中药配合肝动脉栓塞化疗辅助治疗原发性肝癌随机对照试验的质量评价

目的:对中药配合肝动脉栓塞化疗(Transcatheter Arterial Chemoembolization,TACE)辅助治疗原发性肝癌随机对照试验(Randomized controlledtrial,RCT)文献进行评价。方法:对国内外公开发表的有关中药配合TACE辅助治疗原发性肝癌的随机对照试验进行检索,检索数据库包括Cochrane图书馆临床对照试验库,MED-LINE、CBM、CNKI和VIP电子数据库。手工检索中文相关期刊以及附加检索相关会议论文集。质量评价采用Jadad评分量表、CONSORT标准和其他自拟评价指标进行分析。结果:共纳入103篇RCTs,其中Jadad评分得5分有1篇文献,3分1篇,2分10篇,71篇1分,其余20篇均为0分,有3篇文献报告了分配隐藏。按CONSORT标准,仅1篇(0.97%)RCT描述了如何产生随机顺序,没有RCT报道如何执行随机,其中1篇为半随机,有1篇(0.97%)RCT采用安慰剂对照,有54篇(52.43%)报道了终点指标,分别各有2篇(1.94%)报道了双盲和单盲,14篇(13.59%)进行了具体统计量计算,54篇(52.43%)提供了随访记录,7篇(6.80%)报道了阴性结果,16篇(15.53%)报道不良事件,仅有1篇(0.97%)进行样本含量计算与意向性分析(ITT),有2篇(1.94%)进行分层分析,属于多中心的仅有1篇(0.97%),均未进行伦理审批和知情同意。描述了中医证型的有3篇(2.91%)。结论:目前中药配合TACE辅助治疗原发性肝癌临床研究的方法学和报告质量尚低,且多数RCT可能存在选择性偏倚和测量性偏倚,期待更多高质量的随机双盲对照试验为临床应用提供可靠的依据。

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

Objective:To investigate the quality of the reports on randomized controlled trials(RCTs)on Chinese herb medicine and chemotherapy for hepatocellular carcinoma and assessed whether it was adequate to provide evidence for clinical practice.Methods:We collected All the published clinical studies on Chinese Herb Medicine and Chemotherapy for Hepatocellular Carcinoma were collected and all the included reports were assessed according to Jadad scale,CONSORT statements and all other self-laying items,The electric searched databases comprised CENTER,Medline,Embase,CBM,CNKI and VIP.Results:The Jadad score of one was 5,one was 3,ten RCTs were 2,seventy-one RCTs were 1 and twenty RCTs were 0.Three RCTs performed allocation concealment.According to CONSORT criteria,Only one(0.97%)described randomization sequence generation,among them one was quasi-randomized,no RCT provided randomization implementation,one(0.97%)carried out placebo control,fifty-four RCTs(52.43%)reported endpoint,two RCTs(1.94%)adopted single blinding,two RCTs(1.94%)adopted double blinding,fourteen RCTs(13.59%)calculated statistic values,fifty-four RCTs(52.43%)reported record of follow-up,seven RCTs(6.80%)reported negative outcome,sixteen RCTs(15.53%)offered adverse events,only one(0.97%)described estimation of sample size,intent-to-treat analysis(ITT),two RCTs reported correlation analysis,one reported muti-center,no RCT completed ethicapprobation and informed consent,and tree RCTs(2.91%)described syndrome type of TCM.Conclusion:Because the majority of RCTs may existed selective and measurement bias in this study,currently the quality of methodology and report of studies on Chinese Herb Medicine and Chemotherapy for Hepatocellular Carcinoma were not good enough to provide reliable evidence for clinical practice.