关键词: 痛风, 药物, 临床试验, 注册

Abstract:

Objective： To analyze the development of gout drug clinical trials in China from 2018 to 2023.Methods： Data were extracted from Drug Clinical Trial Registration and Information Disclosure Platform （http：//www.chinadrugtrials.org.cn，hereinafter referred to as the Platform） and the list of accepted varieties of Center for Drug Evaluation of the National Medical Products Administration （NMPA）.Gout drug clinical trials registered on the Platform between January 1， 2018 and December 31， 2023 were retrieved based on the date of initial publicity. The data on gout drug clinical trials were then summarized and analyzed.Results： From 2018 to 2023， a total of 231 gout drug clinical trials were registered on the Platform，and the number of registered projects showed an overall upward trend， with the highest peak in 2021. In terms of the types of investigational drugs， chemical drugs accounted for the largest proportion， and the proportion of biological products and traditional Chinese medicine/natural medicines increased in recent years.From the application type of investigational drugs， innovative drugs are the most， followed by generic drugs. From the stage of trial， bioequivalence trial and phaseⅠ clinical trials accounted for more.From the perspective of indications， there were more gout drug clinical trials for the chronic treatment phase than for the acute phase， which had statistical difference in trial stage， drug category， the setting of date monitoring committee（DMC）， drug clinical trial insurance for subjects .The regional distribution of leading research institutes of gout drug clinical trials was uneven.Most sponsors did not setp up DMC， and most sponsors purchased insurance for trial subjects.Conclusion： From 2018 to 2023， a large number of gout drug clinical trials were carried out in China.Although the conventional gout therapeutic drugs have certain toxic and side effects， they still play an important role in the treatment of gout.The research and development of innovative biological products and traditional Chinese medicine/natural medicine for the acute phase of gout， as well as the research and development of new chemical drugs for the chronic phase of gout are booming. Domestic pharmaceutical enterprises have become the main force in the research and development of gout drugs in China， and international multi-center clinical trials need to be further carried out in the future.

Key words: Gout； , Drug； , Clinical trials； , Registration