Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Clin Exp Rheumatol. 2011 Sep-Oct;29(5 Suppl 68):S85-92. Epub 2011 Oct 21.
To systematically analyse the literature on reported adverse events (AEs) of intravenous pulse glucocorticoids (GCs) (≥ 250 mg prednisone equivalent) for inflammatory diseases.
A literature search was done using PubMed, Embase, and Cochrane databases. Studies were selected by two reviewers (NAMS and ND). Available data on the prevalence of GC-related AEs in patients with inflammatory diseases were retrieved.
In only 8 studies (344 patients), 4 placebo-controlled and 4 not placebo-controlled studies, intravenous pulse GC-related AEs had been documented (in total 323 AEs), with an AE rate of 35/100 patient-years. In the 4 placebo-controlled studies among RA and systemic sclerosis patients, most of the odds ratios of individual AEs were not statistically significant, except for flushing, heart rhythm disorder, disturbance of taste, lower respiratory infection, and headache. In the 4 not placebo-controlled studies increased diastolic blood pressure was most frequent, followed by flushing and diabetes mellitus. Adverse events seen in more than 15% of patients of all included studies were increased blood pressure, flushing, headache, disturbance of taste, tachycardia and hyperglycemia.
GC pulse therapy results in a high AE rate, i.e. 35/100 patient-years. Cardiovascular AEs are most frequently reported in the literature. Furthermore, flushing had the highest odds ratio in the placebo-controlled studies and also a high event rate in the not placebo-controlled studies.
系统分析静脉注射脉冲糖皮质激素(GCs)(≥250mg 泼尼松等效剂量)治疗炎症性疾病的不良事件(AE)报告文献。
使用 PubMed、Embase 和 Cochrane 数据库进行文献检索。两名评审员(NAMS 和 ND)选择研究。检索到关于炎症性疾病患者中与 GC 相关的 AE 患病率的可用数据。
仅在 8 项研究(344 例患者)中,4 项安慰剂对照研究和 4 项非安慰剂对照研究记录了静脉脉冲 GC 相关 AE(共 323 例 AE),AE 发生率为 35/100 患者年。在 RA 和系统性硬化症患者的 4 项安慰剂对照研究中,除潮红、心律紊乱、味觉障碍、下呼吸道感染和头痛外,大多数单个 AE 的比值比没有统计学意义。在 4 项非安慰剂对照研究中,最常见的是舒张压升高,其次是潮红和糖尿病。所有纳入研究中超过 15%的患者出现的不良事件为血压升高、潮红、头痛、味觉障碍、心动过速和高血糖。
GC 脉冲治疗导致 AE 发生率高,即 35/100 患者年。心血管 AE 是文献中最常报道的。此外,潮红在安慰剂对照研究中具有最高的比值比,并且在非安慰剂对照研究中也具有较高的发生率。