目的:评价重组人血管内皮抑制素联合紫杉醇+顺铂(TPE)方案治疗晚期非小细胞肺癌(NSCLC)的有效性和安全性,并与紫杉醇+顺铂(TP)方案进行比较。方法:计算机检索Cochrane图书馆、PubMed、EMbase、CNKI、万方等数据库,收集重组人血管内皮抑制素联合TP方案与TP方案治疗晚期非小细胞肺癌的随机对照试验,由两名研究者独立评价纳入研究的质量,采用RevMan 5.1软件进行Meta分析。结果:共纳入文献8篇,合计399例晚期非小细胞肺癌患者;分析结果显示,重组人血管内皮抑制素联合TP方案与单纯使用TP方案治疗晚期NSCLC的总有效率(RR=1.66,95%CI:1.31-2.11,P〈0.000 1)和疾病控制率(RR=1.24,95%CI:1.11-1.40,P=0.000 3)的差异有统计学意义,TPE方案的总有效率和疾病控制率均高于TP方案;两组在白细胞减少(RR=1.01,95%CI:0.86-1.17,P=0.94)、血小板减少(RR=0.97,95%CI:0.69-1.37,P=0.88)、恶心呕吐(RR=1.03,95%CI:0.87-1.21,P=0.75)、心脏毒性(RR=1.55,95%CI:0.52-4.58,P=0.43)的发生率方面,差异无统计学意义。结论:与单纯使用TP方案治疗晚期NSCLC患者相比,重组人血管内皮抑制素联合TP方案能提高治疗的总有效率和疾病控制率,而不明显增加不良反应发生率;由于纳入分析的研究较少,上述结果尚需高质量随机对照试验进一步验证。
Objective: To evaluate the efficacy and safety of rh-endostatin plus the combination of pacli- taxe and cisplatin (TPE) in the treatment of advanced non-small cell lung cancer (NSCLC), and to compare it with the chemotherapy containing paclitaxe and cisplatin (TP) alone. Methods. Randomized controlled trials (RCTs) on rh-endostatin combined with paclitaxe and cisplatin for advanced NSCLC were searched in The Cochrane Library, PubMed, Embase, CNKI, Wangfang Data, etc. The quality of trials was evaluated by two reviewers independently, and the softwareRevMan5.1 was used for meta-analysis. Results: Eight trials with 399 patients with advanced NSCLC were included. Meta analysis results suggested that the response rate and disease control rate of the rh-endostatin combined with TP group were significantly higher than that of the TP alone group (RR:1. 66, 95%CI:1.31 to 2.11, P〈0.0001;RR=1. 24, 95%CI.1.11-1. 40, P= 0. 0003 ; respectively), there were no significant differences between the two groups in the occur- rence of leukopenia (RR = 1.01, 95 % CI:0. 86-1.17, P = 0.94), thrombocytopenia (RR = 0.97, 95%CI.0. 69-1. 37, P=0.88), nausea and vomiting (RR=1. 03, 95%CI.0. 87-1. 21, P=0.75) and cardiotoxicity (RR=1. 55, 95%CI:0. 52-4. 58, P=0.43). Conclusion: Compared to the TP chemotherapy alone, rh-endostatin combined with TP chemotherapy can improve both the response rate and disease control rate without increasing the incidence rate of adverse reaction. Due to the small sample size of included trials, the results still need to be proved by high quality RCTs.