Dropped head syndrome: a rare adverse drug reaction identified in the FDA adverse event reporting system and review of case reports in the literature
Dropped head syndrome: a rare adverse drug reaction identified in the FDA adverse event reporting system and review of case reports in the literature
复制标题
低头综合征：FDA不良事件报告系统和文献病例报告回顾中发现的一种罕见药物不良反应
DOI：
10.1080/14740338.2022.2054986
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发表时间：
2022
影响因子：
3.1
通讯作者：
Y. Dai
中科院分区：
文献类型：
--
作者：
Xin Liu;Xiaoyue Zhao;Ya;Yan Tang;Xuelian Yan;Bin Zhao;Y. Dai
摘要背景垂头综合征（DHS）是一种相对罕见的疾病，其与药物暴露的潜在关系已被假定，但知之甚少。研究设计和方法本回顾性研究评估了2004年1月1日至2021年3月31日期间FDA不良事件报告系统（FAERS）中DHS的不良事件报告。计算经验贝叶斯几何平均值（EBGM）和EBGM的95%单侧CI下限，以确定与药物相关的DHS不成比例报告。此外，截至2021年8月5日，在PubMed、Embase和科克伦图书馆中发现了已发表的病例报告。结果FAERS共报告DHS 193例，其中神经系统药物最多，其次为抗肿瘤药物和免疫调节剂。普拉克索、罗匹尼罗、左旋多巴、普瑞巴林、罗替戈汀、顺铂、伊马替尼和肉毒杆菌毒素均显示出基于5例以上病例的毒性信号。在文献中确定了10份已发表的DHS病例报告。结论通过对FAERS数据的分析，我们可以更清楚地了解药物相关DHS的发生情况和特点，并提示药物暴露与DHS风险的增加具有一定的相关性，提示进一步的临床和观察研究的重要性。
ABSTRACT Background Dropped head syndrome (DHS) is a relatively rare disease, and its potential relationship with drug exposure has been postulated but is poorly understood. Research design and methods This retrospective study evaluated the adverse event reports of DHS in the FDA adverse event reporting system （FAERS) between 1 January 2004, to 31 March 2021. Empirical Bayes Geometric Means (EBGM) and the lower 95% one-sided CI of EBGM were calculated to identify disproportionate reporting of DHS associated with drugs. In addition, published case reports were identified in the PubMed, Embase and Cochrane Library up to 5 August 2021. Results There were 193 reports of DHS in the FAERS, in which nervous system agents were most frequently reported, followed by antineoplastic and immunomodulating agents. Pramipexole, ropinirole, levodopa, pregabalin, rotigotine, cisplatin, imatinib and botulinum toxin showed disproportionality signal based each on more than 5 cases. Ten published DHS case reports were identified in the literature. Conclusion Our study provides a more explicit profile on the occurrences and characteristics of DHS associated with drugs by analyzing the FAERS data and indicates that exposure of certain drug showed disproportionality signal with the increased DHS risk, which suggests the importance of further clinical and observational investigations.