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氟喹诺酮类药物全身治疗在欧洲的适应证和法国、德国和英国初级保健处方中的流行情况:描述性基于人群的研究。

Indications for Systemic Fluoroquinolone Therapy in Europe and Prevalence of Primary-Care Prescribing in France, Germany and the UK: Descriptive Population-Based Study.

机构信息

Pharmacovigilance and Epidemiology Department, European Medicines Agency, 30 Churchill Pl, Canary Wharf, London, E14 5EU, UK.

Population Health Sciences Division, University of Dundee, Dundee, UK.

出版信息

Clin Drug Investig. 2018 Oct;38(10):927-933. doi: 10.1007/s40261-018-0684-7.

Abstract

BACKGROUND AND OBJECTIVES

In the USA the benefit-risk profile of fluoroquinolones for treating patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections (uUTIs) is considered unfavorable. However, the number of fluoroquinolone products in the EU indicated and prescribed for these infections is uncertain. The objective of this study was to provide data on indications for fluoroquinolones in Europe and examine the prevalence of prescribing in France, Germany and the UK.

METHODS

Descriptive analysis of indications for systemic fluoroquinolone antibiotics across the European Economic Area (EEA) and descriptive analysis of systemic fluoroquinolone antibiotic prescribing in France, Germany and UK electronic health records (2000-2015).

RESULTS

All EEA countries had fluoroquinolone products indicated for acute sinusitis, acute bronchitis, or uUTIs, with differences in the number of products between countries for: acute sinusitis (19.5-51.9%), acute bronchitis (22.2-73.4%), and uUTIs (52.0-89.1%). The prevalence of fluoroquinolone prescribing for the treatment of respiratory tract infections (RTIs) appeared to fall with time in all countries and for UTI in France and UK only. Changes were greatest in the UK. In France, Germany, and the UK, respectively: acute sinusitis accounted for 29.5, 20.6, and 40.7% of all oral fluoroquinolone prescriptions for upper RTIs; acute bronchitis accounted for 63.0, 83.0, and 89.9% of all fluoroquinolone prescriptions for lower RTIs; uUTIs accounted for 83.3, 89.9, and 32.2% of all fluoroquinolone prescriptions for UTIs.

CONCLUSION

Large numbers of fluoroquinolone products in Europe are listed for the treatment of milder infections such as acute bronchitis, acute sinusitis and uUTIs. Among the countries assessed, fluoroquinolones were commonly prescribed for these conditions and potentially should lead to a review of therapeutic guidelines.

摘要

背景和目的

在美国,氟喹诺酮类药物治疗急性细菌性鼻窦炎、慢性支气管炎急性加重和单纯性尿路感染(uUTIs)的获益-风险比被认为是不利的。然而,欧盟中用于治疗这些感染的氟喹诺酮类药物的数量尚不确定。本研究的目的是提供欧洲氟喹诺酮类药物的适应证数据,并检查法国、德国和英国的处方流行率。

方法

对整个欧洲经济区(EEA)全身氟喹诺酮类抗生素的适应证进行描述性分析,并对法国、德国和英国电子健康记录中全身氟喹诺酮类抗生素的处方进行描述性分析(2000-2015 年)。

结果

所有 EEA 国家都有氟喹诺酮类产品用于治疗急性鼻窦炎、急性支气管炎或 uUTIs,各国之间的产品数量存在差异:急性鼻窦炎(19.5-51.9%)、急性支气管炎(22.2-73.4%)和 uUTIs(52.0-89.1%)。所有国家治疗呼吸道感染(RTIs)的氟喹诺酮类药物处方的流行率似乎随时间下降,仅在法国和英国治疗 UTI 时下降。英国的变化最大。在法国、德国和英国,分别为:急性鼻窦炎占上呼吸道 RTIs 所有口服氟喹诺酮类药物处方的 29.5%、20.6%和 40.7%;急性支气管炎占下呼吸道 RTIs 所有氟喹诺酮类药物处方的 63.0%、83.0%和 89.9%;uUTIs 占所有氟喹诺酮类药物处方的 83.3%、89.9%和 32.2%。

结论

欧洲有大量的氟喹诺酮类药物产品用于治疗较轻的感染,如急性支气管炎、急性鼻窦炎和 uUTIs。在所评估的国家中,氟喹诺酮类药物常用于治疗这些疾病,这可能需要对治疗指南进行审查。

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