Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial.
Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial.
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中药联合治疗激素依赖性溃疡性结肠炎：随机对照试验研究方案
DOI：
10.1186/s13063-016-1763-9
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发表时间：
2017-01-10
期刊：
影响因子：
2.5
通讯作者：
Shen Z
中科院分区：
文献类型：
--
作者：
Zheng K;Shen H;Jia J;Lu Y;Zhu L;Zhang L;Shen Z
大约20%的溃疡性结肠炎患者成为类固醇依赖者。硫唑嘌呤被推荐用于类固醇依赖性溃疡性结肠炎，但其副作用限制了其使用。中草药治疗溃疡性结肠炎在我国已得到广泛应用。然而，其在类固醇依赖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性溃疡性结肠炎的疗效。方法/设计这是一项平行、多中心、随机对照试验。120例符合条件的患者将被随机分配到中药组或硫唑嘌呤组。所有患者将接受基本治疗，包括类固醇和5-氨基水杨酸。分配到中药组的患者将接受基础治疗加中草药颗粒剂，硫唑嘌呤组的患者将接受基础治疗加硫唑嘌呤。整个研究将持续24周。主要的结局指标是无类固醇缓解率。次要结果的措施是健康相关的生活质量，疗效的内镜反应，粘膜愈合程度，和炎症indicators.DiscussionResults从这项研究中可能提供证据的有效性，中药结合5-氨基水杨酸在类固醇依赖性溃疡性结肠炎患者。研究结果将为进一步的确证性研究提供基础。 ChiCTR-IPR-15005760 .于2015年1月2日注册。
BackgroundApproximately 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/DesignThis 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.DiscussionResults 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.Trial registrationChinese Clinical Trial Register, ChiCTR-IPR-15005760 . Registered on 2 January 2015.