一项评估硝呋沙嗪治疗溃疡性结肠炎患者安全性和有效性的随机对照先导研究。

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-06-30 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S522755

Hayam Ali AlRasheed, Mahmoud S Abdallah, Eman El-Khateeb, Marwa Kamal, Sarah Alrubia, Amsha S Alsegiani, Tarek I Ahmed, Mostafa M Bahaa

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引用次数: 0

摘要

背景：在一些溃疡性结肠炎（UC）的实验研究中，硝呋沙嗪在结肠炎中的治疗潜力已经被探索。目的：评价硝呋沙嗪治疗UC的疗效。方法：50例轻至中度UC患者随机分为两组，每组25例。安慰剂组在服用美沙拉明的同时服用安慰剂（每日三次，每次1克），持续6个月。硝呋沙嗪组给予硝呋沙嗪（200mg，每日2次）联合美沙拉胺（1g，每日1次）。胃肠病学家使用部分梅奥评分（PMS）评估疾病严重程度。检测治疗前后血清c反应蛋白（CRP）、核因子κB （NF-κB）、白细胞介素-6 （IL-6）、信号传导与转录激活因子3 （STAT3）水平。使用炎症性肠病问卷（IBDQ-32）评估生活质量。主要结局：经前综合症的改变。次要结局：IBDQ-32和测量的生物标志物水平的变化。结果：各组间基线测量具有可比性（p < 0.05）。与基线相比，两组的治疗后值均有显著改善。然而，nifuroxazide组表现出比安慰剂组更大的改善，包括PMS的减少（p = 0.005）和IBDQ评分的增加（p = 0.002）。此外，IL-6 （p = 0.03）、NF-κB （p = 0.03）、CRP （p = 0.02）、STAT3 （p = 0.03）水平均显著降低。安慰剂组的缓解率为56%(14/25)，缓解率为24%(6/25)，而nifuroxazide组基于经前症候群的缓解率为76%(19/25)，缓解率为56%（14/25）。结论：与单独使用美沙拉胺相比，硝呋沙嗪联合美沙拉胺可改善临床结果，包括更高的缓解率和缓解率，通过降低IL-6/STAT3减少炎症，提高UC患者的生活质量。试验注册标识符：NCT05988528。

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A Randomized Controlled Pilot Study Evaluating the Safety and Efficacy of Nifuroxazide in Patients with Ulcerative Colitis.

Background: The therapeutic potential of nifuroxazide in colitis has been explored in several experimental studies of ulcerative colitis (UC).

Aim: To evaluate the efficacy of nifuroxazide in patients with UC.

Methods: Fifty patients with mild to moderate UC were randomly assigned into two groups (n = 25 each). The placebo group received a placebo alongside mesalamine (1 g three times daily [t.i.d.]) for six months. The nifuroxazide group received nifuroxazide (200 mg twice daily) in combination with mesalamine (1 g t.i.d). A gastroenterologist assessed disease severity using the partial Mayo score (PMS). Serum levels of C-reactive protein (CRP), nuclear factor kappa B (NF-κB), interleukin-6 (IL-6), and signal transducer and activator of transcription 3 (STAT3) were measured before and after treatment. Quality of life was evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ-32). Primary outcomes: Change in PMS. Secondary outcomes: change in IBDQ-32 and in the level of measured biomarkers.

Results: Baseline measurements were comparable between groups (p > 0.05). Post-treatment values showed significant improvements within both groups compared to baseline. However, the nifuroxazide group demonstrated significantly greater improvements than the placebo group, including reductions in PMS (p = 0.005) and increases in IBDQ scores (p = 0.002). Additionally, significant decreases were observed in IL-6 (p = 0.03), NF-κB (p = 0.03), CRP (p = 0.02), and STAT3 (p = 0.03) levels. The placebo group had a response rate of 56% (14/25) and a remission rate of 24% (6/25), whereas the nifuroxazide group achieved a response rate of 76% (19/25) and a remission rate of 56% (14/25), based on PMS.

Conclusion: Co-administration of nifuroxazide with mesalamine improved clinical outcomes, including higher response and remission rates, reduced inflammation by reducing IL-6/STAT3, and enhanced quality of life in patients with UC, compared to mesalamine alone.

Trial registration identifier: NCT05988528.

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.