Association of outpatient fluoroquinolone prescribing with the National Medical Products Administration announcements of label changes in China.

IF 4.2 2区 医学 Q1 INFECTIOUS DISEASES
Houyu Zhao, Yexiang Sun, Xi Yao, Peng Shen, Hongbo Lin, Siyan Zhan
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引用次数: 0

Abstract

Background: In 2017 and 2021, the National Medical Products Administration (NMPA) announced to revise the drug label of fluoroquinolones. We aimed to evaluate the association of fluoroquinolone prescribing with the NMPA announcements of label changes.

Research design and methods: Monthly prevalence of fluoroquinolone prescriptions for uncomplicated urinary tract infections (uUTI), acute exacerbation of chronic bronchitis (AECB), and acute sinusitis (AS) between 2016 and 2022 was calculated, and interrupted time series analysis was applied to assess the impacts of NMPA label changes on fluoroquinolone use.

Results: Prevalence of fluoroquinolone prescriptions decreased by 2.39% (95% CI, -4.72% to -0.07%) for uUTI but increased by 3.02% (95% CI, 1.71% to 4.34%) for AS immediately after the 2017 label change. Moreover, after the 2021 label change, fluoroquinolone use decreased shortly in all the three indications. However, a significant increasing trend was observed in fluoroquinolone use for AECB episodes, and fluoroquinolons were used for 61.4% of treated uUTI, 31.6% of treated AECB, and 5.42% of treated AS at the end of 2022, respectively.

Conclusions: The label changes issued by the NMPA had no substantial impacts on fluoroquinolone prescribing in the study region in China. Fluoroquinolone prescribing was still highly prevalent for uUTI and AECB and thus requiring further antimicrobial stewardship.

中国门诊氟喹诺酮类药物处方与国家医药产品监督管理局标签变更公告的关联。
背景:2017年和2021年,国家医药产品管理局(NMPA)宣布修订氟喹诺酮类药物的药品标签。我们旨在评估氟喹诺酮类药物处方与国家医保局宣布修改标签之间的关联:计算了2016年至2022年间无并发症尿路感染(uUTI)、慢性支气管炎急性加重(AECB)和急性鼻窦炎(AS)的氟喹诺酮类药物月处方流行率,并应用间断时间序列分析评估了NMPA标签变更对氟喹诺酮类药物使用的影响:结果:在2017年标签变更后,氟喹诺酮类药物处方的流行率在UTI方面下降了2.39%(95% CI,-4.72%至-0.07%),但在AS方面却增加了3.02%(95% CI,1.71%至4.34%)。此外,在 2021 年标签变更后,氟喹诺酮类药物在所有三个适应症中的使用量均出现短期下降。然而,在AECB病例中,氟喹诺酮类药物的使用呈明显增加趋势,氟喹诺酮类药物分别用于61.4%的UTI治疗、31.6%的AECB治疗和5.42%的AS治疗:结论:国家药品管理局发布的标签变更对中国研究地区的氟喹诺酮类药物处方没有实质性影响。氟喹诺酮类药物在尿UTI和AECB中的处方仍很普遍,因此需要进一步加强抗菌药物管理。
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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来源期刊
CiteScore
11.20
自引率
0.00%
发文量
66
审稿时长
4-8 weeks
期刊介绍: Expert Review of Anti-Infective Therapy (ISSN 1478-7210) provides expert reviews on therapeutics and diagnostics in the treatment of infectious disease. Coverage includes antibiotics, drug resistance, drug therapy, infectious disease medicine, antibacterial, antimicrobial, antifungal and antiviral approaches, and diagnostic tests.
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