生血宁片治疗肿瘤相关性贫血有效性和安全性的Meta分析

Efficacy and Safety of Shengxuening Tablets in the Treatment of Cancer-related Anemia:A Meta-analysis

目的:系统评价生血宁片治疗肿瘤相关性贫血(CRA)的疗效和安全性,旨为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国期刊全文数据库、中文科技期刊全文数据库、万方数据、中国生物医学文献数据库,收集生血宁片单用或联合常规治疗(试验组)对比常规治疗或空白对照(对照组)治疗CRA的随机对照试验(RCT),检索时限为建库起至2019年7月。筛选文献、提取数据并采用Cochrane干预措施系统评价手册3.0.2提供的偏倚风险评估工具评价纳入文献质量后,采用Rev Man 5.3软件进行Meta分析。结果:共纳入9项RCT,合计681例患者。Meta分析结果显示,试验组患者治疗后红细胞计数[MD=0.62,95%CI(0.30,0.93),P=0.0001]、红细胞压积水平[MD=6.12,95%CI(4.97,7.27),P<0.00001]、血红蛋白水平[MD=7.47,95%CI(5.29,9.66),P<0.00001]、白细胞计数[MD=0.31,95%CI(0.12,0.50),P=0.001]、血小板计数[MD=3.06,95%CI(0.84,5.28),P=0.007],功能状态评分[MD=5.15,95%CI(2.79,7.51),P<0.0001]、生存质量评分[MD=28.27,95%CI(19.27,37.28),P<0.00001]均显著高于对照组,不良反应发生率[RR=0.14,95%CI(0.03,0.76),P=0.02]显著低于对照组。结论:生血宁片治疗CRA的疗效与安全性均较好。

OBJECTIVE:To systematically evaluate efficacy and safety of Shengxuening tablets in the treatment of cancerrelated anemia(CRA),and to provide evidence-based reference for clinical drug use. METHODS:Retrieved from the Cochrane Library,PubMed,Embase,CJFD,CSJD,Wanfang database and CBM,RCTs about Shengxuening tablets alone or combined with routine therapy(trial group)versus routine therapy or blank control(control group)in the treatment of CRA were collected from inception to July 2019. After literature screening and data extraction, quality evaluation of included literatures with system evaluation bias risk evaluation tool provided by Cochrane intervention measure system evaluation manual 3.0.2,Meta-analysis of the included literatures was carried out by using Rev Man 5.3 software. RESULTS:A total of 9 RCTs involving 681 patients were included. Results of Meta-analysis showed that red blood cell count [MD=0.62,95%CI(0.30,0.93),P=0.000 1],hematocrit level[MD=6.12,95%C(I4.97,7.27),P<0.000 01],hemoglobin level [MD=7.47,95%C(I5.29,9.66),P<0.000 01],white blood cell count [MD=0.31,95% CI(0.12,0.50),P=0.001],platelet count [MD=3.06,95% CI(0.84,5.28),P=0.007],KPS score[MD=5.15,95% CI(2.79,7.51),P<0.000 1],quality of life score [MD=28.27,95% CI(19.27,37.28),P<0.000 01] after treatment in trial group were significantly higher than control group,while the incidence of ADR [RR=0.14,95%CI(0.03,0.76),P=0.02] in trial group was significantly lower than control group. CONCLUSIONS:Shengxuening tablets have good efficacy and safety in the treatment of CRA.