Department of Pharmacology, Mandya Institute of Medical Sciences, Mandya, India.
Indian J Pharmacol. 2010 Dec;42(6):358-61. doi: 10.4103/0253-7613.71916.
Several new drugs for rheumatoid arthritis are available including leflunomide. Comparative studies of treatment with leflunomide (against methotrexate) report a better quality of life.
This study was designed to evaluate the efficacy of combination of methotrexate and hydroxychloroquine with leflunomide, a new disease modifying antirheumatoid drug. Analysis was of intent to treat group.
This was an open labeled, randomized, comparative clinical trial in the department of rheumatology and immunology, at a tertiary care center in Bangalore. Patients who have diagnosed with rheumatoid arthritis as per American College of Rheumatology aged between 18 and 60 years were recruited and randomized to receive leflunomide (10 mg/day p.o.) or a combination of methotrexate and hydroxychloroquine (7.5 mg/week p.o. and 200 mg/day p.o., respectively) along with folate supplementation for 12 weeks. The European League Against Rheumatism criteria of improvement according to disease activity score 28 was considered as the primary efficacy variable. Baseline and end of study values were evaluated. The duration of the study period was 1 year. Analysis of variance (ANOVA) and Wilcoxon Signed rank test were used for statistical analysis.
After 12 weeks, improvement noted in patients treated with leflunomide was similar to those treated with a combination of methotrexate and hydroxychloroquine. There was no statistical significance in improvement in disease activity between the two groups (P = 0.377).
Combination of methotrexate and hydroxychloroquine is equivalent to leflunomide in terms of efficacy in reducing disease activity in the initial treatment of severe rheumatoid arthritis.
有几种新的类风湿关节炎药物可供选择，包括来氟米特。与甲氨蝶呤相比，来氟米特治疗的对照研究报告称生活质量更好。
本研究旨在评估甲氨蝶呤和羟氯喹联合来氟米特（一种新的改善病情的抗风湿药物）治疗的疗效。分析是基于意向治疗组。
这是在班加罗尔的一家三级护理中心的风湿病和免疫学系进行的开放标签、随机、对照临床试验。招募了年龄在 18 至 60 岁之间、被诊断为类风湿关节炎的患者，并将其随机分为来氟米特（10mg/天口服）或甲氨蝶呤和羟氯喹联合组（7.5mg/周口服和 200mg/天口服，分别），同时补充叶酸，疗程为 12 周。根据疾病活动评分 28，将欧洲抗风湿病联盟的改善标准作为主要疗效变量。评估基线和研究结束时的值。研究期间为 1 年。采用方差分析（ANOVA）和 Wilcoxon 符号秩检验进行统计学分析。
治疗 12 周后，来氟米特治疗患者的改善与甲氨蝶呤和羟氯喹联合治疗患者相似。两组间疾病活动改善无统计学意义（P=0.377）。
在严重类风湿关节炎的初始治疗中，甲氨蝶呤和羟氯喹联合治疗在降低疾病活动方面与来氟米特等效。
