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金诺芬与硫代苹果酸金钠治疗类风湿关节炎的三年对照研究。

A three year comparative study of auranofin and gold sodium thiomalate in rheumatoid arthritis.

作者信息

Rau R, Schattenkirchner M, Muller-Fassbender H, Kaik B, Zeidler H, Missler B

机构信息

Rheumaklinik, Evangelisches Fachkrankenhaus, Ratingen, Germany.

出版信息

Clin Rheumatol. 1990 Dec;9(4):461-74. doi: 10.1007/BF02030507.

Abstract

UNLABELLED

One hundred twenty-one patients with active RA were randomly assigned to receive 6 mg auranofin (AF)/day (60 patients) or 50 mg gold sodium thiomalate (GST)/week (62 patients) in a double-blind fashion. There were no intergroup differences with respect to sex, age, duration (median 2 years), stage and activity of the disease. In the case of "striking improvement" after 24 weeks a dose reduction to 50 mg GST/month or 4 mg AF/day was allowed and carried out in all GST patients and no AF patient. The serum gold levels were 5 times higher with weekly GST, they approached those of the AF group with monthly GST injections. The clinical parameters--number of swollen joints, activity index, articular index, grip strength, ESR--improved significantly in both groups, but grip strength, articular index and ESR improved more pronounced in the GST group. The X-ray progression (hands and forefeet) was significantly greater in the AF group. Forty-eight AF patients (80%) and 39 GST patients (36%) completed the first year. Thereafter the study was continued as an open study but the patients were allowed to switch from GST to AF. After the first and second year 14/7 GST patients switched to AF. The second/third year was completed by 37/22 AF pat. (62%/37%) and by 15/8 GST pat. (24%/13%). Skin reactions were more common with GST (41.9%/26.7%), diarrhoea was more common with AF (36.7%/19.4%), proteinuria occurred in 10% in both groups, leucopenia and thrombocytopenia were rare in both groups (1.7%). The withdrawal rate due to adverse events was 10%/26% in the AF/GST group during the first year (p less than 0.05) and 25%/32% over the three year period (n.s.).

CONCLUSION

Both AF and GST are effective in the long-term treatment of RA, but GST is more so in radiological progression and ESR.

摘要

未标记

121例活动性类风湿关节炎患者被随机分为两组,采用双盲法,一组每日服用6mg金诺芬(AF)(60例患者),另一组每周服用50mg硫代苹果酸金钠(GST)(62例患者)。两组在性别、年龄、病程(中位数2年)、疾病分期和活动度方面无差异。若24周后“显著改善”,所有服用GST的患者允许并实施剂量减至每月50mg GST,而服用AF的患者则无此情况。每周服用GST时血清金水平高出5倍,每月注射GST时血清金水平接近AF组。两组的临床参数——肿胀关节数、活动指数、关节指数、握力、血沉——均有显著改善,但握力、关节指数和血沉在GST组改善更为明显。AF组手部和前足的X线进展明显更大。48例服用AF的患者(80%)和39例服用GST的患者(36%)完成了第一年的治疗。此后,该研究作为开放研究继续进行,但患者可从GST换用AF。第一年和第二年之后,14/7例服用GST的患者换用了AF。第二年/第三年,37/22例服用AF的患者(62%/37%)和15/8例服用GST的患者(24%/13%)完成了治疗。皮肤反应在服用GST的患者中更常见(41.9%/26.7%),腹泻在服用AF的患者中更常见(36.7%/19.4%),两组蛋白尿发生率均为10%,两组白细胞减少和血小板减少均少见(1.7%)。第一年因不良事件导致的退出率在AF/GST组分别为10%/26%(p<0.05),三年期间为25%/32%(无显著差异)。

结论

AF和GST在类风湿关节炎的长期治疗中均有效,但GST在放射学进展和血沉方面效果更佳。

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