Evaluating the safety and short-term equivalence of colchicine versus prednisone in older patients with acute calcium pyrophosphate crystal arthritis (COLCHICORT): an open-label, multicentre, randomised trial

医学 焦磷酸钙 强的松 不利影响 痛风 关节炎 内科学 外科
作者
Tristan Pascart,P. Robinet,Sébastien Ottaviani,Rémi Leroy,N. Segaud,Aurore Pacaud,Agathe Grandjean,H. Luraschi,Thibault Rabin,Xavier Deplanque,Pierre Maciejasz,Fabien Visade,A Mackowiak,N. Baclet,Sylvestre Maréchaux,Antoine Lefebvre,Jean‐François Budzik,Thomas Bardin,Pascal Richette,Laurène Norberciak
出处
期刊:The Lancet Rheumatology [Elsevier BV]
卷期号:5 (9): e523-e531 被引量:23
标识
DOI:10.1016/s2665-9913(23)00165-0
摘要

Background Acute calcium pyrophosphate crystal arthritis causes intense joint pain mainly affecting older people. Because guidance and evidence remain scarce, management of this disease relies on expert opinion. We therefore aimed to compare the safety and short-term equivalence of low-dose colchicine with oral prednisone in older patients with acute calcium pyrophosphate crystal arthritis. Methods We did an open-label, multicentre, randomised, trial (COLCHICORT) at six hospitals in Paris and northern France. We enrolled patients who were admitted to hospital who were 65 years or older and who presented with acute calcium pyrophosphate crystal arthritis with a symptom duration of less than 36 h. Diagnosis of calcium pyrophosphate crystal arthritis was made by the identification of calcium pyrophosphate crystals on synovial fluid analysis or typical clinical presentation (onset of joint pain and swelling). Key exclusion criteria included absence of calcium pyrophosphate crystals on synovial fluid analysis or a history of gout. Participants were randomly allocated (1:1), using a centralised electronic treatment group allocation module, to receive either colchicine 1·5 mg on day 1 and 1 mg on day 2 (ie, the colchicine group) or oral prednisone 30 mg on days 1 and 2 (ie, the prednisone group). The primary outcome was change in joint pain (measured by visual analogue scale [VAS] from 0 mm to 100 mm) at 24 h. Equivalence was determined whether the 95% CI of the between-group difference at 24 h was within the –13 mm to +13 mm margin in the per-protocol analysis. Adverse events were recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). This trial is completed and is registered with ClinicalTrials.gov, NCT03128905. Findings Between Feb 5, 2018, and May 7, 2022, 111 patients who were admitted to hospital were randomly assigned (57 [51%] to the colchicine group and 54 [49%] to the prednisone group). 95 (86%) of 111 patients were included in the per-protocol analysis (49 [52%] in the colchicine group and 46 [48%] in the prednisone group). The median age was 88·0 years (IQR 82·0–91·0) and 69 (73%) of 95 participants were women and 26 (27%) were men. Acute calcium pyrophosphate crystal arthritis affected mainly the knee in 46 (48%) of 95 participants, the wrist in 19 (20%), and the ankle in 12 (13%). Pain VAS at baseline was 68 mm (SD 17). At 24 h, change in pain VAS was –36 mm (SD 32) in the colchicine group and –38 mm (SD 23) in the prednisone group. The between-group difference in change in pain VAS at 24 h was –1 mm (95% CI –12 to 10), showing equivalence between the two drugs. In the colchicine group, 12 (22%) of 55 patients had diarrhoea, one (2%) had hypertension, and none had hyperglycaemia. In the prednisone group, three (6%) of 54 had diarrhoea, six (11%) had hypertension, and three (6%) had hyperglycaemia. No deaths occurred in the colchicine group; two deaths occurred in the prednisone group, which were deemed unrelated to prednisone (one due to infectious valvular endocarditis leading to heart failure, and one due to a stroke). Interpretation Colchicine and prednisone exhibit equivalent short-term efficacy for the treatment of acute calcium pyrophosphate crystal arthritis, with different safety profiles in the older population. Funding French Inter-regional Hospital Program of Clinical Research.
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
zhui完成签到,获得积分10
1秒前
RESLR完成签到,获得积分10
2秒前
2秒前
2秒前
用户5063899发布了新的文献求助10
2秒前
4秒前
雨的痕迹完成签到,获得积分10
5秒前
Loik发布了新的文献求助10
5秒前
充电宝应助绛川采纳,获得10
5秒前
量子星尘发布了新的文献求助10
7秒前
7秒前
CAOHOU应助sue采纳,获得10
8秒前
8秒前
Loik完成签到,获得积分10
11秒前
11秒前
苗条梦玉发布了新的文献求助10
12秒前
12秒前
12秒前
17秒前
绛川发布了新的文献求助10
18秒前
momo发布了新的文献求助10
19秒前
搜集达人应助潘善若采纳,获得10
19秒前
yyer发布了新的文献求助10
20秒前
实心小墩墩完成签到,获得积分10
22秒前
27秒前
28秒前
香蕉觅云应助su采纳,获得10
28秒前
深情安青应助momo采纳,获得10
30秒前
30秒前
31秒前
可爱的函函应助hu采纳,获得10
33秒前
33秒前
34秒前
ABS发布了新的文献求助10
34秒前
35秒前
FashionBoy应助忘记时间采纳,获得30
36秒前
爆米花应助无情的匪采纳,获得10
37秒前
38秒前
刘寄奴发布了新的文献求助10
39秒前
su发布了新的文献求助10
41秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
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 3989297
求助须知:如何正确求助?哪些是违规求助? 3531418
关于积分的说明 11253893
捐赠科研通 3270097
什么是DOI,文献DOI怎么找? 1804884
邀请新用户注册赠送积分活动 882087
科研通“疑难数据库(出版商)”最低求助积分说明 809158