使用美国食品和药物管理局不良事件报告系统,分析年龄与达托霉素诱发的不良事件发生率之间的关系。

IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES
Chihiro Shiraishi, Hideo Kato, Toru Ogura, Takuya Iwamoto
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引用次数: 0

摘要

背景:达托霉素是一种脂肽类抗生素,对革兰氏阳性菌具有广谱抗菌活性。虽然在临床试验中可以找到有关达托霉素诱发不良反应的信息,但有关年龄对这些不良反应影响的数据并不充分。因此,我们利用美国食品和药物管理局(FDA)提供的上市后阶段药物不良事件报告,评估了年龄是否会影响达托霉素诱发不良事件的发生:方法:分析了FDA不良事件报告系统中7307份达托霉素治疗患者的报告数据集。患者被分为七个年龄组:0-28 天、>28 天-23 个月、2-11 岁、12-17 岁、18-64 岁、65-80 岁和 >80 岁。通过比例失调分析,计算出报告的几率比例,并得出 95% 的置信区间。使用每种不良事件的百分比和年龄组进行单变量回归分析:结果:与 18-64 岁的报告数相比,65-80 岁和大于 80 岁患者的嗜酸性粒细胞肺炎、12-17 岁患者的过敏反应和伪膜性结肠炎以及 65-80 岁患者的急性肾功能衰竭的报告数明显增加。嗜酸性粒细胞肺炎报告比例的回归系数呈显著正值:我们的研究结果表明,达托霉素引起的不良反应与年龄呈相关趋势,这支持了实施与年龄相关的随访和支持性护理有助于继续使用达托霉素治疗的观点。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Association between age and onset of daptomycin-induced adverse events using the U.S. food and drug administration adverse event reporting system.

Background: Daptomycin is a lipopeptide antibiotic with a broad spectrum of activity against gram-positive bacteria. Although information on daptomycin-induced adverse events can be found in clinical trials, data regarding the impact of age on these events are insufficient. Therefore, we evaluated whether age affects the occurrence of daptomycin-induced adverse events using adverse drug event reports in post-marketing stages provided by the U.S. Food and Drug Administration (FDA).

Methods: A total dataset of 7307 reports of patients treated with daptomycin in the FDA's Adverse Event Reporting System were analyzed. The patients were divided into seven age groups: 0-28 days, >28 days-23 months, 2-11 years, 12-17 years, 18-64 years, 65-80 years, and >80 years. A disproportionality analysis was conducted to calculate the reporting odds ratio, with a 95 % confidence interval. The univariate regression analysis was conducted using the percentage of each adverse event and age groups.

Results: Compared with the number of reports aged 18-64 years, there were significantly increased reports of eosinophilic pneumonia in patients aged 65-80 years and >80 years, anaphylactic reaction and pseudomembranous colitis in patients aged 12-17 years, and acute renal failure in patients aged 65-80 years. The regression coefficient for the reporting proportion of eosinophilic pneumonia was significantly positive.

Conclusions: Our findings revealed age-related trends in daptomycin-induced adverse events, supporting the idea that implementing age-dependent follow-up and supportive care helps in the continuation of daptomycin therapy.

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来源期刊
Journal of Infection and Chemotherapy
Journal of Infection and Chemotherapy INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY
CiteScore
4.10
自引率
4.50%
发文量
303
审稿时长
47 days
期刊介绍: The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.
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