Department of Radiology, Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan.
Department of Radiology, Komaki City Hospital, Komaki, Aichi, Japan.
BMJ Open. 2020 Mar 9;10(3):e033023. doi: 10.1136/bmjopen-2019-033023.
Iodinated contrast media are commonly used in medical imaging and can cause hypersensitivity reactions, including rare but severe life-threatening reactions. Although several prophylactic approaches have been proposed for severe reactions, their effects remain unclear. Therefore, we aim to review systematically the preventive effects of pharmacologic and non-pharmacologic interventions and predictors of acute, hypersensitivity reactions.
We will search the PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases from 1 January 1990 through 31 December 2019 and will examine the bibliographies of eligible studies, pertinent review articles and clinical practice guidelines. We will include prospective and retrospective studies of any design that evaluated the effects of pharmacological and non-pharmacological preventive interventions for adverse reactions of non-ionic iodinated contrast media. Two assessors will independently extract the characteristics of the study and intervention and the quantitative results. Two independent reviewers will assess the risk of bias using standard design-specific validity assessment tools. The primary outcome will be reduction in acute contrast media-induced hypersensitivity reactions. The secondary outcomes will include characteristics associated with the development of contrast media-induced acute hypersensitivity reactions, and adverse events associated with specific preventive interventions. Unique premedication regimens (eg, dose, drug and duration) and non-pharmacological strategies will be analysed separately. Average-risk and high-risk patients will be considered separately. A meta-analysis will be performed if appropriate.
Ethics approval is not applicable, as this will be a secondary analysis of publicly available data. The results of the analysis will be submitted for publication in a peer reviewed journal.
CRD42019134003.
碘造影剂在医学成像中被广泛应用,但可能引发过敏反应,包括罕见但严重的危及生命的反应。尽管已经提出了几种预防严重反应的方法,但它们的效果仍不清楚。因此,我们旨在系统地回顾药物和非药物干预措施的预防效果,以及预测急性过敏反应的因素。
我们将从 1990 年 1 月 1 日至 2019 年 12 月 31 日在 PubMed、EMBASE 和 Cochrane 中央对照试验登记库中进行检索,并将检查合格研究、相关综述文章和临床实践指南的参考文献。我们将纳入任何设计的前瞻性和回顾性研究,这些研究评估了非离子型碘造影剂不良反应的药物和非药物预防干预措施的效果。两名评估员将独立提取研究和干预的特征以及定量结果。两名独立的审查员将使用标准的特定设计有效性评估工具评估偏倚风险。主要结局是减少急性造影剂引起的过敏反应。次要结局将包括与造影剂引起的急性过敏反应发生相关的特征,以及与特定预防干预措施相关的不良事件。独特的预处理方案(例如剂量、药物和持续时间)和非药物策略将分别进行分析。平均风险和高风险患者将分别进行考虑。如果合适,将进行荟萃分析。
不需要伦理批准,因为这将是对公开可用数据的二次分析。分析结果将提交给同行评审期刊发表。
PROSPERO 注册号:CRD42019134003。