复方苦参注射液联合化疗治疗胃癌疗效的荟萃分析

Meta-analysis of Efficiency in Treatment of Gastric Cancer by Compound Kushen Injection Combined with Chemotherapy

目的:系统评价复方苦参注射液联合化疗治疗中晚期胃癌的临床疗效和生存质量改善情况。方法:检索Cochrane图书馆、PubMed、EMBASE、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)、万方数字化期刊全文库、中国期刊全文数据库(CNKI)中复方苦参注射液联合化疗治疗中晚期胃癌的随机对照试验(RCTs)。由2名研究人员采用Cochrane系统评价的方法独立评价纳入研究的方法学质量,并提取有效数据用RevMan 5.1软件进行Meta分析。结果:共纳入12项RCT(共1 004例患者)。Meta分析结果显示,复方苦参注射液联合化疗治疗胃癌的总有效率[OR=1.51,95%CI(1.18,1.94)]、生存质量改善率[OR=1.95,95%CI(1.49,2.55)]、白细胞减少率[OR=0.36,95%CI(0.26,0.50)]等差异都具有统计学意义,均优于单纯化疗。发表偏倚分析:倒漏斗图两侧对称性有偏差,可能是少数临床实验的报告偏倚导致。结论:复方苦参注射液联合化疗治疗中晚期胃癌可明显改善患者的生存质量,且安全性较好,值得开展临床试验验证及推广应用。

Objective： To evaluate the safety and efficacy of compound Kushen injection（CKI） as adjunctive treatment of patients with advanced gastric cancer（AGC）.Method： A computer-based online search of literatures prior to March 2012 was performed in Medline,the Cochrane Library,EMBASE,CENTRAL,PubMed,Google Scholar,CNKI,CBM,VIP and Wanfang by using a combination of synonyms for compound kushen injection,gastric cancer and chemotherapy.Randomized controlled trials（RCT） of CKI as adjunctive treatment for AGC were included.Bias risks of included RCT studies were evaluated and homogeneity studies were Meta-analyzed by Revman 5.1 software.Result： Twelve RCT studies including 1 004 patients were involved in this research.Pooling data of the Meta-analysis indicated that compared with chemotherapy alone,the combination had a statistically significant benefit in total effect rate [OR = 1.51,95% CI（1.18,1.94）,P = 0.001],quality of life improvement rate [OR = 1.95,95% CI（1.49,2.55）,P 0.000 01] and improved the incidence of Leukopenia [OR = 0.36,95% CI（0.26,0.50）,P 0.000 01].Conclusion： The results of this Meta-analysis confirmed that CKI plus chemotherapy shows a good efficacy and an acceptable safety profile in AGC patients,and may prove to be worthy of widespread use.