目的:系统评价艾迪注射液联合紫杉醇和顺铂治疗中晚期非小细胞肺癌的疗效和安全性,以为临床提供循证参考。方法:计算机检索PubMed、EMBase、Cochrane图书馆、中国期刊全文数据库、中文科技期刊数据库和万方数据库,收集在紫杉醇联合顺铂(对照组)的基础上加用艾迪注射液(试验组)治疗中晚期非小细胞肺癌疗效和安全性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,并采用Cochrane系统评价员手册5.1.0进行质量评价,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入16项RCT,合计1 025例患者。Meta分析结果显示,试验组患者有效率[RR=1.34,95%CI(1.17,1.52),P<0.001]、生存质量改善率[RR=1.69,95%CI(1.45,1.97),P<0.001]均显著高于对照组;Ⅱ度及以上恶心呕吐 [RR=0.49,95%CI(0.38,0.63),P<0.001]、白细胞减少 [RR=0.48,95%CI(0.38,0.62),P<0.001]、血小板降低[RR=0.45,95%CI(0.29,0.69),P<0.001]发生率均显著低于对照组,差异均有统计学意义。结论:艾迪注射液联合紫杉醇和顺铂可显著提高中晚期非小细胞肺癌的疗效,改善患者生存质量,安全性较好。
Abstract
OBJECTIVE:To systematically review the efficacy and safety of Aidi injection combined with paclitaxel and cisplatin in the treatment of advanced non-small cell lung cancer (NSCLC), and provide evidence-based reference for clinic. METHODS: Retrieved from PubMed, EMBase, Cochrane Library, CJFD,VIP and Wanfang Database,randomized controlled trials (RCT) about the efficacy and safety of Aidi injection (test group) based on paclitaxel combined with cisplatin (control group) in the treatment of NSCLC were collected. Meta-analysis was performed by using Rev Man 5.2 software after data extraction and quality evaluation with Cochrane systematic reviewer manual 5.1.0. RESULTS: Totally 16 RCT were included, involving 1 025 patients. Results of Meta-analysis showed that, the effective rate [RR=1.34,95%CI(1.17,1.52),P<0.001] and improvement rate of life quality[RR=1.69,95%CI(1.45,1.97),P<0.001] in test group were significantly higher than control group; the incidences of grade Ⅱ or above nausea and vomiting [RR=0.49,95%CI(0.38,0.63),P<0.001],grade Ⅱ or above leukopenia[RR=0.48,95%CI(0.38,0.62),P<0.001] and grade Ⅱor above thrombocytopenia [RR=0.45,95%CI(0.29,0.69),P<0.001] were significantly lower than control group, the differences were statistically significant. CONCLUSIONS: Aidi injection combined with paclitaxel and cisplatin can significantly improve efficacy of NSCLC, improve life quality, with good safety.