Efficacy and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis: a randomized controlled study.

IF 2.7 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-09-09 DOI:10.1007/s00228-025-03911-w

Tarek M Mostafa, Abeer A El-Sayed, Abdel Moaty A Afifi, Dalia R El-Afify

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引用次数: 0

Abstract

Objective: This research aimed at evaluating the effectiveness and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis (RA).

Methods: In this randomized controlled parallel study, 90 patients with active RA were randomized into three groups; group 1 (control group; n = 30) which received traditional therapy, group 2 (Nitazoxanide group; n = 30) which received traditional therapy plus 1 gm/day oral nitazoxanide, and group 3 (Escitalopram group; n = 30) which received traditional therapy plus 10 mg/day oral escitalopram for three months. At baseline and 3 months after treatment, clinical and functional assessments were done through the 28-joint count disease activity score using C-reactive protein (DAS28-CRP), the health assessment questionnaire-disability index (HAQ-DI), and the patient's global assessment (PGA). Also, serum levels of high-sensitivity C-reactive protein (hs-CRP), signal transducer and activator of transcription-3 (STAT-3), Janus kinase-2 (JAK-2), toll-like receptors 4 (TLR-4), interleukin-1 beta (IL-1β), and malondialdehyde (MDA) were assessed. Data were analyzed using paired t-test and one-way analysis of variance, followed by Tukey's HDS test.

Results: Three months after treatment and as compared to the control group, the nitazoxanide group showed a significant decline in PGA (P = 0.042), and serum levels of STAT-3 (P < 0.001), JAK-2 (P < 0.001), TLR-4 (P < 0.001), and IL-1β (P < 0.001). On the other hand, the escitalopram group produced a significant decrease in DAS28-CRP score (P = 0.029), HAQ-DI score (P = 0.001), and serum levels of JAK-2 (P = 0.001), TLR-4 (P < 0.001), IL-1β (P < 0.001), and MDA (P < 0.001). As compared to nitazoxanide group, the escitalopram group produced a significant decline in fatigue score (P < 0.001) and serum levels of both IL-1β (P = 0.023) and MDA (P < 0.001). Both medications were safe; however, chromaturia was the only significant nitazoxanide-related adverse effect.

Conclusion: Nitazoxanide and escitalopram could serve as potential adjuvant therapies for patients with RA based on their effectiveness and safety data.

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nitazoxanide和escitalopram作为辅助治疗类风湿性关节炎患者的疗效和安全性：一项随机对照研究

目的：本研究旨在评价硝唑尼特和艾司西酞普兰作为辅助治疗类风湿性关节炎（RA）患者的有效性和安全性。方法：在这项随机对照平行研究中，90例活动期RA患者随机分为三组；1组（对照组，n = 30）给予传统治疗，2组（尼唑昔尼特组，n = 30）给予传统治疗加尼唑昔尼特1 gm/d口服，3组（艾司西酞普兰组，n = 30）给予传统治疗加艾司西酞普兰10 mg/d口服，疗程3个月。在基线和治疗后3个月，通过28个关节计数疾病活动性评分（c -反应蛋白DAS28-CRP）、健康评估问卷-残疾指数（HAQ-DI）和患者整体评估（PGA）进行临床和功能评估。此外，还评估了血清中高敏c反应蛋白（hs-CRP）、信号传感器和转录激活因子-3 （STAT-3）、Janus激酶-2 （JAK-2）、toll样受体4 （TLR-4）、白细胞介素-1β (IL-1β)和丙二醛（MDA）的水平。数据分析采用配对t检验和单因素方差分析，然后采用Tukey’s HDS检验。结果：治疗3个月后，与对照组相比，尼唑昔尼特组患者PGA水平显著下降（P = 0.042），血清STAT-3水平显著下降（P = 0.042）。结论：尼唑昔尼特和艾司西酞普兰的有效性和安全性均可作为RA患者潜在的辅助治疗药物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.