Gharib Mahmoud, Elbaz Walaa, Darweesh Ebtissam, Sabri Nagwa Ali, Shawki May Ahmed
Pharmacy Practice and Clinical Pharmacy Department, Faculty of Pharmacy-Future University in Egypt, New Cairo, Egypt.
Department of Internal Medicine, Rheumatology, and Immunology, Faculty of Medicine-Alazhar University, Cairo, Egypt.
Front Pharmacol. 2021 Sep 22;12:726490. doi: 10.3389/fphar.2021.726490. eCollection 2021.
To evaluate the efficacy and safety of metformin use in rheumatoid arthritis (RA) patients receiving conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). A prospective, randomized, controlled, single blinded, study was carried on 66 RA patients with moderate and high disease activity state, receiving csDMARDs. Patients were simply randomized to receive either metformin 850 mg twice daily (Metformin group, = 33), or placebo twice daily (Control group, = 33) in addition to their stable anti-rheumatic regimen and followed up for 6 months. Serum C-reactive protein (CRP), disease activity of 28 joints based on CRP (DAS-28-CRP), and quality of life (QOL) were evaluated at baseline and then every 3 months. Moreover, serum adiponectin was assessed at baseline and after 6 months. Sixty patients completed the study. Drop out was due to intolerance to metformin side effects ( = 3) and non-compliance ( = 3). Metformin significantly decreased CRP levels and DAS-28-CRP after 6 months compared to the control group (-value <0.001). A significant improvement in QOL of metformin group was observed as early as after 3 months (-value = 0.006) with a continued improvement observed at 6 months (-value <0.001) compared to the control group. Despite the significantly higher serum adiponectin in the metformin group at baseline, it was significantly reduced after 6 months in the metformin group with median percent change of -63.49% compared to the significant increase in the control group with median percent change of 92.40%. Metformin significantly improved inflammation, disease severity, and QOL in RA patients with high safety profile. : Clinical-Trials.gov, identifier [NCT08363405].
评估二甲双胍在接受传统合成抗风湿药物(csDMARDs)治疗的类风湿关节炎(RA)患者中的疗效和安全性。对66例处于中度和高度疾病活动状态、正在接受csDMARDs治疗的RA患者进行了一项前瞻性、随机、对照、单盲研究。患者被简单随机分组,在维持稳定抗风湿治疗方案的基础上,分别接受每日两次850毫克二甲双胍治疗(二甲双胍组,n = 33)或每日两次安慰剂治疗(对照组,n = 33),并随访6个月。在基线时以及之后每3个月评估血清C反应蛋白(CRP)、基于CRP的28个关节疾病活动度(DAS-28-CRP)和生活质量(QOL)。此外,在基线时和6个月后评估血清脂联素。60例患者完成了研究。退出原因是对二甲双胍副作用不耐受(n = 3)和不依从(n = 3)。与对照组相比,6个月后二甲双胍显著降低了CRP水平和DAS-28-CRP(P值<0.001)。与对照组相比,二甲双胍组早在3个月后QOL就有显著改善(P值 = 0.006),6个月时持续改善(P值<0.001)。尽管二甲双胍组基线时血清脂联素显著更高,但6个月后二甲双胍组显著降低,中位百分比变化为-63.49%,而对照组显著升高,中位百分比变化为92.40%。二甲双胍显著改善了RA患者的炎症、疾病严重程度和QOL,且安全性良好。试验注册:ClinicalTrials.gov,标识符[NCT08363405]
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