Abstract：
To our knowledge, no prior study has analysed a possible association between acetazolamide and pulmonary oedema. The aim of this study was to use data from the EudraVigilance to detect a safety signal for acetazolamide-induced pulmonary oedema. We performed a disproportionality analysis (case-noncase method), calculating reporting odds ratios (RORs) up to 22 February 2024. Among 11 684 208 spontaneous cases of adverse reactions registered in EudraVigilance, 38 275 were pulmonary oedemas. Acetazolamide was involved in 31 cases. In more than half of those cases, the patients received a single dose of acetazolamide after undergoing cataract surgery: latency was 10-90 min. Remarkably, there were five cases of positive rechallenge and six cases resulted in death. The ROR for acetazolamide was 3.63 (95% CI 2.55-5.17). Disproportionality was also observed in VigiBase®: ROR 4.44 (95% CI 3.34-5.90). Our study confirms a signal that suggests a risk of serious pulmonary oedema associated with acetazolamide.
摘要：
据我们所知,之前没有研究分析乙酰唑胺与肺水肿之间的可能关联.这项研究的目的是使用EudraVigilance的数据来检测乙酰唑胺引起的肺水肿的安全信号。我们进行了不成比例分析(病例-非病例方法)，计算截至2024年2月22日的报告赔率比(ROR)。在EudraVigilance登记的11684208例自发性不良反应病例中，38275例肺水肿。31例涉及乙酰唑胺。在超过一半的案例中，患者在接受白内障手术后接受单剂量乙酰唑胺治疗:潜伏期为10-90分钟.值得注意的是,有5例阳性再激发,6例导致死亡.乙酰唑胺的ROR为3.63(95%CI2.55-5.17)。在VigiBase®:ROR4.44中也观察到不成比例(95%CI3.34-5.90)。我们的研究证实了一个信号，表明与乙酰唑胺相关的严重肺水肿的风险。
