2018年我院药物不良反应报告分析

Analysis of reports on adverse drug reactions in our hospital in 2018

目的掌握我院药物不良反应(ADR)发生频次及特点,为临床安全合理用药提供参考。方法回顾性分析2018年1~12月于我院住院治疗并上报ADR的181例报告进行汇总,并对年龄、性别、涉及药品种类等多项资料进行归纳整理。结果在研究的181份ADR报告中,男性ADR发生率显著低于女性,且随着年龄的增高,ADR发生频次更高。上报例数排名前三的科室为肿瘤外科、呼吸内科和消化内科。最常见的引发ADR的给药方式为静脉给药,占比全部上报ADR的76.24%。在临床各类药品中,抗肿瘤药物及抗感染药物导致ADR出现的概率更高,临床的常见表现包括全身性损害、消化系统和血液系统损害等。按临床关联性标准评价,"肯定"、"很可能"、"可能"和"待评价"分别占比46.96%、38.67%、11.61%和2.76%。按照报告类型分类,已知的一般反应、新的不良反应、严重不良反应分别为147例(81.21%)、19例(10.50%)和15例(8.29%)。结论抗肿瘤药物和抗感染药物在临床使用过程中ADR发生频次最高,这可能与药物本身结构及性质有关,临床应加强对此类药物的监控及管理,同时针对该类药物常见不良反应,临床应定期组织医护人员进行该类药物ADR发生的处理培训。

Objective To know the frequency and characteristics of adverse drug reactions(ADR) in our hospital, and to provide a reference for clinically safe and rational drug use. Methods 181 patients admitted to our hospital from January to December 2018 with ADR reported were retrospectively analyzed, and the age, gender, and types of drugs involved were summarized. Results Among the 181 ADR reports, the incidence of ADR in male was significantly lower than that in female, and the incidence of ADR was higher as age grew. The top three departments with the most reported cases were oncology surgery, respiratory medicine, and gastroenterology. The most common channel inducing ADR was intravenous administration, accounting for 76.24% of all reported ADR. Among various clinical drugs, anti-tumor drugs and anti-infectious drugs caused higher probability of ADR. Common clinical manifestations included systemic damage, digestive system and blood system damage, etc. According to the clinical relevance criteria, the number of "affirmative", "very likely", "possible", and "to be evaluated" accounted for 46.96%, 38.67%, 11.61%, and 2.76%, respectively. According to the type of report, 147 cases(81.21%), 19 cases(10.50%), and 15 cases(8.29%) were known general reactions, new adverse reactions, and severe adverse reactions, respectively. Conclusion Anti-tumor drugs and anti-infective drugs have the highest frequency of ADR during clinical use, which may be related to the structure and properties of the drug itself. The clinical monitoring and management of such drugs should be strengthened. Medical personnel should be regularly organized to conduct training concerning the dealing of ADR caused by such drugs.