使用 FAERS 數據比較性別間氯胺酮和艾氯胺酮的不良反應?
貴州醫科大學 麻醉與心臟電生理課題組
翻譯：王璐 編輯：趙游霄 審校：曹瑩
背景：氯胺酮是作為麻醉劑而開發的。Esketamine 是氯胺酮 S-對映異構體。它們為治療抑郁癥，特別是難治性抑郁癥提供了新途徑。考慮到不同性別患者的氯胺酮藥代動力學和激素狀態存在差異，艾司氯胺酮不良事件（ADE）也可能存在性別差異。本研究對氯胺酮和艾氯胺酮的性別間不良事件進行數據挖掘和安全性分析，促進臨床實踐的個體化。
方法：在美國食品藥品監督管理局（FDA）不良事件報告系統（FAERS）中，2004年第一季度至2023年第二季度期間氯胺酮（Ketamine）和艾司氯胺酮（Esketamine）的不良藥物反應（Adverse Drug Reactions, ADRs）被摘錄。此后，計算了95%置信區間(CI)的報告比值比(ROR)。
結果：分析中總共納入了2907份女性報告和1634份男性報告。ROR 表明，自殺發生低、治療效果低、尿潴留和高血壓在男性中很常見。此外，還記錄了 552 名女性和 653 名男性氯胺酮報告。ROR顯示，各種藥物的毒性、心動過緩、膀胱炎和激越更可能發生在男性中，而女性更容易出現自殺意念、轉氨酶水平升高、硬化性膽管炎和無菌性膿尿。
結論：氯胺酮因性別而異，臨床實踐中應考慮這一點，以提供個體化治療。
原始文獻：
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 ?rst 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% con?dence 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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