Leflunomide or methotrexate for juvenile rheumatoid arthritis
Leflunomide or methotrexate for juvenile rheumatoid arthritis
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DOI：
10.1056/nejmoa041810
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发表时间：
2005-04-21
影响因子：
158.5
通讯作者：
Strand, V
中科院分区：
文献类型：
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作者：
Silverman, E;Mouy, R;Strand, V
背景：我们比较了来氟米特与甲氨蝶呤在治疗多关节型幼年类风湿关节炎的安全性和有效性，在一项多国，随机，对照trial.METHODS：患者3至17岁，接受来氟米特或甲氨蝶呤16周的双模拟，盲法，随后32周盲法延长。在基线和每4周为16周和每8周在32周的扩展study.RESULTS：94例患者随机，86完成16周的治疗，其中70人进入扩展研究的美国流变学学院儿科30%的反应（ACR Pedi 30）和百分比改善指数进行了评估。在第16周，甲氨蝶呤组比来氟米特组有更多的患者有ACR Pedi 30反应（89% vs. 68%，P=0.02），而百分比改善指数值没有显著差异（-52.87% vs.-44.41%，P=0.18）。在两组中，第16周获得的改善在第48周得以维持。两组中最常见的不良事件包括胃肠道症状、头痛和鼻咽症状。氨基转移酶升高更频繁与甲氨蝶呤比来氟米特在最初的研究和扩展study.CONCLUSIONS：在多关节型幼年类风湿关节炎患者，甲氨蝶呤和来氟米特都导致临床改善率高，但率略高于甲氨蝶呤。在本研究中使用的剂量下，甲氨蝶呤比来氟米特更有效。
BACKGROUND:We compared the safety and efficacy of leflunomide with that of methotrexate in the treatment of polyarticular juvenile rheumatoid arthritis in a multinational, randomized, controlled trial.METHODS:Patients 3 to 17 years of age received leflunomide or methotrexate for 16 weeks in a double-dummy, blinded fashion, followed by a 32-week blinded extension. The rates of American College of Rheumatology Pediatric 30 percent responses (ACR Pedi 30) and the Percent Improvement Index were assessed at baseline and every 4 weeks for 16 weeks and every 8 weeks during the 32-week extension study.RESULTS:Of 94 patients randomized, 86 completed 16 weeks of treatment, 70 of whom entered the extension study. At week 16, more patients in the methotrexate group than in the leflunomide group had an ACR Pedi 30 response (89 percent vs. 68 percent, P=0.02), whereas the values for the Percent Improvement Index did not differ significantly (-52.87 percent vs. -44.41 percent, P=0.18). In both groups, the improvements achieved at week 16 were maintained at week 48. The most common adverse events in both groups included gastrointestinal symptoms, headache, and nasopharyngeal symptoms. Aminotransferase elevations were more frequent with methotrexate than with leflunomide during the initial study and the extension study.CONCLUSIONS:In patients with polyarticular juvenile rheumatoid arthritis, methotrexate and leflunomide both resulted in high rates of clinical improvement, but the rate was slightly greater for methotrexate. At the doses used in this study, methotrexate was more effective than leflunomide.