Capell H A, Lewis D, Carey J
Ann Rheum Dis. 1986 Sep;45(9):705-11. doi: 10.1136/ard.45.9.705.
Ninety patients randomly allocated to receive auranofin, matching placebo, or sodium aurothiomalate have been followed up for three years. Inefficacy led to cessation of treatment in 14 patients receiving auranofin, 27 receiving placebo, and one receiving sodium aurothiomalate. Twenty seven of the patients receiving placebo were reallocated within the study and 16 continued therapy at three years. This group showed similar statistically significant improvement in clinical and laboratory parameters at one, two, and three years to those on an active drug from the outset. Patients who discontinued auranofin because of inefficacy were offered sodium aurothiomalate therapy--eight patients in this group completed three years of treatment on sodium aurothiomalate and showed significant improvement in some but not all parameters. A hand radiograph erosion score showed a deterioration in 80% of patients remaining on auranofin, 75% of those on sodium aurothiomalate, and 80% of the original placebo group who continued an active drug for three years. Although more patients discontinued auranofin over the study period because of inefficacy, no difference could be shown between the degree of improvement in the subgroup who remained on auranofin and those receiving sodium aurothiomalate. No disadvantage in outcome could be shown for patients originally assigned to placebo.
90名被随机分配接受金诺芬、匹配安慰剂或硫代苹果酸金钠治疗的患者已被随访三年。治疗无效导致14名接受金诺芬治疗的患者、27名接受安慰剂治疗的患者和1名接受硫代苹果酸金钠治疗的患者停止治疗。27名接受安慰剂治疗的患者在研究期间被重新分配，16名患者在三年时继续治疗。该组在1年、2年和3年时的临床和实验室参数改善在统计学上与一开始就接受活性药物治疗的患者相似。因治疗无效而停止使用金诺芬的患者接受了硫代苹果酸金钠治疗——该组中有8名患者完成了三年的硫代苹果酸金钠治疗，部分但并非所有参数都有显著改善。手部X线片侵蚀评分显示，继续使用金诺芬的患者中有80%病情恶化，使用硫代苹果酸金钠的患者中有75%病情恶化，最初接受安慰剂治疗且继续使用活性药物三年的患者中有80%病情恶化。尽管在研究期间因治疗无效而停用金诺芬的患者更多，但继续使用金诺芬的亚组与接受硫代苹果酸金钠治疗的亚组在改善程度上没有差异。最初分配接受安慰剂治疗的患者在结局方面没有显示出劣势。
