Department of Dermatology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea.
School of Pharmacy, Sungkyunkwan University, Suwon, South Korea.
JAMA Netw Open. 2024 Jul 1;7(7):e2423563. doi: 10.1001/jamanetworkopen.2024.23563.
The use of oral corticosteroids for prolonged periods may be associated with adverse events (AEs). Nevertheless, the risk of AEs with oral corticosteroids, especially among patients with atopic dermatitis (AD), has not been comprehensively investigated and lacks evidence on duration of treatment.
To assess the association between long-term exposure to oral corticosteroids and AEs among adult patients with AD.
DESIGN, SETTING, AND PARTICIPANTS: This nested case-control study used data from the Health Insurance Review and Assessment Service database of South Korea between January 1, 2012, and October 31, 2021, which included 1 year prior to the cohort entry date of January 1, 2013, for assessing exclusion criteria and baseline characteristics, and 1 year after the study end date of October 31, 2020, to ensure a minimum duration for assessing exposure. Among the population of adults with AD, patients diagnosed with any of 11 AEs were matched with patients who had never received a diagnosis of any of the 11 AEs.
Long-term use of oral corticosteroids was defined as cumulative supply of more than 30 days or more than 90 days of oral corticosteroid prescription per year.
We used multivariable conditional logistic regression analyses to measure the risk of 11 individual outcomes (osteoporosis, fracture, type 2 diabetes, hyperlipidemia, hypertension, myocardial infarction, stroke, heart failure, avascular necrosis, cataract, or glaucoma) as the composite outcome, controlling for potential confounders. We further classified the composite outcome to individual outcomes to evaluate the AE-specific risk.
Among 1 025 270 patients with AD between 2013 and 2020, 164 809 cases (mean [SD] age, 39.4 [14.8]; 56.9% women) were matched with 328 303 controls (mean [SD] age, 39.3 [14.7]; 56.9% women) for sex, age, cohort entry date, follow-up duration, and severity of AD, where the balance of most baseline characteristics was achieved. A total of 5533 cases (3.4%) and 10 561 controls (3.2%) were exposed to oral corticosteroids for more than 30 days, while 684 cases (0.4%) and 1153 controls (0.4%) were exposed to oral corticosteroids for more than 90 days. Overall, there was no increased risk of AEs with use of oral corticosteroids for more than 30 days (adjusted odds ratio [AOR], 1.00; 95% CI, 0.97-1.04), whereas the risk was slightly higher with use of oral corticosteroids for more than 90 days (AOR, 1.11; 95% CI, 1.01-1.23). The small elevation in experiencing an AE was observed with each cumulative or consecutive year of ever long-term use.
This case-control study found a slightly increased risk of AEs associated with use of oral corticosteroids for more than 90 days per year, which warrants future research to fully elucidate the observed findings.
长期使用口服皮质类固醇可能与不良事件（AE）有关。然而，口服皮质类固醇，特别是特应性皮炎（AD）患者的 AE 风险尚未得到全面调查，并且缺乏关于治疗持续时间的证据。
评估 AD 成年患者长期暴露于口服皮质类固醇与 AE 之间的关联。
设计、设置和参与者：本嵌套病例对照研究使用了韩国健康保险审查和评估服务数据库 2012 年 1 月 1 日至 2021 年 10 月 31 日的数据，包括 2013 年 1 月 1 日队列入组日期前 1 年，用于评估排除标准和基线特征，以及 2020 年 10 月 31 日研究结束日期后 1 年，以确保有足够的时间来评估暴露情况。在 AD 成年患者人群中，将被诊断出任何 11 种 AE 的患者与从未被诊断出任何 11 种 AE 的患者相匹配。
长期使用口服皮质类固醇定义为累积供应超过 30 天或每年口服皮质类固醇处方超过 90 天。
我们使用多变量条件逻辑回归分析来衡量 11 个个体结果（骨质疏松症、骨折、2 型糖尿病、血脂异常、高血压、心肌梗死、中风、心力衰竭、骨坏死、白内障或青光眼）作为复合结果，控制潜在的混杂因素。我们进一步将复合结果分类为个体结果，以评估特定 AE 的风险。
在 2013 年至 2020 年间，1025270 名 AD 患者中，有 164809 例（平均[SD]年龄 39.4[14.8]；56.9%为女性）与 328303 名对照（平均[SD]年龄 39.3[14.7]；56.9%为女性）相匹配，匹配性别、年龄、入组日期、随访时间和 AD 严重程度，大多数基线特征的平衡得到了实现。共有 5533 例（3.4%）和 10561 例（3.2%）患者暴露于口服皮质类固醇超过 30 天，而 684 例（0.4%）和 1153 例（0.4%）患者暴露于口服皮质类固醇超过 90 天。总体而言，使用口服皮质类固醇超过 30 天并没有增加 AE 的风险（调整后的优势比[OR]，1.00；95%CI，0.97-1.04），而使用口服皮质类固醇超过 90 天的风险略高（OR，1.11；95%CI，1.01-1.23）。随着每年累计或连续使用口服皮质类固醇的时间增加，经历 AE 的风险略有增加。
这项病例对照研究发现，与每年使用口服皮质类固醇超过 90 天相关的 AE 风险略有增加，这需要进一步研究来充分阐明观察到的结果。
