使用 FAERS 数据比较性别间氯胺酮和艾氯胺酮的不良反应
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贵州医科大学 麻醉与心脏电生理课题组
翻译：王璐 编辑：赵游霄 审校：曹莹
背景：氯胺酮是作为麻醉剂而开发的。Esketamine 是氯胺酮 S-对映异构体。它们为治疗抑郁症，特别是难治性抑郁症提供了新途径。考虑到不同性别患者的氯胺酮药代动力学和激素状态存在差异，艾司氯胺酮不良事件（ADE）也可能存在性别差异。本研究对氯胺酮和艾氯胺酮的性别间不良事件进行数据挖掘和安全性分析，促进临床实践的个体化。
方法：在美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中，2004年第一季度至2023年第二季度期间氯胺酮（Ketamine）和艾司氯胺酮（Esketamine）的不良药物反应（Adverse Drug Reactions, ADRs）被摘录。此后，计算了95%置信区间(CI)的报告比值比(ROR)。
结果：分析中总共纳入了2907份女性报告和1634份男性报告。ROR 表明，自杀发生低、治疗效果低、尿潴留和高血压在男性中很常见。此外，还记录了 552 名女性和 653 名男性氯胺酮报告。ROR显示，各种药物的毒性、心动过缓、膀胱炎和激越更可能发生在男性中，而女性更容易出现自杀意念、转氨酶水平升高、硬化性胆管炎和无菌性脓尿。
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结论：氯胺酮因性别而异，临床实践中应考虑这一点，以提供个体化治疗。
原始文献：
Yang X,Chen D. Comparing the adverse effects of ketamine and esketamine between genders using FAERS data. Front Pharmacol. 2024;15:1329436. doi:10.3389/fphar.2024.1329436
英文原文：
Comparing the adverse effects of ketamine and esketamine between genders using FAERS data
Background: Ketamine was developed as an anesthetic. Esketamine is the isolated S-enantiomer of racemic ketamine. They provide new avenues forthe treatment of depression, especially treatment-resistant depression.Considering differences in the pharmacokinetics and hormonal status of ketamine in patients of different genders, sex-based differences in esketamineadverse drug events (ADE) may also be observed. This study presents data miningand safety analysis of adverse events of ketamine and esketamine betweengenders, promoting the individualization of clinical practice.
Methods: Adverse drug reactions to ketamine and esketamine reported between the first quarter of 2004 and the second quarter of 2023 in the U.S. Food and DrugAdministration on Adverse Event Reporting System (FAERS) were extracted.Thereafter, the reporting odds ratio (ROR) with 95% confidence interval (CI)was calculated.
Results: A total of 2907 female reports and 1634 male reports on esketamine were included in the analysis. ROR mining showed that completed suicide,decreased therapeutic product effects, urinary retention, and hypertensionwere common in men. Additionally, 552 female and 653 male ketaminereports were recorded. ROR mining revealed that toxicity to various agents,bradycardia, cystitis and agitation, were more likely to occur in men, whereaswomen were more likely to develop suicidal ideation, increased transaminaselevels, sclerosing cholangitis, and sterile pyuria.
Conclusion: The adverse events of esketamine and ketamine differ across genders, which should be considered in clinical practice to provideindividualized treatment.
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