关键词: 特发性肾病综合征, 临床试验, 国际临床试验注册, 儿童

Abstract: ObjectiveTo analyze the clinical research characteristics of clinical trial registration of idiopathic nephrotic syndrome in children at home and abroad.MethodsThe clinical trials about idiopathic nephrotic syndrome in children published from September 31, 2020 were collected by ICTRP, an international clinical trial registration platform, and the database was established. The number of clinical trial registration, distribution, trial design, intervention measures and outcome indicators were analyzed.ResultsA total of 129 related clinical trials were retrieved, which were mainly carried out in India(23.3%), China(13.2%) and Japan(13.2%). The sponsors were mainly universities and medical institutions(68.5%). Most of the studies were intervention clinical studies(76.7%), more than half of which were randomized controlled trials(58.1%). Most of the trial stages were concentrated in stage Ⅲ(28.7%). The main intervention measures were western medicine(97%), and there were 2 items of traditional Chinese medicine intervention and one special diet. The main outcome indicators included the time of first recurrence, clinical remission rate (including partial remission and complete remission) and urinary protein.ConclusionSince 2005, the number of clinical trials registered in children with idiopathic nephrotic syndrome has increased as a whole, but the number of registrations varies greatly in different regions, and the registration information of some trials is incomplete. There is an urgent need to improve the awareness of registration, standardize the registration information of clinical trials, and further strengthen the related researches on clinical standardized management, individualized treatment, genomics and traditional Chinese medicine intervention in children with idiopathic nephritic syndrome.

Key words:

Idiopathic nephrotic syndrome, Clinical trials, International registration of clinical trials, Child