基于Meta分析的复方苦参注射液治疗乳腺癌系统评价研究  

Systematic Review on Compound Kushen Injection in Treatment of Breast Cancer Based on Meta Analysis

作　　者：郑捷文[1] 刘殊羽 王凯欢 吴嘉瑞[1] 段笑娇 倪梦蔚 ZHENG Jiewen;LIU Shuyu;WANG Kaihuan;WU Jiarui;DUAN Xiaojiao;NI Mengwei(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 100102,China)

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《中国医院用药评价与分析》2018年第8期1015-1020,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家自然科学基金项目(No.81473547;81673829)

摘　　要：目的:系统评价复方苦参注射液联合化疗治疗乳腺癌的临床疗效及安全性,为临床治疗与合理用药提供循证医学依据。方法:计算机检索中国期刊全文数据库、中文科技期刊全文数据库、万方数据库、中国生物医学文献数据库、PubMed、Embase和the Cochrane Library等数据库,检索时间为建库至2018年5月1日,全面检索复方苦参注射液治疗乳腺癌的随机对照试验(对照组患者采用化疗,观察组患者在对照组基础上加用复方苦参注射液),采用Cochrane风险评价表评价其研究质量,提取资料并通过RevMan5.3软件进行文献荟萃分析(Meta分析)。结果:共纳入24篇文献,累计受试者1 896例。Meta分析结果显示,观察组患者临床治疗总有效率(RR=1.33,95%CI=1.19~1.48,P<0.000 01)明显高于对照组,生活质量改善情况明显优于对照组(RR=1.63,95%CI=1.33~2.01,P<0.000 01),白细胞计数降低发生率(RR=0.53,95%CI=0.45~0.61,P<0.000 01)、胃肠道反应发生率(RR=0.58,95%CI=0.51~0.66,P<0.000 01)明显低于对照组,肝功能异常改善情况明显优于对照组(RR=0.29,95%CI=0.19~0.45,P=0.000 01),上述差异均有统计学意义。结论:复方苦参注射液联合化疗治疗可以显著提高乳腺癌患者临床治疗总有效率,改善患者生活质量,减少不良反应的发生。但本研究结论尚需更多设计良好的大样本随机对照、双盲试验加以证实。OBJECTIVE： To systematically review the clinical efficacy and safety of compound Kushen injection in treatment of breast cancer,so as to provide evidence-based references for rational medication. METHODS： Randomized controlled trials on compound Kushen injection in treatment of breast cancer（ the control group was given chemotherapy,the observation group was given compound Kushen injection combined with chemotherapy） from database-building to May 1st,2018 were retrieved from CNKI,VIP,Wanfang,CBM,PubMed,Cochrane Library and Embase. Cochrane bias assessment tool was adopted to evaluate the literature quality,data extracting was conducted and RevMan 5. 2 was used to carry out Meta analysis. RESULTS： A total of 24 studies was involved,including 1 896 subjects. Results of Meta analysis indicated the clinical total effective rate of observation group was significantly higher than that of the control group（ RR = 1. 33,95% CI = 1. 19-1. 48,P〈0. 000 01）,the improvement of life quality（ RR = 1. 63,95% CI = 1. 33-2. 01,P〈0. 000 01）,incidence of white blood cell count decreasing（ RR = 0. 53,95% CI = 0. 45-0. 61,P〈0. 000 01） and incidence of gastrointestinal reaction（ RR = 0. 58,95% CI = 0. 51-0. 66,P〈0. 000 01） of observation group were significantly lower than those of the control group,the improvement of abnormal liver function of observation group was significantly better than that of the control group（ RR = 0. 29,95% CI = 0. 19-0. 45,P = 0. 000 01）,all with statistically significantly differences.CONCLUSIONS： The combination of compound Kushen injection with chemotherapy can significantly improve the total efficacy and patients＇ life quality in treatment of breast cancer,with few adverse drug reactions. However,this conclusion still needs further verification by double blind trials and RCT with better design and larger sample.

关 键 词：复方苦参注射液 乳腺癌 系统评价 随机对照试验 

分 类 号：R932[医药卫生—生药学]