544例精神障碍住院患者抗抑郁药超说明书用药调查

Investigation on the off-label use of antidepressants in 544 inpatients with mental disorders

目的调查我院精神障碍住院患者中抗抑郁药的超说明书用药情况,为制订合理的超说明书用药策略提供基础数据。方法采用回顾性调查研究方法,分层抽样法筛选出2017年1月1日至2017年12月31日我院使用抗抑郁药的出院精神疾病患者544例,应用自编住院患者用药信息调查表,以CFDA药品说明书作为判定依据,从适应症、给药剂量、给药人群3个方面进行超说明书用药判定。结果我院精神障碍住院患者中抗抑郁药的超说明书用药率为44.3%,超适应症用药率32.2%、超剂量用药率12.7%、超人群用药率2.4%;精神分裂症、神经症性疾病(躯体化障碍、应激相关障碍、分离(转换)性障碍)、非器质性失眠症、器质性精神障碍、精神活性物质所致精神障碍的超适应症用药率为100.0%,焦虑障碍的超适应症用药率也较高(84.4%);抗抑郁药的超人群使用体现在儿童青少年和老年人群中。结论我院抗抑郁药超说明书用药现象较普遍,以超适应症用药最多见,提示应加强医院用药规范管理及探讨超说明书用药的合理性。

Objective To investigate the off-label use of antidepressants in 544 inpatients with mental disorders of our hospital,and provide the basic data for formulating the rational strategy of off-label use.Methods With a retrospective study,a total of 544 discharged psychiatric patients from January 1,2017 to December 31,2017 who used antidepressants were selected by stratified sampling method.We used the self-designed questionnaire to investigate the medication information of these inpatients,and judged the off-label use of antidepressants from three aspects:indications,dosage and population,according to the CFDA drug directions.Results The total usage rate of the off-label prescribing of antidepressants was 44.3%.The usage rate of over-indication was 32.2%.The usage rate of over-dosage was 12.7%and the usage rate of over-population was 2.4%.The usage rate of over-indication was 100.0%in schizophrenia,neurotic disorders(somatoform disorders,stress-related disorders,dissociative(conversion)disorders),non-organic insomnia,organic disorders and mental disorders caused by psychoactive substances.The usage rate of over-indication in anxiety disorder was 84.4%.The over-population use of antidepressants was reflected in children,adolescents and the elderly.Conclusion Off-label use of antidepressants was a common phenomenon in our hospital,and the over-indication use was the most.It suggests us to strengthen the standardized management of drug use and discuss the rationality of off-label use.