抗抑郁药说明书警示语及预防措施分析  

Words of Warning and Preventive Measures in Labels of Antidepressants

作　　者：邹远磊 夏清荣 梁俊 何孔亮 莫大明 吴文宁 ZOU Yuanlei;XIA Qingrong;LIANG Jun;HE Kongliang;MO Daming;WU Wenning(Department of Pharmacy,Hefei Anhui 230022,China;Department of Pharmacology,School of Basic Medicine,Anhui Medical University,Hefei Anhui 230031,China;Department of Psychopharmacology Research Laboratory,Hefei Anhui 230022,China;Psychological Counseling Center,Hefei Anhui 230022,China;Department of Child and Adolescent Psychology,Affiliated Psychological Hospital of Anhui Medical University,Anhui Mental Health Center,Hefei Fourth People's Hospital,Hefei Anhui 230022,China)

机构地区：[1]安徽医科大学附属心理医院,安徽省精神卫生中心,合肥市第四人民医院药剂科,安徽合肥230022 [2]安徽医科大学基础医学院药理学教研室,安徽合肥230031 [3]安徽医科大学附属心理医院,安徽省精神卫生中心,合肥市第四人民医院精神药理研究室,安徽合肥230022 [4]安徽医科大学附属心理医院,安徽省精神卫生中心,合肥市第四人民医院心理咨询中心,安徽合肥230022 [5]安徽医科大学附属心理医院,安徽省精神卫生中心,合肥市第四人民医院儿童青少年心理科,安徽合肥230022

出　　处：《中国药物警戒》2025年第3期329-333,共5页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82171449);合肥市第七周期重点专科资助。

摘　　要：目的分析某精神专科三甲医院抗抑郁药说明书警示语及预防措施,为抗抑郁药说明书警示语及预防措施的规范书写提供参考。方法统计安徽医科大学附属心理医院2022年9月1日至2022年9月30日期间抗抑郁药说明书警示语及预防措施的频数,分析警示语及预防措施现状。结果19种抗抑郁药说明书纳入统计,说明书有警示语的总频数共33,对应预防措施的总频数为33,3种警示语中说明书无对应警示语的总频数10;警示语内容完善的总频数为17,预防措施内容完善的总频数为22。警示语出现的频数情况为“自杀倾向和抗抑郁药物”30(90.91%),“乙肝病毒患者/携带者、丙肝病毒患者/携带者、肝功能损害患者或转氨酶升高超过正常上限者禁用”2(6.06%),“癫痫、青光眼、尿潴留、近期有心肌梗死发作史、对本品过敏者禁用”1(3.03%)。警示语对应的预防措施频数为“自杀倾向和抗抑郁药物”预防措施30(90.91%),“乙肝病毒患者/携带者、丙肝病毒患者/携带者、肝功能损害患者或转氨酶升高超过正常上限者禁用”预防措施2(6.06%),“癫痫、青光眼、尿潴留、近期有心肌梗死发作史、对本品过敏者禁用”预防措施1(3.03%)。结论“自杀倾向和抗抑郁药物”和“癫痫、青光眼、尿潴留、近期有心肌梗死发作史、对本品过敏者禁用”警示语及预防措施存在缺失和不完善现象,建议相关生产企业补充缺失的警示语及预防措施,“自杀倾向和抗抑郁药物”警示语及预防措施中明确青年患者自杀倾向易发人群的年龄范围,完善“警示语内容解释说明”“病史筛查”“自杀先兆症状描述”“改变药物治疗描述”等预防措施内容。Objective To analyze the warning statements and preventive measures in the instructions of antidepressants in a tertiary mental health hospital in order to provide references for standardized wording in the instructions of antidepressants.Methods The frequency at which warning statements and preventive measures appeared in the instructions of antidepressants in the Affiliated Mental Hospital of Anhui Medical University from September 1 to September 30,2022 was statistically analyzed.Results A total of 19 antidepressant instructions were included in the statistics.The total frequency of warning statements was 33,so was the total frequency of corresponding preventive measures.Among the 3 types of warning statements,the total frequency of instructions without corresponding warning statements was 10.The total frequency of complete warning statements was 17,compared with 22 for complete pre ventive meas-ures.Such warning statements as"Suicidal tendencies and antidepressants"appeared 30 times(90.91%),"Prohibited for patients with hepatitis B virus,hepatitis C virus,liver function impairment,or elevated transaminase levels above the normal upper limit"was used twice(6.06%),and"Prohibited for patients with epilepsy,glaucoma,urinary retention,recent history of myocardial infarction,or allergy to this product"turned up once(3.03%).The frequency of preventive measures corresponding to warning statements was 30(90.91%)for preventive measures against"Suicidal tendencies and antidepressants",2(6.06%)for preventive measures related to Prohibited for patients with hepatitis B virus,hepatitis C virus,liver function impairment,or elevated transaminase levels above the normal upper limit",and 1(3.03%)for preventive measures relating to"Prohibited for patients with epilepsy,glaucoma,urinary retention,recent history of myocardial infarction,or allergy to this product".Conclusion There are inadequacies in the warning statements and preventive measures specified in instructions for antidepressants.It is recommended that related enterpr

关 键 词：药品说明书 警示语 预防措施 自杀倾向 抗抑郁药 合理用药 

分 类 号：R971[医药卫生—药品]