摘 要
抗菌药物在现代医学中发挥着不可替代的作用，但其不良反应严重影响患者健康并增加医疗负担。为全面了解我国抗菌药物不良反应监测与管理现状，本研究基于2018 - 2022年全国药品不良反应监测网络数据，结合文献分析和专家访谈，对国内抗菌药物不良反应的监测体系、管理制度及临床应用情况进行系统梳理。结果表明，我国已初步建立覆盖广泛的监测网络，但仍存在地区发展不平衡、基层医疗机构监测能力不足等问题；部分新型抗菌药物缺乏足够的安全性数据积累，且特殊人群用药安全问题亟待重视。本研究创新性地构建了基于大数据分析的抗菌药物不良反应风险预警模型，为优化监测流程、提升管理水平提供了科学依据，有助于推动抗菌药物合理使用政策的有效实施，保障公众用药安全。
关键词：抗菌药物不良反应; 监测体系; 风险管理
Abstract
Antimicrobial agents play an indispensable role in modern medicine, yet their adverse reactions significantly impact patient health and increase healthcare burdens. To comprehensively understand the current status of antimicrobial adverse reaction monitoring and management in China, this study analyzed data from the national pharmacovigilance network covering 2018-2022, supplemented by literature reviews and expert interviews, to systematically examine the monitoring system, management policies, and clinical application of antimicrobial agents in China. The findings indicate that China has preliminarily established a broad-reaching surveillance network; however, issues such as regional disparities and insufficient monitoring capabilities in primary healthcare institutions persist. Additionally, some novel antimicrobial agents lack adequate safety data, and medication safety for special populations requires immediate attention. This study innovatively developed a risk warning model for antimicrobial adverse reactions based on big data analysis, providing a scientific basis for optimizing monitoring procedures and enhancing management practices. This advancement facilitates the effective implementation of policies promoting rational antimicrobial use and ensures public medication safety.
Key words:Antimicrobial Drug Adverse Reactions; Monitoring System; Risk Management
目 录
中文摘要 I
英文摘要 II
引 言 1
第1章、抗菌药物不良反应监测体系 3
1.1、监测系统的构成与运作 3
1.2、数据收集与分析方法 3
1.3、监测结果的应用与反馈 4
第2章、不良反应的临床表现与危害 5
2.1、常见不良反应类型 5
2.2、严重不良事件评估 5
2.3、对患者健康的影响 6
第3章、管理措施与防控策略 7
3.1、合理用药指导原则 7
3.2、医疗机构管理实践 7
3.3、政策法规支持体系 8
第4章、当前监测管理存在的问题 9
4.1、系统性缺陷分析 9
4.2、医护人员认知水平 9
4.3、改善建议与未来方向 10
结 论 11
参考文献 12
