参一胶囊联合化疗治疗晚期非小细胞肺癌的疗效与安全性的Meta分析

目的:系统评价参一胶囊联合化疗对比单纯化疗治疗晚期非小细胞肺癌(NSCLC)的有效性和安全性。方法:计算机检索中国期刊全文数据库、维普中文科技期刊全文数据库、万方数据库、PubMed、Springer Link、Science Direct等,纳入参一胶囊联合化疗对比单纯化疗治疗晚期NSCLC的随机对照试验(RCT)。由两名评价者独立评价并交叉核对纳入研究质量,对纳入的同质研究采用Rev Man 5.0统计软件进行Meta分析。结果:共纳入12项研究,合计865例患者。Meta分析结果显示,与单纯化疗相比,参一胶囊联合化疗能够显著提高患者的有效率[RR=1.47,95%CI(1.25,1.72),P<0.000]、疾病控制率[RR=1.19,95%CI(1.05,1.35),P=0.006]、生存质量(KPS)评分[RR=1.58,95%CI(1.31,1.91),P<0.000]、1年生存率[RR=1.51,95%CI(1.20,1.89),P=0.004]和2年生存率[RR=3.45,95%CI(1.71,6.94)P=0.005]。对于化疗的毒副反应的改善方面,参一胶囊联合化疗与单纯化疗比较差异无统计学意义(P>0.05)。结论:参一胶囊联合化疗治疗晚期NSCLC比单纯化疗有效,主要体现在提高患者近期有效率、生存率、改善生存质量等方面;而安全性并无显著变化。由于纳入研究较少,质量不高,该结论尚待更大规模的多中心RCT进一步验证。

A Meta-analysis of Therapeutic Efficacy of Shenyi Capsule Combined with Chemotherapy for Advanced Non-small Cell Lung Cancer

OBJECTIVE： To evaluate the effectiveness and safety of Shenyi capsule combined with chemotherapy vs. chemotherapy alone for advanced non-small cell lung cancer （NSCLC）. METHODS： Retrieved from CNKI, VIP, Wanfang database, PubMed, Springer Link, Science Direct, RCTs about Shenyi capsule combined with chemotherapy for advanced NSCLC were included. 2 reviewers evaluated the quality of included trials independently. Rev Man 5.0 software was used for Meta-analysis. RESULTS： 12 RCTs were included, involving 865 patients. Results of Meta-analysis showed that Shenyi capsule combined with chemotherapy significantly improved effective rate [RR= 1.47, 95 % CI （1.25,1.72）, P〈 0.000], disease control rate [RR= 1.19, 95 % CI （1.05,1.35）, P=0.006], KPS score [RR=l.58, 95%CI （1.31,1.91）, P〈0.000] and one year survival rate [RR=1.51, 95%CI （1.20, 1.89）, P=0.004] and two years survival rate [RR=3.45, 95%CI （1.71,6.94）, P〈0.000], compared with chemotherapy alone. There was no statistical significance in the improvement of chemotherapy-induced side effect between Shenyi capsule combined with chemotherapy and chemotherapy alone （P〉0.05）. CONCLUSIONS： Shenyi capsule combined with chemotherapy is bet ter than chemotherapy alone in the treatment of advanced NSCLC in respects of short-term efficacy, the quality of life and survival rate. The safeties of them are similar to each other. Considering about low quality of included studies, more large-scale multiple-center RCTs are required.