国内抗菌药物临床应用分级管理目录与WHO抗菌药物AWaRe分级目录的对比分析

杨瑶瑶; 凌可欣; 张翕; 杜可欣; 张琬朦; 胡琳; 郑波; 管晓东; 史录文

doi:10.6039/j.issn.1001-0408.2022.24.01

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国内抗菌药物临床应用分级管理目录与WHO抗菌药物AWaRe分级目录的对比分析

药事管理 | 更新时间：2023-02-22

- 国内抗菌药物临床应用分级管理目录与WHO抗菌药物AWaRe分级目录的对比分析
- Comparative analysis of domestic classification management list for clinical use of antibiotics versus WHO AWaRe classification list of antibiotics
- 中国药房 2022年33卷第24期页码：2945-2951
- 作者机构：
  
  1.北京大学药学院药事管理与临床药学系，北京　100191
  2.北京大学第一医院临床药理研究所，北京　100191
  3.北京大学医药管理国际研究中心，北京　100191
- 作者简介：
  
  硕士研究生。研究方向：药事管理。电话：010-82805019。E-mail：yyy211anne@163.com
  助理研究员，博士。研究方向：合理用药与药物经济学。电话：010-82805019。E-mail：kaiser@pku.edu.cn
- 基金信息：
  
  国家自然科学基金国际（地区）合作与交流项目(81861138048);国家自然科学基金面上项目(81973294)
- DOI：10.6039/j.issn.1001-0408.2022.24.01
  中图分类号： R95
- 纸质出版日期：2022-12-30，
  
  收稿日期：2022-08-22，
  
  修回日期：2022-11-16，
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杨瑶瑶,凌可欣,张翕等.国内抗菌药物临床应用分级管理目录与WHO抗菌药物AWaRe分级目录的对比分析 ^Δ[J].中国药房,2022,33(24):2945-2951.

YANG Yaoyao,LING Kexin,ZHANG Xi,et al.Comparative analysis of domestic classification management list for clinical use of antibiotics versus WHO AWaRe classification list of antibiotics[J].ZHONGGUO YAOFANG,2022,33(24):2945-2951.
杨瑶瑶,凌可欣,张翕等.国内抗菌药物临床应用分级管理目录与WHO抗菌药物AWaRe分级目录的对比分析 ^Δ[J].中国药房,2022,33(24):2945-2951. DOI： 10.6039/j.issn.1001-0408.2022.24.01.

YANG Yaoyao,LING Kexin,ZHANG Xi,et al.Comparative analysis of domestic classification management list for clinical use of antibiotics versus WHO AWaRe classification list of antibiotics[J].ZHONGGUO YAOFANG,2022,33(24):2945-2951. DOI： 10.6039/j.issn.1001-0408.2022.24.01.

摘要

目的

为我国动态调整抗菌药物临床应用分级管理目录、促进其合理使用提供参考和建议。

方法

汇总各省份最新版抗菌药物临床应用分级管理目录作为“国家版目录”，与2021年WHO抗菌药物AWaRe分级目录（简称“AWaRe分级目录”）进行对比，描述性统计分析两目录中不同级别抗菌药物品种数及其差异。

结果

根据不同的分级原则，国家版目录将262种抗菌药物制剂分为非限制（84种）、限制（83种）和特殊使用级（95种），AWaRe分级目录将258种抗菌药物制剂分为可用（87种）、慎用（142种）和备用级（29种）；两目录共同收录的抗菌药物制剂有182种。在国家版目录中，非限制使用级抗菌药物制剂有36种为可用级，30种为慎用级，1种为备用级；限制使用级抗菌药物制剂有7种为可用级，46种为慎用级，3种为备用级；特殊使用级抗菌药物制剂有9种为可用级，35种为慎用级，15种为备用级；其中，91种抗菌药物制剂是WHO不推荐使用的（20种）或AWaRe分级目录未收录的（71种）。

结论

两目录的分级方法在分级原则以及部分药品的级别制定上不尽相同。抗菌药物临床应用分级管理目录是抗菌药物管理工作的抓手之一，未来需要开展更多的研究为优化我国抗菌药物分级管理提供充足证据。

Abstract

OBJECTIVE

To provide reference and suggestions for dynamic adjustment of classification management lists for clinical use of antibiotics and the promotion of rational use of antibiotics.

METHODS

The latest version of provincial classification management lists for clinical use of antibiotics were aggregated into the “national list”， which was compared with 2021 WHO AWaRe classification list of antibiotics （hereinafter referred as to “AWaRe classification list”） to make a descriptive statistical analysis about the number of different classes of antibiotics in the two lists and their differences.

RESULTS

Based on the different classification principles， 262 kinds of antibiotic preparations in the national list were classified into non-restricted （84）， restricted （83） and highly-restricted classes （95）， and 258 kinds in the AWaRe classification list were classified into access （87）， watch （142） and reserve classes （29）； 182 kinds of antibiotic preparations were both included in the two lists. In the national list， among the non-restricted antibiotic preparations， 36 kinds belonged to access class， 30 belonged to watch class and 1 belonged to reserve class； among restricted antibiotic preparations， 7 belonged to access class， 46 kinds belonged to watch class and 3 belonged to reserve class； among highly-restricted antibiotic preparations， 9 belonged to access class， 35 belonged to watch class and 15 kinds belonged to reserve class. Among them， 91 kinds of antibiotic preparations were not recommended by WHO （20 kinds） or not included in the AWaRe classification list （71 kinds）.

CONCLUSIONS

The classification methods of two lists are different in classification principles and grading of some similar drugs. The classification management list of antibiotics is one of the key points of antibiotics management， more research is needed in the future to provide sufficient evidence for optimizing antibiotics classification management.

关键词

抗菌药物分级管理AWaRe分级目录中国世界卫生组织

Keywords

classification managementAWaRe classification listChinaWorld Health Organization

references

Organization for Economic Co-operation and Development. Antimicrobial resistance tackling the burden in the European Union[EB/OL]. [2022-06-02]. https：//www.oecd.org/health/health-systems/AMR-Tackling-the-Burden-in-the-EU-OECD-ECDC-Briefing-Note-2019.pdfhttps://www.oecd.org/health/health-systems/AMR-Tackling-the-Burden-in-the-EU-OECD-ECDC-Briefing-Note-2019.pdf.

World Health Organization. WHO releases the 2019 AWaRe classification antibiotics[EB/OL].（2019-08-01）[2022-06-02].https：//www.who.int/news/item/01-10-2019-who-releases-the-2019-aware-classification-antibioticshttps://www.who.int/news/item/01-10-2019-who-releases-the-2019-aware-classification-antibiotics.

New South Wales Justice Health and Forensic Mental Health Network. Antimicrobial stewardship policy[EB/OL].（2019-11-07）[2022-06-02]. https：//www.justicehealth.nsw.gov.au/about-us/right-to-information/1-437_ policy_1119.pdfhttps://www.justicehealth.nsw.gov.au/about-us/right-to-information/1-437_policy_1119.pdf.

World Health Organization. WHO model list of essential medicines，20th list[EB/OL].（2017-03-29）[2022-06-02].https：//apps.who.int/iris/rest/bitstreams/1145259/retrievehttps://apps.who.int/iris/rest/bitstreams/1145259/retrieve.

World Health Organization. AWaRe policy brief[EB/OL]. [2022-06-02].https：//adoptaware.org/assets/pdf/aware_ policy_brief.pdfhttps://adoptaware.org/assets/pdf/aware_policy_brief.pdf.

陈志东. 《2019年世界卫生组织抗菌药物AWaRe分级目录》及其存在问题[J]. 上海医药，2020，41（13）：49-52，72.

World Health Organization. Adopt AWaRe：handle antibio- tics with care[EB/OL].[2022-06-02]. https：//adoptaware.org/#resourceshttps://adoptaware.org/#resources.

World Health Organization. 2021 ‎AWaRe classification[EB/OL].（2021-09-30）[2022-06-02]. https：//www.who.int/publications/i/item/2021-aware-classificationhttps://www.who.int/publications/i/item/2021-aware-classification.

World Health Organization. AWaRe brochure[EB/OL]. [2022-06-02].https：//adoptaware.org/assets/pdf/aware_ brochure.pdfhttps://adoptaware.org/assets/pdf/aware_brochure.pdf.

XIAO Y H. Antimicrobial stewardship in China：systems，actions and future strategies[J]. Clin Infect Dis，2018，67（suppl 2）：S135-S141.

国家卫生健康委员会.关于施行《抗菌药物临床应用指导原则》的通知[EB/OL].（2004-08-22）[2021-07-17].http：//www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=18544http://www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=18544.

国家卫生健康委员会.关于印发抗菌药物临床应用指导原则（2015年版）的通知[EB/OL].（2015-08-27）[2021-07-17].http：//www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=c18e1014de6c45ed9f6f9d592b43db42http://www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=c18e1014de6c45ed9f6f9d592b43db42.

国家卫生健康委员会.抗菌药物临床应用管理办法：卫生部令第84号[EB/OL].（2012-05-08）[2021-07-17].http：//www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=347e8d20a6d442ddab626312378311b4http://www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=347e8d20a6d442ddab626312378311b4.

国家卫生健康委员会.《抗菌药物临床应用管理办法》有关问题答疑[EB/OL].（2012-05-09）[2021-07-17]. http：//www.nhc.gov.cn/wjw/zcjd/201304/43c21ad2846d4cd58785310fc1fc775a.shtmlhttp://www.nhc.gov.cn/wjw/zcjd/201304/43c21ad2846d4cd58785310fc1fc775a.shtml.

WUSHOUER H，ZHOU Y，ZHANG X，et al. Secular trend analysis of antibiotic utilisation in China’s hospitals 2011-2018，a retrospective analysis of procurement data[J]. Antimicrob Resist Infect Control，2020，9（1）：53.

World Health Organization. The 2021 WHO AWaRe classi- fication of antibiotics for evaluation and monitoring of use[EB/OL]. [2022-06-02]. https：//apps.who.int/iris/rest/bitstreams/1374989/retrievehttps://apps.who.int/iris/rest/bitstreams/1374989/retrieve.

World Health Organization. Critically important antimicrobials for human medicine：6th revision 2018[EB/OL].（2019-03-20）[2022-06-02]. https：//apps.who.int/iris/rest/bitstreams/1217095/retrievehttps://apps.who.int/iris/rest/bitstreams/1217095/retrieve.

World Health Organization. Prioritization of pathogens to guide discovery，research and development of new anti-biotics for drug-resistant bacterial infections，including tuberculosis[EB/OL].（2017-09-04）[2022-06-02]. https：//apps.who.int/iris/rest/bitstreams/1214671/retrievehttps://apps.who.int/iris/rest/bitstreams/1214671/retrieve.

World Health Organization. WHO antibiotic categorization[EB/OL]. [2022-06-02].https：//aware.essentialmeds.org/groupshttps://aware.essentialmeds.org/groups.

World Health Organization. The selection and use of essential medicines[EB/OL].（2017-01-30）[2022-06-02].https：//apps.who.int/iris/rest/bitstreams/1091561/retrievehttps://apps.who.int/iris/rest/bitstreams/1091561/retrieve.

HSIA Y，LEE B R，VERSPORTEN A，et al. Use of the WHO Access，Watch，and Reserve classification to define patterns of hospital antibiotic use （AWaRe）：an analysis of paediatric survey data from 56 countries[J]. Lancet Glob Health，2019，7（7）：e861-e871.

KLEIN E Y，MILKOWSKA-SHIBATA M，TSENG K K，et al. Assessment of WHO antibiotic consumption and access targets in 76 countries，2000-15：an analysis of pharmaceutical sales data[J]. Lancet Infect Dis，2021，21（1）：107-115.

WANG C N，HUTTNER B D，MAGRINI N，et al. Pediatric antibiotic prescribing in China according to the 2019 World Health Organization access，watch，and reserve （AWaRe）antibiotic categories[J]. J Pediatr，2020，220：125-131.e5.

HSIA Y，SHARLAND M，JACKSON C，et al. Consumption of oral antibiotic formulations for young children according to the WHO Access，Watch，Reserve （AWaRe） antibiotic groups：an analysis of sales data from 70 middle-income and high-income countries[J].Lancet Infect Dis，2019，19（1）：67-75.

SULIS G，ADAM P，NAFADE V，et al. Antibiotic prescription practices in primary care in low- and middle-income countries：a systematic review and meta-analysis[J]. PLoS Med，2020，17（6）：e1003139.

PAUWELS I，VERSPORTEN A，DRAPIER N，et al. Hospital antibiotic prescribing patterns in adult patients according to the WHO Access，Watch and Reserve classification （AWaRe）：results from a worldwide point prevalence survey in 69 countries[J]. J Antimicrob Chemother，2021，76（6）：1614-1624.

WUSHOUER H，TIAN Y，GUAN X D，et al. Trends and patterns of antibiotic consumption in China’s tertiary ho-spitals：based on a 5 year surveillance with sales records，2011-2015[J]. PLoS One，2017，12（12）：e0190314.

PALWE S，VEERARAGHAVAN B，PERIASAMY H，et al. Unorthodox parenteral β-lactam and β-lactamase inhibitor combinations：flouting antimicrobial stewardship and compromising patient care[J]. Antimicrob Agents Chemother，2020，64（5）：e00168-e00120.

BUDD E，CRAMP E，SHARLAND M，et al. Adaptation of the WHO Essential Medicines List for national antibio- tic stewardship policy in England：being AWaRe[J]. J Antimicrob Chemother，2019，74（11）：3384-3389.

国家卫生健康委员会. 中国抗微生物药物管理和耐药现状报告：2021[M]. 北京：中国协和医科大学出版社，2021：28.

耐甲氧西林金黄色葡萄球菌感染防治专家委员会. 耐甲氧西林金黄色葡萄球菌感染防治专家共识[J]. 中华实验和临床感染病杂志（电子版），2010，4（2）：215-223（2010-05-15）[2022-06-02]. https：//kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2010&filename=ZSGR201002021&uniplatform=NZKPT&v=v4wVzkq7zco53pKw5nYnez5ajR4eGeFnOkO8AL0qw_xD3raZekOfxd0KBY-5mdqonhttps://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2010&filename=ZSGR201002021&uniplatform=NZKPT&v=v4wVzkq7zco53pKw5nYnez5ajR4eGeFnOkO8AL0qw_xD3raZekOfxd0KBY-5mdqon.

European Centre for Disease Prevention and Control. WHO and ECDC report：antimicrobial resistance remains a health threat in Europe[EB/OL].（2022-01-26）[2022-06-02]. https：//www.ecdc.europa.eu/en/news-events/who-and- ecdc-report-antimicrobial-resistance-remains-health-threat- europehttps://www.ecdc.europa.eu/en/news-events/who-and-ecdc-report-antimicrobial-resistance-remains-health-threat-europe.

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