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药品评价

基于德尔菲法与层次分析法的HIV职业暴露后预防用抗反转录药物临床综合评价指标体系构建

  • 陈潮光 ,
  • 罗青锚 ,
  • 黄树庭 ,
  • 蒋周倩 ,
  • 廖嫒秋 ,
  • 李繁 ,
  • 易文燕
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  • 贺州市人民医院, 广西 贺州 542899
韦明中,男,主管药师,研究方向:临床药学

收稿日期: 2025-11-07

  修回日期: 2026-04-02

  录用日期: 2026-05-19

  网络出版日期: 2026-08-12

基金资助

广西壮族自治区卫生健康委员会第二批药品临床综合评价项目(YPPJ019)

Construction of Clinical Comprehensive Evaluation Index System of Antiretroviral Drugs for HIV Occupational Exposure Post-Exposure Prophylaxis#br#      Based on Delphi Method and Analytic Hierarchy Process

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  • Hezhou People′s Hospital, Guangxi Hezhou 542899, China

Received date: 2025-11-07

  Revised date: 2026-04-02

  Accepted date: 2026-05-19

  Online published: 2026-08-12

Supported by


摘要

目的:解决HIV职业暴露后预防(PEP)临床实践中多种抗反转录病毒治疗方案优化选择难题,构建一套系统化的药物临床综合评价指标体系。方法:基于文献分析和专家访谈建立初始指标框架,邀请15位专家开展两轮德尔菲咨询,采用层次分析法(AHP)确定指标权重。结果:最终形成6个一级指标、17个二级指标及58项评分细则。两轮专家积极系数为80%和100%,综合权威系数为0.861,Kendall协调系数为0.301和0.582(P<0.001)。一级指标权重为:有效性(0.358 6)、安全性(0.364 0)、经济性(0.093 8)、创新性(0.045 3)、适宜性(0.058 7)、可及性(0.079 6)。结论:本研究构建的HIV职业暴露PEP抗反转录病毒药物临床综合评价指标体系兼具科学性与系统性,整合疗效、安全性、经济性等多维度现实因素,可为临床合理用药提供系统化决策支持。

本文引用格式

陈潮光 , 罗青锚 , 黄树庭 , 蒋周倩 , 廖嫒秋 , 李繁 , 易文燕 . 基于德尔菲法与层次分析法的HIV职业暴露后预防用抗反转录药物临床综合评价指标体系构建[J]. 中国药物评价, 2026 , 43(3) : 231 -231-236 . DOI: 10.2095-3593.2026.050018

Abstract

Objective: To address the challenge of optimizing the selection of multiple antiretroviral treatment regimens in the clinical practice of post-exposure prophylaxis (PEP) for HIV occupational exposure, and to construct a clinical comprehensive evaluation index system of antiretroviral drugs. Methods: Based on literature analysis and expert interviews, an initial indicator framework was established. Fifteen experts were invited to conduct two rounds of Delphi consultation, and the analytic hierarchy process (AHP) was used to determine the weight of indicators. Results: Ultimately, six primary indicators, seventeen secondary indicators, and fifty-eight scoring criteria were formed. The positive coefficients of the two rounds of experts were 80% and 100%, the authority coefficients was 0.861, and the Kendall concordance coefficients were 0.301 and 0.582 (P<0.001). The weights of primary indicators were: effectiveness (0.358 6), safety (0.364 0), economy (0.093 8), innovation (0.045 3), suitability (0.058 7), and accessibility (0.079 6). Conclusion: The comprehensive evaluation index system for antiretroviral drugs in HIV occupational exposure PEP clinical practice constructed in this study is both scientific and systematic, integrating multiple dimensions of practical factors such as efficacy, safety, and economy, and can provide systematic decision support for rational clinical drug use.

参考文献

[1] Bekker LG, Beyrer C, Mgodi N, et al. HIV infection[J]. Nat Rev Dis Primers, 2023, 9(1):42.
     [2] Nkolola JP, Barouch DH. Prophylactic HIV-1 vaccine trials:past,present,and future[J]. Lancet HIV, 2024, 11(2):e117-e124.
     [3] UNAIDS. Global HIV & AIDS statistics:Fact sheet[EB/OL]. (2024-08-02) [2025-06-10]. https://www. unaids. org/en/resources/fact-sheet.
     [4] 沈银忠.中国艾滋病诊疗指南(2024版)[J]. 中国病毒病杂志,2025,15(1):4-32.
     [5] 中国疾病预防控制中心,性病艾滋病预防控制中心. 人类免疫缺陷病毒暴露后预防技术指南(试用)[EB/OL]. (2020-11-16) [2025-06-10]. http://ncaids. chinacdc. cn/tzgggd/202011/W020201116802422550750. pdf.
     [6] 中华医学会感染病学分会艾滋病丙型肝炎学组,中国疾病预防控制中心. 中国艾滋病诊疗指南(2021年版)[J]. 协和医学杂志,2022,13(2):203-226.
     [7] Bryant J,Baxter L,Hird S.Non-occupational postexposure prophylaxis for HIV:a systematic review[J]. Health Technol Assess, 2009, 13(14):1-60.
     [8] Goldschmidt RH. CDC Releases Updated Guidelines for Postexposure Prophylaxis After Sexual, Injection Drug, or Other Nonoccupational Exposures to HIV[J]. Am Fam Physician, 2016, 5:392-393.
     [9] Ryom L, Boesecke C, Bracchi M, et al. Highlights of the 2017 European AIDS Clinical Society (EACS) Guidelines for the treatment of adult HIV-positive persons version 9.0[J]. HIV Med, 2018, 5:309-315.
     [10] World Health Organization. Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV:interim guidelines[EB/OL]. [2025-06-10]. http://www. who. int/iris/handle/10665/273632. Licence:CCBY-NC-SA 3.0 IGO.
     [11] 国家卫生健康委员会办公厅.关于规范开展药品临床综合评价工作的通知[J]. 中华人民共和国国家卫生健康委员会公报, 2021,(7):21-28.
     [12] 国家卫生健康委员会. 《药品临床综合评价管理指南(2021年版 试行)[EB/OL]. (2021-07-15) [2025-06-10]. http://www. nhc. gov. cn/yaozs/s2908/202107/532e20800a47415d84adf3797b0f4869. shtml.
     [13] 国家卫生健康委员会卫生发展研究中心.心血管病药品临床综合评价技术指南(2021年版) [EB/OL]. (2021-12-31) [2025-06-10]. http://www. nhei. cn/nhei/znfb/202112/9e350a54d2ea4c3ab9a0237ee4eab9f0/files/0ac56 e4cd1e848da859d623212dd0171. pdf.
     [14] 国家药物和卫生技术综合评估中心(国家卫生健康委员会卫生发展研究中心),国家癌症中心,国家卫生健康委员会药具管理中心.抗肿瘤药品临床综合评价技术指南(2022年版 试行)[EB/OL]. (2022-06-29) [2025-06-10]. https://www. hnysfww. com/data/article/1656481023744041713. pdf.
     [15] 国家卫生健康委员会卫生发展研究中心. 儿童药品临床综合评价技术指南(2022年版 试行)[EB/OL]. (2022-06-29) [2025-06-10]. https://www. cn-healthcare. com/article/20220629/content-570822. html.
     [16] 林思思,陈丽萍,江绮云,等. 抗肺癌药品临床综合评价指标体系的构建及实证研究[J]. 中国药房,2023,34(11):1313-1319.
     [17] 司天梅,王振,李凌江. 抗抑郁药品临床综合评价专家共识[J]. 中国药房,2023,34(13):1547-1554.
     [18] 杭州市药事管理质控中心药品评价专家组,浙江大学医学院附属杭州市第一人民医院,严伟,等. 心血管慢病药品临床综合评价杭州专家共识[J]. 中国药房,2022,33(9):1025-1030.
     [19] 江依帆,陈丽萍,张若钰,等. 抑酸药物的临床综合评价指标体系构建[J]. 中国药物评价,2023,40(5):416-421.
     [20] Zhang C, Ma EL, Liu BL, et al. Framework development for clinical comprehensive evaluation of drugs-a study protocol using the delphi method and analytic hierarchy process[J]. Front Pharmacol, 2022, 13:869319.
     [21] Luo Z, Zhou Z, Hao Y, et al. Establishment of an indicator framework for the transmission risk of the mountain-type zoonotic visceral leishmaniasis based on the Delphi-entropy weight method[J]. Infect Dis Poverty, 2022, 11(1):122.
     [22] Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness[J]. World J Methodol, 2021, 11(4):116-129.
     [23] Cheng K, Xu Z, Zhang Y, et al. Construction of an evaluation index system for hospital resilience to emerging infectious diseases: a Delphi study from China[J]. BMC Public Health, 2025, 25(1):1337.
     [24] 陈彤丹,高奇隆,任晋文,等. 基于德尔菲法构建慢性病药物可及性评价指标体系[J]. 中国现代应用药学,2022,39(20):2652-2657.
     [25] 张方,张大为,孟丽华,等. 药品临床价值评估指标体系的构建研究[J]. 中国药学杂志,2017,52(8):706-710.
     [26] Shi Y, Sun S, Deng J, et al. Establishment and application of an index system for the risk of drug shortages in China: based on delphi method and analytic hierarchy process[J]. Int J Health Policy Manag, 2022, 11(12):2860-2868.
     [27] 肖熠. 贵州省基本医疗保险药品价值评价体系构建及应用研究[D]. 贵阳:贵州医科大学,2022.
     [28] Liu C, Liu Y, Xuan B, et al. Developing a quality indicator system for pediatric clinical trials management of research centers in China: a modified Delphi-Analytic Hierarchy Process study[J]. BMC Pediatr, 2025, 25(1):256.
     [29] Wang S, Li L, Jin Y,et al. Identifying key factors for burnout among orthopedic surgeons using the analytic hierarchy pss method[J]. Int J Public Health, 2023, 68:1605719.
     [30] Yu Z, Sun G, Lin S, et al. Operationalizing game-theoretic weighting in public hospital cost control: an implementation framework from Chinese tertiary hospitals[J]. Cost Eff Resour Alloc, 2025, 23(1):11.
     [31] 程莹. 基于层次分析法的房地产代管代建风险管理研究[D]. 长春:吉林大学,2024.
     [32] 赵志刚,董占军,刘建平. 中国医疗机构药品评价与遴选快速指南(第二版)[J]. 医药导报,2023,42(4):447-456.
     [33] 吴锋耀,董文逸,韦彩云,等. 艾滋病高发地区传染病医院医护人员职业卫生防护体系建设[J]. 中国护理管理,2018,18(2):150-153.
     [34] 卢慧兰,马玉霞,韩琳,等. 医护人员HIV职业暴露与防护现状调查[J]. 职业与健康,2019,35(8):1071-1074.
     [35] 王少娜,董瑞,谢晖,等. 德尔菲法及其构建指标体系的应用进展[J]. 蚌埠医学院学报,2016,41(5):695-698.
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