基于Meta分析的华蟾素注射剂辅助治疗肝癌的临床评价研究

Meta-analysis on the Randomized Controlled Trials of Huachansu Injection in the Treatment of Liver Cancer

目的:采用Meta分析方法评价华蟾素注射剂辅助肝动脉栓塞化疗术(TACE)治疗肝癌的临床疗效及安全性,为临床治疗与合理用药提供循证依据。方法:计算机检索中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、万方数据库、中国生物医学文献数据库(Sino Med)、Pub Med、Cochrane Library和Embase数据库,全面搜集华蟾素注射剂辅助TACE治疗肝癌的随机对照试验,采用Cochrane风险评价表评价研究的偏倚风险,提取资料并通过Rev Man 5.3软件进行数据分析。结果:共纳入11篇文献,累计受试者783例,Meta分析结果显示:在TACE基础上联用华蟾素注射剂可有效提高客观缓解率[RR=1.36,95%CI(1.16,1.58),P=0.000 1],改善生活质量[RR=1.96,95%CI(1.56,2.47),P<0.000 01]。同时,华蟾素注射剂辅助TACE治疗肝癌可以降低患者的血清总胆红素、丙氨酸氨基转移酶等。结论:临床治疗肝癌的过程中,在TACE基础上加用华蟾素注射剂可以提高临床疗效,但其安全性仍需进一步探讨,受限于纳入文献的数量及质量,本研究结论尚需更多设计良好、严格执行的大样本随机对照双盲试验加以证实。

Objective： To systematically assess the clinical effectiveness and safety of Huachansu injection combined with transcatheter arterial chemoembolization（ TACE） in the treatment of liver cancer. Methods： A thorough and systematic retrieval of randomized controlled trials（ RCTs） which regarding Huachansu injection combined with TACE in the treatment of liver cancer was conducted by using literature databases. Quality of included RCTs was evaluated by the risk of bias assessment tool,and then the required information was extracted and Meta-analyzed by Rev Man 5. 3 software.Results： A total of 11 RCTs with 783 participants were included in this study. In the meta analysis,Huachansu injection combined with TACE could achieve a better effect than receiving TACE therapy alone in respect of objective response rate[RR = 1. 36,95% CI（ 1. 16,1. 58）,P = 0. 000 1],improvement of life quality [RR = 1. 96,95% CI（ 1. 56,2. 47）,P〈0. 000 01]. In addition,Huachansu injection could decrease serum total bilirubin,alanine aminotransferase and so on.Conclusion： Huachansu injection combined with TACE was effective in treating liver cancer,but its safety needed to be further explored,limited by the number and quality of the literature,while our conclusion should be confirmed by more largescale randomized controlled of double-blind RCTs.