{"title":"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。","authors":"Houyu Zhao, Yexiang Sun, Xi Yao, Peng Shen, Hongbo Lin, Siyan Zhan","doi":"10.1080/14787210.2024.2368823","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":12213,"journal":{"name":"Expert Review of Anti-infective Therapy","volume":null,"pages":null},"PeriodicalIF":4.2000,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Association of outpatient fluoroquinolone prescribing with the National Medical Products Administration announcements of label changes in China.\",\"authors\":\"Houyu Zhao, Yexiang Sun, Xi Yao, Peng Shen, Hongbo Lin, Siyan Zhan\",\"doi\":\"10.1080/14787210.2024.2368823\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":12213,\"journal\":{\"name\":\"Expert Review of Anti-infective Therapy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2024-06-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Review of Anti-infective Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14787210.2024.2368823\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Anti-infective Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14787210.2024.2368823","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Association of outpatient fluoroquinolone prescribing with the National Medical Products Administration announcements of label changes in China.
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.
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.