Weinblatt M E, Germain B F, Kremer J M, Wall B A, Weisman M H, Maier A L, Coblyn J S
Brigham and Women's Hospital, Boston, MA 02115.
Arthritis Rheum. 1994 Sep;37(9):1321-5. doi: 10.1002/art.1780370908.
To assess whether the synthetic prostaglandin misoprostol is renal protective in rheumatoid arthritis (RA) patients who are beginning cyclosporin A (CSA) therapy.
In this randomized, placebo-controlled, multicenter trial, 50 patients with active RA were randomized to receive either misoprostol (800 micrograms/day) or placebo for 16 weeks. After 2 weeks of pretreatment with misoprostol or placebo, all patients concomitantly received CSA at an initial and maximum dosage of 5 mg/kg/day for 12 weeks.
A significant increase in the serum creatinine level was observed in both treatment groups, with no difference noted between groups. There was a high withdrawal rate in both groups, primarily due to adverse events.
A renal-protective effect was not demonstrated for misoprostol compared with placebo in RA patients who are beginning CSA therapy.
评估合成前列腺素米索前列醇对开始接受环孢素A（CSA）治疗的类风湿关节炎（RA）患者是否具有肾脏保护作用。
在这项随机、安慰剂对照、多中心试验中，50例活动性RA患者被随机分为两组，分别接受米索前列醇（800微克/天）或安慰剂治疗，为期16周。在使用米索前列醇或安慰剂预处理2周后，所有患者均开始联合使用CSA，初始剂量和最大剂量均为5毫克/千克/天，持续12周。
两个治疗组的血清肌酐水平均显著升高，两组之间无差异。两组的退出率都很高，主要原因是不良事件。
对于开始CSA治疗的RA患者，与安慰剂相比，米索前列醇未显示出肾脏保护作用。
