辛伐他汀能否减少治疗葡萄膜炎所需的免疫调节药物？一项前瞻性、随机、安慰剂对照试验。

Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?: A Prospective, Randomized, Placebo-Controlled Trial.

作者信息

Al-Janabi Ahmed, Sharief Lazha, Al Qassimi Noura, Chen Yi-Hsing, Ding Tao, Ambler Gareth, Ladas Dimitris, Lightman Sue, Tomkins-Netzer Oren

机构信息

Moorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UK.

Department of Statistical Science, University College London, London, UK.

出版信息

Ophthalmol Sci. 2023 May 19;3(4):100333. doi: 10.1016/j.xops.2023.100333. eCollection 2023 Dec.

DOI:10.1016/j.xops.2023.100333

PMID:37449048

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10336795/

Abstract

OBJECTIVE

To assess the efficacy of simvastatin 80 mg/day versus placebo in patients with noninfectious nonanterior uveitis receiving prednisolone ≥ 10 mg/day.

DESIGN

Randomized, double-masked, controlled trial.

SUBJECTS

Adult patients with noninfectious nonanterior uveitis on oral prednisolone dose of ≥ 10 mg/day.

METHODS

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).

MAIN OUTCOME MEASURES

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.

RESULTS

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; = 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.

CONCLUSIONS

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.

FINANCIAL DISCLOSURES

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

摘要

目的

评估每天80毫克辛伐他汀与安慰剂对接受≥10毫克/天泼尼松龙治疗的非感染性非前葡萄膜炎患者的疗效。

设计

随机、双盲、对照试验。

研究对象

口服泼尼松龙剂量≥10毫克/天的非感染性非前葡萄膜炎成年患者。

方法

患者按1:1比例随机分配，接受每天80毫克辛伐他汀或安慰剂治疗。共招募32名患者（每组16名），所有患者均完成主要终点指标，21名患者完成2年随访（次要终点指标）。

主要观察指标

主要终点指标为随访12个月时泼尼松龙每日剂量的平均减少量。次要终点指标为24个月时泼尼松龙剂量的平均减少量、二线免疫调节剂减少的患者百分比、疾病复发时间及不良事件。

结果

我们的结果显示，每天80毫克辛伐他汀在12个月时没有显著的糖皮质激素节省效应（估计值：3.62；95%置信区间[CI]：-8.15至15.38；P = 0.54）。两组在12个月和24个月时的泼尼松龙剂量或剂量变化方面没有显著差异。两组在24个月时二线药物减少的患者百分比方面没有差异。在疾病达到静止的患者中，接受辛伐他汀治疗的患者首次复发的中位时间（38周，95%CI：14 - 54）比接受安慰剂治疗的患者（14周，95%CI：12 - 52）长，尽管这在统计学上不显著。两组在不良事件或严重不良事件方面没有显著差异。