University of Basel, Basel, Switzerland.
Genentech, South San Francisco, California.
Arthritis Care Res (Hoboken). 2019 Apr;71(4):498-511. doi: 10.1002/acr.23611.
Using the UK Clinical Practice Research Datalink, we examined the incidence of glucocorticoid (GC)-related serious adverse events (SAEs) in rheumatoid arthritis (RA) and non-RA patients and quantified the risk of SAEs in patients with RA.
We matched incident patients with RA to an age- and sex-matched, non-RA comparison group of equal size. In a cohort analysis, we estimated incidence rates (IRs) and IR ratios (IRRs) for GC-related AEs (i.e., diabetes mellitus [DM], osteoporosis, fractures, glaucoma, hypertension, gastrointestinal [GI] perforation or bleeding, thrombotic stroke or myocardial infarction [MI], or death), stratified by GC use. We conducted a series of nested case-control analyses among patients with RA, evaluating the effects of increasing cumulative and average daily GC dose. Cases of each outcome were matched to controls for age, sex, and general practice. We calculated adjusted odds ratios (ORs) with 95% confidence intervals (95% CIs) for each outcome.
Patients with RA had a higher incidence for all investigated SAEs except glaucoma, compared to non-RA patients. IRRs were greater in those patients prescribed a GC than in those without. In patients with RA, GCs were associated with an elevated risk of DM (adjusted OR 1.33 [95% CI 1.14-1.56]), osteoporosis (adjusted OR 1.41 [95% CI 1.25-1.59]), thrombotic stroke or MI (adjusted OR 1.28 [95% CI 1.07-1.52]), serious infection (adjusted OR 1.28 [95% CI 1.11-1.48]), and death (adjusted OR 1.33 [95% CI 1.19-1.48]). There was a trend of increasing risk with increasing cumulative and average daily GC dose for all outcomes other than glaucoma, hypertension, and GI perforations or bleeding (P < 0.05).
Patients with RA had an increased incidence of GC-related AEs. Increasing cumulative and average daily GC doses were found to be associated with an increasing risk of developing an AE.
利用英国临床实践研究数据库，我们检查了类风湿关节炎（RA）和非 RA 患者中糖皮质激素（GC）相关严重不良事件（SAE）的发生率，并量化了 RA 患者发生 SAE 的风险。
我们将 RA 新发患者与年龄和性别匹配、大小相等的非 RA 对照组相匹配。在队列分析中，我们估计了 GC 相关 AE（即糖尿病[DM]、骨质疏松症、骨折、青光眼、高血压、胃肠道[GI]穿孔或出血、血栓性中风或心肌梗死[MI]或死亡）的发生率（IR）和 IR 比（IRR），并按 GC 使用情况进行分层。我们在 RA 患者中进行了一系列嵌套病例对照分析，评估了累积和平均每日 GC 剂量增加的影响。每种结果的病例均与年龄、性别和全科医生匹配的对照相匹配。我们计算了每个结果的调整后比值比（OR）及其 95%置信区间（95%CI）。
与非 RA 患者相比，RA 患者发生所有研究 SAE 的发生率更高，除了青光眼。与未使用 GC 的患者相比，使用 GC 的患者 IRR 更高。在 RA 患者中，GC 与 DM（调整后 OR 1.33[95%CI 1.14-1.56]）、骨质疏松症（调整后 OR 1.41[95%CI 1.25-1.59]）、血栓性中风或 MI（调整后 OR 1.28[95%CI 1.07-1.52]）、严重感染（调整后 OR 1.28[95%CI 1.11-1.48]）和死亡（调整后 OR 1.33[95%CI 1.19-1.48]）的风险升高有关。除了青光眼、高血压和 GI 穿孔或出血外，随着累积和平均每日 GC 剂量的增加，所有其他结局的风险均呈上升趋势（P<0.05）。
RA 患者发生 GC 相关 AE 的发生率增加。累积和平均每日 GC 剂量的增加与发生 AE 的风险增加有关。
