Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, The Netherlands.
Ann Rheum Dis. 2010 Nov;69(11):1913-9. doi: 10.1136/ard.2009.124958. Epub 2010 Aug 6.
To develop recommendations on monitoring for adverse events (AEs) of low-dose glucocorticoid (GC) therapy (≤7.5 mg prednisone or equivalent daily) in clinical trials and daily practice.
Literature was searched for articles containing information on incidence and monitoring of GC-related AEs using PubMed, EMBASE and Cochrane databases. Second, the authors searched for broad accepted guidelines on the monitoring of certain AEs (eg, WHO guidelines on screening for diabetes). Available data were summarised and discussed among experts (rheumatologists and patients) of the EULAR Task Force to decide which potential AEs should be monitored, how and at which interval.
Data on monitoring proved to be scarce; most articles were focused on therapeutic effects of GCs, not on occurrence and monitoring of AEs. Most recommendations had to be based on consensus. Those for clinical trials aimed at getting insights into incidence, prevalence and clinical relevance of AEs to create a comprehensive and valid AE-profile of GC therapy. The set of AEs to monitor is therefore more extensive, and often consists of assessments at baseline and at end of trials. Recommendations for daily practice are meant to protect patients from real dangers, which can be prevented or treated. Standard care monitoring needs NOT be extended for patients on low-dose GC therapy, except for osteoporosis (follow national guidelines), and baseline assessments of ankle edema, fasting blood glucose and risk factors for glaucoma.
Given the incompleteness of literature data, consensus-based recommendations on monitoring for GC-related AEs were created, separately for daily practice and clinical trials.
制定关于监测低剂量糖皮质激素（GC）治疗（≤7.5mg 泼尼松龙或等效日剂量）不良事件（AE）的建议，包括临床试验和日常实践。
通过 PubMed、EMBASE 和 Cochrane 数据库检索包含 GC 相关 AE 发生率和监测信息的文献。其次，作者搜索了关于监测某些 AE 的广泛接受的指南（例如，WHO 糖尿病筛查指南）。总结可用数据并在 EULAR 工作组的专家（风湿病学家和患者）之间进行讨论，以决定应监测哪些潜在 AE、如何以及在何时进行监测。
监测数据证明非常有限；大多数文章都集中在 GC 的治疗效果上，而不是 AE 的发生和监测上。大多数建议都必须基于共识。那些针对临床试验的建议旨在深入了解 AE 的发生率、患病率和临床相关性，以创建 GC 治疗的综合有效 AE 概况。因此，需要监测的 AE 种类更多，通常包括基线和试验结束时的评估。日常实践的建议旨在保护患者免受真正的危险，这些危险可以预防或治疗。除了骨质疏松症（遵循国家指南）和基线评估踝关节肿胀、空腹血糖和青光眼风险因素外，不需要为接受低剂量 GC 治疗的患者扩展标准护理监测。
鉴于文献数据的不完整性，针对 GC 相关 AE 的监测制定了基于共识的建议，分别针对日常实践和临床试验。
