探讨检验危急值在严重药品不良反应监测中的应用

Application of critical value in monitoring of serious adverse drug reactions

目的探讨检验危急值在严重药品不良反应(SADR)监测中的应用价值。方法回顾性分析2016年1月—2017年6月我院收集到的基于检验危急值及传统监测模式的SADR报告表,对两种监测模式从患者性别与年龄、不良反应特点、科室分布及潜伏期、因果关系及转归方面,分别进行归类整理并进行统计分析。结果福州市长乐区医院共收集SADR 395例,65岁以上年龄段的患者引起SADR最多,占54.44%;基于检验危急值的有251例,占63.54%,与传统监测模式比较差异显著(P<0.01);科室分布方面,居前3位的科室分别为消化内科、内分泌科、神经内科,两种监测模式无显著差异;检验危急值监测模式居前3位的不良反应分别为肝功能异常、低血糖、肾功能损害,传统监测模式居前3位的分别为胃肠系统损害、全身性损害、代谢和营养障碍,二者互为补充;潜伏期评价中,最短的为3 min,最长的为7年;关联性评价中,"很可能"46例,占11.65%,"可能"349例,占88.35%;转归情况方面,痊愈74份,占18.73%,好转283份,占71.65%。结论本研究为药品安全性信息的更新及补充提供重要数据,检验危急值在SADR监测工作中具有重要意义,可有效提高监测工作效率和能力。

Objective To investigate the application value of critical value in monitoring serious adverse drug reactions（SADR）. Methods A report of SADR, which was collected by Fuzhou Changle District Hospital from January 2016 to June 2017, was reviewed based on the critical value of inspection and the traditional monitoring model. The two types of monitoring models were classified and analyzed from the gender, age, the characteristics of adverse reactions, the distribution and incubation period of the department, the correlation, and the outcome. Results A total of 395 cases of SADR were collected in Fuzhou Changle District Hospital, which was based on the critical value of the 251 cases, accounting for 63.54%; Compared with the traditional monitoring mode has a significant difference（P〈0.01）. Patients aged 65 and above had the most SADR, accounting for 54.44%. In the area of department distribution, the top three departments were the department of digestive medicine, the department of endocrinology, and the department of neurology, which of the two monitoring modes had no significant differences. The top three adverse reactions in the critical value monitoring model were liver dysfunction, hypoglycemia, and renal function damage respectively. The top three in the traditional monitoring model were gastrointestinal system damage, systemic damage, metabolism and nutritional disorders, and the two were supplemented by each other. The shortest incubation period was 3 min and the longest was 7 years. In correlation assessment, 46 cases were likely to be involved, accounting for 11.65%, and 349 cases were possible, accounting for 88.35%. In terms of outcome, 74 cases recovered, accounting for 18.73%, and 283 cases improved, accounting for 71.65%. Conclusion This study provides important data for updating and supplementation of drug safety information. The critical value of test is of great significance in the monitoring of SADR. By analyzing the critical value of the test, we can effectively improve the efficiency and ability of monitoring SADR.