The efficacy of mesalazine on nonspecific terminal ileal ulcers: A randomized controlled trial.

The efficacy of mesalazine on nonspecific terminal ileal ulcers: A randomized controlled trial.
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美沙拉秦对非特异性回肠末端溃疡的疗效:一项随机对照试验

DOI:
10.3389/fphar.2022.989654
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发表时间:
2022
影响因子:
5.6
通讯作者:
--
中科院分区:
医学2区
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--
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背景:非特异性末端回肠溃疡是末端回肠常见的溃疡性疾病之一。然而,关于治疗效果的研究很少。我们的目的是研究美沙拉秦治疗这种疾病的疗效。研究方法:入选2016年4月至2019年1月在武汉协和医院消化内科门诊就诊的82例非特异性末端回肠溃疡患者,随机分为两组。实验组口服美沙拉秦,4.0g/d,1次/d,疗程3个月。对照组不做特殊干预,随访观察。主要终点是第6个月和第12个月的内镜缓解率。次要终点包括第1、6和12个月的临床缓解率和不良事件(ChiCTR 1900027503)。结果如下:内镜下疗效:治疗6个月时,试验组和对照组的缓解率分别为73.2%和61.0%(RR = 1.20,95%CI 0.88 ± 1.63,p = 0.24);治疗12个月时,试验组和对照组的缓解率分别为87.8%和78.0%(RR = 1.13,95%CI 0.92 ± 1.37,p = 0.24)。在临床疗效方面,治疗1个月时缓解率为70.3%,对照组为43.8(RR = 1.61,95%CI 1.03 - 2.51,p = 0.03),第6个月时为83.8 vs 68.8%(RR = 1.22,95%CI 0.93 ± 1.60,p = 0.14),第12个月时为91.9 vs 81.3%(RR = 1.13,95%CI 0.93 ± 1.37,p = 0.34)。在随访期间,没有患者被诊断为克罗恩病或肠结核,也没有患者发生重大并发症。结论:对于非特异性末端回肠溃疡患者,短期内没有疾病进展。此外,接受美沙拉秦治疗的患者与接受随访但未进行特殊干预的患者在临床或内窥镜检查疗效方面没有显著差异。
Background: Nonspecific terminal ileal ulcers are one of the common ulcerative diseases in terminal ileum. However, the studies about treatment efficacy are scarce. We aimed to investigate the efficacy of mesalazine in the treatment of this disease. Methods: Eighty-two patients with nonspecific terminal ileal ulcers who sought outpatient medical treatment in the Division of Gastroenterology, Wuhan Union Hospital, from April 2016 to January 2019 were enrolled and randomly divided into two groups. The experimental group took mesalazine orally, 4.0 g/d, once a day for 3 months. The control group was followed up without special intervention. The primary endpoint was the endoscopic remission rate at the 6th and 12th month. Secondary endpoints included the clinical remission rate at the 1st, 6th and 12th month and adverse events (ChiCTR1900027503). Results: About the endoscopic efficacy, the remission rate of the experimental group and control group was 73.2 versus 61.0% at the 6th month (RR = 1.20, 95%CI 0.88∼1.63, p = 0.24) and 87.8 versus 78.0% at the 12th month (RR = 1.13, 95%CI 0.92∼1.37, p = 0.24). About the clinical efficacy, the remission rate was 70.3 versus 43.8% at the 1st month (RR = 1.61, 95%CI 1.03∼2.51, p = 0.03), 83.8 versus 68.8% at the 6th month (RR = 1.22, 95%CI 0.93∼1.60, p = 0.14) and 91.9 versus 81.3% at the 12th month (RR = 1.13, 95%CI 0.93∼1.37, p = 0.34). During follow-up, no patients were diagnosed with Crohn’s disease or intestinal tuberculosis, and no patients developed significant complications. Conclusion: For patients with nonspecific terminal ileal ulcers, there is no disease progression over a short term. In addition, there is no significant difference in clinical or endoscopic efficacy between patients who received mesalazine and patients who are followed up without special intervention.
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