基于中国医院药物警戒系统的药源性帕金森综合征真实世界研究  

Real world study of drug-induced Parkinson's syndrome based on Chinese hospital pharmacovigilance system

作　　者：任丛丛 贾光伟[1,2] 梁良[1] 郭菲[1] 张帆[1] REN Congcong;JIA Guangwei;LIANG Liang;GUO Fei;ZHANG Fan(Department of Pharmacy,Liaocheng People's Hospital,Liaocheng,Shandong 252000,China;Key Laboratory of Clinical Pharmacology,Liaocheng People's Hospital,Liaocheng,Shandong 252000,China)

机构地区：[1]聊城市人民医院药学部,山东聊城252000 [2]聊城市人民医院临床药理学重点实验室,山东聊城252000

出　　处：《安徽医药》2023年第7期1480-1484,共5页Anhui Medical and Pharmaceutical Journal

基　　金：中国卒中学会脑血管病全程管理启航基金(2020017);山东省医学会临床科研专项基金(YXH2020ZX048)。

摘　　要：目的探索利用中国医院药物警戒系统(CHPS)开发主动监测药源性帕金森综合征(DIP)的方法,并分析DIP的人群特征。方法利用CHPS制订主动监测方案,对2019年1月至2020年12月的聊城市人民医院入院病人从病历、医嘱、体征、影像学检查中通过关键词检索出报警病例,对其临床症状、治疗药物、体征检查、既往用药等方面的资料进行分析判断后,生成最终监测结果。结果在纳入研究的36369病例中,实际使用研究药物的为12021例,CHPS报警病例2488例,经人工复核后确定阳性病例52例,CHPS阳性预警率为2.1%(52/2488),DIP实际发生率为0.43%(52/12021)。可疑药物有曲美他嗪、利血平、氟桂利嗪、丙戊酸盐、氟哌啶醇、奥氮平、氯氮平、阿普唑仑、多奈哌齐、利培酮。52例阳性病例的年龄为(68.36±12.98)岁,年龄>65岁者共38例(73.08%),女性病人34例(65.38%),既往有缺血性脑病病史者18例(34.62%),双侧肢体阳性症状者40例(76.92%),颅脑CT或MRI检查显示异常者37例(71.15%),11例(21.15%)未停用可疑药物,32例(61.54%)症状未缓解或缓解但遗留后遗症,20例(38.46%)症状消失。9例(17.31%)发生在用药1年之内,24例(46.15%)发生在用药1~5年,13例(25%)发生在用药5~10年,6例(9.62%)发生在用药10年以上。结论利用CHPS可及时发现DIP,较传统监测模式优势明显。DIP以女性多见,发生时间大多在用药5年之内,年龄>65岁、既往缺血性脑病史是发生DIP的危险因素。双侧肢体阳性症状、颅脑CT、MRI检查显示异常有助于DIP的早期诊断和鉴别。Objective To explore a method for active surveillance of drug-induced Parkinson's syndrome(DIP)by using the Chinese Hospital Pharmacovigilance System(CHPS)and to analyze the population characteristics of DIP.Methods Using CHPS to make an active monitoring scheme for patients admitted to Liaocheng People's Hospital from January 2019 to December 2020,the alarm cases were retrieved through keywords from medical records,doctor's advice,physical signs,and imaging examinations.The final monitoring results were generated after analyzing and judging the data of clinical symptoms,therapeutic drugs,signs and previous medication.Results Among the 36369 cases included in the study,12021 cases were actually using the study drug,2488 were alarmed as CHPS alarm cases,and 52 were confirmed as positive cases after manual review.The CHPS positive early warning rate was 2.1%(52/2488),and the actual DIP incidence was 0.43%(52/12021).The suspected drugs were trimetazidine,reserpine,flunarizine,valproate,haloperidol,olanzapine,clozapine,alprazolam,donepezil,and risperidone.The age of the 52 positive cases was(68.36±12.98)years old,38(73.08%)were over 65 years old,34(65.38%)were female,and 18(34.62%)had a history of ischemic encephalopathy,40 cases(76.92%)had positive symptoms of bilateral limbs,37 cases(71.15%)had abnormal findings on cranial CT or MRI,11 cases(21.15%)did not stop suspicious drugs,and 32 cases(61.54%)did not relieve symptoms or relieved but left sequelae,20 cases(38.46%)disappeared symptoms.Nine cases(17.31%)occurred within 1 year of treatment,24 cases(46.15%)occurred within 1-5 years,13 cases(25%)occurred within 5-10 years,6 cases(9.62%)occured after 10 years of medication.Conclusions CHPS can detect DIP in time,which is superior to traditional monitoring mode.DIP is more common in females,most of which occurred within 5 years of medication.Age>65 years and a history of ischemic encephalopathy are risk factors for DIP.Positive symptoms of bilateral limbs and abnormal findings of cranial CT and MRI are helpful for ea

关 键 词：帕金森病 继发性 药物相关性副作用和不良反应 中国医院药物警戒系统 药物监测 真实世界研究 

分 类 号：R742.5[医药卫生—神经病学与精神病学]