目的：系统评价中医药联合同步放化疗治疗晚期非小细胞肺癌（NSCLC）的疗效及安全性。方法计算机检索 PubMed、中国生物医学文献服务系统（CBM）、中国知网数据库、万方数据库、维普中文期刊全文数据库（VIP）、Cochrane 等电子数据库，检索时间从建库至2013年12月。手工检索相关杂志、会议论文及未发表的灰色文献等。根据 Cochrane 系统评价手册5.0，筛选关于中医药联合同步放化疗（试验组）对比单纯放化疗组（对照组）治疗晚期 NSCLC 的中、英文随机对照试验（RCT），进行纳入文献的资料提取和质量评价，采用 RevMan 5.2软件进行 Meta分析。比较两组治疗晚期 NSCLC 的临床客观疗效、生活质量、免疫能力、毒副作用及生存时间。结果共纳入20个符合标准的 RCT，Meta 分析结果显示：采用世界卫生组织（WHO）评价标准评价临床客观疗效，试验组有效率高于对照组〔相对危险度（RR）＝1.83，95% CI（1.31，2.56），P ＝0.0004〕，中药注射类亚组有效率高于对照组〔 RR＝1.76，95% CI（1.26，3.00），P ＝0.002〕；采用实体瘤的疗效评价标准（RESIST）评价临床客观疗效，试验组有效率高于对照组〔RR ＝1.93，95% CI（1.24，3.01），P ＝0.004〕，中药口服类亚组有效率高于对照组〔 RR ＝1.90，95% CI（1.17，3.09），P ＝0.010〕；采用体力状况（ KPS）评分评价生活质量，试验组 KPS 评分高于对照组〔 RR＝3.16，95% CI（2.09，4.77），P ＜0.00001〕，中药口服类亚组 KPS 评分高于对照组〔 RR ＝3.11，95% CI（1.81，5.34），P ＜0.0001〕，中药注射类亚组 KPS 评分高于对照组〔RR ＝3.23，95% CI（1.71，6.10），P ＜0.0001〕；两组CD4＋、CD8＋、CD4＋/ CD8＋、自然杀伤细胞（NK）所占比例比较，差异均无统计学意义（P ＞0.05）；试验组放射性肺炎〔RR ＝0.49，95% CI（0.34，0.69），P ＜0.0001〕及白细胞计数减少发生率〔RR ＝0.58，95% CI（0.39，0.87）， P ＝0.009〕较对照组降低。结论中医药联合同步放化疗治疗晚期 NSCLC 的 RCT 研究目前开展较少，仍有很大提升的空间；在应用价值方面，两者联用可增加治疗效果，同时降低毒副作用的发生。%December 2013. Relevant journals,conference papers and unpublished literatures were retrieved manually. According to Cochrane system evaluation manual 5. 0,data was extracted from the included literatures,and the quality of the included studies was assessed,and the data analyses were performed by the RevMan 5. 2 software. The objective curative effect,quality of life, immune ability,side effects and survival time were compared between the experiment group and the control group. Results A total of 20 RCT were included. The objective curative effect was evaluated according to solid tumor's effect evaluation criterion by WHO. Meta analysis results showed that the effective rate in experiment group was significantly higher than that in control group〔RR = 1. 83,95% CI ( 1. 31,2. 56 ), P = 0. 000 4 〕, the effective rate in Chinese medicine injection subgroup was significantly higher than that in control group〔RR = 1. 76,95% CI(1. 26,3. 00),P = 0. 002〕. The objective curative effect was evaluated according to RECIST(Response Evaluation Criteria in Solid Tumors),the effective rate in experiment group was significantly higher than that in control group〔 RR = 1. 93,95% CI(1. 24,3. 01),P = 0. 004〕,the effective rate in oral Chinese medicine subgroup was significantly higher than that in control group〔 RR = 1. 90,95% CI(1. 17,3. 09),P =0. 010〕. The KPS score was used to evaluate quality of life,KPS score in experiment group was significantly higher than that in control group〔RR = 3. 16,95% CI(2. 09,4. 77),P < 0. 000 01〕,KPS score in oral Chinese medicine subgroup〔 RR =3. 11,95% CI(1. 81,5. 34),P < 0. 000 1〕and in Chinese medicine injection subgroup〔 RR = 3. 23,95% CI(1. 71, 6. 10),P < 0. 000 1〕was significantly higher than that in control group,respectively,There was no significant difference in proportion of T cells(CD4 + 、CD8 + 、CD4 + / CD8 + )and NK cells between experiment group and control group(P > 0. 05). The incidence of radioactive lung injury〔RR = 0. 49,95% CI(0. 34,0. 69),P < 0. 000 1〕,and reduction in white blood cell counts〔RR = 0. 58,95% CI(0. 39,0. 87),P = 0. 009〕in experiment group was significantly higher than that in control group,respectively. Conclusion There are a small number of RCT on treating advanced NSCLC using TCM combined with concurrent chemoradiotherapy,so there is still much room for improvement. TCM combined with concurrent chemoradiotherapy can improve curative effect and can reduce side effects,thus the combination therapy has good application value.
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