摘要
目的对我院参麦注射液应用情况及不良反应进行分析,为临床应用和药品监管部门决策提供参考。方法采用医院集中监测的方法,对2011年1月～10月期间我院应用参麦注射液的住院患者病历,进行回顾性调查,并进行统计。结果共收集到468份应用参麦注射液的住院患者病历,85.5%为50岁以上老年患者;适应证、用法用量和疗程均比较规范,基本符合药品说明书规定;不良反应发生率为1.7%,属常见范畴;主要表现为头晕、乏力、胸闷、不适等,临床表现多样,无明显特异性,且多为一过性,停药即可,不需特别处理。结论医院集中监测法是对自发性呈报系统良好的补充,其得出的不良反应发生率具有可参考性,但需要进行多中心的研究,使数据更具代表性。
Objective To analyze the clinical application and adverse reaction of Shenmai injection at our hospital, and provide reference for medical staff and regulators, Methods By the method of hospital intensive monitoring, we reviewed the medical records of all patients who ever used Shenmai injection from January to October 2011 at our hospital, and statistically analyzed the ADR of Shenmai injection, Results We collected 468 cases, 85.5% patients are over 50 years old. In most cases, indications, dosage and duration of treatment of Shenmai injection are consistent with the drug instruction. The incidence of ADR is 1.7%, belonging to a common category.The symptoms of adverse reactions are relatively light and transient, such as dizziness, fatigue, chest pain and discomfort. Conclusion Hospital intensive monitoring method is a good supplement of spontaneous reporting system, which can get a referential incidence rate of ADR, but multicenter studies are needed to make the data more representative.
出处
《中国药物警戒》
2013年第2期111-114,共4页
Chinese Journal of Pharmacovigilance
关键词
参麦注射液
不良反应
医院集中监测
Shenmai injection
adverse reaction
hospital intensive monitoring
