肾炎康复片治疗糖尿病肾病回顾性临床分析  

Retrospective study on Shenyan Kangfu tablet in the treatment of diabetes kidney disease

作　　者：许苑 王佳[2] 杨艳辉 李荣[4] 杨虎 单春艳[3] XU Yuan;WANG Jia;YANG Yanhui;LI Rong;YANG Hu;SHAN Chunyan(Department of Nephrology,Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510030,Guangdong Province,China;Tianjin Tongrentang Group Co.,LTD.,Tianjin 300380,China;Department of Nephrology,Chu Hsien-I Memorial Hospital&Tianjin Institute of Endocrinology of Tianjin Medical University,NHC Key Laboratory of Hormones and Development,Tianjin Key Laboratory of Metabolic Diseases,Tianjin 300134,China;Department of Nephrology,the Second Hospital of Tianjin Medical University,Tianjin 300211,China)

机构地区：[1]广州中医药大学第二附属医院,广东省中医院肾内科,广东广州510030 [2]天津同仁堂集团股份有限公司,天津300380 [3]天津医科大学朱宪彝纪念医院/天津市内分泌研究所肾病内科,国家卫健委激素与发育重点实验室,天津市代谢性疾病重点实验室,天津300400 [4]天津医科大学第二医院肾内科,天津300211

出　　处：《世界临床药物》2024年第10期1078-1084,共7页World Clinical Drug

基　　金：天津同仁堂集团股份有限公司中央引导地方科技发展资金(21ZYCGSY00690);广州中医药大学第二附属医院横向课题(2022KT1038)。

摘　　要：目的收集糖尿病肾病(diabetic kidney disease,DKD)患者肾炎康复片疗程中的病历资料,分析肾炎康复片在真实世界中治疗DKD的临床特点及对肾功能的改善作用。方法基于医院电子病历信息系统,收集2016年10月1日至2021年10月31日处方肾炎康复片的503例DKD患者病例信息,分析肾炎康复片在真实世界中的用药人群特征、用药疾病分布情况、肾功能改善情况、安全性及合并治疗方案,评估其有效性和安全性。结果在服用肾炎康复片的DKD患者中,年龄主要集中在30~80岁,其中50~60岁占33.20%,60~70岁占30.22%;男性多于女性(67.40%vs 32.60%)。结果示,肾炎康复片可显著降低24 h尿蛋白、尿白蛋白与肌酐比值(urinary protein/creatinine ratio,ACR)、糖化血红蛋白(glycosylated hemoglobin,Hb)A1c等指标。在服用肾炎康复片3个月后,24 h尿蛋白水平升高,血红蛋白、血清白蛋白、HbA1c水平降低;在3~6个月,24 h尿蛋白、肌酐、HbA1c水平降低;在6个月过后,ACR水平升高,24 h尿蛋白及HbA1c水平降低。用药期间未见不良反应记录,安全性较好。临床合并用药主要包括血糖控制药物、血压控制药物及调脂药物等。结论临床上DKD患者应用肾炎康复片较多,初步显示肾炎康复片联合常规西医治疗DKD安全、有效。Objective To collect the medical records of patients with diabetic kidney disease(DKD)during the course of Shenyan Kangfu tablets,and to analyze the clinical features of Shenyan Kangfu tablets in the treatment of DKD and the improvement of renal function in the real world.Methods Based on the hospital electronic medical record information system,503 cases of DKD patients with prescription Shenyan Kangfu tablets from October 1,2016 to October 31,2021 were collected to analyze the characteristics of the population taking Shenyan Kangfu tablets in the real world,the distribution of drug diseases,the improvement of renal function,the safety and the combined treatment plan,and to evaluate its efficacy and safety.Results The age of DKD patients taking Shenyan Kangfu tablets was mainly 30~80 years old,of which 50~60 years old accounted for 33.20%and 60~70 years old accounted for 30.22%.There were more males than females(67.40%vs 32.60%).The results showed that Shenyan Kangfu tablets could significantly reduce urinary protein,urinary albumin/creatinine ratio(ACR),glycosylated hemoglobin(Hb)A1c and other indexes at 24 h.After taking Shenyan Kangfu tablets for 3 months,24 h urinary protein level increased,hemoglobin,serum albumin,HbA1c levels decreased.During 3 to 6 months,24 h urinary protein,creatinine and HbA1c levels decreased.After 6 months,ACR levels increased and 24 h urinary protein and HbA1c levels decreased.No adverse reactions were recorded during the administration,and the safety was good.Clinical drug combinations mainly include blood glucose control drugs,blood pressure control drugs,lipid-regulating drugs,etc.Conclusion There are more DKD patients using Shenyan Kangfu tablet in clinical practice,and the preliminary results show that Shenyan Kangfu tablet combined with conventional western medicine treatment of DKD is safe and effective.

关 键 词：肾炎康复片 糖尿病肾病 回顾性研究 

分 类 号：R587.2[医药卫生—内分泌] R692.9[医药卫生—内科学]