Eskandari Moein, Alkhafaji Ayat Heydar-Abdolamir, Al-Asady Abdulridha Mohammed, Naimi Hamideh, Ahmadzadeh Amir Mahmoud, Avan Amir, Vossoughinia Hassan, Mehri Ali, Ryzhikov Mikhail, Khazaei Majid, Ahadi Mitra, Hassanian Seyed Mahdi
Department of Clinical Biochemistry, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Medical Sciences, Faculty of Nursing, University of Warith Al-Anbiyaa, Iraq.
Curr Pharm Des. 2025 Jul 7. doi: 10.2174/0113816128372513250616182826.
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.
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.
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.
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.
IRCT20220115053713N2.
溃疡性结肠炎（UC）是一种大肠的炎症性疾病，其特征是结肠和直肠区域的黏膜组织发生炎症。在本初步研究中，我们评估了甲苯达唑与美沙拉嗪联合应用于中度UC患者的疗效。
在本旨在评估甲苯达唑安全性和初步疗效的探索性初步试验中，共纳入10名梅奥评分在6至9分的中度UC患者。参与者被随机分为两组，每天接受3克美沙拉嗪加300毫克/天甲苯达唑或匹配的安慰剂治疗3个月。在8周和12周时用梅奥评分评估治疗效果。此外，还通过实验室检查评估了给予UC患者的甲苯达唑剂量的安全性。
在UC患者的治疗方案中，将甲苯达唑添加到美沙拉嗪中，与美沙拉嗪单药治疗相比，在8周和12周时患者的梅奥评分下降幅度更大。尽管有这种趋势，但未达到统计学显著性，可能是由于样本量有限。此外，甲苯达唑组的所有患者在12周时均实现临床缓解，但安慰剂组的5名患者中有4名处于临床缓解状态，这表明甲苯达唑使临床缓解率提高了20%。实验室检查结果表明，给予的甲苯达唑剂量对患者无毒性。
在UC治疗中，将甲苯达唑添加到美沙拉嗪中似乎是一种安全且可能有益的方法，可提高美沙拉嗪的疗效并减轻临床症状。然而，鉴于样本量小和研究持续时间短，需要进一步进行大规模、长期试验来验证这些初步发现。
IRCT20220115053713N2。
