日照市193例倍他司汀不良反应报告分析

Analysis of 193 Cases of Betahistine-Related Adverse Reaction Reports in Rizhao

目的为临床安全使用倍他司汀提供参考。方法收集山东省日照市药品不良反应监测中心2014年1月1日至2023年1月1日上报至国家药品不良反应监测系统以倍他司汀为怀疑药物且已完成评价的药品不良反应(ADR)报告,分析ADR类型、患者基本情况、给药途径、累及系统/器官及临床表现、转归、严重ADR等。结果共收集到ADR报告193例(268例次),其中一般ADR 183例(94.82%),含新的一般ADR 26例(13.47%);严重ADR 10例(5.18%)。关联性评价结果分别为很可能(71例、36.79%)和可能(122例、63.21%)。涉及患者193例,其中男71例,女122例;年龄20~95岁,以60岁以上居多(113例、58.55%);给药途径以静脉滴注最多(174例、90.16%)。主要累及系统/器官为神经系统、胃肠道系统、皮肤及皮下组织,主要临床表现为头痛、头晕、心悸等;严重ADR主要表现为胸闷、呼吸困难等。痊愈123例(63.73%),好转66例(34.20%),未好转1例(0.52%),转归情况不详3例(1.55%)。结论临床使用倍他司汀时应做好药学监护,并结合已有ADR评估用药风险,保障患者用药安全。

Objective To provide a reference for the safe use of betahistine in clinical practice.Methods The adverse drug reaction(ADR)reports with betahistine as the suspicious drug reported to the National Adverse Drug Reaction Monitoring System from January 1,2014 to January 1,2023 that had been evaluated were collected by the Drug Adverse Reaction Monitoring Center of Rizhao.The ADR types,patients′basic information,route of administration,involved systems/organs,clinical manifestations,outcomes and serious ADRs were analyzed.Results A total of 193 cases of ADR reports(268 case times)were collected,there were 183 cases of general ADRs(94.82%),26 cases of new general ADRs(13.47%)and 10 cases of serious ADRs(5.18%).The ADRs were probably and possibly associated with betahistine,with 71 cases(36.79%)and 122 cases(63.21%)respectively.A total of 193 patients were involved,including 71 males and 122 females,aged from 20 to 95 years,with the majority being over 60 years(113 cases,58.55%).The most common route of administration was intravenous drip(174 cases,90.16%).The main involved systems/organs were the nervous system,gastrointestinal system,skin and subcutaneous tissue.The main clinical manifestations included headache,dizziness,palpitations and so on,while those in patients with serious ADRs included chest tightness,dyspnea and so on.A total of 123 cases(63.73%)recovered,66 cases(34.20%)improved,one case(0.52%)did not improve,and three cases(1.55%)had unclear outcomes.Conclusion When using betahistine in clinical practice,we should pay attention to pharmaceutical care,evaluate medication risks based on existing ADRs to ensure the patients′medication safety.