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小剂量泼尼松龙治疗早期类风湿关节炎与晚期心血管结局及生存率:一项为期2年的随机试验的10年随访

Low-dose prednisolone treatment of early rheumatoid arthritis and late cardiovascular outcome and survival: 10-year follow-up of a 2-year randomised trial.

作者信息

Ajeganova Sofia, Svensson Björn, Hafström Ingiäld

机构信息

Rheumatology Unit, Department of Medicine, Karolinska Institutet at Karolinska University Hospital Huddinge, Stockholm, Sweden.

出版信息

BMJ Open. 2014 Apr 7;4(4):e004259. doi: 10.1136/bmjopen-2013-004259.

DOI:10.1136/bmjopen-2013-004259
PMID:24710131
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3987742/
Abstract

OBJECTIVE

To examine the long-term effects of early low-dose prednisolone use in patients with rheumatoid arthritis (RA) on cardiovascular (CV) morbidity and mortality.

DESIGN

Retrieval of data from a 2-year open randomised trial comparing prednisolone 7.5 mg/day in addition to disease-modifying antirheumatic drugs (DMARDs) with DMARD therapy alone. Participants were followed for 10 years since inclusion into the original prednisolone trial or until occurrence of the studied outcomes.

SETTING

Secondary level of care; six participating centres from southern Sweden; both urban and rural populations.

PARTICIPANTS

Overall, 223 patients with early RA were included. The participants had no history of CV events at baseline and incident cases were identified via the Swedish Hospital Discharge and Cause of Death Registries.

OUTCOMES

Composite CV events, that is, ischaemic coronary and cerebrovascular events, components of the composite CV outcome, and death. Relative HRs from Cox proportional-hazards regression models were calculated.

RESULTS

Within 2041 person-years, 17 incident composite CV events occurred in 112 patients (15%) randomised to prednisolone, and 15 events of 111 patients (14%) who were assigned not to receive prednisolone. There were nine deaths (8%) in each group. The age-adjusted relative hazards (HRs; 95% CI) for the first composite CV event, first coronary event and death in the prednisolone group versus the group not treated with prednisolone were 1.8 (0.9 to 3.6), 0.98 (0.4 to 2.6) and 1.6 (0.6 to 4.1), respectively. The risk for the first cerebrovascular event showed a 3.7-fold increased relative hazard (95% CI 1.2 to 11.4) among prednisolone treated patients.

CONCLUSIONS

In this inception cohort study of low-dose prednisolone use during the first 2 years of RA disease, the incidence of ischaemic coronary artery events was similar in the two treatment groups, whereas the long-term risk of ischaemic cerebrovascular events was higher in the prednisolone group. There was a trend towards reduced survival in the prednisolone group.

TRIAL REGISTRATION NUMBER

ISRCTN20612367.

摘要

目的

探讨类风湿关节炎(RA)患者早期使用低剂量泼尼松龙对心血管(CV)发病率和死亡率的长期影响。

设计

从一项为期2年的开放随机试验中检索数据,该试验比较了在使用改善病情抗风湿药物(DMARDs)的基础上加用7.5毫克/天泼尼松龙与单独使用DMARDs治疗的效果。自纳入原泼尼松龙试验起,对参与者进行了10年的随访,直至出现研究结局。

设置

二级医疗保健机构;瑞典南部的六个参与中心;包括城市和农村人口。

参与者

共纳入223例早期RA患者。参与者在基线时无CV事件史,通过瑞典医院出院和死亡原因登记处识别新发病例。

结局

复合CV事件,即缺血性冠状动脉和脑血管事件、复合CV结局的组成部分以及死亡。计算Cox比例风险回归模型的相对风险比(HRs)。

结果

在2041人年中,随机分配到泼尼松龙组的112例患者(15%)发生了17例复合CV事件,未接受泼尼松龙治疗的111例患者(14%)发生了15例。每组有9例死亡(8%)。泼尼松龙组与未接受泼尼松龙治疗组相比,首次复合CV事件、首次冠状动脉事件和死亡的年龄调整相对风险(HRs;95%CI)分别为1.8(0.9至3.6)、0.98(0.4至2.6)和1.6(0.6至4.1)。泼尼松龙治疗的患者首次脑血管事件的风险显示相对风险增加了3.7倍(95%CI 1.2至11.4)。

结论

在这项关于RA疾病最初2年使用低剂量泼尼松龙的队列研究中,两个治疗组缺血性冠状动脉事件的发生率相似,而泼尼松龙组缺血性脑血管事件的长期风险更高。泼尼松龙组有生存降低的趋势。

试验注册号

ISRCTN20612367。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad3f/3987742/0b1e315f5b37/bmjopen2013004259f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad3f/3987742/e93c13559456/bmjopen2013004259f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad3f/3987742/0b1e315f5b37/bmjopen2013004259f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad3f/3987742/e93c13559456/bmjopen2013004259f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad3f/3987742/0b1e315f5b37/bmjopen2013004259f02.jpg

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