PDF(Pubmed)
Abstract：
The Gram-positive anaerobic bacterium Clostridioides difficile (CD) can produce intense exotoxins, contributing to nosocomial infections, and it is the most common cause of health-care-associated infectious diarrhea. Based on spontaneous Individual Case Safety Reports from EudraVigilance (EV), we conducted a descriptive analysis of Clostridioides difficile infection (CDI) cases that reported a spontaneous adverse reaction related to using ceftriaxone, colistimethate, ciprofloxacin, gentamicin, linezolid, meropenem, and piperacillin/tazobactam. Most ADR reports registered in EV that were related to CDI were associated with ceftriaxone (33%), ciprofloxacin (28%), and piperacillin/tazobactam (21%). Additionally, the disproportionality analysis performed showed that all studied antibiotics had a lower reporting probability when compared to clindamycin. A causal relationship between a drug and the occurrence of an adverse reaction cannot be established from EV data alone because the phenomena of underreporting, overreporting, and reporting bias may affect the results. Based on the analysis of the collected data, this study underlines the importance of surveillance and monitoring programs for the consumption of antibiotics. Furthermore, it is essential to use standardized laboratory tests to define CDI\'s nature accurately. To prevent this infection, specialists should collaborate and adhere strictly to antibiotic stewardship programs, hygiene practices, and isolation protocols.
摘要：
革兰氏阳性厌氧细菌艰难梭菌（CD）可以产生强烈的外毒素，导致医院感染，它是卫生保健相关感染性腹泻的最常见原因。基于EudraVitilance(EV)自发的个体病例安全报告，我们对艰难梭菌感染（CDI）病例进行了描述性分析，这些病例报告了与使用头孢曲松有关的自发性不良反应，多粘氨甲磺酸盐,环丙沙星,庆大霉素,利奈唑胺,美罗培南,还有哌拉西林/他唑巴坦.大多数在EV中登记的与CDI相关的ADR报告与头孢曲松相关（33%），环丙沙星（28%），哌拉西林/他唑巴坦（21%）。此外,进行的不成比例分析显示,与克林霉素相比,所有研究的抗生素报告概率较低.药物与不良反应发生之间的因果关系不能仅从EV数据来确定,多报,报告偏差可能会影响结果。在对收集到的数据进行分析的基础上,这项研究强调了抗生素消费监测和监测计划的重要性.此外，使用标准化的实验室测试来准确定义CDI的性质至关重要。为了防止这种感染，专家应该合作并严格遵守抗生素管理计划，卫生习惯,和隔离协议。
