【摘要】 目的 为药品上市许可持有人（MAH）开展中药注射剂安全性主动监测的研究设计和质量管理提供思路。方法 分析中药注射剂不良反应的特点及发生原因，借鉴文献研究中安全性主动监测现状，结合主动监测工作经验提出建议。结果 安全性主动监测设计要素包括全面调研政策与产品相关信息、确定与监测目标人群相关的因素、收集尽可能全面的用药信息、设置实现主动监测研究目标的评价指标、设计规范完整的数据采集表、选择科学适宜的数据管理和分析方法。主动监测研究的质量管理包括组建权责明确的研究团队、建立全面的标准操作流程并加强人员培训、选择恰当的数据管理系统、充分利用中心化的监查技术。结论 安全性主动监测研究为发现中药注射剂安全风险信号的有效手段之一，可为风险信号的评价与验证提供证据。更多还原

【Abstract】 Objective To provide ideas for MAH to carry out the research design and quality management of active safety monitoring of traditional Chinese medicine injections. Methods It analyzed the characteristics and causes of adverse reactions of traditional Chinese medicine injections, drawing lessons from the current status of active safety surveillance in literature research and the experiences of Spontaneous monitoring, and it put forward suggestions on the research design and quality management of active safety surveillance in MAH. Results The design elements of active safety surveillance included comprehensively investigating policy and product related information, determining the factors related to the target population, collecting comprehensive usage information, setting evaluation indicators to achieve the objectives of active monitoring research, designing standardized and completed data collection tables, and selecting scientific and appropriate data management and analysis methods. The quality management of active surveillance research included establishing a research team with clear rights and responsibilities, setting a standard operating process and strengthening personnel training, selecting an appropriate data management system, and making full use of centralized monitoring technology.Conclusion Active safety surveillance is one of the effective ways to find safety risk signal of traditional Chinese medicine injections, and it also can provide evidence for risk signal review and validation.更多还原