右美沙芬致成瘾及精神异常等严重不良事件分析

Analysis of serious adverse drug events of dextromethorphan induced addiction and mental disorders

目的 以深圳市右美沙芬不良事件报告为依据,分析右美沙芬致成瘾、精神异常等严重不良事件的发生特点和规律,为促进右美沙芬合理使用和监管提供参考。方法 对2021—2022年度深圳市医疗机构上报的44例右美沙芬致成瘾、精神异常等严重不良事件的患者性别、年龄、开始用药时间、滥用药物持续时间、过量中毒年龄、剂量和戒断难易程度等方面进行回顾性分析。结果 44例报告中男性29例,女性15例,男女比例为1.93∶1,平均年龄(23.68±6.98)岁。44例报告中因滥用致成瘾、精神异常就诊的28例,因过量中毒送入急诊的16例。从未成年时期即开始使用右美沙芬的男女比例相当。44例报告的患者滥用药物平均持续时间(5.48±5.61)年。过量中毒患者的平均年龄(16.75±2.29)岁,入院前平均使用剂量为(10.42±4.82)mg·kg^(-1);成瘾、精神异常就诊的患者平均年龄(27.64±5.47)岁,入院前平均使用剂量为(8.46±6.19)mg·kg^(-1)。青少年受同学、朋友影响使用右美沙芬的占比多,且右美沙芬成瘾后戒断困难,再次使用的概率大。结论 右美沙芬滥用后果严重,各相关部门应加强监管,如药品上市许可持有人应加强产品的相关安全性警示信息;药品监管部门在切实保障产品适应证用药可及性的前提下,加大非医用目的的购买难度;社会共治共同促进右美沙芬的合理使用。

Objective Based on the adverse event report of dextromethorphan in Shenzhen,the characteristics and regularity of serious adverse events caused by dexmethorphan such as addiction and mental disorders were analyzed,so as to provide reference for promoting the rational use and supervision of dexmethorphan.Methods The gender,age,initiation time,duration of drug abuse,age of overdose,dosage and withdrawal difficulty of 44 patients with serious adverse events such as addiction and mental disorders caused by dextromethorphan reported by medical institutions in Shenzhen from 2021 to 2022 were retrospectively analyzed.Results Among the 44 cases reported,29 were males and 15 were females,with a male to female ratio of 1.93:1 and an average age of(23.68±6.98)years.Among the 44 cases reported,28 cases were treated for addiction and mental abnormality caused by abuse,and 16 cases were sent to emergency department due to overdose poisoning.The proportion of men and women who started using dextromethorphan in early adulthood was equal.The mean duration of drug abuse in the 44 reported patients was(5.48±5.61)years.The average age of patients with overdose poisoning was(16.75±2.29)years,and the average dose before admission was(10.42±4.82)mg·kg^(-1).The mean age of patients with addiction and mental disorders was(27.64±5.47)years,and the mean dose before admission was(8.46±6.19)mg·kg^(-1).More teenagers use Dextromethorphan under the influence of classmates and friends,and Dextromethorphan is difficult to quit after addiction,the probability of re-use is high.Conclusion The abuse of dextromethorphan has serious consequences,and relevant departments should strengthen supervision,such as drug marketing authorization holders should strengthen the relevant safety warning information of products;the drug regulatory department shall increase the difficulty of purchasing for non-medical purposes on the premise of ensuring the accessibility of the products for indications;Social co-governance promotes rational use of dextromethorphan.