未经证实:头部脱落综合征(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。
UNASSIGNED:这项回顾性研究评估了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均值(EBGM)和EBGM的较低95%单侧CI,以识别与药物相关的DHS的不成比例报告。此外,已发表的病例报告在PubMed,Embase和Cochrane图书馆截至2021年8月5日。
未经批准:FAERS有193份国土安全部报告,神经系统病原体是最常见的报道,其次是抗肿瘤和免疫调节剂。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在超过5例病例中显示出不成比例的信号.在文献中确定了十例已发表的DHS病例报告。
未经评估:我们的研究通过分析FAERS数据提供了与药物相关的DHS的发生和特征的更明确的概况,并表明某些药物的暴露显示出与DHS风险增加不成比例的信号。这表明进一步临床和观察研究的重要性。
UNASSIGNED: Dropped head syndrome (DHS) is a relatively rare disease, and its potential relationship with drug exposure has been postulated but is poorly understood.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.