复方苦参注射液联合NP方案治疗中晚期非小细胞肺癌的系统评价*

目的从循证医学的角度系统评价复方苦参注射液联合NP方案治疗非小细胞肺癌的疗效和安全性。方法计算机检索MEDLINE、EMBASE、CochraneI临床对照试验资料库、中国Cochrane中心临床对照试验资料数据库、中国生物医学文献数据库，以上数据库均检索至2010年12月。获取和评价有关复方苦参注射液联合NP方案治疗中晚期非小细胞肺癌的随机对照试验。治疗组采用复方苦参注射液联合NP方案，对照组采用单纯NP方案。并采用RevMan5．0软件对纳入的合格文献进行系统评价。结果9个随机对照试验纳入系统评价，均为7adad评分小于等于3分的低质量研究，共287例患者。5个研究纳入Meta分析，复方苦参注射液联合NP方案治疗中晚期非小细胞肺癌在近期疗效和生活质量改善评分上均优于单纯NP方案组，两组近期疗效差异具有统计学意义OR 1．75，95％CI（1．06，2．89），P〈0．05]；两组生活质量改善的Kamofsky评分差异有统计学意义OR2．38，95％CI（1．43，3．95），P〈0．001]。在安全性方面，运用复方苦参注射液联合NP方案时，骨髓抑制和消化道反应的发生率均低于单纯运用NP方案，两组骨髓抑制发生率的差异有统计学意义OR0．23，95％CI（0．13，0．41），P〈0．00001]；两组消化道反应的发生率差异具有统计学意义OR0．32，95％CI（0．18，0．55），P〈0．0001]。结论现有有限证据表明，复方苦参注射液联合NP方案治疗中晚期非小细胞肺癌的疗效优于单纯NP方案的同时不良反应发生率更低，即安全性更好。但由于受纳入研究的数量和质量的限制，复方苦参注射液联合NP方案治疗中晚期非小细胞肺癌的疗效与安全性需更多高质量的随机、双盲、安慰剂对照临床试验加以验证。

A systematic review for compound Kushen injection combined with NP model chemotherapy for the treatment of advanced stage of non-small cell lung cancer

Objective To systematically appraise the effectiveness and safety of compound Kushen injection combined with NP model chemotherapy for non-small cell lung cancer （ NSCLC ）, in order to provide an evidence based guidance for clinical practice. Method Reports of clinical trials on compound Kushen injection combined with NP model chemotherapy for NSCLC were extensively retrieved from MEDLINE, EMBASE, Coehrane RCT database, Chinese central controlled clinical trial data base,CBMdise, and databases mentioned above till Dec.2010,in order to get and appraise RCTs which have something to do with compound Ku, shen injection combinod with NP model chemotherapy for NSCLC, that is to say only NP modal chemotherapy in control group, while compound Kusben injection combined with NP modal chemotherapy in treatment group. Results Nine randomized controlled trials were included in the systematic review. All the studies were assessed as poor-quality ones by the methodological quality appraisal, which including 287 cases. And five RCTs were included into Meta-analysis at last. The Meta-analysis showed that the treatment of compound Kusben injection and NP model chemotherapy integrated for NSCLC revealed a higher short-term effectiveness power and KlX3 score than NP model chemotherapy only, there has statistical significance in differences between treatment and control group. The adds ratio （OR） value and 95%CI on the two outcomes were 1.75 （1.06,2.89）and 2.38 （1.43,3.95）,respetively. Besides, the combination of compound Kushen injection and NP chemotherapy had lower currence of digestive reaction and myelo-suppression. The OR value and 95%CI on the two outcomes were 0.23 （0.13-0.41） and 0.32 （0.18-0.55）, respectively. Conclusion Present limited evidence show that the combination of compound Kusben injection and NP model chemotherapy may have ~tter effectiveness power and safety for NSCLC than the regular NP model chemotherapy had. Because of quantity and quality of RCTs got, the effectiveness and safety of compound Kushen injection on NSCLC should be proofed by many more RCTs with high quality, double-bhnd and pla eel30.