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与欧洲药品管理局建议相关的门诊氟喹诺酮类药物使用情况:爱沙尼亚全国性药物利用研究。

Outpatient fluoroquinolone use in relation to European Medicines Agency's recommendation: An Estonian nationwide drug utilization study.

作者信息

Kurvits Katrin, Uusküla Maia, Vestman Helve, Laius Ott

机构信息

Department of Post-authorisation Safety, State Agency of Medicines, Tartu, Estonia.

Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia.

出版信息

Pharmacoepidemiol Drug Saf. 2023 Jun;32(6):643-650. doi: 10.1002/pds.5593. Epub 2023 Feb 3.

Abstract

PURPOSE

To determine possible changes in prescribing of fluoroquinolones in relation to the European Medicines Agency's (EMA) recommendation in October 2018.

METHODS

We conducted a nationwide time-series study on outpatient use of fluoroquinolones during January 2016-June 2021 in Estonia. Joinpoint regression was used to identify change points over time. Several subgroup analyses by prescriber specialty, indication group, risk factors for tendon injury, aortic aneurysm/dissection or heart valve regurgitation/incompetence and the prescribing of other antibiotics were performed.

RESULTS

During the study period 236 989 prescriptions of fluoroquinolones were dispensed to 142 659 persons. The number of episodes per month declined from 3780 (2.9/1000 inhabitants) to 2570 (1.9/1000 inhabitants). We identified three change points with four different trend segments: from January 2016 to November 2018 monthly percent change (MPC) -0.4%, from November 2018 to June 2019 MPC -2.5%, from June 2019 to July 2020 MPC 1.7% and from July 2020 to June 2021 MPC -3.3%. Prescribing for indications which were removed or restricted by EMA's recommendation comprised a small proportion of all fluoroquinolone episodes -2.8% and 6.3%, respectively. The risk factors for tendon injury and for cardiac disorders (aortic aneurysm/dissection or heart valve regurgitation/incompetence) were present in 46.4% and 57.8% episodes of fluoroquinolone users, respectively. No changes in the trend of prescribing to users with risk factors was detected.

CONCLUSIONS

The EMA's recommendation may have contributed to the greater decline in the use of fluoroquinolones. However, there is still a high proportion of users with predisposing factors for tendon injury and serious cardiac disorders.

摘要

目的

确定与欧洲药品管理局(EMA)2018年10月的建议相关的氟喹诺酮类药物处方可能发生的变化。

方法

我们对2016年1月至2021年6月爱沙尼亚门诊使用氟喹诺酮类药物进行了一项全国性时间序列研究。采用连接点回归来确定随时间的变化点。按处方医生专业、适应证组、肌腱损伤、主动脉瘤/夹层或心脏瓣膜反流/功能不全的危险因素以及其他抗生素的处方进行了多项亚组分析。

结果

在研究期间,共向142659人发放了236989份氟喹诺酮类药物处方。每月的处方量从3780份(2.9/1000居民)降至2570份(1.9/1000居民)。我们确定了三个变化点和四个不同的趋势段:2016年1月至2018年11月,月变化百分比(MPC)为-0.4%;2018年11月至2019年6月,MPC为-2.5%;2019年6月至2020年7月,MPC为1.7%;2020年7月至2021年6月,MPC为-3.3%。EMA建议中被移除或限制的适应证的处方量分别占所有氟喹诺酮类药物处方量的一小部分,即2.8%和6.3%。肌腱损伤和心脏疾病(主动脉瘤/夹层或心脏瓣膜反流/功能不全)的危险因素分别出现在46.4%和57.8%的氟喹诺酮类药物使用者中。未检测到有危险因素的使用者处方趋势的变化。

结论

EMA的建议可能导致了氟喹诺酮类药物使用量的更大幅度下降。然而,仍有很大比例的使用者存在肌腱损伤和严重心脏疾病的易感因素。

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