Effects of Hydroxychloroquine on Symptomatic Improvement in Primary Sjögren Syndrome

羟基氯喹 医学 安慰剂 临床终点 内科学 随机对照试验 优势比 物理疗法 安慰剂对照研究 儿科 疾病 双盲 病理 替代医学 传染病(医学专业) 2019年冠状病毒病(COVID-19)
作者
Jacques-Éric Gottenberg,Philippe Ravaud,Xavier Puéchal,Véronique Le Guern,Jean Sibilia,Vincent Goëb,Claire Larroche,Jean‐Jacques Dubost,Stéphanie Rist,Alain Saraux,Valérie Devauchelle‐Pensec,Jacques Morel,Gilles Hayem,P.Y. Hatron,Aleth Perdriger,Damien Sène,Charles Zarnitsky,Djilali Batouche,Valérie Furlan,Joëlle Bénessiano,Élodie Perrodeau,Raphaèle Séror,Xavier Mariette
出处
期刊:JAMA [American Medical Association]
卷期号:312 (3): 249-249 被引量:236
标识
DOI:10.1001/jama.2014.7682
摘要

Importance

Primary Sjögren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness, pain, and fatigue. Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome. However, evidence regarding its efficacy is limited.

Objective

To evaluate the efficacy of hydroxychloroquine for the main symptoms of primary Sjögren syndrome: dryness, pain, and fatigue.

Design, Setting, and Participants

From April 2008 to May 2011, 120 patients with primary Sjögren syndrome according to American-European Consensus Group Criteria from 15 university hospitals in France were randomized in a double-blind, parallel-group, placebo-controlled trial. Participants were assessed at baseline, week 12, week 24 (primary outcome), and week 48. The last follow-up date for the last patient was May 15, 2012.

Interventions

Patients were randomized (1:1) to receive hydroxychloroquine (400 mg/d) or placebo until week 24. All patients were prescribed hydroxychloroquine between weeks 24 and 48.

Main Outcomes and Measures

The primary end point was the proportion of patients with a 30% or greater reduction between weeks 0 and 24 in scores on 2 of 3 numeric analog scales (from 0 [best] to 10 [worst]) evaluating dryness, pain, and fatigue.

Results

At 24 weeks, the proportion of patients meeting the primary end point was 17.9% (10/56) in the hydroxychloroquine group and 17.2% (11/64) in the placebo group (odds ratio, 1.01; 95% CI, 0.37-2.78;P = .98). Between weeks 0 and 24, the mean (SD) numeric analog scale score for dryness changed from 6.38 (2.14) to 5.85 (2.57) in the placebo group and 6.53 (1.97) to 6.22 (1.87) in the hydroxychloroquine group. The mean (SD) numeric analog scale score for pain changed from 4.92 (2.94) to 5.08 (2.48) in the placebo group and 5.09 (3.06) to 4.59 (2.90) in the hydroxychloroquine group. The mean (SD) numeric analog scale for fatigue changed from 6.26 (2.27) to 5.72 (2.38) in the placebo group and 6.00 (2.52) to 5.94 (2.40) in the hydroxychloroquine group. All but 1 patient in the hydroxychloroquine group had detectable blood levels of the drug. Hydroxychloroquine had no efficacy in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. During the first 24 weeks, there were 2 serious adverse events in the hydroxychloroquine group and 3 in the placebo group; in the last 24 weeks, there were 3 serious adverse events in the hydroxychloroquine group and 4 in the placebo group.

Conclusions and Relevance

Among patients with primary Sjögren syndrome, the use of hydroxychloroquine compared with placebo did not improve symptoms during 24 weeks of treatment. Further studies are needed to evaluate longer-term outcomes.

Trial Registration

clinicaltrials.gov Identifier:NCT00632866
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
1秒前
靖123456发布了新的文献求助10
1秒前
拓跋箴完成签到,获得积分10
1秒前
彭于晏应助zy采纳,获得10
2秒前
精明玲完成签到 ,获得积分10
3秒前
3秒前
乐乐完成签到,获得积分10
4秒前
VirSnorlax完成签到,获得积分10
4秒前
SciGPT应助LL采纳,获得10
4秒前
妖孽宇发布了新的文献求助10
5秒前
aa完成签到,获得积分20
5秒前
aaaa完成签到,获得积分10
5秒前
马香芦完成签到,获得积分10
6秒前
西红柿完成签到,获得积分10
7秒前
8秒前
懵懂的冬灵完成签到,获得积分10
8秒前
碧蓝可仁完成签到 ,获得积分10
9秒前
王拉拉完成签到 ,获得积分10
9秒前
西西完成签到,获得积分10
9秒前
深情安青应助mkmimii采纳,获得10
10秒前
上官若男应助小王采纳,获得10
10秒前
bkagyin应助旦皋采纳,获得10
10秒前
Orange应助欣欣采纳,获得10
11秒前
玄学大哥完成签到,获得积分10
11秒前
11秒前
11秒前
kk完成签到,获得积分10
11秒前
ww007完成签到,获得积分10
13秒前
科研通AI5应助hahaha123213123采纳,获得10
13秒前
misstwo完成签到,获得积分10
14秒前
研友_ZzrwqZ发布了新的文献求助10
14秒前
JY'完成签到,获得积分10
15秒前
一只小鲨鱼完成签到,获得积分10
16秒前
漂亮的哈密瓜完成签到,获得积分10
16秒前
量子星尘发布了新的文献求助10
16秒前
17秒前
LL发布了新的文献求助10
17秒前
苏苏完成签到,获得积分10
18秒前
18秒前
fabc5653219完成签到,获得积分10
19秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
Research on Disturbance Rejection Control Algorithm for Aerial Operation Robots 500
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038388
求助须知:如何正确求助?哪些是违规求助? 3576106
关于积分的说明 11374447
捐赠科研通 3305798
什么是DOI,文献DOI怎么找? 1819322
邀请新用户注册赠送积分活动 892672
科研通“疑难数据库(出版商)”最低求助积分说明 815029