van Roon Eric N, van de Laar Mart A F J, Janssen Matthijs, Kruijsen Marijn W M, Jansen Tim L T A, Brouwers Jacobus R B J
Department of Clinical Pharmacy and Clinical Pharmacology, Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands.
J Rheumatol. 2005 Jun;32(6):1026-30.
For reasons of insufficient quality of the raw material, aurothioglucose was withdrawn from the Dutch market at the end of 2001. Aurothiomalate became available as an alternative preparation. We followed a cohort of patients during the first year after switching from aurothioglucose to aurothiomalate to study efficacy and tolerability.
Patients were observed at baseline and at 3 and 12 months after switching. At each visit, data on adverse drug reactions (ADR), withdrawal, and disease activity were collected.
In total 120 patients were included [age 63(SD 15) yrs, 68% female, 93% with rheumatoid arthritis, duration of disease 15 (SD 9) years, 82% IgM rheumatoid factor-positive, with 9 (SD 9, range 0.1-45) yrs of previous aurothioglucose therapy]. Nineteen patients (16%) reported an ADR taking aurothiomalate not previously experienced with aurothioglucose, the most frequently reported being pruritus, dermatitis/stomatitis, and chrysiasis/hyperpigmentation. Twenty-nine patients (24%) withdrew from aurothiomalate within 12 months of followup for reasons of inefficacy (14%), ADR (7%), or disease in state of remission (3%). Kaplan-Meier estimates show aurothiomalate survival rates of 78.5% after 12 months. No statistically significant differences between the disease activity indicators during followup visits compared with the baseline visit were detected for the patients continuing aurothiomalate.
Within the first 12 months after switching from aurothioglucose, 24% of patients withdrew from aurothiomalate. Sixteen percent of patients reported novel ADR. For the population continuing to take aurothiomalate no clinically relevant changes in disease activity were recorded after switching.
由于原材料质量欠佳，金硫葡萄糖于2001年底退出荷兰市场。硫代苹果酸金钠作为替代制剂可供使用。我们对从金硫葡萄糖转换为硫代苹果酸金钠后的第一年患者队列进行了跟踪研究，以探讨疗效和耐受性。
在基线以及转换后3个月和12个月对患者进行观察。每次就诊时，收集有关药物不良反应（ADR）、停药情况和疾病活动的数据。
共纳入120例患者[年龄63（标准差15）岁，68%为女性，93%患有类风湿关节炎，病程15（标准差9）年，82% IgM类风湿因子阳性，既往接受金硫葡萄糖治疗9（标准差9，范围0.1 - 45）年]。19例患者（16%）报告服用硫代苹果酸金钠出现了之前使用金硫葡萄糖时未经历过的ADR，最常报告的是瘙痒、皮炎/口腔炎和金中毒/色素沉着。29例患者（24%）在随访的12个月内因无效（14%）、ADR（7%）或疾病缓解（3%）而停用硫代苹果酸金钠。Kaplan - Meier估计显示，12个月后硫代苹果酸金钠的生存率为78.5%。继续使用硫代苹果酸金钠的患者在随访期间的疾病活动指标与基线访视相比，未发现有统计学显著差异。
从金硫葡萄糖转换后的前12个月内，24%的患者停用了硫代苹果酸金钠。16%的患者报告了新的ADR。对于继续服用硫代苹果酸金钠的人群，转换后未记录到疾病活动的临床相关变化。
