Treatment of active ulcerative colitis with Yinmei Kuijie decoction combined with 5-aminosalicylic acid:A non-randomized multicenter prospective observational protocol based on real-world conditions  

作　　者：Xinyu Zhang Yuan Li Ping Li Yunze Liu Junmei Zhang Jingwei Wu Qi Wang Xia Ding 

机构地区：[1]Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing,100070,China [2]Department of Gastroenterology,Beijing Erlonglu Hospital,Beijing,100120,China [3]National Institute of Traditional Chinese Medicine Constitution and Preventive Medicine,Beijing University of Chinese Medicine,Beijing,100029,China [4]School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing,102488,China

出　　处：《Journal of Traditional Chinese Medical Sciences》2024年第4期423-427,共5页中医科学杂志（英文）

基　　金：supported by the Key Project of Traditional Chinese Medicine in Anhui Province(202303a07020003);Basic Research Expenses of Beijing University of Chinese Medicine(2024-JYB-JBZD-044);Vertical Development Fund of Beijing University of Chinese Medicine(2023-ZXFZJJ-005).

摘　　要：Objective:To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-ami-nosalicylic acid(5-ASA)in treating mildly to moderately active ulcerative colitis(UC)under real-world conditions.Methods:This multicenter,prospective,non-randomized,observational study will be conducted in real-world settings.A total of 204 eligible patients will be consecutively enrolled in the study.Patients in the combination treatment group will receive Yinmei Kuijie decoction in combination with 5-ASA,whereas those in the control group will be treated with 5-ASA alone.The primary endpoint will be a clinical response at week 12,defined as a≥3 point and≥30%reduction from baseline in the Mayo total score with≥1 reduction in rectal bleeding or rectal bleeding score=0 or 1.Secondary efficacy endpoints at week 12 will include health-related quality of life,mucosal healing,and inflammation indicators.Conclusion:The results of this study may provide evidence of the efficacy and safety of Yinmei Kuijie decoction combined with 5-ASA in treating patients with mildly to moderately active UC under real-world principles.The results will provide a basis for further confirmatory studies on the efficacy of Yinmei Kuijie decoction.

关 键 词：Chinese medicine 5-aminosalicylic acid Ulcerative colitis Real-world study Study protocol Observational study 

分 类 号：R285.5[医药卫生—中药学]