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目的系统评价全脑放疗联合替莫唑胺(whole brain radiation therapy+Temozolomide,WBRT+TMZ)治疗非小细胞肺癌(non-small cell lung cancer,NSCLC)脑转移的疗效、患者生存情况及不良反应。方法利用Meta分析方法对国内外从建库到2016年5月发表的有关WBRT+TMZ与单纯WBRT治疗NSCLC脑转移的文献进行汇总定量分析。由两名研究者独立提取有效数据。使用的Cochrane风险偏倚评估工具对文献进行质量分析及评价。使用RevMan 5.3对各效应量进行统计分析。结果共纳入文献6篇(427例患者)。Meta分析结果显示:采用WBRT+TMZ模式治疗的客观缓解率(62.6%)明显优于单纯WBRT治疗模式(46.0%),相对危险度(risk ratio,RR)为1.41[95%CI(1.17,1.71),P=0.0004]。但WBRT+TMZ治疗模式使血液毒性反应及胃肠道副反应的发生率增加,其中WBRT+TMZ组血液毒性反应发生率是单纯WBRT组的2.29倍,RR为2.14[95%CI(1.12,4.06),P=0.02];胃肠道副反应发生率是单纯WBRT组的1.9倍,RR=1.84[95%CI(0.98,3.47),P=0.06]。两种治疗模式的总生存时间与无进展生存期比较,差异均无统计学意义,危险比分别为1.09[95%CI,(0.80,1.48),P>0.05],1.15[95%CI,(0.73,1.80),P>0.05],表明WBRT+TMZ治疗模式并未增加患者远期生存获益。结论对于NSCLC脑转移的治疗,WBRT+TMZ与单纯WBRT相比,改善了客观反应率,但增加了患者Ⅲ/Ⅳ期血液毒性反应,而胃肠道不良反应未明显增加,联合治疗方案未能将近期的局控获益转化为远期的生存获益。因此,对于WBRT+TMZ治疗NSCLC脑转移的疗效和安全性,还需要进一步的大规模、高质量、前瞻性的临床研究进行验证。
Objective To evaluate the efficacy of whole brain radiation therapy combined with temozolomide (WBRT + TMZ) in the treatment of brain metastases of non-small cell lung cancer (NSCLC) and its survival and adverse reactions. Methods Meta-analysis was used to summarize and quantitatively analyze the literatures about the brain metastases of WBRT + TMZ and WBRT treated NSCLC published from the establishment of the database at home and abroad to May 2016. Two researchers independently extracted valid data. The Cochrane Risk Bias Assessment Tool used was used for quality analysis and evaluation of the literature. Use RevMan 5.3 to perform a statistical analysis of the effects. Results A total of 6 articles were included (427 patients). Meta-analysis showed that the objective response rate (62.6%) in WBRT + TMZ group was significantly better than that in simple WBRT group (46.0%) and the relative risk ratio (RR) was 1.41 [95% CI 1.17,1.71 ), P = 0.0004]. However, the WBRT + TMZ treatment mode increased the incidence of hematologic toxicity and gastrointestinal adverse reactions. The incidence of hematologic toxicity in WBRT + TMZ group was 2.29 times higher than that in WBRT group alone (RR 2.14 [95% CI 1.12,4.06 ), P = .02]. The incidence of gastrointestinal side effects was 1.9 times higher than that of the WBRT group alone. RR = 1.84 [95% CI (0.98, 3.47), P = .06]. There was no significant difference in the overall survival and progression-free survival between the two treatment modalities, with hazard ratios of 1.09 [95% CI, (0.80, 1.48), P> 0.05], 1.15 [95% CI 0.73,1.80), P> 0.05], indicating that WBRT + TMZ treatment did not increase the long-term survival benefit of patients. Conclusion For the treatment of NSCLC brain metastases, WBRT + TMZ improved the objective response rate compared with WBRT alone, but increased the patients’ stage III / IV hematotoxic reaction, but the gastrointestinal adverse reaction did not increase obviously. The combination therapy failed The recent Bureau control benefits into long-term survival benefits. Therefore, the efficacy and safety of WBRT + TMZ in the treatment of NSCLC brain metastases also need further large-scale, high-quality, prospective clinical studies to verify.