金水宝胶囊治疗肾脏疾病的快速卫生技术评估  

Technology Assessment of Jinshuibao Capsules in the Treatment of Renal Disease

作　　者：杭永付[1] 谢诚[1] 张晶晶[1] 李芸[1] 朱建国[1] 缪丽燕[1] 江璐[1] 吴甜甜 HANG Yongfu;XIE Cheng;ZHANG Jingjing;LI Yun;ZHU Jianguo;MIAO Liyan;JIANG Lu;WU Tiantian(Dept.of Pharmacy,the First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215000,China;Dept.of Pharmacy,Zhengzhou Central Hospital Affiliated to Zhengzhou University,Zhengzhou 450007,China)

机构地区：[1]苏州大学附属第一医院药学部,江苏苏州215000 [2]郑州大学附属郑州中心医院药学部,郑州450007

出　　处：《中国医院用药评价与分析》2024年第7期848-852,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：江苏省医学重点学科(No.ZDXK202247);苏州市科技发展计划指导性项目(No.SKYXD2022017)。

摘　　要：目的:运用快速卫生技术评估(HTA)方法,对金水宝胶囊治疗肾脏疾病的有效性、安全性和经济性进行综合评价,为临床提供循证依据佐证用药。方法:检索PubMed、the Cochrane Library等外文数据库和万方数据库、中国知网、维普数据库、中国生物医学文献数据库等中文数据库,国际卫生技术评估机构网络、英国国家卫生与临床优化研究所、加拿大药物和卫生技术局等机构的官方网站及相关数据库,获取金水宝胶囊治疗肾脏疾病的系统评价/Meta分析、HTA报告以及药物经济学研究,检索时限均为建库至2023年6月。根据纳入与排除标准筛选文献、提取资料、评价质量,并对结果进行定性分析。结果:纳入系统评价/Meta分析13篇(11篇涉及糖尿病肾病,2篇涉及慢性肾衰竭),未检索到药物经济学研究和HTA报告。结果显示,金水宝胶囊联合常规治疗/血管紧张素转换酶抑制剂(ACEI)/血管紧张素Ⅱ受体阻断剂(ARB)用于肾脏疾病,临床总有效率优于对照组,在降低血肌酐、血尿素氮、24 h尿蛋白定量、尿微量蛋白排泄率、尿微量白蛋白/尿肌酐、三酰甘油、胱抑素C、尿中N-乙酰-β-D氨基葡萄糖苷酶和提高肌酐清除率方面具有优势;同时,不良反应发生率低且均为轻症,无严重不良事件发生,安全性良好。结论:金水宝胶囊在治疗肾脏疾病中的有效性和安全性较好,未来需要进一步开展药物经济学研究。OBJECTIVE:To evaluate the efficacy,safety and economy of Jinshuibao capsules in the treatment of renal disease by rapid health technology assessment(HTA),so as to provide efficient and convenient evidence-based evidence for the clinic.METHODS:PubMed,the Cochrane Library,Wanfang Data,CNKI,VIP,CBM and other English and Chinese databases,official websites and related databases of institutions such as INAHTA,NICE,and CADTH were searched to obtain the systematic review/Meta-analysis,HTA report and pharmacoeconomic study of Jinshuibao capsules in the treatment of renal disease,the search period was from database establishment to Jun.2023.Literature was screened,information was extracted,quality was evaluated,and results were analyzed qualitatively based on inclusion and exclusion criteria.RESULTS:A total of 13 systematic review/Meta-analysis were enrolled(including 11 studies for diabetic nephropathy and 2 studies for chronic renal failure).Pharmacoeconomic studies and HTA reports were not retrieved.Results showed that Jinshuibao capsules combined with conventional therapy/angiotensin-converting enzyme inhibitors(ACEI)/angiotensin-Ⅱreceptor blockers(ARB)in the treatment of renal disease,the overall response rate was significantly better than that of the control group,and had advantages in reducing serum creatinine,blood erea nitrogen,24 h urine protein quantification,urinary albumin excretion rate,urinary trace albumin/urinary creatinine,triglyceride,cystatin C,urinary N-acetyl-β-D glucosaminidase,and increasing creatinine clearance rate;meanwhile,the incidence of adverse drug reactions was low and mild,with no severe adverse events and higher safety.CONCLUSIONS:The efficacy and safety of Jinshuibao capsules in the treatment of renal diseases are significant,and further pharmacoeconomic research is needed in the future.

关 键 词：金水宝胶囊 肾脏疾病 快速卫生技术评估 

分 类 号：R932[医药卫生—生药学]