Schattenkirchner M, Bröll H, Kaik B, Müller-Fassbender H, Rau R, Zeidler H
Medizinische Poliklinik, Universität München.
Klin Wochenschr. 1988 Feb 15;66(4):167-74. doi: 10.1007/BF01727786.
In a 48-week, double-blind trial, 122 patients were randomly assigned to treatment with auranofin (60) and gold sodium thiomalate (GST) (62) at five centers. Both groups showed significant improvement (P less than 0.05) from baseline in parameters of disease activity. Results of the covariance analysis for all patients who completed the trial showed no significant differences (P less than 0.05) in efficacy between the two groups. The proportions of patients showing 50% or greater improvement in tender joints, swollen joints, activity index, severity of pain, general health rating, and erythrocyte sedimentation rate (ESR) were similar for both auranofin-treated and GST-treated patients who completed the 48-week trial. When all patients who entered the trial were evaluated, a slightly greater proportion of patients on auranofin had improved. Diarrhea occurred more frequently with auranofin (32%) compared to GST (19%), whereas rash and pruritus were twice as common in those patients treated with GST compared to those treated with auranofin. The withdrawal rate due to adverse reactions was 10% for auranofin vs 26% for GST. It was concluded that the efficacy of auranofin was comparable to that of injectable gold and was better tolerated, as evidenced by the lower withdrawal rate from adverse events for the auranofin patients.
在一项为期48周的双盲试验中，122名患者在五个中心被随机分配接受金诺芬治疗（60例）和硫代苹果酸金钠（GST）治疗（62例）。两组患者的疾病活动参数较基线水平均有显著改善（P<0.05）。对所有完成试验的患者进行协方差分析的结果显示，两组在疗效上无显著差异（P<0.05）。在完成48周试验的接受金诺芬治疗和GST治疗的患者中，在压痛关节、肿胀关节、活动指数、疼痛严重程度、总体健康评分和红细胞沉降率（ESR）方面改善50%或更多的患者比例相似。当对所有进入试验的患者进行评估时，接受金诺芬治疗的患者中改善的比例略高。与GST（19%）相比，金诺芬治疗时腹泻更频繁（32%），而接受GST治疗的患者出现皮疹和瘙痒的频率是接受金诺芬治疗患者的两倍。因不良反应导致的停药率，金诺芬组为10%，GST组为26%。得出的结论是，金诺芬的疗效与注射用金相当，且耐受性更好，这一点从金诺芬组因不良事件导致的较低停药率得到证明。
