin)床研(yan)(yan)(yan)究中，３４０項(xiang)（７２１９％）未區分ＴＴＨ類型，１０８項(xiang)（２２９３％）納(na)入(ru)慢性(xing)(xing)ＴＴＨ，１５項(xiang)（３１８％）納(na)入(ru)頻發性(xing)(xing)ＴＴＨ，８項(xiang)（１７０％）納(na)入(ru)反復發作(zuo)性(xing)(xing)ＴＴＨ患者(zhe)（包(bao)括偶發性(xing)(xing)ＴＴＨ和頻發性(xing)(xing)ＴＴＨ）。見圖(tu)７。　　關于并(bing)發癥的(de)研(yan)(yan)(yan)究較少，有(you)３３項(xiang)為ＴＴＨ并(bing)發癥的(de)臨(lin)床研(yan)(yan)(yan)究。其中ＴＴＨ合(he)并(bing)焦慮抑郁(yu)的(de)研(yan)(yan)(yan)究最(zui)多（１７／３３，５１５２％），其次是ＴＴＨ合(he)并(bing)抑郁(yu)（６／３３，１８１８％）。見圖(tu)８。

2.5樣(yang)本(ben)(ben)量(liang)分(fen)布情況　４７１篇(pian)(pian)文獻有４７０篇(pian)(pian)文獻報(bao)(bao)告(gao)了樣(yang)本(ben)(ben)量(liang)，１篇(pian)(pian)未報(bao)(bao)告(gao)樣(yang)本(ben)(ben)量(liang)。在隨機對照試驗(yan)中，樣(yang)本(ben)(ben)量(liang)為(wei)５１～１００例(li)(li)的臨床研(yan)究所(suo)占比(bi)例(li)(li)最(zui)多(duo)（２４２／３７７，６４１９％）；在非隨機對照試驗(yan)中，受(shou)試者樣(yang)本(ben)(ben)量(liang)多(duo)為(wei)５１～１００例(li)(li)（２１／４１，５１２２％）；在病例(li)(li)系列(lie)研(yan)究中，樣(yang)本(ben)(ben)量(liang)≤５０例(li)(li)占比(bi)例(li)(li)最(zui)多(duo)（２８／５１，５４９０％）。見表１，圖９。

2.6中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)干預類(lei)型(xing)(xing)分(fen)布　中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)干預類(lei)型(xing)(xing)包括中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)和(he)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)湯(tang)(tang)(tang)(tang)劑(ji)(ji)(ji)兩大類(lei)別(bie)，中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)研究(jiu)(jiu)２０７項，中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)湯(tang)(tang)(tang)(tang)劑(ji)(ji)(ji)研究(jiu)(jiu)２６４項。在(zai)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)湯(tang)(tang)(tang)(tang)劑(ji)(ji)(ji)研究(jiu)(jiu)中(zhong)(zhong)(zhong)(zhong)(zhong)，中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)湯(tang)(tang)(tang)(tang)劑(ji)(ji)(ji)單用研究(jiu)(jiu)最多(duo)（１５３／４７１，３２４８％），其(qi)(qi)次(ci)(ci)(ci)為中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)湯(tang)(tang)(tang)(tang)劑(ji)(ji)(ji)聯(lian)合(he)西藥(yao)(yao)(yao)(yao)（５２／４７１，１１０４％）。本研究(jiu)(jiu)共(gong)納入１９５個中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)湯(tang)(tang)(tang)(tang)劑(ji)(ji)(ji)，其(qi)(qi)中(zhong)(zhong)(zhong)(zhong)(zhong)半夏白術天(tian)麻(ma)湯(tang)(tang)(tang)(tang)、柴(chai)胡疏肝散、歸脾湯(tang)(tang)(tang)(tang)、柔筋方(fang)、丹梔逍遙散研究(jiu)(jiu)較(jiao)多(duo)。在(zai)中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)研究(jiu)(jiu)中(zhong)(zhong)(zhong)(zhong)(zhong)，中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)聯(lian)合(he)西藥(yao)(yao)(yao)(yao)研究(jiu)(jiu)最多(duo)（９７／４７１，２０５９％），其(qi)(qi)次(ci)(ci)(ci)為中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)單用（７３／４７１，１５５０％）。本研究(jiu)(jiu)共(gong)納入５９個中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)，出現頻(pin)次(ci)(ci)(ci)≥６次(ci)(ci)(ci)的中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)從高到低依次(ci)(ci)(ci)為養血(xue)清腦顆粒、頭痛(tong)寧膠(jiao)(jiao)囊(nang)(nang)、丹珍頭痛(tong)膠(jiao)(jiao)囊(nang)(nang)、烏靈膠(jiao)(jiao)囊(nang)(nang)、天(tian)舒膠(jiao)(jiao)囊(nang)(nang)、天(tian)麻(ma)素(su)注射液、正天(tian)丸、逍遙丸、二十五味(wei)珊瑚丸、都梁(liang)軟膠(jiao)(jiao)囊(nang)(nang)。中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)干預類(lei)型(xing)(xing)分(fen)布見圖(tu)１０。常見中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)及中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)湯(tang)(tang)(tang)(tang)劑(ji)(ji)(ji)（頻(pin)次(ci)(ci)(ci)≥３次(ci)(ci)(ci)）分(fen)布見圖(tu)１１。

2.7中(zhong)(zhong)(zhong)藥(yao)(yao)治(zhi)療(liao)(liao)方案療(liao)(liao)效(xiao)(xiao)評(ping)(ping)(ping)價　中(zhong)(zhong)(zhong)藥(yao)(yao)治(zhi)療(liao)(liao)ＴＴＨ的(de)(de)結(jie)局指(zhi)(zhi)標(biao)(biao)(biao)評(ping)(ping)(ping)價主要包(bao)括以(yi)下幾個類(lei)別(bie)。１）癥狀(zhuang)(zhuang)體(ti)征：頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)特征如頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)程度、疼(teng)痛(tong)(tong)(tong)(tong)(tong)(tong)目測(ce)(ce)類(lei)比視覺模擬評(ping)(ping)(ping)分(fen)(fen)(fen)法（ＶｉｓｕａｌＡｎａｌｏｇｕｅＳｃａｌｅ，ＶＡＳ）評(ping)(ping)(ping)分(fen)(fen)(fen)、疼(teng)痛(tong)(tong)(tong)(tong)(tong)(tong)數(shu)(shu)字(zi)評(ping)(ping)(ping)分(fen)(fen)(fen)法（ＮｕｍｅｒｉｃａｌＲａｔｉｎｇＳｃａｌｅ，ＮＲＳ）評(ping)(ping)(ping)分(fen)(fen)(fen)、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)持(chi)續時(shi)(shi)間、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)發(fa)(fa)作次(ci)(ci)(ci)數(shu)(shu)、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)指(zhi)(zhi)數(shu)(shu)、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)積(ji)分(fen)(fen)(fen)、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)天數(shu)(shu)、急性(xing)止痛(tong)(tong)(tong)(tong)(tong)(tong)藥(yao)(yao)使用(yong)天數(shu)(shu)；精神與行(xing)為癥狀(zhuang)(zhuang)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)如匹茲堡(bao)睡眠(mian)質(zhi)量(liang)(liang)(liang)(liang)(liang)指(zhi)(zhi)數(shu)(shu)（ＰｉｔｔｓｂｕｒｇｈＳｌｅｅｐＱｕａｌｉｔｙＩｎｄｅｘ，ＰＳＱＩ）量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)、焦慮(lv)自評(ping)(ping)(ping)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)（ＳｅｌｆｒａｔｉｎｇＡｎｘｉｅｔｙＳｃａｌｅ，ＳＡＳ）、抑(yi)(yi)郁自評(ping)(ping)(ping)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)（ＳｅｌｆｒａｔｉｎｇＤｅｐｒｅｓｓｉｏｎＳｃａｌｅ，ＳＤＳ）、漢(han)密(mi)頓(dun)抑(yi)(yi)郁量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)（ＨａｍｉｌｔｏｎＤｅｐｒｅｓｓｉｏｎＳｃａｌｅ，ＨＡＭＤ）、漢(han)密(mi)頓(dun)焦慮(lv)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)（ＨａｍｉｌｔｏｎＡｎｘｉｅｔｙＳｃａｌｅ，ＨＡＭＡ）；伴隨癥狀(zhuang)(zhuang)如顱周肌肉(rou)壓痛(tong)(tong)(tong)(tong)(tong)(tong)、煩躁易怒、失眠(mian)；總有(you)效(xiao)(xiao)率(lv)(lv)。２）生命(ming)質(zhi)量(liang)(liang)(liang)(liang)(liang)：生命(ming)質(zhi)量(liang)(liang)(liang)(liang)(liang)測(ce)(ce)定(ding)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)（ＷＨＯＱＯＬ）、癥狀(zhuang)(zhuang)自評(ping)(ping)(ping)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)（ＳＣＬ９０）、健康調查(cha)表(biao)(biao)(biao)（ＳＦ３６）、生命(ming)質(zhi)量(liang)(liang)(liang)(liang)(liang)核心量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)（ＱＬＱＣ３０）、偏頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)特異性(xing)生命(ming)質(zhi)量(liang)(liang)(liang)(liang)(liang)問卷（ＭｉｇｒａｉｎｅＳｐｅｃｉｆｉｃＱｕａｌｉｔｙｏｆＬｉｆｅＱｕｅｓｔｉｏｎｎａｉｒｅ，ＭＳＱ量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)）、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)影響測(ce)(ce)驗（ＨｅａｄａｃｈｅＩｍｐａｃｔＴｅｓｔ，ＨＩＴ）、疼(teng)痛(tong)(tong)(tong)(tong)(tong)(tong)行(xing)為評(ping)(ping)(ping)估量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)。３）中(zhong)(zhong)(zhong)醫(yi)病證(zheng)(zheng)：中(zhong)(zhong)(zhong)醫(yi)證(zheng)(zheng)候積(ji)分(fen)(fen)(fen)、中(zhong)(zhong)(zhong)醫(yi)證(zheng)(zheng)候療(liao)(liao)效(xiao)(xiao)。４）安(an)全(quan)性(xing)事件：實驗室安(an)全(quan)性(xing)指(zhi)(zhi)標(biao)(biao)(biao)（如血(xue)(xue)(xue)常(chang)規、尿(niao)常(chang)規、便(bian)常(chang)規、肝腎功、心電圖(tu)）、不(bu)良反應、不(bu)良事件。５）理(li)化檢查(cha)：經(jing)顱多普勒超(chao)聲（ＴｒａｎｓｃｒａｎｉａｌＤｏｐｐｌｅｒ，ＴＣＤ）、血(xue)(xue)(xue)液流變學(xue)(xue)指(zhi)(zhi)標(biao)(biao)(biao)（如血(xue)(xue)(xue)漿５羥(qian)色胺水(shui)平(ping)、血(xue)(xue)(xue)漿甲硫腦啡膚測(ce)(ce)定(ding)、血(xue)(xue)(xue)漿一氧化氮水(shui)平(ping)、血(xue)(xue)(xue)清鉀離子等電解(jie)質(zhi)水(shui)平(ping)度、血(xue)(xue)(xue)小板聚集(ji)率(lv)(lv)、紅(hong)細(xi)胞聚集(ji)指(zhi)(zhi)數(shu)(shu)等）、肌電圖(tu)檢查(cha)。６）經(jing)濟學(xue)(xue)評(ping)(ping)(ping)估：治(zhi)療(liao)(liao)費用(yong)、成(cheng)本效(xiao)(xiao)果比值。７）遠(yuan)期(qi)預(yu)后(hou)(hou)：復發(fa)(fa)率(lv)(lv)。常(chang)見(jian)(jian)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)和中(zhong)(zhong)(zhong)藥(yao)(yao)湯劑(ji)(ji)(ji)（出現頻次(ci)(ci)(ci)≥３次(ci)(ci)(ci)）的(de)(de)療(liao)(liao)效(xiao)(xiao)證(zheng)(zheng)據(ju)評(ping)(ping)(ping)價情況見(jian)(jian)圖(tu)１２～１３。由氣(qi)泡圖(tu)可(ke)以(yi)看出，常(chang)見(jian)(jian)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)治(zhi)療(liao)(liao)ＴＴＨ的(de)(de)臨(lin)床研究(jiu)(jiu)(jiu)對(dui)(dui)總有(you)效(xiao)(xiao)率(lv)(lv)、安(an)全(quan)性(xing)事件、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)持(chi)續時(shi)(shi)間、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)發(fa)(fa)作次(ci)(ci)(ci)數(shu)(shu)、焦慮(lv)抑(yi)(yi)郁癥狀(zhuang)(zhuang)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)、ＶＡＳ評(ping)(ping)(ping)分(fen)(fen)(fen)、ＮＲＳ評(ping)(ping)(ping)分(fen)(fen)(fen)關注(zhu)(zhu)較(jiao)多，對(dui)(dui)生命(ming)質(zhi)量(liang)(liang)(liang)(liang)(liang)、遠(yuan)期(qi)預(yu)后(hou)(hou)、經(jing)濟學(xue)(xue)指(zhi)(zhi)標(biao)(biao)(biao)的(de)(de)關注(zhu)(zhu)相對(dui)(dui)較(jiao)少；在常(chang)見(jian)(jian)中(zhong)(zhong)(zhong)藥(yao)(yao)湯劑(ji)(ji)(ji)治(zhi)療(liao)(liao)ＴＴＨ的(de)(de)臨(lin)床研究(jiu)(jiu)(jiu)中(zhong)(zhong)(zhong)，總有(you)效(xiao)(xiao)率(lv)(lv)、安(an)全(quan)性(xing)事件、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)指(zhi)(zhi)數(shu)(shu)、焦慮(lv)抑(yi)(yi)郁癥狀(zhuang)(zhuang)量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)持(chi)續時(shi)(shi)間、中(zhong)(zhong)(zhong)醫(yi)病證(zheng)(zheng)、ＶＡＳ評(ping)(ping)(ping)分(fen)(fen)(fen)關注(zhu)(zhu)較(jiao)多，遠(yuan)期(qi)預(yu)后(hou)(hou)、經(jing)濟學(xue)(xue)指(zhi)(zhi)標(biao)(biao)(biao)關注(zhu)(zhu)相對(dui)(dui)較(jiao)少，二(er)者均對(dui)(dui)總有(you)效(xiao)(xiao)率(lv)(lv)、安(an)全(quan)性(xing)事件、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)持(chi)續時(shi)(shi)間、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)強度、頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)發(fa)(fa)作頻率(lv)(lv)、焦慮(lv)抑(yi)(yi)郁量(liang)(liang)(liang)(liang)(liang)表(biao)(biao)(biao)的(de)(de)頭(tou)(tou)(tou)(tou)(tou)(tou)(tou)痛(tong)(tong)(tong)(tong)(tong)(tong)特征指(zhi)(zhi)標(biao)(biao)(biao)關注(zhu)(zhu)度較(jiao)高，對(dui)(dui)經(jing)濟學(xue)(xue)指(zhi)(zhi)標(biao)(biao)(biao)、遠(yuan)期(qi)預(yu)后(hou)(hou)的(de)(de)關注(zhu)(zhu)較(jiao)少。圖(tu)１２　中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)治(zhi)療(liao)(liao)ＴＴＨ臨(lin)床研究(jiu)(jiu)(jiu)證(zheng)(zheng)據(ju)分(fen)(fen)(fen)布(bu)　　注(zhu)(zhu)：橫坐(zuo)(zuo)標(biao)(biao)(biao)表(biao)(biao)(biao)示臨(lin)床研究(jiu)(jiu)(jiu)結(jie)局指(zhi)(zhi)標(biao)(biao)(biao)，縱(zong)坐(zuo)(zuo)標(biao)(biao)(biao)表(biao)(biao)(biao)示中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)名稱，圓(yuan)圈(quan)大小表(biao)(biao)(biao)示評(ping)(ping)(ping)價該中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)結(jie)局指(zhi)(zhi)標(biao)(biao)(biao)療(liao)(liao)效(xiao)(xiao)的(de)(de)文(wen)獻(xian)數(shu)(shu)量(liang)(liang)(liang)(liang)(liang)圖(tu)１３　中(zhong)(zhong)(zhong)藥(yao)(yao)湯劑(ji)(ji)(ji)治(zhi)療(liao)(liao)ＴＴＨ臨(lin)床研究(jiu)(jiu)(jiu)證(zheng)(zheng)據(ju)分(fen)(fen)(fen)布(bu)　　注(zhu)(zhu)：橫坐(zuo)(zuo)標(biao)(biao)(biao)表(biao)(biao)(biao)示臨(lin)床研究(jiu)(jiu)(jiu)結(jie)局指(zhi)(zhi)標(biao)(biao)(biao)，縱(zong)坐(zuo)(zuo)標(biao)(biao)(biao)表(biao)(biao)(biao)示中(zhong)(zhong)(zhong)藥(yao)(yao)湯劑(ji)(ji)(ji)名稱，圓(yuan)圈(quan)大小表(biao)(biao)(biao)示評(ping)(ping)(ping)價該中(zhong)(zhong)(zhong)藥(yao)(yao)湯劑(ji)(ji)(ji)結(jie)局指(zhi)(zhi)標(biao)(biao)(biao)療(liao)(liao)效(xiao)(xiao)的(de)(de)文(wen)獻(xian)數(shu)(shu)量(liang)(liang)(liang)(liang)(liang)

2.8療(liao)程(cheng)分(fen)布情況　納入４７１項臨床研究(jiu)中(zhong)，明確報告研究(jiu)療(liao)程(cheng)的(de)(de)有４３７項。氣泡圖(tu)和百分(fen)條圖(tu)顯示(shi)隨(sui)(sui)機(ji)對照試驗、非隨(sui)(sui)機(ji)對照試驗和病(bing)例系列(lie)研究(jiu)的(de)(de)療(liao)程(cheng)均(jun)以１５～３０ｄ為主，其(qi)次(ci)是５～１４ｄ，在所有報告療(liao)程(cheng)的(de)(de)臨床研究(jiu)中(zhong)，療(liao)程(cheng)最短的(de)(de)為５ｄ，最長的(de)(de)為９０ｄ。具體見(jian)圖(tu)１４～１５。

3.討論

本研究(jiu)(jiu)(jiu)應用證據圖方法呈(cheng)現中(zhong)藥(yao)(yao)治(zhi)療(liao)(liao)ＴＴＨ的臨(lin)床研究(jiu)(jiu)(jiu)文獻發(fa)表質量(liang)與數量(liang)、研究(jiu)(jiu)(jiu)人(ren)群(qun)類型(xing)及并發(fa)癥研究(jiu)(jiu)(jiu)情況(kuang)、樣本量(liang)分布、中(zhong)藥(yao)(yao)干預類型(xing)、結局(ju)指標評(ping)價及療(liao)(liao)程分布情況(kuang)，展現了中(zhong)藥(yao)(yao)治(zhi)療(liao)(liao)ＴＴＨ領域的研究(jiu)(jiu)(jiu)概況(kuang)。下文分別(bie)從中(zhong)藥(yao)(yao)治(zhi)療(liao)(liao)ＴＴＨ的臨(lin)床研究(jiu)(jiu)(jiu)文獻質量(liang)評(ping)價結果(guo)、中(zhong)藥(yao)(yao)干預類型(xing)、結局(ju)指標評(ping)價及療(liao)(liao)程分布結果(guo)進(jin)行討論(lun)，以期為(wei)未(wei)來研究(jiu)(jiu)(jiu)的開展提供借鑒。

3.1納(na)入研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)文(wen)獻質(zhi)(zhi)量(liang)(liang)(liang)評價(jia)　中(zhong)(zhong)藥(yao)治療ＴＴＨ的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)臨(lin)床研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)質(zhi)(zhi)量(liang)(liang)(liang)較(jiao)低，主(zhu)(zhu)要(yao)表現在以(yi)(yi)下幾個(ge)方(fang)面：１）隨(sui)(sui)(sui)機(ji)(ji)分配的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)誤用。正(zheng)確(que)(que)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)隨(sui)(sui)(sui)機(ji)(ji)分配方(fang)法(fa)(fa)(fa)(fa)可以(yi)(yi)保證組間(jian)(jian)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)均(jun)衡性(xing)，是(shi)臨(lin)床試(shi)驗(yan)設(she)計(ji)(ji)(ji)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)關(guan)鍵［１５］。本(ben)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)納(na)入的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)隨(sui)(sui)(sui)機(ji)(ji)對(dui)(dui)照試(shi)驗(yan)絕大(da)多(duo)數(shu)對(dui)(dui)隨(sui)(sui)(sui)機(ji)(ji)分配方(fang)法(fa)(fa)(fa)(fa)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)使(shi)(shi)用不當(dang)，６４０２％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)僅(jin)提(ti)及(ji)隨(sui)(sui)(sui)機(ji)(ji)未(wei)(wei)(wei)(wei)(wei)具體(ti)描述隨(sui)(sui)(sui)機(ji)(ji)序(xu)列產(chan)生(sheng)方(fang)法(fa)(fa)(fa)(fa)，２５４０％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)隨(sui)(sui)(sui)機(ji)(ji)對(dui)(dui)照試(shi)驗(yan)使(shi)(shi)用了錯(cuo)誤的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)方(fang)法(fa)(fa)(fa)(fa)產(chan)生(sheng)隨(sui)(sui)(sui)機(ji)(ji)序(xu)列，９９２１％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)未(wei)(wei)(wei)(wei)(wei)提(ti)及(ji)隨(sui)(sui)(sui)機(ji)(ji)分配隱藏(zang)，０７９％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)使(shi)(shi)用錯(cuo)誤的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)方(fang)法(fa)(fa)(fa)(fa)進(jin)(jin)行(xing)分配隱藏(zang)，以(yi)(yi)上均(jun)導致一(yi)(yi)定(ding)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)選擇偏(pian)倚。２）盲(mang)法(fa)(fa)(fa)(fa)使(shi)(shi)用不當(dang)。盲(mang)法(fa)(fa)(fa)(fa)可以(yi)(yi)一(yi)(yi)定(ding)程度上避免(mian)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)者(zhe)及(ji)受試(shi)者(zhe)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)主(zhu)(zhu)觀影(ying)響(xiang)，所(suo)有的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)均(jun)未(wei)(wei)(wei)(wei)(wei)具體(ti)描述對(dui)(dui)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)者(zhe)和(he)(he)患者(zhe)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)盲(mang)法(fa)(fa)(fa)(fa)實(shi)施情況(kuang)(kuang)，在頭(tou)痛特征、中(zhong)(zhong)醫病證、生(sheng)命質(zhi)(zhi)量(liang)(liang)(liang)等主(zhu)(zhu)觀性(xing)結(jie)(jie)(jie)局指(zhi)標評價(jia)上均(jun)未(wei)(wei)(wei)(wei)(wei)使(shi)(shi)用盲(mang)法(fa)(fa)(fa)(fa)，可能會(hui)存在夸大(da)干(gan)預(yu)療效(xiao)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)問(wen)題，降低研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)真實(shi)性(xing)［１６］。３）對(dui)(dui)臨(lin)床試(shi)驗(yan)進(jin)(jin)行(xing)方(fang)案注(zhu)冊的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)認識不足。本(ben)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)納(na)入的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)所(suo)有臨(lin)床研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)均(jun)未(wei)(wei)(wei)(wei)(wei)對(dui)(dui)臨(lin)床試(shi)驗(yan)方(fang)案進(jin)(jin)行(xing)注(zhu)冊，可能存在陰性(xing)結(jie)(jie)(jie)果和(he)(he)不明確(que)(que)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)結(jie)(jie)(jie)果未(wei)(wei)(wei)(wei)(wei)報告(gao)(gao)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)情況(kuang)(kuang)，導致一(yi)(yi)定(ding)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)發表偏(pian)倚［１７］。４）缺(que)乏對(dui)(dui)隨(sui)(sui)(sui)訪(fang)(fang)(fang)數(shu)據的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)報告(gao)(gao)。在納(na)入的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)，僅(jin)有７６４％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)臨(lin)床研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)清楚(chu)地報告(gao)(gao)了隨(sui)(sui)(sui)訪(fang)(fang)(fang)時間(jian)(jian)及(ji)數(shu)據，１２１０％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)僅(jin)在研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)方(fang)法(fa)(fa)(fa)(fa)中(zhong)(zhong)提(ti)及(ji)隨(sui)(sui)(sui)機(ji)(ji)時間(jian)(jian)，未(wei)(wei)(wei)(wei)(wei)在結(jie)(jie)(jie)果中(zhong)(zhong)報告(gao)(gao)隨(sui)(sui)(sui)訪(fang)(fang)(fang)數(shu)據，而大(da)部分臨(lin)床研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)未(wei)(wei)(wei)(wei)(wei)設(she)計(ji)(ji)(ji)隨(sui)(sui)(sui)訪(fang)(fang)(fang)，無(wu)法(fa)(fa)(fa)(fa)證實(shi)中(zhong)(zhong)藥(yao)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)遠期療效(xiao)。５）對(dui)(dui)失(shi)(shi)(shi)訪(fang)(fang)(fang)和(he)(he)脫(tuo)落情況(kuang)(kuang)報告(gao)(gao)不足。由于(yu)受試(shi)者(zhe)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)失(shi)(shi)(shi)訪(fang)(fang)(fang)脫(tuo)落造成的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)數(shu)據缺(que)失(shi)(shi)(shi)可能對(dui)(dui)試(shi)驗(yan)結(jie)(jie)(jie)果的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)可信度產(chan)生(sheng)一(yi)(yi)定(ding)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)影(ying)響(xiang)［１８］。在本(ben)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)，僅(jin)有４０３％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)對(dui)(dui)失(shi)(shi)(shi)訪(fang)(fang)(fang)和(he)(he)脫(tuo)落的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)病例進(jin)(jin)行(xing)了詳細的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)報告(gao)(gao)，但是(shi)未(wei)(wei)(wei)(wei)(wei)對(dui)(dui)缺(que)失(shi)(shi)(shi)數(shu)據進(jin)(jin)行(xing)處(chu)理(li)；４４６％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)對(dui)(dui)失(shi)(shi)(shi)訪(fang)(fang)(fang)病例的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)原因(yin)報告(gao)(gao)不充分；８８１％的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)臨(lin)床研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)未(wei)(wei)(wei)(wei)(wei)描述失(shi)(shi)(shi)訪(fang)(fang)(fang)脫(tuo)落情況(kuang)(kuang)。６）樣(yang)本(ben)量(liang)(liang)(liang)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)估(gu)算。樣(yang)本(ben)量(liang)(liang)(liang)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)設(she)計(ji)(ji)(ji)，是(shi)中(zhong)(zhong)醫臨(lin)床研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)必(bi)須考慮的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)關(guan)鍵要(yao)素之一(yi)(yi)［１９］。正(zheng)確(que)(que)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)樣(yang)本(ben)量(liang)(liang)(liang)估(gu)算可以(yi)(yi)提(ti)高(gao)研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)結(jie)(jie)(jie)果的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)準確(que)(que)性(xing)和(he)(he)可重復性(xing)，一(yi)(yi)定(ding)程度地避免(mian)假陽性(xing)或者(zhe)假陰性(xing)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)結(jie)(jie)(jie)果［２０］。在納(na)入的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)４７１項(xiang)(xiang)臨(lin)床研(yan)(yan)(yan)究(jiu)(jiu)(jiu)(jiu)(jiu)中(zhong)(zhong)，僅(jin)有５項(xiang)(xiang)提(ti)及(ji)樣(yang)本(ben)量(liang)(liang)(liang)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)估(gu)算［２１２５］，且(qie)均(jun)來(lai)源(yuan)于(yu)學位論文(wen)，其(qi)中(zhong)(zhong)４項(xiang)(xiang)使(shi)(shi)用了正(zheng)確(que)(que)的(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)(de)計(ji)(ji)(ji)算方(fang)法(fa)(fa)(fa)(fa)［２２２５］。

3.2中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ的(de)(de)(de)干(gan)預類別　中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ的(de)(de)(de)類別中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)，以中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)湯(tang)劑(ji)研(yan)(yan)(yan)究(jiu)(jiu)數(shu)量(liang)最多。本(ben)研(yan)(yan)(yan)究(jiu)(jiu)得到１９５個治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ的(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)湯(tang)劑(ji)，但是單個中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)湯(tang)劑(ji)的(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)數(shu)量(liang)相(xiang)對(dui)較少，并(bing)且由于(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)湯(tang)劑(ji)的(de)(de)(de)特色化差異，進行證(zheng)據整合(he)分(fen)析較為困難，故目(mu)前(qian)尚(shang)無中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)湯(tang)劑(ji)治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ的(de)(de)(de)系統綜述出現，這(zhe)(zhe)也在一定程度(du)限制了中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)湯(tang)劑(ji)的(de)(de)(de)發(fa)展［２６］。中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)也是中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ的(de)(de)(de)重要分(fen)類之(zhi)一，本(ben)研(yan)(yan)(yan)究(jiu)(jiu)得到養血清(qing)腦(nao)顆(ke)粒、頭(tou)(tou)痛(tong)寧(ning)膠(jiao)囊(nang)(nang)是治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ最常用(yong)(yong)(yong)的(de)(de)(de)２種(zhong)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)。養血清(qing)腦(nao)顆(ke)粒，功善養血平肝(gan)，活血通絡(luo)，臨床(chuang)可用(yong)(yong)(yong)于(yu)血虛肝(gan)旺所致頭(tou)(tou)痛(tong)；頭(tou)(tou)痛(tong)寧(ning)膠(jiao)囊(nang)(nang)，功善熄(xi)風滌痰，逐(zhu)瘀(yu)止(zhi)痛(tong)，臨床(chuang)可用(yong)(yong)(yong)于(yu)偏(pian)頭(tou)(tou)痛(tong)，緊張性頭(tou)(tou)痛(tong)屬痰瘀(yu)阻絡(luo)證(zheng)。中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)華中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)學(xue)會(hui)發(fa)布(bu)的(de)(de)(de)最新版指南中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)也推薦(jian)這(zhe)(zhe)２種(zhong)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)用(yong)(yong)(yong)于(yu)治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ［２７］。然而指南中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)對(dui)這(zhe)(zhe)２種(zhong)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)的(de)(de)(de)推薦(jian)強(qiang)度(du)較低(di)（頭(tou)(tou)痛(tong)寧(ning)膠(jiao)囊(nang)(nang)：證(zheng)據級(ji)別Ｃ，弱推薦(jian)。養血清(qing)腦(nao)顆(ke)粒：證(zheng)據級(ji)別Ｄ，弱推薦(jian)），說明中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)治(zhi)(zhi)(zhi)療(liao)(liao)(liao)ＴＴＨ的(de)(de)(de)臨床(chuang)研(yan)(yan)(yan)究(jiu)(jiu)質量(liang)有待提高。中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)西(xi)藥(yao)(yao)(yao)聯用(yong)(yong)(yong)研(yan)(yan)(yan)究(jiu)(jiu)占所有研(yan)(yan)(yan)究(jiu)(jiu)的(de)(de)(de)３１６３％，研(yan)(yan)(yan)究(jiu)(jiu)的(de)(de)(de)重點在于(yu)驗證(zheng)藥(yao)(yao)(yao)物的(de)(de)(de)有效性和安全性問題(ti)［２８］。在本(ben)研(yan)(yan)(yan)究(jiu)(jiu)的(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)西(xi)藥(yao)(yao)(yao)聯用(yong)(yong)(yong)研(yan)(yan)(yan)究(jiu)(jiu)中(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)(zhong)，６４４３％的(de)(de)(de)研(yan)(yan)(yan)究(jiu)(jiu)未報告(gao)安全性事件，忽視了聯合(he)用(yong)(yong)(yong)藥(yao)(yao)(yao)的(de)(de)(de)安全性問題(ti)，將不利(li)于(yu)聯合(he)用(yong)(yong)(yong)藥(yao)(yao)(yao)的(de)(de)(de)應用(yong)(yong)(yong)和推廣。

3.3中(zhong)藥治(zhi)療(liao)(liao)方(fang)案的(de)(de)(de)(de)療(liao)(liao)效(xiao)評價(jia)　本研(yan)究使用氣泡(pao)圖較(jiao)(jiao)(jiao)為(wei)(wei)直觀地(di)呈現(xian)了常見中(zhong)藥治(zhi)療(liao)(liao)ＴＴＨ臨(lin)床(chuang)研(yan)究的(de)(de)(de)(de)療(liao)(liao)效(xiao)證據(ju)分(fen)布，發現(xian)中(zhong)藥治(zhi)療(liao)(liao)ＴＴＨ的(de)(de)(de)(de)臨(lin)床(chuang)研(yan)究對(dui)總有效(xiao)率(lv)、安全(quan)性事(shi)件(jian)關(guan)(guan)(guan)注(zhu)較(jiao)(jiao)(jiao)高，對(dui)經(jing)濟(ji)學指(zhi)(zhi)標及遠期(qi)(qi)預(yu)后(hou)指(zhi)(zhi)標關(guan)(guan)(guan)注(zhu)較(jiao)(jiao)(jiao)低(di)。療(liao)(liao)效(xiao)指(zhi)(zhi)標的(de)(de)(de)(de)使用缺乏規范性。總有效(xiao)率(lv)為(wei)(wei)出現(xian)頻次最多(duo)的(de)(de)(de)(de)結局指(zhi)(zhi)標，該指(zhi)(zhi)標為(wei)(wei)復合指(zhi)(zhi)標，療(liao)(liao)效(xiao)評價(jia)標準為(wei)(wei)自(zi)擬(ni)或者參考其他文獻制定［２９３３］，描述(shu)較(jiao)(jiao)(jiao)為(wei)(wei)籠統且具(ju)有一定的(de)(de)(de)(de)主觀性，這降低(di)了療(liao)(liao)效(xiao)評價(jia)的(de)(de)(de)(de)準確(que)(que)性［３４］。安全(quan)性事(shi)件(jian)的(de)(de)(de)(de)報告不(bu)(bu)(bu)規范，納入(ru)的(de)(de)(de)(de)臨(lin)床(chuang)研(yan)究對(dui)于(yu)不(bu)(bu)(bu)良(liang)反應的(de)(de)(de)(de)報告僅局限于(yu)有和(he)無，而對(dui)不(bu)(bu)(bu)良(liang)反應的(de)(de)(de)(de)發生情(qing)況、處理措施及預(yu)后(hou)關(guan)(guan)(guan)注(zhu)較(jiao)(jiao)(jiao)少，因(yin)此不(bu)(bu)(bu)能提供準確(que)(que)的(de)(de)(de)(de)安全(quan)性證據(ju)［３５］。納入(ru)研(yan)究對(dui)經(jing)濟(ji)學指(zhi)(zhi)標及遠期(qi)(qi)預(yu)后(hou)關(guan)(guan)(guan)注(zhu)度不(bu)(bu)(bu)夠，ＴＴＨ為(wei)(wei)慢(man)性反復發作性疾病，對(dui)社會經(jing)濟(ji)造成較(jiao)(jiao)(jiao)大(da)負擔，但目前的(de)(de)(de)(de)研(yan)究難以(yi)驗證中(zhong)藥治(zhi)療(liao)(liao)ＴＴＨ的(de)(de)(de)(de)社會經(jing)濟(ji)學優勢(shi)和(he)長期(qi)(qi)療(liao)(liao)效(xiao)，未(wei)來還需要更多(duo)相關(guan)(guan)(guan)的(de)(de)(de)(de)臨(lin)床(chuang)研(yan)究進行不(bu)(bu)(bu)斷地(di)探索［３］。

3.4納(na)入研(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)療(liao)程(cheng)(cheng)(cheng)(cheng)分析　納(na)入的(de)(de)(de)(de)４７１篇(pian)文(wen)獻(xian)中(zhong)，３４篇(pian)文(wen)獻(xian)未明確報(bao)告療(liao)程(cheng)(cheng)(cheng)(cheng)，這嚴重降低了(le)(le)研(yan)究(jiu)(jiu)(jiu)結果的(de)(de)(de)(de)可(ke)(ke)(ke)靠性。療(liao)程(cheng)(cheng)(cheng)(cheng)在藥(yao)(yao)(yao)(yao)物治(zhi)療(liao)過(guo)程(cheng)(cheng)(cheng)(cheng)中(zhong)不可(ke)(ke)(ke)或(huo)缺，不可(ke)(ke)(ke)忽(hu)視，療(liao)程(cheng)(cheng)(cheng)(cheng)的(de)(de)(de)(de)長短直接影響藥(yao)(yao)(yao)(yao)物的(de)(de)(de)(de)療(liao)效(xiao)(xiao)(xiao)［３６］。關于(yu)中(zhong)藥(yao)(yao)(yao)(yao)治(zhi)療(liao)ＴＴＨ最(zui)佳(jia)療(liao)程(cheng)(cheng)(cheng)(cheng)，目前(qian)尚(shang)無(wu)文(wen)獻(xian)報(bao)道。歐(ou)洲頭痛聯合(he)會（ＥｕｒｏｐｅａｎＨｅａｄａｃｈｅＦｅｄｅｒａｔｉｏｎ，ＥＨＦ）發(fa)布《頭痛初級保健管理》［３７］，對ＴＴＨ的(de)(de)(de)(de)療(liao)程(cheng)(cheng)(cheng)(cheng)提出建議：為(wei)(wei)了(le)(le)防止藥(yao)(yao)(yao)(yao)物療(liao)程(cheng)(cheng)(cheng)(cheng)不夠(gou)導致療(liao)效(xiao)(xiao)(xiao)不好，似乎無(wu)效(xiao)(xiao)(xiao)的(de)(de)(de)(de)干(gan)預(yu)(yu)措施不應(ying)該(gai)過(guo)早停(ting)止，可(ke)(ke)(ke)最(zui)少使(shi)用２～３個月(yue)(yue)；療(liao)效(xiao)(xiao)(xiao)較好的(de)(de)(de)(de)干(gan)預(yu)(yu)藥(yao)(yao)(yao)(yao)物，一般治(zhi)療(liao)６個月(yue)(yue)后可(ke)(ke)(ke)以(yi)停(ting)藥(yao)(yao)(yao)(yao)，有時(shi)也需要根(gen)據實際治(zhi)療(liao)效(xiao)(xiao)(xiao)果延長干(gan)預(yu)(yu)時(shi)間。國際頭痛協(xie)會（ＩｎｔｅｒｎａｔｉｏｎａｌＨｅａｄａｃｈｅＳｏｃｉｅｔｙ，ＩＨＳ）臨床試(shi)驗小組委員會發(fa)布的(de)(de)(de)(de)ＴＴＨ藥(yao)(yao)(yao)(yao)物試(shi)驗指(zhi)南中(zhong)推薦預(yu)(yu)防性用藥(yao)(yao)(yao)(yao)療(liao)程(cheng)(cheng)(cheng)(cheng)應(ying)≥３個月(yue)(yue)［３８］。但從本研(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)研(yan)究(jiu)(jiu)(jiu)結果來看，中(zhong)藥(yao)(yao)(yao)(yao)治(zhi)療(liao)ＴＴＨ的(de)(de)(de)(de)臨床研(yan)究(jiu)(jiu)(jiu)可(ke)(ke)(ke)能存在療(liao)程(cheng)(cheng)(cheng)(cheng)不充足的(de)(de)(de)(de)問題(ti)，７１％的(de)(de)(de)(de)臨床研(yan)究(jiu)(jiu)(jiu)治(zhi)療(liao)ＴＴＨ的(de)(de)(de)(de)療(liao)程(cheng)(cheng)(cheng)(cheng)集(ji)中(zhong)在１５～３０ｄ，僅有４％的(de)(de)(de)(de)臨床研(yan)究(jiu)(jiu)(jiu)療(liao)程(cheng)(cheng)(cheng)(cheng)為(wei)(wei)６１～９０ｄ。

3.5對未來(lai)的(de)(de)(de)(de)展望(wang)　本研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)對未來(lai)中(zhong)藥(yao)治療(liao)ＴＴＨ的(de)(de)(de)(de)臨床(chuang)(chuang)(chuang)研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)提(ti)出如下(xia)建議：１）重視臨床(chuang)(chuang)(chuang)研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)質量，正(zheng)確使用隨機分配、盲(mang)法，提(ti)前進行臨床(chuang)(chuang)(chuang)研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)方(fang)案的(de)(de)(de)(de)注(zhu)冊，按(an)照不同的(de)(de)(de)(de)研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)類(lei)型進行樣本量的(de)(de)(de)(de)估(gu)算［３９４０］。２）重視臨床(chuang)(chuang)(chuang)研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)規(gui)范(fan)(fan)報(bao)告(gao)，按(an)照中(zhong)藥(yao)復方(fang)臨床(chuang)(chuang)(chuang)試驗報(bao)告(gao)規(gui)范(fan)(fan)（ＣＯＮＳＯＲＴＥｘｔｅｎｓｉｏｎｆｏｒＣｈｉｎｅｓｅＨｅｒｂａｌＭｅｄｉｃｉｎｅＦｏｒｍｕｌａｓ，ＣＯＮＳＯＲＴＣＨＭＦｏｒｍｕｌａｓ）［４１］、非隨機研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)報(bao)告(gao)規(gui)范(fan)(fan)（ＴｒａｎｓｐａｒｅｎｔＲｅｐｏｒｔｉｎｇｏｆＥｖａｌｕａｔｉｏｎｓｗｉｔｈＮｏｎｒａｎｄｏｍｉｚｅｄＤｅｓｉｇｎｓ，ＴＲＥＮＤ）［４２］、觀(guan)察性研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)報(bao)告(gao)規(gui)范(fan)(fan)（ＳｔｒｅｎｇｔｈｅｎｉｎｇｔｈｅＲｅｐｏｒｔｉｎｇｏｆＯｂｓｅｒｖａｔｉｏｎａｌＳｔｕｄｉｅｓｉｎＥｐｉｄｅｍｉｏｌｏｇｙ，ＳＴＲＯＢＥ）進行研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)規(gui)范(fan)(fan)報(bao)告(gao)［４３］。３）在結(jie)局(ju)指(zhi)(zhi)標設(she)計上(shang)(shang)，重視經濟學指(zhi)(zhi)標及遠期預(yu)后指(zhi)(zhi)標方(fang)面的(de)(de)(de)(de)研(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)；在結(jie)局(ju)指(zhi)(zhi)標的(de)(de)(de)(de)報(bao)告(gao)上(shang)(shang)，盡(jin)量避免只報(bao)告(gao)復合結(jie)局(ju)指(zhi)(zhi)標，同時設(she)置結(jie)局(ju)測量者盲(mang)法，減(jian)少由(you)于主觀(guan)因素導致的(de)(de)(de)(de)信息偏倚［４４］。４）重視療(liao)程對療(liao)效的(de)(de)(de)(de)影響，探索最(zui)合適的(de)(de)(de)(de)用藥(yao)療(liao)程［４５］。

4.結論

中藥較為(wei)廣泛地(di)用于治(zhi)(zhi)(zhi)療ＴＴＨ，但是在臨床研究的(de)(de)設計和報告上存在一定的(de)(de)問題，因(yin)此可以(yi)獲得高質量的(de)(de)證(zheng)據較少，限制(zhi)了中藥治(zhi)(zhi)(zhi)療ＴＴＨ的(de)(de)臨床應用與推廣。未來(lai)需要(yao)開展更多規范(fan)的(de)(de)高質量臨床研究，為(wei)中藥治(zhi)(zhi)(zhi)療ＴＴＨ提供更充(chong)分(fen)的(de)(de)證(zheng)據。

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作者:魏競(jing)競(jing) 樊雪(xue)鳴 樸(pu)京澤 宮曉 陳文潔 郭春莉 梁(liang)曉 申偉 張允嶺 單位:中(zhong)國中(zhong)醫(yi)科學(xue)院(yuan)西苑醫(yi)院(yuan) 北京中(zhong)醫(yi)藥大(da)學(xue)研究生院(yuan)