某地区601例新的药品不良反应报告及其质量分析

601 Cases of New Drug Adverse Reaction Reports and Their Quality Analysis in a Certain Region

目的:了解我市2013年以来新的药品不良反应报告情况,为医务人员准确判断新的药品不良反应提供参考,为提高我市整体药品不良反应(ADR)报告水平提出建设性意见。方法:对比2012年我市的ADR报告,汇总2013-2015年我市上报的ADR病例,统计分析其中的601例新的ADR报告。结果:新的ADR报告数量快速上升,抗微生物类药种次最多,占比29.30%,其次为中药类制剂,占比27.07%;注射剂型占比81.38%,外用途径给药占比0.85%,口服给药占比17.77%;胃肠道、皮肤及其附件、神经系统发生的ADR较多,血液系统反应最少。报告准确性整体不高,省评价肯定的报告太少,仅有1份。结论:我市新的ADR报告数量快速上升,但其完整性、准确性较低,关联性评价达不到省评价要求,不能客观反应新的ADR的整体状况。

Objective： To review situations of new drug adverse reaction reports since 2013, so as to provide medical personnel in Dingxi with references on accurately determining new adverse drug reactions and put forward constructive suggestions to improve overall level of ADR reports in the city. Methods： Compared with ADR report during 2012, the reported ADR cases in Dingxi during 2013-2015 were summarized. A retrospective statistical analysis of 601 cases of new ADR reports was carried out. Results： New ADR report number rose fast. Among all the precipitating factors, the antimicrobial drugs were the most common ones, accounting for more than 29.30%, followed by the traditional Chinese medicine preparations, which accounted for 27.07%; the injection dosage forms accounted for 81.38%; topical approach to medicine accounted for 0.85%; and the oral medicine accounted for 17.77%. ADR was apt to be observed in the gastrointestinal tracts skin and its accessories, as well as nervous system, but less observed in blood system. The overall accuracy of reports was low, and there was only one affirmative copy of the provincial evaluation report. Conclusion： The number of new ADR rises quickly, but the completeness and accuracy are low. Relevance evaluation cannot meet the provincial assessment requirements, which cannot objectively reflect the new ADR overall situation.