氨磺必利临床药物不良反应分析及合理用药

Analysis of clinical adverse drug reactions and rational drug use of amisulpride

目的分析氨磺必利药物不良反应的发生特点以及分布规律,为临床合理用药提供参考。方法回顾性分析我院2012至2018年上报至国家不良反应监测中心的氨磺必利不良反应报告,对性别、年龄、给药剂量、给药频率、血药浓度、合并用药情况、累及器官/系统、药物不良反应转归等进行统计分析。用液相色谱-质谱联用技术测定患者的血药浓度数据。结果 89例不良反应报告中以19~40岁的患者居多,女性明显多于男性;药物不良反应常见临床表现为锥体外系不良反应、心动过缓、催乳素增高、QT间期延长、低血压等;血药浓度超出治疗窗的现象频繁,此时发生药物不良反应的风险增加;绝大多数药物不良反应在减少剂量、对症治疗或者停药后,均能得到良好的控制。结论虽然氨磺必利具有良好的安全性,但是药物不良反应的发生不利于疾病的治疗,临床应加强用药以及药物不良反应监测以确保患者用药安全。

Objective To analyze the characteristics of adverse drug reactions( ADR) induced by amisulpride,so as to provide references for rational clinical drug use. Methods The datas including gender,age, dosage,administration frequency,amisulpride serum trough concentration,involving the organ or system,concomitant medication and the prognosis of 89 cases of ADRs reports which were reported to the national adverse drug reaction monitoring center were reviewed from 2012 to 2018. Results Among the 89 ADR reports,the proportion of ADR in female patients was obviously higher than that in male patients and most of them were aged from 18 to 40. The most commen clinical manifestations of adverse reactions were extrapyramidal system reaction,bradycardia,hyperprolactinaemia,QT interval prolonged,hypotension and so on. The phenomenons of amisulpride concentration beyond the therapeutic window are frequent which can lead to the increased risk of adverse reactions. Most of ADRs were controlled well after reducing dose,symptomatic treatment or drug withdrawal. Conclusion Amisulpride with good safety,but the occurrence of ADRs are harmful to the treatment of disease . ADRs monitoring of amisulpride should be strengthened to ensure safe and rational medication.