甲苯达唑联合美沙拉明提高溃疡性结肠炎患者的疗效和维持治疗:一项初步研究。

IF 2.8 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Moein Eskandari, Ayat Heydar-Abdolamir Alkhafaji, Abdulridha Mohammed Al-Asady, Hamideh Naimi, Amir Mahmoud Ahmadzadeh, Amir Avan, Hassan Vossoughinia, Ali Mehri, Mikhail Ryzhikov, Majid Khazaei, Mitra Ahadi, Seyed Mahdi Hassanian
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引用次数: 0

摘要

背景:溃疡性结肠炎(UC)是一种以结肠和直肠粘膜组织炎症为特征的大肠炎症性疾病。在本初步研究中,我们评估了甲苯达唑联合美沙拉明治疗中度UC患者的疗效。方法:本探索性试验旨在评估甲苯达唑的安全性和初步疗效,共纳入10例中度UC患者,Mayo评分为6 ~ 9分。参与者随机分为两组,每天3克美沙拉明加300毫克/天甲苯达唑或相应的安慰剂治疗3个月。在8周和12周的时间线上用Mayo评分评估治疗效果。此外,还通过实验室试验评估了给予剂量的甲苯达唑对UC患者的安全性。结果:在UC患者的治疗方案中,美沙拉胺加用甲苯达唑可使患者在8周和12周时的Mayo评分较美沙拉胺单药治疗有更大的下降。尽管有这种趋势,但可能由于样本量有限,没有达到统计显著性。此外,甲苯达唑组所有患者在12周时间线均出现临床缓解,而安慰剂组5例患者中有4例出现临床缓解状态,说明甲苯达唑使临床缓解率提高了20%。实验室检查结果表明,甲苯达唑给药对患者无毒性。结论:美沙拉胺加用甲苯达唑治疗UC是一种安全且可能有益的方法,可提高美沙拉胺的疗效,减轻临床症状。然而,由于样本量小,研究持续时间短,需要进一步的大规模、长期试验来验证这些初步发现。临床试验注册号:IRCT20220115053713N2。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Mebendazole as an Adjunct Therapy with Mesalamine to Increase Efficacy and Maintenance Therapy for Ulcerative Colitis Patients: A Pilot Study.

Background: Ulcerative colitis (UC) is an inflammatory disorder of the large intestine characterized by inflammation in the mucosal tissue of the colon and rectal area. In the present pilot study, we assessed the efficacy of combining mebendazole with mesalamine in moderate UC patients.

Methods: In the present exploratory pilot trial, designed to assess both the safety and preliminary efficacy of mebendazole, a total number of 10 moderate UC patients with Mayo scores ranging from 6 to 9 were enrolled. The participants were divided into two groups at random and were treated with 3 gr mesalamine per day plus 300 mg/day mebendazole or matching placebo for 3 months. The efficacy of treatment was assessed in 8 and 12-week timelines with Mayo score. Moreover, the safety of the given dose of mebendazole in UC patients was also assessed by laboratory tests.

Results: The addition of mebendazole to the mesalamine in the treatment regimen of patients suffering from UC caused a greater decrease in the Mayo score of the patients compared to the mesalamine monotherapy at 8 and 12-week timelines. Despite this trend, statistical significance was not reached, likely due to the limited sample size. Moreover, all the patients in the mebendazole group experienced clinical remission at the 12-week timeline, but 4 of 5 patients in the placebo group experienced a clinical remission state, indicating that mebendazole caused a 20% increase in the clinical remission rate. As indicated by the results of the laboratory tests, the given dose of mebendazole showed no toxicity in the patients.

Conclusion: The addition of mebendazole to mesalamine for UC treatment appears to be a safe and potentially beneficial approach to enhance mesalamine's efficacy and reduce clinical symptoms. However, given the small sample size and the short study duration, further large-scale, long-term trials are necessary to validate these preliminary findings.

Clinical trial registration number: IRCT20220115053713N2.

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来源期刊
CiteScore
6.30
自引率
0.00%
发文量
302
审稿时长
2 months
期刊介绍: Current Pharmaceutical Design publishes timely in-depth reviews and research articles from leading pharmaceutical researchers in the field, covering all aspects of current research in rational drug design. Each issue is devoted to a single major therapeutic area guest edited by an acknowledged authority in the field. Each thematic issue of Current Pharmaceutical Design covers all subject areas of major importance to modern drug design including: medicinal chemistry, pharmacology, drug targets and disease mechanism.
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