华蟾素注射液联合西医疗法治疗肝癌有效性与安全性的系统评价Meta分析

Systematic evaluation and meta⁃analysis of the efficacy and safety of cinobufagin injection combined with western medicine in the treatment of liver cancer

目的:评价华蟾素注射液治疗肝癌的临床有效性及安全性。方法:计算机检索Pubmed数据库、Embase数据库、Cochrane Library数据库、中国知网(CNKI)、万方数据库(WanFang)、维普数据库(VIP)、中国生物医学文献服务系统(SinoMed)检索有关华蟾素注射液联合西医治疗原发性肝癌的随机对照实验,检索时间均为建库至2021年6月4日。由2位独立的研究员分别按照纳入标准对文章进行系统筛选、文献纳入、质量评估,采用RevMan 5.4软件对数据进行Meta分析。结果:共纳入30项研究,总计2355例患者。华蟾素注射液联合西医治疗相比于常规西医治疗临床有效率更高[RR=1.16,95%CI=(1.11,1.22),P<0.00001],能够有效减小瘤体大小[RR=1.33,95%CI=(1.17,1.51),P<0.00001]、延长患者生存时间[RR=1.41,95%CI=(1.31,1.52),P<0.00001]、提高生活质量[RR=1.37,95%CI=(1.19,1.57),P<0.00001]、改善患者肝功能[RR=−14.52,95%CI=(−16.15,−12.88),P<0.00001],减轻骨髓抑制[RR=0.44,95%CI=(0.31,0.62),P<0.00001]等不良反应[RR=0.94,95%CI=(0.85,1.42),P=0.25]的发生。结论:华蟾素注射液联合西医疗法可有效改善原发性肝癌的临床症状,且安全性好。但纳入文献的方法学质量较低,影响结局的客观性,尚需要更加全面的多样本、多中心、随机双盲对照实验进行验证。

Objective:To evaluate the clinical efficacy and safety of cinobufagin injection in the treatment of liver cancer.Methods:PubMed database,Embase database and Cochrane Library database,CNKI,Wanfang database,VIP database and Sinomed database were used to search for the randomized controlled trials of cinobufagin injection combined with Western medicine in the treatment of primary liver cancer.The retrieval time was from the establishment to December 15,2020.Two indepen‑dent researchers conducted systematic screening,literature inclusion and quality assessment of the articles according to the inclusion criteria,respectively.Meta‑analysis of the data was performed using RevMan 5.4 software.Results:A total of 30 studies with a total of 2355 patients were included.Compared with conventional western medicine treatment,the clinical effective rate of Hububutin injection combined with western medicine was significantly higher[RR=1.16,95%CI=(1.11,1.22),P<0.00001].It could effectively reduce the tumor size[RR=1.33,95%CI=(1.17,1.51),P<0.00001],prolong the survival time of patients[RR=1.41,95%CI=(1.31,1.52),P<0.00001],improve the quality of life[RR=1.37,95%CI=(1.19,1.57),P<0.00001],improve the liver function of patients[RR=−14.52,95%CI=(−16.15,−12.88),P<0.00001],and reduce the occurrence of adverse reactions[RR=0.94,95%CI=(0.85,1.42),P=0.25]such as bone marrow suppression[RR=0.44,95%CI=(0.31,0.62),P<0.00001].Conclusion:Cinobufagin injection combined with western medicine therapy can effectively improve the clinical symptoms of primary liver cancer,and the safety is good.However,the methodological quality of the included literature is low,which affects the objectivity of the outcome,and it still needs to be verified by multi‑sample,multi‑center,randomized double‑blind controlled trial.