华蟾素胶囊联合化疗治疗胃癌的Meta分析

Meta-analysis of Cinobufagin Capsules combined with chemotherapy in treating gastric cancer

目的:通过Meta分析探讨华蟾素胶囊联合化疗治疗胃癌的有效性及安全性。方法:计算机检索中文数据库(VIP、CNKI、WanFang、CBM)及英文数据库(PubMed、CochraneLibrary、EMBase)自建库至2020年6月收录的华蟾素胶囊联合化疗治疗胃癌的临床随机对照试验(RCTs)。对纳入文献进行数据提取及方法学质量评价。Meta分析及证据质量评价分别采用RevMan 5.3及GRADEpro 3.6软件。结果:最终纳入12个RCT,830例患者。Meta分析结果显示:在提高肿瘤客观缓解率(ORR)[RR=1.65,95%CI(1.41,1.93),P<0.00001];改善生活质量评分(KPS评分)[RR=1.77,95%CI(1.43,2.19),P<0.00001];降低恶心呕吐反应[RR=0.46,95%CI(0.29,0.74),P=0.001]、白细胞毒性[RR=0.40,95%CI(0.25,0.64),P<0.0001]、血小板毒性[RR=0.45,95%CI(0.22,0.93),P=0.03]的发生率;提高CD4+[MD=6.99,95%CI(4.32,9.66),P<0.00001]水平等方面,华蟾素胶囊联合化疗治疗胃癌均优于单纯化疗,差异均具有统计学意义。GRADE评价显示证据质量为低级。结论:华蟾素胶囊联合化疗治疗胃癌有较好的有效性及安全性。

Objective:To evaluate the efficacy and safety of Cinobufagin Capsules combined with chemotherapy in the treatment of gastric cancer by meta-analysis.Methods:Randomized controlled trials(RCTs)of Cinobufagin Capsules combined with chemotherapy for the treatment of gastric cancer were searched in Chinese databases(VIP,CNKI,WanFang,CBM)and English databases(PubMed,Cochrane Library,EMBase)from the establishment of databases to June 2020.Data extraction and methodological quality evaluation were carried out for the included literature.The methodological quality assessment was based on Cochrane bias risk assessment tool.RevMan 5.3 and GRADEpro 3.6 were used for meta-analysis and evidence quality assess-ment,respectively.Results:A total of 12 trials with 830 patients were included in the review.Meta-analysis results showed that Cinobufagin Capsules combined with chemotherapy in the treatment of gastric cancer enhanced the objective response rate[RR=1.65,95%CI(1.41,1.93),P<0.00001];improved quality of Life Score(KPS score)[RR=1.77,95%CI(1.43,2.19),P<0.00001];reduced the incidence of nausea and vomiting[RR=0.46,95%CI(0.29,0.74),P=0.001],leukocyte toxicity[RR=0.40,95%CI(0.25,0.64),P<0.0001],and platelet toxicity[RR=0.45,95%CI(0.22,0.93),P=0.03];increased the level of CD4+[MD=6.99,95%CI(4.32,9.66),P<0.00001]better than chemotherapy alone,with statistically significant dif-ferences.GRADE evaluation showed low quality of evidence.Conclusions:Cinobufagin Capsules combined with chemotherapy has better efficacy and safety in the treatment of gastric cancer.