Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Department of Pharmacy, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.
Sci Rep. 2024 Mar 1;14(1):5095. doi: 10.1038/s41598-024-55185-4.
The clinical application of conventional doxorubicin (CDOX) was constrained by its side effects. Liposomal doxorubicin was developed to mitigate these limitations, showing improved toxicity profiles. However, the adverse events associated with liposomal doxorubicin and CDOX have not yet been comprehensively evaluated in clinical settings. The FAERS data from January 2004 to December 2022 were collected to analyze the adverse events of liposomal doxorubicin and CDOX. Disproportionate analysis and Bayesian analysis were employed to quantify this association. Our analysis incorporated 68,803 adverse event reports related to Doxil/Caelyx, Myocet and CDOX. The relative odds ratios (RORs, 95%CI) for febrile neutropenia associated with CDOX, Doxil/Caelyx, and Myocet were 42.45 (41.44; 43.48), 17.53 (16.02; 19.20), and 34.68 (26.63; 45.15) respectively. For cardiotoxicity, they were 38.87(36.41;41.49), 17.96 (14.10; 22.86), and 37.36 (19.34; 72.17). For Palmar-Plantar Erythrodysesthesia (PPE), the RORs were 6.16 (5.69; 6.68), 36.13 (32.60; 40.06), and 19.69 (11.59; 33.44). Regarding onset time, significant differences adverse events including neutropenia, PPE, pneumonia and malignant neoplasm progression. This study indicates that clinical monitoring for symptoms of cardiotoxicity of CDOX and Myocet, and PPE and interstitial lung disease of Doxil should be performed. Additionally, the onset time of febrile neutropenia, malignant neoplasm progression, and pneumonia associated with Doxil and Myocet merits particular attention. Continuous surveillance, risk evaluations, and additional comparative studies between liposomal doxorubicin and CDOX were recommended.
传统阿霉素（CDOX）的临床应用受到其副作用的限制。脂质体阿霉素的开发旨在减轻这些限制，显示出改善的毒性特征。然而，脂质体阿霉素和 CDOX 相关的不良事件尚未在临床环境中得到全面评估。从 2004 年 1 月至 2022 年 12 月，收集了 FAERS 数据，以分析脂质体阿霉素和 CDOX 的不良事件。采用不相称分析和贝叶斯分析来量化这种关联。我们的分析纳入了 68803 份与 Doxil/Caelyx、Myocet 和 CDOX 相关的不良事件报告。与 CDOX、Doxil/Caelyx 和 Myocet 相关的发热性中性粒细胞减少症的相对优势比（ROR，95%CI）分别为 42.45（41.44；43.48）、17.53（16.02；19.20）和 34.68（26.63；45.15）。对于心脏毒性，它们分别为 38.87（36.41；41.49）、17.96（14.10；22.86）和 37.36（19.34；72.17）。对于掌跖红细胞感觉异常（PPE），ROR 分别为 6.16（5.69；6.68）、36.13（32.60；40.06）和 19.69（11.59；33.44）。关于发病时间，中性粒细胞减少症、PPE、肺炎和恶性肿瘤进展等不良事件存在显著差异。本研究表明，应进行 CDOX 和 Myocet 心脏毒性、Doxil 的 PPE 和间质性肺病以及 Myocet 的肺炎的临床监测。此外，Doxil 和 Myocet 相关的发热性中性粒细胞减少症、恶性肿瘤进展和肺炎的发病时间值得特别关注。建议进行持续监测、风险评估以及脂质体阿霉素和 CDOX 之间的额外比较研究。
