摘要
目的系统评价百令胶囊辅助治疗糖尿病肾病的有效性和安全性。方法计算机检索PubMed、中国学术期刊全文数据库(CNKI)、维普中文期刊全文数据库(VIP)、中国生物医学文献数据库(CBM)和万方数据库中有关百令胶囊单独或联合其他药物治疗糖尿病肾病的临床随机对照试验(RCT),检索时间从各数据库建库至2020年1月,按照纳入与排除标准将筛选出的文献进行信息提取与质量评价,采用RevMan5.3软件进行Meta分析。结果共纳入12篇RCTs,包括1011例患者。Meta分析结果显示:与对照组相比,百令胶囊能提高糖尿病肾病患者临床疗效[OR=5.04,95%CI=(3.16,8.03),P<0.00001],并降低尿白蛋白排泄率[SMD=-1.95,95%CI=(-2.74,-1.17),P<0.00001]、血肌酐[SMD=-2.14,95%CI=(-3.57,-0.71),P=0.003]、24 h尿蛋白定量[SMD=-1.56,95%CI=(-2.45,-0.76),P=0.0001]及空腹血糖[SMD=-0.52,95%CI=(-0.59,-0.47),P<0.00001];纳入文献均描述未发生不良反应。结论百令胶囊对糖尿病肾病有一定的疗效且安全性较好,值得临床借鉴;但由于本研究存在一定不足之处,故需质量更高、样本量较大的临床研究进一步证实。
Objective To systematically evaluate the efficacy and safety of Bailing Capsule for treating diabetic kidney disease(DKD).Methods Randomized controlled trials of Bailing Capsule in the treatment of DKD was collected by searching PubMed,CNKI,VIP,CBM and Wanfang databases by computer from inception to January 2020.Extract the information and evaluate the quality of the included literature.RevMan 5.3 software was used for Meta-analysis.Results A total of 12 studies involving 1011 patients were included into the study.The results of meta-analysis showed that Bailing Capsule in the treatment of DKD can improve total effective rate[OR=5.04,95%CI=(3.16,8.03),P<0.00001]and decrease urinary albumin excretion rate[SMD=-1.95,95%CI=(-2.74,-1.17),P<0.00001],serum creatinine[SMD=-2.14,95%CI=(-3.57,-0.71),P=0.003],24-hour urine protein[SMD=-1.56,95%CI=(-2.45,-0.76),P=0.0001]and fasting blood glucose[SMD=-0.52,95%CI=(-0.59,-0.47),P<0.00001].No adverse reactions were reported in all the included literatures.Conclusion Bailing Capsule have certain effect to treat DKD and the safety is good,which is worthy of being learned in clinic.However,there are some deficiencies in this study,so more highquality and large sample clinical studies are still needed to further confirm.
作者
高岩
宋宗良
段玉红
张效科
GAO Yan;SONG Zongliang;DUAN Yuhong;ZHANG Xiaoke(Shaanxi University of Chinese Medicine,Xianyang 712046,China;Affiliated Hospital of Shaanxi University of Chinese Medicine,Xianyang 712000,China)
出处
《药物评价研究》
CAS
2021年第1期161-169,共9页
Drug Evaluation Research
基金
国家自然科学基金资助项目(81774304)
陕西省中医药管理局科研课题(2019-GJ-QT002)。
关键词
百令胶囊
糖尿病肾病
临床疗效
META分析
Bailing Capsule
diabetic kidney disease
clinical efficacy
Meta-analysis