摘要
目的系统评价黄葵胶囊联合血管紧张素转化酶抑制剂(ACEI)/血管紧张素Ⅱ受体阻滞剂(ARB)治疗2型糖尿病肾病Ⅲ期蛋白尿疗效和安全性。方法检索中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中国生物医学文献数据库(CBM)、中文科技期刊数据库(维普网)、PubMed、Cochrane Library、Medline、EMbase建库至2018年1月收录的黄葵胶囊联合ACEI/ARB治疗2型糖尿病肾病Ⅲ期的随机对照试验文献。根据Cochrane Reviewer's Handbook 5.1.0评价工具对纳入文献进行方法学质量评价,采用RevMan5.3软件进行Meta分析。结果纳入文献12篇,涉及884例受试者。Meta分析结果显示:黄葵胶囊联合ACEI/ARB治疗2型糖尿病肾病Ⅲ期尿蛋白,在降低患者尿白蛋白排泄率[SMD=-1.13,95%CI(-1.36,-0.89),Z=9.39,P<0.000 01]、24 h尿蛋白定量[SMD=-0.84,95%CI(-1.18,-0.50),Z=4.85,P<0.000 01)]方面明显优于单纯使用ACEI/ARB,差异有统计学意义。安全性方面[WMD=0.49,95%CI(0.20,1.20),Z=1.56,P>0.000 01)]二者差异无统计学意义。结论黄葵胶囊联合ACEI/ARB治疗2型糖尿病肾病Ⅲ期蛋白尿疗效确切,黄葵胶囊在使用剂量范围内是安全的、有效的辅助药物。但纳入研究质量普遍不高,需更多大样本、多中心、高质量临床随机对照试验进一步验证。
Objective To investigate the efficacy and safety of Huangkui Capsules combined with angiotensin converting enzyme inhibitor(ACEI)or angiotensin II receptor blocker(ARB)in the treatment of type 2 diabetic nephropathy stageⅢproteinuria.Methods Randomized controlled trial literature about Huangkui Capsules combined with ACEI/ARB in the treatment of type 2 diabetic nephropathy stageⅢproteinuria was retrieved from CNKI,Wanfang database,CBM,VIP,PubMed,Cochrane Library,Medline,and EMbase from the building to January 2018.The methodological quality of the included literature was evaluated according to the Cochrane Reviewer's Handbook 5.1.0 evaluation tool,and Meta-analysis was performed using RevMan5.3 software.Results Totally 12 randomized controlled trials were included,involving 884 subjects.The results of Meta-analysis showed that Huangkui Capsules combined with ACEI/ARB in the treatment of type 2 diabetic nephropathy stageⅢproteinuria could better decrease UAER[SMD=-1.13,95%CI(-1.36,-0.89),Z=9.39,P<0.000 01],and 24 h urinary protein quantification[SMD=-0.84,95%CI(-1.18,-0.50]Z=4.85,P<0.000 01]than solely use of ACEI/ARB,with statistical significance.There was no statistical significance in safety[WMD=0.49,95%CI(0.20,1.20),Z=1.56,P>0.000 01]of both groups.Conclusion Huangkui Capsules combined with ACEI/ARB has confirmed efficacy for type 2 diabetic nephropathy stageⅢproteinuria.Huangkui Capsules is a safe and effective auxiliary drug in the dosage range.However, the quality of the included studies is generally not high, and more large-sample, multi-center, high-qualityclinical randomized controlled trials are needed for further validation.
作者
姚志
郑启艳
张冬梅
孙鲁英
张笑笑
赵庆
陈美玲
YAO Zhi;ZHENG Qiyan;ZHANG Dongmei;SUN Luying;ZHANG Xiaoxiao;ZHAO Qing;CHEN Meiling(First Clinical Medical College,Beijing University of Chinese Medicine,Beijing 100700,China)
出处
《中国中医药信息杂志》
CAS
CSCD
2019年第9期99-103,共5页
Chinese Journal of Information on Traditional Chinese Medicine
基金
国家科技支撑计划(2011BAI10B01)
