肾康注射液联合西药治疗肾病综合征疗效的Meta分析  

Effect of Shenkang Injection Combined with Western Medicine on Nephrotic Syndrome:A Meta-analysis

作　　者：张丽[1,2] 郭静[1,2] 李春晓[2] 杨玉晴 张佳楠 杨亚蕾[1,2] 凌霄 王盼盼[1,2] ZHANG Li;GUO Jing;LI Chun-xiao;YANG Yu-qing;ZHANG Jia-nan;YANG Ya-lei;LING Xiao;WANG Pan-pan(Henan University of Chinese Medicine,Zhengzhou Henan 450046;Henan Engineering Research Center of Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine,Henan Key Laboratory of Traditional Chinese Medicine Clinical Pharmacy,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou Henan 450000)

机构地区：[1]河南中医药大学,河南郑州450046 [2]河南中医药大学第一附属医院,河南省中药临床应用、评价与转化工程研究中心,河南省中药临床药学中医药重点实验室,河南郑州450000

出　　处：《世界中西医结合杂志》2023年第7期1302-1309,1318,共9页World Journal of Integrated Traditional and Western Medicine

基　　金：国家重点研发计划项目(2017YFC1703400);河南省科技攻关项目(232102310476);河南省科技攻关项目(202102310182);河南省中医药拔尖人才培养项目(2022ZYBJ05);河南省中医药科学研究专项课题(2022ZY1049)。

摘　　要：目的系统评价肾康注射液联合西药治疗肾病综合征的临床疗效及安全性。方法检索中国知网、万方数据库、维普中文数据库、中国生物医学文献服务系统、Web of Science、Embase、PubMed及Cochrane Library数据库自建库至2022年6月30日期间所有肾康注射液联合西药治疗肾病综合征(Nephrotic syndrome,NS)的随机对照试验(Randomized controlled trial,RCT),并由两名研究人员提取资料并进行质量评价,采用Review Manager 5.4.1软件和R语言进行Meta分析。结果共纳入19篇文献,涉及1509例患者,治疗组763例,对照组746例。Meta分析结果显示:肾康注射液联合西药较单纯西药治疗肾病综合征可以显著提高临床总有效率[RR=1.27,95%CI(1.20;1.34),P<0.00001]、内生肌酐清除率(Creatinine clearance rate,Ccr)[MD=6.36,95%CI(3.04;9.68),P=0.0002]、血浆白蛋白(Plasma Albumin,ALB)[MD=4.94,95%CI(3.23;6.64),P<0.00001]水平,能有效降低甘油三酯(Triglycerides,TG)[MD=-0.86,95%CI(-1.05;-0.67),P<0.00001]、总胆固醇(Total cholesterol,TC)[MD=-1.44,95%CI(-2.14;-0.74),P<0.00001]、血清肌酐(Serum creatinine,Scr)[MD=-33.60,95%CI(-67.03;-0.17),P<0.00001]、尿素氮(Urea nitrogen,BUN)[MD=-2.47,95%CI(-2.89;-2.05),P<0.00001]、24 h尿蛋白定量(24 h urine total protein,24 h UTP)[MD=-0.57,95%CI(-0.78;-0.35),P<0.00001]水平,且差异有统计学意义。结论肾康注射液联合西药可以提高肾病综合征患者的临床总有效率,提高Ccr和ALB,能有效降低TG、低胆固醇、Scr、BUN和24 h UTP,在一定程度上可以减少肾病综合征患者的肾功能的损伤。Objective To systematically evaluate the clinical efficacy and safety of Shenkang Injection combined with western medicine in the treatment of nephrotic syndrome.Methods All the randomized controlled trials(RCTs)of Shenkang Injection combined with western medicine in the treatment of nephrotic syndrome were retrieved from CNKI,Wanfang Data,VIP,SinoMed,Web of Science,Embase,PubMed,and Cochrane Library with the time interval from inception to June 2022.Two researchers extracted the data and evaluated the quality,and meta-analysis was performed with Review Manager 5.4.1 and R.Results A total of 19 articles were included,involving 1509 patients(763 in the observation group and 746 in the control group).Meta-analysis showed that Shenkang Injection combined with western medicine significantly improved the total response rate[RR=1.27,95%CI(1.20,1.34),P<0.00001],creatinine clearance rate(Ccr)[MD=6.36,95%CI(3.04,9.68),P=0.0002],plasma albumin(ALB)[MD=4.94,95%CI(3.23,6.64),P<0.00001]compared with western medicine alone.Moreover,the combined therapy lowered the levels of triglycerides(TG)[MD=-0.86,95%CI(-1.05,-0.67),P<0.00001],total cholesterol(TC)[MD=-1.44,95%CI(-2.14,-0.74),P<0.00001],serum creatinine(Scr)[MD=-33.60,95%CI(-67.03,-0.17),P<0.00001],urea nitrogen(BUN)[MD=-2.47,95%CI(-2.89,-2.05),P<0.00001],and 24-h urine total protein(24 h UTP)[MD=-0.57,95%CI(-0.78,-0.35),P<0.00001].Conclusion Shenkang Injection combined with western medicine can improve the clinical total response rate by increasing Ccr and ALB,reducing triglycerides,cholesterol,Scr,BUN,and 24 h UTP,and alleviating the damage of renal function in the patients with nephrotic syndrome.

关 键 词：肾康注射液 肾病综合征 META分析 

分 类 号：R692[医药卫生—泌尿科学]