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8、23.07.045.药物警戒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任丛丛a,贾光伟ab,梁良a,郭菲a,张帆a作者单位:聊城市人民医院,a药学部,b临床药理学重点实验室,山东 聊城252000通信作者:张帆,男,副主任药师,研究方向为临床药学,Email:基金项目: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
9、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36 369病例中,实际使用研究药物的为12 021例,CHPS报警病例2 488例,经人工复核后确定阳性病例52例,CHPS阳性预警率为2.1%(52/2 488),DIP实际发生率为0.43%(52/12 021)。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(68.3612.98)岁,年龄65岁者共 38例(73.08%),女性病人
10、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15年,13例(25%)发生在用药510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
11、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。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1480安 徽 医 药 Anhui Medical and Pharmaceutical Journal 2023 Jul,27(7)Real world study of drug-induced Parkinsons syndrome based on Chinese hospital pharmacovigilance systemREN Congconga,JIA Guangweiab,LIANG Liang
12、a,GUO Feia,ZHANG FanaAuthor Affiliation:aDepartment of Pharmacy,bKey Laboratory of Clinical Pharmacology,Liaocheng Peoples Hospital,Liaocheng,Shandong 252000,ChinaAbstract:Objective To explore a method for active surveillance of drug-induced Parkinsons syndrome(DIP)by using the Chinese Hospital Phar
13、macovigilance System(CHPS)and to analyze the population characteristics of DIP.Methods Using CHPS to make an active monitoring scheme for patients admitted to Liaocheng Peoples Hospital from January 2019 to December 2020,the alarm cases were retrieved through keywords from medical records,doctors ad
14、vice,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 36 369 cases included in the study,12 021 cases were actually using the study drug,2 48
15、8 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%(52/2 488),and the actual DIP incidence was 0.43%(52/12 021).The suspected drugs were trimetazidine,reserpine,flunarizine,valproate,haloperidol,olanzapine,cloza
16、pine,alprazolam,donepezil,and risperidone.The age of the 52 positive cases was(68.3612.98)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