中藥及草藥治療丙型肝炎隨機對照試驗的質(zhì)量評價

嚴毓倩　梁士兵　梁寧　趙楠琦　王瑩　胡瑞學(xué)　劉建平

摘要?目的：評價中藥及草藥治療丙型肝炎隨機對照試驗（RCT）的質(zhì)量現(xiàn)狀。方法：檢索CNKI數(shù)據(jù)庫、萬方數(shù)據(jù)庫、VIP、SinoMed、PubMed、Cochrane圖書館、Embase等數(shù)據(jù)庫，獲取相關(guān)RCT。使用Cochrane“偏倚風(fēng)險評估”工具及CONSORT（2010版）條目對納入RCT的方法學(xué)質(zhì)量和報告質(zhì)量進行評價，采用SPSS ?23.0軟件進行描述性統(tǒng)計分析。結(jié)果：截止至2018年12月，共納入114篇RCT，其中英文15篇，中文99篇。隨機方法、分配隱匿、盲法、脫落及方案注冊的實施報告率分別為17.5%、4.4%、14%、20.2%、5.3%。CONSORT（2010版）37個條目中，報告質(zhì)量好的是結(jié)構(gòu)式摘要、納入標準、干預(yù)措施、統(tǒng)計學(xué)方法;報告質(zhì)量一般的是資料收集的場所和地點、招募期和隨訪時間、危害;其余條目報告質(zhì)量差或極差（條目報告率≤10%）。英文RCT報告條目數(shù)更多（P<0.001）。結(jié)論：從總體上看，中藥及草藥治療丙型肝炎RCT的方法學(xué)質(zhì)量和報告質(zhì)量尚低，有較大提升空間。

關(guān)鍵詞?丙型肝炎;中藥;隨機對照試驗;方法學(xué);報告質(zhì)量;方法學(xué)質(zhì)量;現(xiàn)狀

Quality Evaluation on Randomized Controlled Trials of Herbal Remedy for Hepatitis C

Yan Yuqian1，Liang Shibing1，2，Liang Ning1，Zhao Nanqi1，Wang Ying1，Hu Ruixue1，Liu Jianping1

（1 Center for Evidence-based Chinese Medicine，Beijing University of Chinese Medicine，Beijing 100029，China; 2 Shanxi University of Chinese Medicine，Taiyuan 030000，China）

Abstract?Objective：To evaluate the quality of randomized controlled trials（RCTs）of herbal remedy for hepatitis C. Methods：A literature search was thoroughly conducted on multiple databases（CNKI，Wanfang data，VIP，SinoMed，PubMed，Cochrane Library，Embase）to identify RCTs on herbal remedy for hepatitis C. Based on the Cochrane “Risk of Bias” Tool and CONSORT（2010）checklists，the evaluation of methodological quality and reporting quality of RCTs was performed. SPSS 23.0 software was used to perform descriptive statistics analysis. Results：A total of 114 RCTs，including Fifteen English RCTs and 99 Chinese RCTs were included by December 2018. The reported rates of randomized methods，allocation concealment，blinding，drop-outs，and protocol registration were 17.5%，4.4%，14%，20.2%，and 5.3%，respectively. Among the 37 items in CONSORT（2010），the structured abstract，subject qualification criteria，interventions，and statistical methods were evaluated with high reporting quality; the data collection of sites and locations，recruitment period and follow-up duration，and harm were evaluated with medium reporting quality. The remaining items were evaluated with poor or very poor reporting quality（rate of reporting items ≤10%）. The English RCTs has a better compliance than Chinese RCTs（P<0.001）. Conclusion：The overall methodological quality and reporting quality of RCTs of herbal remedy for hepatitis C are generally low，which remain much room for improvement.

Key Words?Hepatitis C; Herbal remedy; Randomized controlled trials; Methodology; Reporting quality; Methodological quality; Current situation

中圖分類號：R256.4;R259;R285.6文獻標識碼：Adoi：10.3969/j.issn.1673-7202.2019.03.020

丙型肝炎是一種嚴重威脅人類健康的全球傳染性疾病，根據(jù)世界衛(wèi)生組織最新數(shù)據(jù)統(tǒng)計，全球有1.85億人感染[1]。目前西醫(yī)針對丙型肝炎的治療方案中存在不良反應(yīng)多、費用昂貴及潛在耐藥風(fēng)險等亟待解決的諸多問題[2-3]。近年來中藥及草藥在治療丙型肝炎的臨床實踐及研究中被證明有一定療效，現(xiàn)今臨床實踐中仍廣泛使用，大量臨床隨機對照試驗（Randomized Controlled Trial，RCT）的研究成果已公開發(fā)表[4-6]。但由于其研究成果轉(zhuǎn)化應(yīng)用率低，未能為臨床實踐指南的制定提供高級別的證據(jù)，不少治法和方藥難以總結(jié)和推廣。……