Faculty of Medicine, Department of Psychosomatic Medicine, Kindai University, Osaka, Japan.
IMPACCT, Faculty of Health, University of Technology Sydney, P O Box 123, Ultimo, New South Wales, 2007, Australia.
Support Care Cancer. 2018 Dec;26(12):3979-3983. doi: 10.1007/s00520-018-4339-2. Epub 2018 Jul 6.
Corticosteroids are commonly used in palliative care settings, but are associated with several side effects. Although adverse events (AEs) are highly distressing for patients, few data are available from prospective studies to look at incidence or predictors of such harms. The aim of this study is to identify AE reporting among studies of patients with advanced cancer receiving corticosteroids for any reason.
A systematic review was conducted using the following data sources: PubMed, Medline, SCOPUS, Cochrane reviews, and CINAHL. Randomized controlled trials (RCTs) with patients with advanced cancer assessing the effect of corticosteroids were included. Consecutive cohort observational studies of corticosteroid toxicities in cancer patients were also included.
Twenty-seven RCTs and 12 consecutive cohort observational studies were identified. The most frequently reported primary outcome of RCTs was nausea and vomiting (8/27). Dexamethasone was prescribed in almost half of RCTs (13/27). In consecutive cohort studies, the primary outcomes were a wide variety of symptoms. Dexamethasone was also the most common glucocorticoid used (7/12). In terms of quality of AE reporting, two RCTs and one consecutive cohort study used a validated AE assessment tool in their studies.
Side effects of corticosteroids in advanced cancer patients were poorly reported with few data using validated tools. Researchers should be aware of the guideline of AE reporting to provide the best evidence of risk-benefit balance. Developing specific consensus guidelines about AE reporting in studies of glucocorticoids in studies of people with advanced cancer would be useful.
皮质类固醇在姑息治疗环境中被广泛应用，但它们与多种副作用相关。尽管不良事件（AE）会给患者带来极大的痛苦，但很少有前瞻性研究的数据可以用来观察这些危害的发生率或预测因素。本研究的目的是确定接受皮质类固醇治疗的晚期癌症患者研究中 AE 的报告情况。
采用以下数据源进行系统评价：PubMed、Medline、SCOPUS、Cochrane 综述和 CINAHL。纳入评估皮质类固醇对晚期癌症患者影响的随机对照试验（RCT）。还纳入了连续队列观察性研究皮质类固醇毒性在癌症患者中的研究。
确定了 27 项 RCT 和 12 项连续队列观察性研究。RCT 中最常报告的主要结局是恶心和呕吐（8/27）。近一半的 RCT（13/27）处方了地塞米松。在连续队列研究中，主要结局是各种症状。地塞米松也是最常用的糖皮质激素（7/12）。就 AE 报告的质量而言，有两项 RCT 和一项连续队列研究在其研究中使用了经过验证的 AE 评估工具。
晚期癌症患者使用皮质类固醇的副作用报告不佳，很少有使用经过验证工具的数据。研究人员应了解 AE 报告的指南，以提供最佳的风险效益平衡证据。制定关于在晚期癌症患者中使用糖皮质激素研究中 AE 报告的具体共识指南将是有用的。
