肿瘤药学2019,Vol.9Issue(5):813-818,832,7.DOI:10.3969/j.issn.2095-1264.2019.05.23
康艾注射液辅助治疗乳腺癌随机对照临床试验的Meta分析★
Efficacy and Safety of Kang’ai Injection in Adjuvant Treatment of Breast Cancer: A Meta-Analysis Based on RCTs★
摘要
Abstract
Objective To review the therapeutic efficacy and safety of Kang'ai injection in the adjuvant therapy of breast cancer. Methods According to include and exclude criterion and searching strategy, randomized controlled trials (RCTs) of Kang'ai injection com-bined with conventional chemotherapy for the treatment of breast cancer were screened out from the Cochrane library, PubMed, Embase, VIP database, Wangfang database, CNKI and Chinese Biological and Medical Database(CBM). Literatures were screened according to the inclusion criteria, and the quality was evaluated by Cochrane Collaborative Network Migration Risk Assessment Tool, followed by Meta-analysis using Revman 5.3 statistical software. Q-test and I2 statistics were used to evaluate the heterogeneity. Random effect model and fixed effect model were used to merge the effects according to the heterogeneity, and forest maps were used to show the effects. Results A total of 13 RCTs were included, involving 910 patients. Meta-analysis showed that there were no significant differences in the main outcome indicators between the research group and the control group in the efficiency of chemotherapy, the improvement rate of quality of life, weight gain and stability. Secondary outcome indicators included reduced incidence of grade Ⅰ-Ⅳ leukopenia (RR=0.78, 95% CI=0.70~0.86, P<0.00001), decreased incidence of grade Ⅱ-Ⅳ leukopenia (RR=0.61, 95% CI=0.43~0.88, P=0.009), decreased incidence of thrombo- cytopenia (RR=0.24, 95% CI=0.12~0.50, P=0.0001), and decreased incidence of liver injury (RR=0.59, 95% CI=0.44~0.80, P=0.0007). There was no significant difference in the incidence of renal function injury, gastrointestinal adverse reactions and alopecia. Conclusion Kang'ai injection in adjuvant treatment of breast cancer can decrease part of toxic and side-effects, but it also need high-quality large-scale long-term studies for further validation.关键词
康艾注射液/乳腺癌/Meta分析Key words
Kang’ai injection/Breast cancer/Meta-analysis分类
医药卫生引用本文复制引用
邓晔,邓紫薇,仇成凤,金远香,龚璐,王宏强,欧阳素英,史志华..康艾注射液辅助治疗乳腺癌随机对照临床试验的Meta分析★[J].肿瘤药学,2019,9(5):813-818,832,7.基金项目
湖南省卫生计生委科研计划项目(20191164). (20191164)