摘要
目的:研究旨在对治疗慢性肾脏病(CKD)的口服中成药药品信息及临床研究现状进行系统梳理。方法:首先检索临床实践指南和相关药物目录获得治疗CKD的口服中成药;继而检索国内外数据库,筛选口服中成药治疗CKD的临床研究,检索时间自建库至2022年9月25日。采用概况性综述的方法,结合可视化图表对中成药的基本信息和临床研究证据进行分析和展示。结果:研究纳入16种治疗CKD的中成药,包括传统中药方剂5种(均为地黄方制剂),新型中成药11种。传统中药方剂未注明具体对应西医病名,新型中成药根据适应证中标明的西医病名分为慢性肾功能不全、慢性肾衰竭、慢性肾炎3类。有4种中成药为单味中药,其中百令制剂、金水宝制剂均为冬虫夏草菌粉,海昆肾喜胶囊主要成分为褐藻多糖硫酸酯,黄葵胶囊主要成分为黄蜀葵花提取物。药物的功效主要围绕肺脾肾三脏,攻补兼施。共纳入文献892篇。其中百令制剂开展研究最多,其次是尿毒清制剂;研究范围覆盖全国,研究数量整体呈增长趋势。对目标药物为单个中成药,且观察组未与其他中成药或中医疗法联用的临床研究文献进行统计,共475项,其中最多的干预类型是联合常规治疗对比常规治疗,累计占比75.58%。475项研究覆盖了慢性肾脏病、慢性肾衰竭、肾病综合征、糖尿病肾病、免疫球蛋白A(IgA)肾病、膜性肾病等不同类型的肾脏病,涉及到了老年患者、儿童特殊人群。36项研究对中医证候进行评价,体现中医药治疗的特色及优势。结论:治疗CKD的口服中成药品种较多,针对不同肾病类型各有特点,但其药品说明书表述不清,欠缺规范;就该领域的临床研究证据来看,治疗CKD的口服中成药研究范围广,研究类型较丰富,覆盖疾病类型完全,但证据稳健性尚待提高。
Objective:To review the information and clinical studies of oral Chinese patent medicines(CPMs)for chronic kidney disease(CKD).Method:The CPMs for treating CKD were retrieved from the Pharmacopoeia of the People's Republic of China,National Essential Drugs List,and Medicine List for National Basic Medical Insurance,Employment Injury Insurance and Maternity Insurance.China National Knowledge Infrastructure(CNKI),VIP,Wanfang Data,SinoMed,PubMed,Embase,Cochrane,and Web of Science were searched for the clinical trials of the treatment of CKD by CPMs from their inception dates to September 25,2022.A database was established with the collected CPMs,and then the general conditions of the clinical trials were analyzed and presented visually.Result:A total of 16 CPMs for CKD were included in this study,including 5 classical traditional Chinese medicine(TCM)prescriptions involving Rehmanniae Radix and 11 new CPMs.The indications of the TCM prescriptions did not mention the corresponding western disease names,and those of the new CPMs mainly included chronic renal insufficiency,chronic renal failure,and chronic nephritis.Four CPMs were prepared with single Chinese medicine or active components.Specifically,Bailing Preparation and Jinshuibao Preparation were mainly prepared with the powder of Cordyceps,and the main components of Haikun Shenxi capsules and Huangkui capsules were fucoidan sulfate and the flower extract of Abelmoschi Corolla,respectively.The CPMs mainly exerted tonifying and eliminating effects on the lung,spleen,and kidney.A total of 892 clinical trials were screened out,covering all the areas in China and presented an increasing trend.Bailing Preparation was the most studied,followed by Niaoduqing Preparation.Among the 892 studies,475 focused on single CPMs without combination with other CPMs or therapies.These studies mainly compared between conventional intervention and conventional intervention+CPM,which accounted for 75.58%.The 475 studies covered different kidney diseases,such as chronic kidney disease,c
作者
王宇凰
孙鲁英
李苗苗
王悦
李希尧
廖星
WANG Yuhuang;SUN Luying;LI Miaomiao;WANG Yue;LI Xiyao;LIAO Xing(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Fangshan Hospital,Beijing University of Chinese Medicine,Beijing 102400,China;Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Basic Theory for Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2023年第20期99-108,共10页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家科学与技术部重点研发计划项目(2018YFC1704304)
中国中医科学院科技创新工程项目(CI2021A05503,CI2021B003,CI2021A00701-3)。
关键词
概况性综述
中成药
慢性肾脏病
临床研究
review
Chinese patent medicine
chronic kidney disease
clinical research
