五个地区药品不良反应病例报告的质量评估与分析

Evaluation and Analysis of ADR Reports' Quality in 5 Areas

目的:提高我国药品不良反应(ADR)报告的真实性、规范性和完整性。方法:采用国家ADR监测中心制定的《药品不良反应病例报告质量评估计分表》填表说明、积分表以及计算公式对四川省五个地区的ADR报表抽样进行质量评估与分析。结果:五个地区在每一类报表的规范性和完整性上都存在不足,规范性方面体现在报告类型、关联性评价和ADR分析上,完整性方面体现在ADR的发生时间、终结时间和治疗措施上,没有一个地区在每一类报表中都做到完全合格。结论:加强药品不良反应监测工作的宣传和上报人员的专业培训有利于较快提高我国药品不良反应监测水平。

Objective ： To improve the validity, standardization and integrity of ADR reports in our country. Method：The ADR reports＇ quality in 5 areas in Sichuan province was evaluated and analyzed by using accounts, tables of integrals and calculation formula acc0rdingto ADR Case Report Quality Assessment Sub metering. Result： very report from all the 5 areas had their shortcomings in terms of standardization and integrity, specifically in its report type of standardization, relevance evaluation and ADR analysis for the former and time of origin, finish time and therapeutic measures of ADR for the latter. No reports were completely qualified. Conclusion： It was important to strengthen the propaganda of ADR surveil- lance and training of professional personnel to improve the monitoring level of ADR.