Tarek M Mostafa, Abeer A El-Sayed, Abdel Moaty A Afifi, Dalia R El-Afify
{"title":"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","authors":"Tarek M Mostafa, Abeer A El-Sayed, Abdel Moaty A Afifi, Dalia R El-Afify","doi":"10.1007/s00228-025-03911-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This research aimed at evaluating the effectiveness and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Nitazoxanide and escitalopram could serve as potential adjuvant therapies for patients with RA based on their effectiveness and safety data.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis: a randomized controlled study.\",\"authors\":\"Tarek M Mostafa, Abeer A El-Sayed, Abdel Moaty A Afifi, Dalia R El-Afify\",\"doi\":\"10.1007/s00228-025-03911-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This research aimed at evaluating the effectiveness and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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). 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Efficacy and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis: a randomized controlled study.
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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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.
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