摘要
目的分析某三甲医院471例抗感染药物不良反应/事件(ADR/ADE)报告,并给予相关对策,为临床合理、安全、有效地使用抗感染药物提供参考。方法收集西安交通大学第一附属医院各科呈报的2012—2018年抗感染药物ADR报告资料471例,分别从年龄、性别、药品种类、累及系统及临床表现、给药途径等对ADR/ADE进行统计和分析。结果471例ADR报告中≤10岁患者ADR构成最高,此年龄段患者涉及最多的药物为注射用拉氧头孢钠(氧头孢烯类)41例(占8.70%)。ADR/ADE涉及的抗感染药物种类共19类,其中喹诺酮类抗菌药物发生率最高(占21.44%)。ADR/ADE涉及的前5名均为莫西沙星氯化钠注射液、伏立康唑注射液、注射用拉氧头孢钠、注射用美罗培南和注射用盐酸万古霉素,总计212例(占45.01%)。在发生ADR的主要临床表现中,涉及皮肤及其附件病例最多,有213例(占45.22%),其次是全身性系统损伤96例(占20.38%)和消化系统损伤38例(占8.07%)。合并用药中单药86.41%,≥两种药合用13.59%,疗程中≥3 d 5.52%,疗程2 d 8.92%,疗程1 d 85.56%。在471例抗感染药物ADR/ADE报告中,严重ADR共18例(占3.82%)。其中抗真菌药伏立康唑(包括针剂和片剂)发生严重ADR例数最多,共9例(占50.00%)。471例抗感染药物ADR/ADE报告中新的ADR 8例(占1.70%),注射用药7例,均为粉针剂(占1.49%),口服用药(片剂)1例(占0.21%)。注射用药(包括粉针剂和注射剂)共421例(占89.38%),口服药物66例(包括片剂、胶囊剂、颗粒剂、缓释片等)(占14.01%),阴道给药2例(占0.42%),吸入给药1例(占0.21%),鼻饲给药1例(占0.21%),由于一例报告中包含不止一种剂型,因此总例数>471例。471例ADR/ADE病例中好转310例(占65.82%),痊愈147例(占31.21%),未好转6例(占1.27%),转归不详8例(占1.70%)。结论在临床治疗中,应合理使用抗感染药物,尤其是儿童与老年患者的抗感染用药,需在用药过程中根据具体情况个体化用药,�
Objective To analyze 471 cases of adverse drug reactions/events(ADR/ADE)reports of anti infective drugs in a tertiary hospital,and provide relevant countermeasures,so as to provide reference for clinical rational,safe and effective use of anti infective drugs.Methods The data of 471 cases of anti infective drug ADR reported by various departments of the First Affiliated Hospital of Xi’an Jiaotong University from 2012 to 2018 were collected.The ADR/ADE was statistically analyzed from age,gender,drug type,involved system and clinical manifestations,route of administration,etc.Results Among the 478 patients with ADR,the age of ADR was the highest.There were 19 kinds of anti infective drugs involved in ADR/ADE,among which quinolones had the highest incidence(21.44%).The top five ADR/ADE patients were moxifloxacin and sodium chloride injection,voriconazole injection,loxef sodium for injection,meropenem for injection and vancomycin hydrochloride for injection,with a total of 212 cases(45.01%).Among the main clinical manifestations of ADR,213 cases(45.22%)involved skin and its appendages,followed by 96 cases(20.38%)with systemic injury and 38 cases(8.07%)with digestive system injury.The combined use of single drug was 86.41%,the combination of two drugs was 13.59%,the course of treatment was more than 3 days,5.52%,2 days,8.92%,1 day,85.56%.In 471 cases of anti infective drug ADR/ADE reports,18 cases(3.82%)were severe ADR.Among them,there were 9 cases(50.00%)of severe ADR caused by antifungal drug voriconazole(including injection and tablet).Among 471 ADR/ADE reports of anti infective drugs,8 cases(1.70%)were new ADR,7 cases(1.49%)were injection drug,and 1 case(0.21%)was oral drug(tablet).There were 421 cases(89.38%)for injection,66 cases(14.01%)for oral administration,2 cases(0.42%)for vaginal administration,1 case(0.21%)for inhalation and 1 case(0.21%)for nasal feeding.The total number of cases was more than 471 due to more than one dosage form in one case report.Of the 471 ADR/ADE cases,310(65.82%)were improved,147(
作者
游翠玉
王茂义
薛思宇
邓祥
郑鑫
魏敏
YOU Cuiyu;WANG Maoyi;XUE Siyuy(Department of Pharmaceutical,the First Affiliated Hospital of Medical College,Xi'an Jiaotong University,Xi'an 710061,China)
出处
《临床合理用药杂志》
2021年第3期25-29,32,共6页
Chinese Journal of Clinical Rational Drug Use
