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目的 系统评价复方苦参注射剂用于辅助治疗中晚期肺癌的疗效及安全性,为临床提供循证参考.方法 计算机检索PubMed、Embase、Cochrane图书馆、中国知网、中国生物医学文献数据库、万方数字化期刊全文库、维普数据库、ClinicalTrials数据库,检索其建库到2017年1月发表的复方苦参注射剂联合放化疗用于治疗晚期肺癌的随机对照试验(RCT),对其进行质量评估,对符合要求的所有文献研究结果进行Meta分析.结果 最终纳入29项随机对照研究,合计2 726例患者.Meta分析结果显示:治疗组治疗有效率、临床受益率、Kamofsky评分改善率显著高于对照组(P＜0.01),肝肾功能损害、便秘、严重骨髓抑制、严重消化道反应发生率显著低于对照组(P＜0.01).结论 复方苦参注射剂联合放化疗治疗肺癌疗效优于单纯放化疗,可提高患者生存质量,降低放化疗引起的不良反应.“,”AIM To systematically review the efficacy and safety of compound sophora injection(CSI) used in adjuvant therapy of advanced lung cancer,and provide evidence-based reference for clinic.METHODS The databases of PubMed,Embase,Cochrane Library,CNKI,CBM,Wanfang,VIP and Clinical Trials were retrieved from databases establish time to Januany 2017,and randomized controlled trials (RCTs) about CSI combined with radiotherapy or chemotherapy in the treatment of advanced lung cancer were collected.Quality assessment was conducted and eligible results were included in Meta analysis.RESULTS Totally 29 RCTs were included,involving 2 726 patients.Results of Meta analysis showed that the effective rate,clinical benefit rate and improvement rate of Kamofsky scores in test group were significantly higher than control group (P ＜0.01).The incidence of hepatorenal damage,constipation,severe bone marrow suppression and severe gastrointestinal reaction were significantly lower than control group (P ＜ 0.01),with statistical significances.CONCLUSION CSI combined with radiotherapy or chemotherapy is superior to conventional radiotherapy or chemotherapy alone in the treatment of lung cancer,which can improve life quality in patients and reduce the adverse reactions induced by chemo thearpy.