Clinical study evaluating the efficacy and safety of Cilostazol as an adjuvant therapy to methotrexate on patients with rheumatoid arthritis.

IF 4.6 2区医学 Q2 IMMUNOLOGY

Inflammopharmacology Pub Date : 2025-05-16 DOI:10.1007/s10787-025-01782-2

Samar M Eldadamony, Sahar M El-Haggar, Abdel Moaty A Ali, Tarek M Mostafa

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引用次数: 0

Abstract

Objective: This study aims to assess the safety as well as effectiveness of Cilostazol as a complementary therapy to methotrexate among individuals with active rheumatoid arthritis.

Method: This study was a randomly allocated, double-blind, placebo-controlled parallel design involving 70 patients who were diagnosed with active rheumatoid arthritis. Participants were randomly assigned to two sets: the control group (n = 35) which received methotrexate "MTX" (7.5 mg IM weekly) plus placebo tablets twice daily and the Cilostazol group (n = 35), which received the same MTX" dose plus Cilostazol 50 mg twice daily for 3 months. Patients were assessed to determine the serum levels of C-reactive protein (CRP) nuclear factor kappa B (NF-κB), hemoxygenase-1 (HO-1), and cyclic adenosine monophosphate (cAMP). Disease Activity Score (DAS28-CRP), Multidimensional Health Assessment Score (MDHAQ), and morning stiffness duration were also assessed.

Results: The Cilostazol group produced a significant improvement in cAMP level as compared to the control group (P = 0.001). cAMP level showed a significant inverse correlation with DAS28-CRP (r = -0.336; P = 0.004). However, Cilostazol group produced non-significant improvements in the serum levels of the other biological markers (CRP, NF-κB, and HO-1), DAS28-CRP score, MDHAQ score, and morning stiffness duration as compared to the control group (P > 0.05). The implication of Cilostazol for patients with rheumatoid arthritis was tolerable and safe.

Conclusion: The beneficial effect of Cilostazol on cAMP and the negative correlation between cAMP and DAS28-CRP could support its impact on the disease activity. Further research seems necessary to elucidate the mechanisms underlying the link between cAMP and disease activity.

Trial registration: Clinical Trials.gov identifier: NCT05594680, The date of registration is: 30/10/2022.

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评价西洛他唑作为甲氨蝶呤辅助治疗类风湿性关节炎患者疗效和安全性的临床研究。

目的：本研究旨在评估西洛他唑作为活动性类风湿关节炎患者甲氨蝶呤补充治疗的安全性和有效性。方法：本研究采用随机分配、双盲、安慰剂对照平行设计，纳入70例诊断为活动性类风湿关节炎的患者。参与者被随机分配到两组：对照组（n = 35）接受甲氨蝶呤“MTX”（每周7.5 mg IM）加安慰剂片，每天两次；西洛他唑组（n = 35）接受相同剂量的MTX加西洛他唑50 mg，每天两次，持续3个月。评估患者血清c反应蛋白（CRP）、核因子κB （NF-κB）、血氧合酶-1 （HO-1）和环磷酸腺苷（cAMP）水平。疾病活动评分（DAS28-CRP）、多维健康评估评分（MDHAQ）和晨僵持续时间也进行了评估。结果：西洛他唑组cAMP水平较对照组有显著提高（P = 0.001）。cAMP水平与DAS28-CRP呈显著负相关(r = -0.336；p = 0.004)。然而，与对照组相比，西洛他唑组其他生物标志物（CRP、NF-κB和HO-1）、DAS28-CRP评分、MDHAQ评分和晨僵持续时间的血清水平无显著改善（P < 0.05）。西洛他唑对类风湿关节炎患者的影响是可耐受和安全的。结论：西洛他唑对cAMP的有益作用和cAMP与DAS28-CRP的负相关关系支持其对疾病活动性的影响。进一步的研究似乎有必要阐明cAMP与疾病活动之间联系的潜在机制。试验注册：Clinical Trials.gov识别码：NCT05594680，注册日期：30/10/2022。

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来源期刊

Inflammopharmacology IMMUNOLOGYTOXICOLOGY-TOXICOLOGY

CiteScore

8.00

自引率

3.40%

发文量

200

期刊介绍： Inflammopharmacology is the official publication of the Gastrointestinal Section of the International Union of Basic and Clinical Pharmacology (IUPHAR) and the Hungarian Experimental and Clinical Pharmacology Society (HECPS). Inflammopharmacology publishes papers on all aspects of inflammation and its pharmacological control emphasizing comparisons of (a) different inflammatory states, and (b) the actions, therapeutic efficacy and safety of drugs employed in the treatment of inflammatory conditions. The comparative aspects of the types of inflammatory conditions include gastrointestinal disease (e.g. ulcerative colitis, Crohn''s disease), parasitic diseases, toxicological manifestations of the effects of drugs and environmental agents, arthritic conditions, and inflammatory effects of injury or aging on skeletal muscle. The journal has seven main interest areas: -Drug-Disease Interactions - Conditional Pharmacology - i.e. where the condition (disease or stress state) influences the therapeutic response and side (adverse) effects from anti-inflammatory drugs. Mechanisms of drug-disease and drug disease interactions and the role of different stress states -Rheumatology - particular emphasis on methods of measurement of clinical response effects of new agents, adverse effects from anti-rheumatic drugs -Gastroenterology - with particular emphasis on animal and human models, mechanisms of mucosal inflammation and ulceration and effects of novel and established anti-ulcer, anti-inflammatory agents, or antiparasitic agents -Neuro-Inflammation and Pain - model systems, pharmacology of new analgesic agents and mechanisms of neuro-inflammation and pain -Novel drugs, natural products and nutraceuticals - and their effects on inflammatory processes, especially where there are indications of novel modes action compared with conventional drugs e.g. NSAIDs -Muscle-immune interactions during inflammation [...]