英国哮喘患者口服皮质类固醇激素不良事件概况：队列研究与巢式病例对照分析
2018/05/08
摘要
背景：评估英国成人哮喘患者口服泼尼松龙的不良反应情况。
方法：利用来自英国临床实践研究数据库的数据，我们进行了一系列队列研究以量化发病率和发病率比率，以及一系列巢式病例对照分析以评估11种不同潜在皮质类固醇相关不良事件的原始和校正比值比（骨相关疾病，高血压，消化性溃疡，重症感染，带状疱疹，2型糖尿病，白内障，青光眼，慢性肾病，情感障碍和心血管事件）。
结果：11个队列中每个队列包括165,900至269,368名哮喘患者，其中836至16,192名患者产生了感兴趣的结果。最近使用口服泼尼松龙患者的潜在皮质类固醇相关不良事件的每千人年发生率从消化性溃疡1.4（95％CI，1.0-1.8）到重症感染78.0（95％CI，74.8 -81.2）。调整混淆之后，与不使用泼尼松龙相比，目前使用口服泼尼松龙与重症感染风险增加最为密切，OR 2.16（95％CI，2.05-2.27）。与不使用泼尼松龙相比，较高剂量泼尼松龙相关的消化性溃疡，情感障碍和白内障的风险较小，带状疱疹，心血管事件，2型糖尿病和骨相关疾病的风险稍微增加。口服泼尼松龙和青光眼，慢性肾病或高血压之间没有发现相关性。
结论：使用口服泼尼松龙与成人哮喘患者中的感染，胃肠道疾病，神经精神障碍，眼部疾病，心血管事件，代谢和骨相关并发症相关。
Adverse events profile of oral corticosteroids among asthma patients in the UK: cohort study with a nested case-control analysis.
Bloechliger M, Reinau D, Spoendlin J, Chang SC, Kuhlbusch K, Heaney LG, Jick SS, Meier CR.
Abstract
BACKGROUND:To evaluate the adverse events profile of oral prednisolone among adult asthma patients in the UK.
METHODS:Using data from the UK-based Clinical Practice Research Datalink, we conducted a series of cohort studies to quantify incidence rates and incidence rate ratios, and a series of nested case-control analyses to estimate crude and adjusted odds ratios, of 11 different potential corticosteroid-related adverse events (bone-related conditions, hypertension, peptic ulcer, severe infections, herpes zoster, diabetes mellitus type 2, cataract, glaucoma, chronic kidney disease, affective disorders, and cardiovascular events).
RESULTS:Between 165,900 and 269,368 asthma patients were included in each of the 11 cohorts, of whom between 836 and 16,192 developed an outcome of interest. Incidence rates per 1000 person-years of potential corticosteroid-related adverse events in patients with new current use of oral prednisolone ranged from 1.4 (95% confidence interval [CI], 1.0-1.8) for peptic ulcer to 78.0 (95% CI, 74.8-81.2) for severe infections. After adjusting for confounding, current oral prednisolone use was most strongly associated with an increased risk of severe infection, compared with non-use of prednisolone; OR 2.16 (95% CI, 2.05-2.27). There were smaller elevated risks of peptic ulcer, affective disorders, and cataract at higher doses, and marginally increased risks of herpes zoster, cardiovascular events, diabetes mellitus type 2, and bone related conditions, compared with non-use of prednisolone. We did not observe an association between oral prednisolone use and glaucoma, chronic kidney disease, or hypertension.
CONCLUSIONS:Oral prednisolone use is associated with infections, gastrointestinal, neuropsychiatric, ocular, cardiovascular, metabolic, and bone-related complications among adult asthma patients.
背景：评估英国成人哮喘患者口服泼尼松龙的不良反应情况。
方法：利用来自英国临床实践研究数据库的数据，我们进行了一系列队列研究以量化发病率和发病率比率，以及一系列巢式病例对照分析以评估11种不同潜在皮质类固醇相关不良事件的原始和校正比值比（骨相关疾病，高血压，消化性溃疡，重症感染，带状疱疹，2型糖尿病，白内障，青光眼，慢性肾病，情感障碍和心血管事件）。
结果：11个队列中每个队列包括165,900至269,368名哮喘患者，其中836至16,192名患者产生了感兴趣的结果。最近使用口服泼尼松龙患者的潜在皮质类固醇相关不良事件的每千人年发生率从消化性溃疡1.4（95％CI，1.0-1.8）到重症感染78.0（95％CI，74.8 -81.2）。调整混淆之后，与不使用泼尼松龙相比，目前使用口服泼尼松龙与重症感染风险增加最为密切，OR 2.16（95％CI，2.05-2.27）。与不使用泼尼松龙相比，较高剂量泼尼松龙相关的消化性溃疡，情感障碍和白内障的风险较小，带状疱疹，心血管事件，2型糖尿病和骨相关疾病的风险稍微增加。口服泼尼松龙和青光眼，慢性肾病或高血压之间没有发现相关性。
结论：使用口服泼尼松龙与成人哮喘患者中的感染，胃肠道疾病，神经精神障碍，眼部疾病，心血管事件，代谢和骨相关并发症相关。
(中日友好医院呼吸与危重症医学科 王瑞茵 摘译 林江涛 审校)
(Respir Res. 2018 Apr 27;19(1):75. doi: 10.1186/s12931-018-0742-y.)
(Respir Res. 2018 Apr 27;19(1):75. doi: 10.1186/s12931-018-0742-y.)
Adverse events profile of oral corticosteroids among asthma patients in the UK: cohort study with a nested case-control analysis.
Bloechliger M, Reinau D, Spoendlin J, Chang SC, Kuhlbusch K, Heaney LG, Jick SS, Meier CR.
Abstract
BACKGROUND:To evaluate the adverse events profile of oral prednisolone among adult asthma patients in the UK.
METHODS:Using data from the UK-based Clinical Practice Research Datalink, we conducted a series of cohort studies to quantify incidence rates and incidence rate ratios, and a series of nested case-control analyses to estimate crude and adjusted odds ratios, of 11 different potential corticosteroid-related adverse events (bone-related conditions, hypertension, peptic ulcer, severe infections, herpes zoster, diabetes mellitus type 2, cataract, glaucoma, chronic kidney disease, affective disorders, and cardiovascular events).
RESULTS:Between 165,900 and 269,368 asthma patients were included in each of the 11 cohorts, of whom between 836 and 16,192 developed an outcome of interest. Incidence rates per 1000 person-years of potential corticosteroid-related adverse events in patients with new current use of oral prednisolone ranged from 1.4 (95% confidence interval [CI], 1.0-1.8) for peptic ulcer to 78.0 (95% CI, 74.8-81.2) for severe infections. After adjusting for confounding, current oral prednisolone use was most strongly associated with an increased risk of severe infection, compared with non-use of prednisolone; OR 2.16 (95% CI, 2.05-2.27). There were smaller elevated risks of peptic ulcer, affective disorders, and cataract at higher doses, and marginally increased risks of herpes zoster, cardiovascular events, diabetes mellitus type 2, and bone related conditions, compared with non-use of prednisolone. We did not observe an association between oral prednisolone use and glaucoma, chronic kidney disease, or hypertension.
CONCLUSIONS:Oral prednisolone use is associated with infections, gastrointestinal, neuropsychiatric, ocular, cardiovascular, metabolic, and bone-related complications among adult asthma patients.
