消癌平注射液联合化疗治疗晚期胃癌疗效与安全性的Meta分析

A Meta-Analysis of Clinical Efficacy and Safety about Xiaoaiping Injection(消癌平注射液) Combined with Chemotherapy on Advanced Gastric Cancer

目的:系统评价消癌平注射液联合化疗治疗晚期胃癌的临床疗效和安全性。方法:通过计算机检索中国期刊全文数据库、中国生物医学文献数据库、万方数据库、维普数据库、Cochrance Library、PubMed、Embase关于消癌平注射液联合化疗治疗晚期胃癌的随机对照临床试验文献。通过Review Manager 5.2软件和stata 14软件对研究进行偏倚风险评估、Meta分析。结果:有14篇文献符合纳入标准,共计1035例患者,文献有一定的偏倚风险,Meta分析结果显示:联合治疗组的治疗有效率[OR=1.815,95%CI(1.409,2.335),Z=4.61,P<0.000,01]、生存质量状况(PFS)改善率[OR=2.79,95%CI(1.86,4.18),Z=4.94,P<0.000,01]和无疾病进展期时间[HR=0.74,95%CI(0.54,0.94),Z=7.19,P<0.000,01]均优于单用化疗对照组;在毒性反应比较中,联合治疗组的白细胞减少[RR=0.65,95%CI(0.56,0.74),P=0.0001]、血小板减少[RR=0.57,95%CI(0.45,0.72),P=0.0001]、恶心呕吐[RR=0.76,95%CI(0.65,0.89),P=0.001]、手足综合征[RR=0.63,95%CI(0.48,0.81),P=0.0001]和口腔炎[RR=0.75,95%CI(0.65,0.76),P=0.0001]的发生率明显低于单用化疗对照组,以上结果均有统计学意义。结论:对于晚期胃癌的治疗,在化疗治疗的基础上联合消癌平注射液疗效更好且毒副作用更小。但受纳入研究质量所限,仍需更多高质量研究予以验证。

Objective: To evaluate the clinical efficacy and safety of Xiaoaiping injection combined with chemotherapy in the treatment of Advanced Gastric Cancer by Meta analysis. Methods: The randomized controlled trials were searched from CNKI, Wanfang Data, Weipu Data, CBM Data, Cochrance Library, PubMed,EMbase by computer. Review 5.2 Manager software and stata14 software were used to bias risk assessment and Meta analysis of the studies. Results: A total of 14 studies with 1035 patients were included into the review.There is a risk of bias in these studies. The Meta analysis results indicated that the treatment group showed better efficacy than the control group in terms of efficiency rate [OR =1.815,95% CI(1.409,2.335), Z =4.61, P <0.000,01], quality of life(PFS) improvement [OR=2.79,95% CI(1.86,4.18),Z=4.94, P<0.000,01]and the of time progression free survival(PFS) [HR=0.74,95% CI(0.54,0.94),Z=7.19, P<0.000,01]. In comparison of toxic reactions,the treatment group showed lower incidence rate than the control group in Leukopenia [RR =0.65, 95% CI(0.56,0.74), P=0.0001<0.05], Thrombocytopenia [RR=0.57, 95%CI(0.45,0.72), P=0.0001], Nausea and vomit [RR=0.76,95%CI(0.65,0.89),P=0.001], Hand-foot syndrome [RR=0.63,95%CI(0.48,0.81),P=0.0001] and Stomatitis[RR =0.75,95% CI(0.65,0.76),P =0.0001], and the above results were statistically significant. Conclusions: The present meta-analysis suggests that Xiaoaiping injection combined with chemotherapy shows better curative effect on advanced gastric cancer with less toxic side effects;because the quality of included RCTs in this study is poor, more RCTs with high quality are needed for confirming this conclusions.