摘要
目的:基于Meta分析和试验序贯分析(TSA),评价黄葵胶囊联合血管紧张素转换酶抑制剂(ACEI)/血管紧张素Ⅱ受体拮抗剂(ARB)类药物治疗早期糖尿病肾病的临床疗效及安全性。方法:检索主要的中英文数据库,收集建库至2021年4月18日有关黄葵胶囊治疗早期糖尿病肾病的随机对照试验(RCT)。由2名研究员进行文献筛选和信息提取,并评价所纳入研究的质量及偏倚风险,采用RevMan 5.3软件进行结局指标的分析,采用TSA 0.9.5.10 Beta软件进行TSA。结果:最终纳入25项RCT,共1 895例患者(研究组949例,对照组946例)。Meta分析结果显示,黄葵胶囊联合ACEI/ARB类药物的治疗方案优于单用ACEI/ARB类药物的治疗方案,其中临床总有效率(RR=1.26,95%CI=1.17~1.34,P<0.000 01)、尿白蛋白排泄率(MD=-17.95,95%CI=-22.45~-13.44,P<0.000 01)、血肌酐水平(MD=-7.24,95%CI=-12.26~-2.23,P=0.005)、血尿素氮水平(MD=-0.33,95%CI=-0.51~-0.14,P=0.000 4)、三酰甘油水平(MD=-0.30,95%CI=-0.38~-0.21,P<0.000 01)和总胆固醇水平(MD=-0.52,95%CI=-0.78~-0.27,P<0.000 1)的差异均有统计学意义;经亚组分析,病程、年龄和疗程可能与尿白蛋白排泄率有关;所有纳入的研究均未报告出现严重不良反应,两组患者不良反应发生率的差异无统计学意义(P>0.05);对尿白蛋白排泄率进行TSA,显示样本量充足,研究组患者的疗效优于对照组,证据确切。结论:黄葵胶囊联合ACEI/ARB类药物治疗早期糖尿病肾病可提高临床总有效率,降低蛋白尿,改善肾功能,调整血脂水平,安全性好,具有一定的临床应用前景。由于纳入的文献质量一般及研究方法学质量不高,仍需更多高质量、多中心、大样本的RCT进行确证。
OBJECTIVE:To evaluate the clinical efficacy and safety of Huangkui capsules combined with angiotensin converting enzyme inhibitors(ACEI)/angiotensinⅡreceptor blockers(ARB)drugs in the treatment of early diabetic nephropathy based on Meta-analysis and trial sequential analysis(TSA).METHODS:Randomized controlled trials(RCT)on Huangkui capsules in the treatment of early diabetic nephropathy were retrieved by searching main databases in Chinese and English from base-building to Apr.18th,2021.Two researchers performed literature screening and information extraction,and evaluated the quality and risk of bias of the enrolled studies.RevMan 5.3 software was adopted to analyze the outcome indicators and TSA 0.9.5.10 Beta software was used for TSA.RESULTS:Finally 25 RCT were enrolled,including 1895 patients(949 patients in research group,946 patients in control group).Results of Meta-analysis indicated the therapeutic regimen of Huangkui capsules combined with ACRI/ARB drugs was better than that of ACRI/ARB drugs alone,of which the differences in clinical total effective rate(RR=1.26,95%CI=1.17-1.34,P<0.00001),urinary albumin excretion rate(MD=-17.95,95%CI=-22.45--13.44,P<0.00001),serum creatinine(MD=-7.24,95%CI=-12.26--2.23,P=0.005),serum blood urea nitrogen(MD=-0.33,95%CI=-0.51--0.14,P=0.0004),triacylglycerol(MD=-0.30,95%CI=-0.38--0.21,P<0.00001)and total cholesterol levels(MD=-0.52,95%CI=-0.78--0.27,P<0.0001)were statistically significant;through subgroup analysis,the course of disease,patients’ages and course of treatment may be related to urinary albumin excretion rate;no severe adverse drug reactions were reported in all enrolled studies,and the difference in the incidences of adverse drug reactions between two groups was not statistically significant(P>0.05);TSA of urinary albumin excretion rate showed that the sample size was sufficient and the efficacy of research group was better than that of the control group,with definite evidence.CONCLUSIONS:Huangkui capsule combined with ACEI/ARB drugs in the treatment of early diabetic nephropathy can improve the clinical total effective rate,reduce proteinuria,improve renal function,adjust blood lipid levels,with good safety and certain clinical application prospects.Due to the general quality of the enrolled literature and the low quality of the study methodology,more high-quality,multicenter,large-sample RCT are still needed for corroboration.
作者
张苗苗
张庆
李冰
翟文生
赵沛东
张晓涵
ZHANG Miaomiao;ZHANG Qing;LI Bing;ZHAI Wensheng;ZHAO Peidong;ZHANG Xiaohan(School of Pediatrics,Henan University of Chinese Medicine,Zhengzhou 450000,China;The First Clinical Medical College,Henan University of Chinese Medicine,Zhengzhou 450000,China;Dept.of Pediatrics,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China)
出处
《中国医院用药评价与分析》
2023年第3期329-338,共10页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
国家自然科学基金面上项目(No.81873339)。
