精神专科医院中成药安全性评价

Safety evaluation of Chinese patent medicines in psychiatric hospitals

目的本研究分析精神专科医院中成药药品不良反应(ADR)的发生原因和特点,并提出相应的改善措施,以期为促进临床安全和合理用药提供有价值的参考。方法回顾性分析江南大学附属精神卫生中心2022年1月至12月上报的59例中成药ADR报告数据,对患者的性别和年龄、中成药的种类、给药方式和药物剂型、ADR累及的系统或器官、ADR的类型和严重程度、ADR的因果关系判断以及转归情况等方面进行统计分析。结果59例中成药ADR报告中,男性与女性比例为1∶1.03,年龄(64±17)岁,其中60岁以上老年患者最多;共涉及8类,28种中成药物,其中心血管类药物占53%;引起ADR的给药途径中口服给药占53%;ADR累及系统(或器官)中,全身性损害占22%;发生新的和严重的ADR各占25%,其中新的严重的中成药ADR占3%;发生的ADR均与中成药关联密切,发生后及时给予对症治疗、停药、减量等处理,好转治愈率达92%。结论中成药所引起的ADR与患者的性别、年龄、中成药种类、给药方式和药物剂型等因素密切相关。临床应严格遵医嘱使用中成药,对于存在上述高风险特征的患者应加强监测;同时重视中成药引起的新的和严重ADR的发生,并及时干预,加强上报、培训和宣教等,确保临床使用中成药更加科学、规范、安全和合理。

Objective To explore and analyze the causes and characteristics of adverse drug reactions(ADR)of Chinese patent medicines in psychiatric hospitals,and to propose corresponding improvement measures,with a view to providing valuable references for promoting clinical safety and rational drug use.Methods A ret-rospective analysis was conducted on a total of 59 ADR report data of Chinese patent medicines reported by Affi-filiated Mental Health Center of Jiangnan University from January 2022 to December 2022.Statistical analysis was carried out on aspects such as the gender and age of patients,the types of Chinese patent medicines,the method of administration and dosage form of drugs,the system or organ involved in ADR,the type and severity of ADR,the causality judgment of ADR,and the outcome.Results Among the 59 ADR reports of Chinese patent medicines,the ratio of male to female was 1∶1.03,the age was(64±17)years old,and the majority of patients were over 60 years old.A total of 8 categories and 28 types of Chinese patent medicines were involved,among which cardiovascular drugs accounted for the largest proportion(53%).Among the routes of administration that caused ADR,oral administration accounted for 53%.Among the systems(or organs)affected by ADR,systemic damage accounted for 22%.The incidence of new and serious ADRs accounted for 25%,of which new and serious ADR of Chinese patent medicine accounted for 3%.All the reported ADRs were closely associated with the Chinese patent medicines.If symptomatic treatment,drug withdrawal,dosage reduction,and other appro-priate measures were taken promptly after ADRs,the cure rate was 92%.Conclusion The ADRs caused by Chinese patent medicines are closely related to factors such as the patient′s gender,age,types of Chinese patent medicines,routes of administration,and dosage forms.We should use Chinese patent medicine strictly according to the Doc-tor′s advice,strengthen the monitoring of the patients with the high risk characteristics,pay more attention to the occurrence of new and serious ADR caused by Chinese patent medicine,and intervene in time,strengthen report-ing,training and education to ensure the clinical use of proprietary Chinese medicine more scientific,stan-dardized,safe,and reasonable.