2010年至2019年替考拉宁负荷剂量实施趋势及安全性和有效性因素评估:基于日本行政索赔数据库的回顾性队列研究。

IF 1.2 Q4 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Health Care and Sciences Pub Date : 2023-11-01 DOI:10.1186/s40780-023-00304-y
Ryota Goto, Yuichi Muraki, Ryo Inose, Moeno Ichii, Keisuke Sawada, Kanako Mizuno, Ryuji Koizumi, Shinya Tsuzuki, Masahiro Ishikane, Norio Ohmagari
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Therefore, we evaluated the trend in the loading dose and factors affecting the efficacy and safety of TEIC administration.</p><p><strong>Methods: </strong>A Japanese administrative claims database was used in this study. Trends in loading doses were evaluated in target populations administered TEIC between 2010 and 2019. Patient characteristics were adjusted by propensity score matching based on the guideline group (total dose of 3 days > 1,600 mg) and non-guideline group (≤ 1,600 mg) of the loading dose. Finally, univariable and multivariable conditional logistic regression analysis was performed to evaluate factors affecting 30-day mortality and liver injury.</p><p><strong>Results: </strong>A total of 10,030 patients were selected based on these criteria. 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摘要

背景:替考拉宁(TEIC)的负荷剂量是推荐实施的。然而,包装说明书和指南中的剂量设置存在重大差异,日本装载剂量的实际状态尚不清楚。此外,TEIC会导致肝损伤作为副作用。尽管根据指南,负荷剂量后发生肝损伤的风险没有增加,但在大量人群中缺乏报告。因此,我们评估了负荷剂量的趋势以及影响TEIC给药疗效和安全性的因素。方法:采用日本行政索赔数据库进行研究。在2010年至2019年期间,对服用TEIC的目标人群的负荷剂量趋势进行了评估。根据指导组(3天的总剂量 > 1600 mg)和非指南组(≤ 1600mg)的负载剂量。最后,进行单变量和多变量条件logistic回归分析,以评估影响30天死亡率和肝损伤的因素。结果:根据这些标准,共选择了10030名患者。无论是否实施治疗药物监测(TDM),基于推荐指南的负荷剂量比例都随着时间的推移而增加,但在实施TDM的情况下尤其如此,负荷剂量是根据指南的建议给予的。条件logistic回归分析显示,药物管理与指导费之间存在关系(比值比[OR]:4.45,95%置信区间[CI]:0.36-0.55),表明药剂师干预的报销,以及30天死亡率的降低。此外,基于推荐指南的负荷剂量对肝损伤没有影响,其他因素与肝损伤发生率的增加没有显著相关性。结论:因此,本研究暗示了药物管理和指导费所表明的药理学管理的好处,并支持根据TEIC给药指南实施负荷剂量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Trends in teicoplanin loading dose implementation from 2010 to 2019 and evaluation of safety and efficacy factors: a retrospective cohort study based on a Japanese administrative claims database.

Background: The loading dose of teicoplanin (TEIC) is recommended for implementation. However, there is significant discrepancy between the dose settings in the package insert and, in the guidelines, and the actual status of loading doses in Japan is unclear. Furthermore, TEIC causes liver injury as side effect. Although the risk of developing liver injury has not been reported to be increased following a loading dose based on the guidelines, there is a lack of reports in large populations. Therefore, we evaluated the trend in the loading dose and factors affecting the efficacy and safety of TEIC administration.

Methods: A Japanese administrative claims database was used in this study. Trends in loading doses were evaluated in target populations administered TEIC between 2010 and 2019. Patient characteristics were adjusted by propensity score matching based on the guideline group (total dose of 3 days > 1,600 mg) and non-guideline group (≤ 1,600 mg) of the loading dose. Finally, univariable and multivariable conditional logistic regression analysis was performed to evaluate factors affecting 30-day mortality and liver injury.

Results: A total of 10,030 patients were selected based on these criteria. The proportion of loading doses based on the recommended guidelines showed an increase over time, regardless of the implementation of therapeutic drug monitoring (TDM), but especially so in cases where TDM was implemented, the loading doses were administered in accordance with the recommendations of the guidelines. Conditional logistic regression analysis showed a relationship between drug management and guidance fees (odds ratio [OR]: 0.45, 95% confidence interval [CI]: 0.36‒0.55), a reimbursement indicating pharmacist intervention, and a reduction in 30-day mortality. In addition, loading doses based on the recommended guidelines had no influence on liver injury, and other factors were not significantly associated with increased incidence of liver injury.

Conclusion: Thus, this study implies the benefits of pharmacological management as indicated by drug management and guidance fee and supports the implementation of loading doses based on the guideline on TEIC administration.

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来源期刊
CiteScore
1.80
自引率
0.00%
发文量
29
审稿时长
8 weeks
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