首页|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

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

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  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
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.

Chinese medicine5-aminosalicylic acidUlcerative colitisReal-world studyStudy protocolObservational study

Xinyu Zhang、Yuan Li、Ping Li、Yunze Liu、Junmei Zhang、Jingwei Wu、Qi Wang、Xia Ding

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Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing,100070,China

Department of Gastroenterology,Beijing Erlonglu Hospital,Beijing,100120,China

National Institute of Traditional Chinese Medicine Constitution and Preventive Medicine,Beijing University of Chinese Medicine,Beijing 100029,China

Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100070,China

School of Traditional Chinese Medicine.Beijing University of Chinese Medicine,Beijing 102488,China

School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing,102488,China

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2024

10.1016/j.jtcms.2024.05.001

中医科学杂志(英文)
北京中医药大学,清华大学出版社有限公司

中医科学杂志(英文)

ISSN：2095-7548
年,卷(期)：2024.11(4)