【摘要】 目的采用系统评价与Meta分析的方法,评价康艾注射液辅助治疗乳腺癌的疗效与安全性。方法制定检索策略,通过网络检索Cochrane图书馆、PubMed、Embase、中文科技期刊全文数据库、万方数据库、中国期刊全文数据库、中国生物医学文献数据库,全面查找乳腺癌常规化疗联合康艾注射液的随机对照临床试验。按照纳入和排除标准筛选文献,采用Cochrane协作网偏移风险评价工具进行质量评价,利用Revman 5.3统计学软件进行Meta分析。采用Q检验与I2统计量评价研究异质性,根据异质性不同采用随机效应模型与固定效应模型合并效应量,并用森林图展示。结果纳入13项RCT,共910例患者。Meta分析结果表明,研究组与对照组在化疗有效率、生活质量改善率、体重增加和稳定率等主要结局指标方面无显著差异(P>0.05)。在次要结局指标方面,研究组Ⅰ-Ⅳ级白细胞减少(RR=0.78,95%CI=0.70～0.86,P<0.00001)、Ⅱ-Ⅳ级白细胞减少(RR=0.61,95%CI=0.43～0.88,P=0.009)、血小板减少(RR=0.24,95%CI=0.12～0.50,P=0.0001)、肝功能损伤(RR=0.59,95%CI=0.44～0.80,P=0.0007)的发生率均较对照组明显降低;两组肾功能损伤、胃肠道反应及脱发的发生率比较,差异无统计学意义(P>0.05)。结论康艾注射液可降低化疗药物引起的部分毒副作用,但由于原始研究质量较低,纳入研究数量不足,上述结论有待高质量、大样本、多中心的长期研究进一步验证。更多还原

【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 combined 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 Metaanalysis 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 thrombocytopenia(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.更多还原