Hussain Saad Abdulrahman, Mortada Ahmed Hashem, Jasim Nazar Abdulateef, Gorial Faiq Isho
Department of Pharmacology and Toxicology, College of Pharmacy, University of Baghdad, Baghdad, Iraq.
Department of Pharmacology and Toxicology, College of Pharmacy, Kufa University, Najaf, Iraq.
Oman Med J. 2016 Jul;31(4):263-9. doi: 10.5001/omj.2016.52.
Our study sought to evaluate the effects of silibinin in patients with active rheumatoid arthritis (RA) treated with methotrexate (MTX).
We conducted a randomized multi-center, double-blind, placebo-controlled clinical trial over a 16-week treatment period at the Al-Sader and Baghdad Teaching Hospitals in Najaf and Baghdad, respectively. A total of 60 patients (30 of each sex) with active RA, already maintained on 12 mg MTX weekly for at least three consecutive months, were included in the study. Patients were randomly allocated to receive either 120 mg silibinin twice daily or a placebo, combined with their regular MTX regimen. The patients were evaluated by measuring disease activity score using the 28-joint Disease Activity Score, Simple Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores at the start and end of the study. Blood samples were evaluated for the erythrocyte sedimentation rate (ESR), hemoglobin (Hb), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK), anti-cyclic citrullinated peptide (CCP), and the serum cytokine levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6, IL-8, IL-10, and IL-2.
Silibinin significantly decreases the already elevated clinical scores compared to placebo treatment. ESR, IL-8, IL-6, TNF-α, anti-CCP, hs-CRP levels were significantly reduced. Additionally, the use of silibinin significantly increases Hb, IL-10, and IL-2 levels.
Silibinin may improve the effects of MTX on certain biochemical and clinical markers of patients with active RA.
我们的研究旨在评估水飞蓟宾对接受甲氨蝶呤（MTX）治疗的活动性类风湿关节炎（RA）患者的影响。
我们分别在纳杰夫的萨德尔教学医院和巴格达的巴格达教学医院进行了一项为期16周的随机多中心、双盲、安慰剂对照临床试验。共有60例活动性RA患者（男女各30例）纳入研究，这些患者已连续至少三个月每周服用12 mg MTX。患者被随机分配接受每日两次120 mg水飞蓟宾或安慰剂，并结合其常规MTX治疗方案。在研究开始和结束时，使用28关节疾病活动评分、简单疾病活动指数和健康评估问卷残疾指数评分来评估疾病活动度。对血样进行红细胞沉降率（ESR）、血红蛋白（Hb）、高敏C反应蛋白（hs-CRP）、肌酸激酶（CK）、抗环瓜氨酸肽（CCP）以及肿瘤坏死因子（TNF）-α、白细胞介素（IL）-6、IL-8、IL-10和IL-2的血清细胞因子水平检测。
与安慰剂治疗相比，水飞蓟宾显著降低了已经升高的临床评分。ESR、IL-8、IL-6、TNF-α、抗CCP、hs-CRP水平显著降低。此外，使用水飞蓟宾显著提高了Hb、IL-10和IL-2水平。
水飞蓟宾可能改善MTX对活动性RA患者某些生化和临床指标的影响。
