我区1129例药品不良反应监测报告分析

Analysis of 1129 Cases of Adverse Drug Reaction Monitoring in Our District

目的:对某区药品不良反应(ADR)发生特点、规律进行分析,并在此基础上提出针对性改进建议,以降低临床ADR发生率。方法:分析某区2013年2月~2015年1月期间4120例患者临床诊疗情况,对其中出现的1129例ADR患者给药途径、ADR临床表现进行分析,总结改进措施。在2015年2月~2017年1月期间进行临床干预措施,干预例数同样为4120例。前期为观察阶段,后期为干预阶段。结果:干预阶段ADR总发生率(3.6%)低于观察阶段ADR发生率(27.4%),两个阶段中均为皮肤及附近损害发生率最高,其次为消化系统损害。观察阶段、干预阶段发生的ADR病例中,给药途径发生最高为静脉滴注,其次为口服途径。ADR监测报告中,粉针剂在8种给药剂型中所占比例最高,最低为颗粒药剂类型。结论:药品不良反应监测工作与药品管理的加强、合理用药的有效落实及用药安全保障之间有着密切联系,再加上上报的病例数量中症状较为明显的所占比例较多,故而在日常上报过程中应不断强化监测工作,以便将ADR发现率提高。

Objective: To analyze the characteristics and rules of adverse drug reaction (ADR) in a district, and to put forward some suggestions on improvement in order to reduce the incidence of clinical ADR. Methods: The clinical diagnosis and treatment of 4120 patients in a district from February 2013 to January 2015 were analyzed, among which 1129 patients with ADR were analyzed for drug delivery routes and clinical manifestations, and improvement measures were summarized. During the period from February 2015 to January 2017, the number of clinical intervention measures was also 4120. The early stage was the observation stage and the late stage was the intervention stage. Results: The total incidence of ADR at the intervention stage (3.6%) was lower than that at the observation stage (27.4%). In both stages, the incidence of skin and adjacent lesions was the highest, followed by digestive system lesions. Among the ADR cases in the observation stage and intervention stage, the highest incidence of drug delivery route was intravenous drip, followed by oral route. In the ADR monitoring report, the proportion of powder injection was the highest among the 8 kinds of agents, and the lowest was granule medicine type. Conclusion: There is a close relationship between the monitoring of adverse drug reactions and the strengthening of drug management, the effective implementation of rational drug use and the safety and security of drugs. In addition, the number of reported cases has a large proportion of obvious symptoms, so the monitoring should be continuously strengthened in the daily reporting process to improve the detection rate of ADR.