Quality Assessment of the Clinical Studies on Randomized Controlled Trials of Chinese Herb Medicineand Chemotherapy in the Treatment of Hepatocellular Carcinoma_West China Medical Journal

Authors：

1Department of Integrated Traditional Chinese and Western Medicine,West China Hospital,Sichuan University,Chengdu 610041,China;2Center of Infectious Disease,West China Hospital,Sichuan University,Chengdu 610041,China;

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Keywords：

肝腫瘤; 栓塞化療; 中西醫結合療法; Jadad評分量表; CONSORT標準

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目的：對中藥配合肝動脈栓塞化療（Transcatheter Arterial Chemoembolization,TACE）輔助治療原發性肝癌隨機對照試驗(Randomized controlled trial,RCT)文獻進行評價。方法：對國內外公開發表的有關中藥配合TACE輔助治療原發性肝癌的隨機對照試驗進行檢索，檢索數據庫包括Cochrane圖書館臨床對照試驗庫，MEDLINE、CBM、CNKI和VIP電子數據庫。手工檢索中文相關期刊以及附加檢索相關會議論文集。質量評價采用Jadad評分量表、CONSORT標準和其他自擬評價指標進行分析。結果：共納入103篇RCTs，其中Jadad評分得5分有1篇文獻，3分1篇，2分10篇，71篇1分，其余20篇均為0分，有3篇文獻報告了分配隱藏。按CONSORT標準，僅1篇(0.97%)RCT描述了如何產生隨機順序，沒有RCT報道如何執行隨機，其中1篇為半隨機，有1篇(0.97%)RCT采用安慰劑對照，有54篇(52.43%)報道了終點指標，分別各有2篇(1.94%)報道了雙盲和單盲，14篇(1359%)進行了具體統計量計算，54篇(52.43%)提供了隨訪記錄，7篇(6.80%)報道了陰性結果，16篇(15.53%)報道不良事件，僅有1篇(0.97%)進行樣本含量計算與意向性分析(ITT),有2篇(1.94%)進行分層分析，屬于多中心的僅有1篇(0.97%)，均未進行倫理審批和知情同意。描述了中醫證型的有3篇(2.91%)。結論:目前中藥配合TACE輔助治療原發性肝癌臨床研究的方法學和報告質量尚低，且多數RCT可能存在選擇性偏倚和測量性偏倚，期待更多高質量的隨機雙盲對照試驗為臨床應用提供可靠的依據。

Citation： MENG Maobin,WANG Gang,CUI Yaoli,et al.. Quality Assessment of the Clinical Studies on Randomized Controlled Trials of Chinese Herb Medicineand Chemotherapy in the Treatment of Hepatocellular Carcinoma. West China Medical Journal, 2008, 23(1): 1-2. doi: Copy

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West China Medical Journal

Quality Assessment of the Clinical Studies on Randomized Controlled Trials of Chinese Herb Medicineand Chemotherapy in the Treatment of Hepatocellular Carcinoma

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