Zheng Kai, Shen Hong, Jia Jia, Lu Yuelin, Zhu Lei, Zhang Lu, Shen Zhaofeng
First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Department of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210029, China.
Trials. 2017 Jan 10;18(1):8. doi: 10.1186/s13063-016-1763-9.
Approximately 20% of patients with ulcerative colitis become steroid dependent. Azathioprine is recommended in steroid-dependent ulcerative colitis, but its side effects limit its use. Chinese herbal medicine has been widely used to treat ulcerative colitis in China. However, its effectiveness in steroid-dependent patients has not been evaluated. This study aims to investigate the efficacy of traditional Chinese medicine combination therapy with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis.
METHODS/DESIGN: This is a parallel, multicenter, randomized controlled trial. One hundred and twenty eligible patients will be randomly assigned to a traditional Chinese medicine group or azathioprine group. All patients will be given basic treatment, which includes steroids and 5-aminosalicylic acid. Patients allocated to the traditional Chinese medicine group will receive basic treatment plus Chinese herbal medicine granules, while patients in the azathioprine group will receive basic treatment plus azathioprine. The whole study will last 24 weeks. The primary outcome measure is the steroid-free remission rate. Secondary outcome measures are health-related quality of life, efficacy of endoscopic response, degree of mucosal healing, and inflammation indicators.
Results from this study may provide evidence for the effectiveness of traditional Chinese medicine combined with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. The findings will provide a basis for further confirmatory studies.
Chinese Clinical Trial Register, ChiCTR-IPR-15005760 . Registered on 2 January 2015.
约20%的溃疡性结肠炎患者会出现激素依赖。对于激素依赖型溃疡性结肠炎，推荐使用硫唑嘌呤，但它的副作用限制了其应用。在中国，中药已被广泛用于治疗溃疡性结肠炎。然而，其在激素依赖型患者中的有效性尚未得到评估。本研究旨在探讨中药联合5-氨基水杨酸治疗激素依赖型溃疡性结肠炎患者的疗效。
方法/设计：这是一项平行、多中心、随机对照试验。120名符合条件的患者将被随机分配至中药组或硫唑嘌呤组。所有患者均接受基础治疗，包括激素和5-氨基水杨酸。分配至中药组的患者将接受基础治疗加中药颗粒，而硫唑嘌呤组患者将接受基础治疗加硫唑嘌呤。整个研究将持续24周。主要结局指标是无激素缓解率。次要结局指标包括健康相关生活质量、内镜反应疗效、黏膜愈合程度和炎症指标。
本研究结果可能为中药联合5-氨基水杨酸治疗激素依赖型溃疡性结肠炎的有效性提供证据。这些发现将为进一步的验证性研究提供依据。
中国临床试验注册中心，ChiCTR-IPR-15005760。于2015年1月2日注册。
