■评估辛伐他汀80mg/天与安慰剂在接受泼尼松龙≥10mg/天的非感染性非前葡萄膜炎患者中的疗效。
■随机化,双面蒙面,对照试验。
■成人非感染性非葡萄膜炎患者口服泼尼松龙剂量≥10mg/天。
患者以1:1的比例随机分配接受辛伐他汀80mg/天或安慰剂。共纳入32例患者(每组16例),所有这些人都完成了主要终点,21人达到2年访视(次要终点).
■主要终点是12个月随访时泼尼松龙每日剂量的平均减少。次要终点是24个月时泼尼松龙剂量的平均减少,二线免疫调节剂减少的患者百分比,疾病复发的时间,和不良事件。
■我们的结果表明,辛伐他汀80mg/天在12个月时没有明显的皮质类固醇保留作用(估计值:3.62;95%置信区间[CI]:-8.15至15.38;P=0.54)。在12个月和24个月时,两组之间的泼尼松龙剂量或剂量变化没有显着差异。到24个月,二线药物减少的患者百分比在两组之间没有差异。在实现疾病静止的患者中,接受辛伐他汀治疗的患者首次复发的中位时间更长(38周,95%CI:14-54)比安慰剂(14周,95%CI:12-52),尽管这在统计学上并不显着。两组间不良事件或严重不良事件无显著差异。
■辛伐他汀80mg/天在1年和2年时对皮质类固醇或常规免疫调节药物的剂量减少没有影响。结果表明,这可能会延长那些达到疾病静止状态的人的疾病复发时间。
■作者对本文讨论的任何材料都没有专有或商业利益。
UNASSIGNED: To assess the efficacy of simvastatin 80 mg/day versus placebo in patients with noninfectious nonanterior uveitis receiving prednisolone ≥ 10 mg/day.
UNASSIGNED: Randomized, double-masked, controlled trial.
UNASSIGNED: Adult patients with noninfectious nonanterior uveitis on oral prednisolone dose of ≥ 10 mg/day.
UNASSIGNED: Patients were randomly assigned at a 1:1 ratio to receive either simvastatin 80 mg/day or placebo. A total of 32 patients were enrolled (16 in each arm), all of whom completed the primary end point, and 21 reached the 2-year visit (secondary end points).
UNASSIGNED: The primary end point was mean reduction in the daily prednisolone dose at 12 months follow-up. Secondary end points were mean reduction in prednisolone dose at 24 months, percent of patients with a reduction in second-line immunomodulatory agents, time to disease relapse, and adverse events.
UNASSIGNED: Our results show that simvastatin 80 mg/day did not have a significant corticosteroid-sparing effect at 12 months (estimate: 3.62; 95% confidence interval [CI]: -8.15 to 15.38; P = 0.54). There was no significant difference between the groups with regard to prednisolone dose or change in dose at 12 and 24 months. There was no difference between the 2 groups in percent of patients with reduction in second-line agent by 24 months. Among patients who achieved disease quiescence, the median time to first relapse was longer for those receiving simvastatin (38 weeks, 95% CI: 14-54) than placebo (14 weeks, 95% CI: 12-52), although this was not statistically significant. There was no significant difference in adverse events or serious adverse events between the 2 groups.
UNASSIGNED: Simvastatin 80 mg/day did not have an effect on the dose reduction of corticosteroids or conventional immunomodulatory drugs at 1 and 2 years. The results suggest that it may extend the time to disease relapse among those who achieve disease quiescence.
UNASSIGNED: The author(s) have no proprietary or commercial interest in any materials discussed in this article.