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目的:系统评价参一胶囊联合化疗治疗非小细胞肺癌的安全性和有效性。方法:利用计算机和手工方式检索中国期刊全文数据库(CNKI),中文科技期刊全文数据库、PubMed和Cochrane图书馆。检索参一胶囊联合化疗治疗非小细胞肺癌的随机对照临床研究。3位研究者对文献质量进行独立的评价,由Cochrane Collaboration′s software RevMan5.0.1进行Meta分析。结果:共有7项研究被纳入本系统评价,纳入病例535例。Meta分析显示参一胶囊联合化疗治疗非小细胞肺癌与单纯化疗相比,化疗缓解率显著增高(PetoOdds Ratio=2.25,95%CI=1.68~3.76),显著改善患者KPS评分(PetoOdds Ratio=3.57,95%CI=2.19~5.83),延长患者的中位生存期(MD=2.98,95%CI=1.02~4.94)。化疗的毒副反应两组基本相同。结论:参一胶囊联合化疗治疗非小细胞肺癌比单纯化疗有效,不增加化疗的毒副反应。这一证据需要更大规模的多中心随机临床对照研究进一步验证。
Objective: To systematically evaluate the safety and efficacy of “Shen capsule” combined with chemotherapy in the treatment of non-small cell lung cancer. Methods: The Chinese Journal Full-text Database (CNKI), Full-text Database of Chinese Sci-tech Periodicals, PubMed and the Cochrane Library were retrieved by computer and manual methods. A Randomized Controlled Clinical Study of Shen Capsule Combined with Chemotherapy for Non - small Cell Lung Cancer. Three researchers independently evaluated the quality of the literature and performed a meta-analysis by the Cochrane Collaboration’s software RevMan 5.0.1. Results: A total of seven studies were included in this review and included 535 cases. Meta-analysis showed that the chemotherapy response rate was significantly higher in patients with non-small cell lung cancer treated with one capsule combined with chemotherapy (Peto Odds Ratio = 2.25, 95% CI = 1.68-3.76), significantly improved KPS score (Peto Odds Ratio = 3.57, 95% CI = 2.19-5.83), prolonging the median survival of patients (MD = 2.98, 95% CI = 1.02 ~ 4.94). The side effects of chemotherapy are basically the same. Conclusion: Shen-capsule combined with chemotherapy is more effective than chemotherapy alone in the treatment of non-small cell lung cancer, without increasing the toxicity of chemotherapy. This evidence requires further validation from larger, multicenter, randomized controlled trials.