系统性红斑狼疮患者糖皮质激素相关不良事件的累积负担：一项为期 12 年的纵向研究结果。
Cumulative Burden of Glucocorticoid-related Adverse Events in Patients with Systemic Lupus Erythematosus: Findings from a 12-year Longitudinal Study.
机构信息
From the Graduate Institute of Clinical Pharmacy, the Graduate Institute of Immunology, the Graduate Institute of Clinical Medicine, and the School of Pharmacy, College of Medicine, National Taiwan University; Department of Internal Medicine, and Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan; Department of Epidemiology, Biogen, Cambridge, Massachusetts, USA.
H.L. Chen, MS, Research Associate, Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University; L.J. Shen, PhD, Associate Professor, Graduate Institute of Clinical Pharmacy, and School of Pharmacy, College of Medicine, National Taiwan University, and Director, Department of Pharmacy, National Taiwan University Hospital; P.N. Hsu, MD, PhD, Attending Physician, Department of Internal Medicine, National Taiwan University Hospital, and Professor, Graduate Institute of Immunology, College of Medicine, National Taiwan University; C.Y. Shen, MD, Visiting Physician, Department of Internal Medicine, National Taiwan University Hospital, and Doctoral Student, Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University; S.A. Hall, PhD, Associate Director, Department of Epidemiology, Biogen; F.Y. Hsiao, PhD, Associate Professor, Graduate Institute of Clinical Pharmacy, and School of Pharmacy, College of Medicine, National Taiwan University, and Adjunct Associate Researcher, Department of Pharmacy, National Taiwan University Hospital. H.L. Chen and L.J. Shen contributed equally as first authors.
出版信息
J Rheumatol. 2018 Jan;45(1):83-89. doi: 10.3899/jrheum.160214. Epub 2017 Nov 15.
OBJECTIVE
The aim of this population-based study is to examine the adverse events (AE) associated with longitudinal systemic glucocorticoid (GC) use among an ethnic Chinese systemic lupus erythematosus (SLE) cohort.
METHODS
Our study subjects were patients with newly diagnosed SLE aged 18 and older who received at least 1 prescription of systemic GC between 2001 and 2012 from Taiwan's National Health Insurance Research Database (NHIRD). The earliest prescription date of systemic GC for each subject was defined as the index date. For each subject, we calculated the average prednisolone-equivalent dose and the medication possession ratio (MPR) of GC use every 90 days for each patient after the index date. Patients with a diagnosis of AE (defined by the International Classification of Diseases-9-Clinical Modification diagnosis code) during the followup were also identified from the NHIRD. Generalized estimating equations adjusted for propensity score were applied to examine the association between longitudinal GC use and risks of prespecified AE (musculoskeletal, gastrointestinal, ophthalmologic, infectious, cardiovascular, neuropsychiatric, metabolic, and dermatologic diseases).
RESULTS
We identified 11,288 patients with SLE (mean followup: 6.28 yrs). Higher doses and higher MPR of GC were associated with increased risk of osteonecrosis [adjusted OR (aOR) 2.87-9.09]. Similar results were found regarding the risk of osteoporosis (aOR 1.71-3.67), bacterial infection (aOR 2.12-3.89), Cushingoid syndrome (aOR 6.51-62.03), and sleep disorder (aOR 1.42-3.59).
CONCLUSION
To our knowledge, this is the first study to show that the dose and intensity of longitudinal use of GC were both associated with risk of AE among a nationwide Asian SLE cohort.
目的
本基于人群的研究旨在探讨汉族系统性红斑狼疮（SLE）患者长期全身使用糖皮质激素（GC）相关的不良事件（AE）。
方法
我们的研究对象为 2001 年至 2012 年期间从台湾全民健康保险研究数据库（NHIRD）中至少接受过 1 次全身 GC 处方的新诊断为 SLE 的年龄在 18 岁及以上的患者。每位患者的最早全身 GC 处方日期定义为索引日期。对于每位患者，我们根据索引日期后每个患者的 90 天内计算 GC 使用的平均泼尼松等效剂量和药物维持率（MPR）。还从 NHIRD 中确定了随访期间发生 AE（通过国际疾病分类-9-临床修订版诊断代码定义）的患者。应用广义估计方程调整倾向评分来检验长期 GC 使用与特定 AE（肌肉骨骼、胃肠道、眼科、感染、心血管、神经精神、代谢和皮肤病）风险之间的关联。
结果
我们确定了 11288 例 SLE 患者（平均随访：6.28 年）。更高剂量和更高 MPR 的 GC 与骨坏死风险增加相关 [校正比值比（aOR）2.87-9.09]。对于骨质疏松症（aOR 1.71-3.67）、细菌感染（aOR 2.12-3.89）、库欣综合征（aOR 6.51-62.03）和睡眠障碍（aOR 1.42-3.59）的风险也发现了类似的结果。
结论
据我们所知，这是第一项表明在亚洲全国性 SLE 队列中，GC 的剂量和长期使用强度均与 AE 风险相关的研究。
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