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首页> 外文期刊>Modern rheumatology >Studies of the efficacy and safety of methotrexate at dosages over 8 mg/week using the IORRA cohort database
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Studies of the efficacy and safety of methotrexate at dosages over 8 mg/week using the IORRA cohort database

机译：使用IORRA队列数据库研究甲氨蝶呤剂量超过8 mg /周的疗效和安全性

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The maximum dosage of methotrexate (MTX) for treatment of rheumatoid arthritis (RA) formally approved in Japan is 8 mg/week. We intended to examine the efficacy and safety of MTX at dosages over 8 mg/week in Japanese rheumatoid arthritis patients using the large Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort database. Among 9,122 patients registered in the IORRA database from the October 2000 survey to the October 2007 survey, 5,201 patients who had been treated with MTX were selected. We attempted to overcome the drawbacks innate to nonrandomized studies by using longitudinal analyses and multifactorial logistic regression analyses. Cross-sectional analysis of data obtained from the October 2007 survey indicated that dosages of MTX higher than 8 mg/week were used in 27.5% of patients treated with MTX. Longitudinal analyses based on data from three consecutive phases showed that final Disease Activity Score-28 (DAS28) values were significantly lower [n = 260, mean difference 0.563, 95% confidence interval (CI) 0.438-0.688, P2.2 9 10 -22, two-sided paired t test] than initial values when MTX was increased from 8 mg/ week or lower to over 8 mg/week. In addition, longitudinal analyses based on data from two consecutive phases indicated decreases in DAS28 values of 0.26 ± 1.04 (n = 690, P = 6.78 9 10 -11, two-sided paired t test) when MTX dosages were increased from 8 mg/week or lower to over 8 mg/week, compared with decreases of 0.07 ± 0.89 (n = 2,125, P = 0.000307) when the dosage was maintained at 8 mg/week. The decreases in DAS28 values were significantly larger in the former than the latter (P = 2.27 9 10 -6, two-sided unpaired t test). Concerning safety of MTX at dosages over 8 mg/week, we performed logistic regression analysis in which the objective variable was the existence or nonexistence of self-reported sideeffects and the explanatory variable was the MTX dosage in the former phase, with adjustments made for age, sex, body mass index (BMI), steroid administration, folic acid administration, concomitant pulmonary diseases, and renal dysfunction. The results indicated that MTX dosages over 8 mg/week did not have any association with either severe or severe ? moderate side-effects. These data regarding both efficacy and safety of MTX at dosages over 8 mg/week in Japanese RA patients would provide the basis for use of the drug at dosages currently not formally approved by the Japanese government.
机译：日本正式批准的甲氨蝶呤（MTX）用于治疗类风湿关节炎（RA）的最大剂量为8毫克/周。我们打算使用大型的风湿病学会，类风湿关节炎（IORRA）队列数据库，以超过8 mg /周的剂量检查MTX在日本类风湿关节炎患者中的疗效和安全性。从2000年10月的调查到2007年10月的调查，在IORRA数据库中注册的9,122位患者中，选择了5,201位接受MTX治疗的患者。我们试图通过使用纵向分析和多因素逻辑回归分析来克服非随机研究固有的弊端。从2007年10月的调查中获得的数据的横断面分析表明，在接受过MTX治疗的患者中，有27.5％的患者使用了高于8 mg /周的MTX剂量。根据来自三个连续阶段的数据进行的纵向分析显示，最终疾病活动评分28（DAS28）值明显更低[n = 260，平均差异0.563，95％置信区间（CI）0.438-0.688，P <2.2 9 10- 22，双向配对t检验]当MTX从8 mg /周或更低增加到超过8 mg /周时的初始值。此外，根据来自两个连续阶段的数据进行的纵向分析表明，当MTX剂量从8 mg / mg增加时，DAS28值降低了0.26±1.04（n = 690，P = 6.78 9 10 -11，双面配对t检验）。每周或更低至超过8毫克/周，而当剂量维持在8毫克/周时则降低了0.07±0.89（n = 2,125，P = 0.000307）。前者中DAS28值的降低明显大于后者（P = 2.27 9 10 -6，两侧未配对t检验）。关于超过8 mg /周剂量的MTX的安全性，我们进行了Logistic回归分析，其中客观变量为自我报告的副作用的存在与否，解释变量为前期的MTX剂量，并根据年龄进行了调整，性别，体重指数（BMI），类固醇给药，叶酸给药，伴随的肺部疾病和肾功能不全。结果表明，超过8 mg /周的MTX剂量与严重或严重？中等副作用。这些有关在日本RA患者中以超过8 mg /周的剂量服用MTX的有效性和安全性的数据，将为以目前日本政府尚未正式批准的剂量使用该药物提供依据。

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