坦索罗辛临床用药安全性评价分析

Clinical Medication Safety Evaluation of Tamsulosin

目的:了解坦索罗辛临床应用过程中致血压降低的特点、影响因素及预防治疗措施。方法:在国家药品不良反应监测系统检索山东省2017年1月1日~2022年6月30日使用坦索罗辛后引发的药品不良反应病例报告;检索2000年1月1日~2022年6月30日中国知网(CNKI)收录的坦索罗辛引发药品不良反应的文献报道。运用Excel和SPSS19.0统计分析软件对监测数据进行描述性分析和相关性分析。结果:共检索到病例报告162例。临床使用中存在超适应症用药、超剂量给药、用法不规范等情况。出现血压下降的患者的平均年龄远高于全部药品不良反应病例的平均年龄。37.89%的药品不良反应表现为头晕、低血压相关症状、皮疹等,严重的药品不良反应均为血压降低引发的一过性意识丧失;患有多系统疾病与使用坦索罗辛出现血压降低具有显著相关性;休息后站立和空腹用药可能增加患者严重血压下降风险。坦索罗辛引发的药品不良反应转归痊愈和好转共计160例(98.77%)。结论:老年患者、多系统疾病患者服用坦索罗辛时,应加强患者用药期间的血压监测,加强患者用药教育,规范临床用药。

Objective:To understand the characteristics and influencing factors of hypotension induced by tamsulosin in clinical application,fi nding better preventive measures.Methods:Case reports of adverse reactions induced by tamsulosin from January 1,2017 to June 30,2022 in Shandong province were searched in the National Adverse drug Reaction monitoring system.Literature reports on adverse reactions caused by tamsulosin collected by CNKI from January 1,2000 to June 30,2022 were searched.Excel software and SPSS 19.0 statistical analysis software were used for descriptive analysis and correlation analysis of monitoring data.Results:A total of 162 case reports were retrieved.There are some irregularities in clinical use,such as off-label use,overdosage use,irregular usage,and etc.The average age of patients with hypotension was much higher than that of all cases.37.89%of the adverse reactions were dizziness,hypotension related symptoms,rash,and etc.The serious adverse reactions were transient loss of consciousness caused by hypotension.There was a signifi cant correlation between multiple system diseases and hypotension with tamsulosin.Getting up after rest and taking drugs on an empty stomach may increase the risk of severe hypotension.160(98.77%)of the adverse reactions caused by tamsulosin were curable and treatable.Conclusion:Elderly patients and patients with multiple systemic diseases should strengthen blood pressure monitoring during medication.Patient medication education should be strengthened.Clinical medication should be more standardized.