Dahl S L, Samuelson C O, Williams H J, Ward J R, Karg M
Cooperative Systematic Studies of Rheumatic Diseases, University of Utah, Salt Lake City.
Pharmacotherapy. 1990;10(2):79-84.
This study assessed the relative efficacy and toxicity of second-line antirheumatic drugs in patients 65 years of age or older compared to younger counterparts. The results of three prospective, double-blind, parallel, randomized, multicenter trials were reanalyzed, stratifying outcomes by intervention and patient age. Efficacy was assessed by categorizing patient responses as follows: important improvement, no meaningful change, or progressive disease. Toxicity was analyzed by comparing withdrawal rates due to adverse effects. The three trials compared the following treatments: (1) D-penicillamine 10-12 mg/day versus azathioprine 1.25-1.5 mg/kg/day; (2) gold sodium thiomalate 50 mg intramuscularly weekly versus auranofin 6 mg/day versus placebo; and (3) pulse oral methotrexate 7.5-15.0 mg weekly versus placebo. At baseline, 103 patients age 65 or older were similar to 485 patients less than 65 years of age, with the exception of disease duration in all studies and erythrocyte sedimentation rate in one study. For patients completing each study, efficacy outcomes based on age were not significantly different. Withdrawal rates due to adverse drug reactions were also not significantly different.
本研究评估了65岁及以上患者与年轻患者相比，二线抗风湿药物的相对疗效和毒性。对三项前瞻性、双盲、平行、随机、多中心试验的结果进行了重新分析，按干预措施和患者年龄对结果进行分层。疗效评估是通过将患者反应分类如下：显著改善、无明显变化或疾病进展。通过比较因不良反应导致的停药率来分析毒性。这三项试验比较了以下治疗方法：(1) 青霉胺10 - 12毫克/天与硫唑嘌呤1.25 - 1.5毫克/千克/天；(2) 硫代苹果酸金钠每周肌肉注射50毫克与金诺芬6毫克/天与安慰剂；以及(3) 脉冲口服甲氨蝶呤每周7.5 - 15.0毫克与安慰剂。在基线时，103名65岁及以上的患者与485名65岁以下的患者相似，但在所有研究中的病程以及一项研究中的红细胞沉降率除外。对于完成每项研究的患者，基于年龄的疗效结果没有显著差异。因药物不良反应导致的停药率也没有显著差异。
