摘要
目的为桂龙咳喘宁制剂的临床合理、安全用药提供参考。方法收集山东省药品不良反应(ADR)数据库中2008年5月1日至2023年4月30日有关桂龙咳喘宁制剂新的和严重ADR报告293份,并对ADR报告的上报机构、年度变化趋势,药物剂型、给药途径、用法用量,以及患者人口学特征、既往史和家族史、用药原因、ADR发生时间及临床表现等进行回顾性分析。比较分析各种桂龙咳喘宁制剂的药品说明书,分析ADR发生的风险因素。结果293份ADR报告涉及患者293例,共发生399例次ADR。其中,新的ADR报告285份(97.27%),268份来源于医疗机构;严重ADR报告8份(2.73%),均来源于医疗机构。2009年至2022年报告的ADR中,2014年的ADR报告最多(47份),之后逐渐减少,2019年又开始呈递增趋势。剂型涉及片剂(240份)、胶囊剂(51份)和颗粒剂(2份);给药途径均为口服,253份(86.35%)符合药品说明书推荐剂量。患者的平均年龄为55.26岁,主要发生于≥60岁的中老年患者(71.68%);男女比例为1.11∶1;既往无ADR/药品不良事件(ADE)史203份(69.28%),既往ADR/ADE史为不详90份(30.72%);家族ADR/ADE史均为不详;有吸烟史38份(12.97%)。用于支气管炎123份(41.98%),咳嗽75份(25.60%),祛痰平喘19份(6.48%),上呼吸道感染17份(5.80%),其他59份(20.14%)。ADR多发生于用药后1 d内(79.18%)。399例次ADR中,合并用药16例次;涉及10个系统/器官分类,主要包括胃肠系统损害、皮肤及其附件损害、中枢及外周神经系统损害、心率及心律紊乱等,主要临床表现为恶心、皮疹、腹泻、瘙痒、头晕、腹痛、呕吐、头痛等,多数患者整体预后良好。药品说明书中仅桂龙咳喘宁蜜炼膏简单标注ADR,其他均为“尚不明确”。结论桂龙咳喘宁制剂临床发生新的和严重ADR较多,但药品说明书中警示内容不够充分,缺乏特殊人群用药指导,应严格掌握药品的适应证及用药原则,用药时密切监测ADR。药品上市许可持有人应主动完善药品说明书,保障用药安全。
Objective To provide a reference for the clinical rational and safe use of Guilong Kechuanning preparations.Methods A total of 293 new and severe adverse drug reaction(ADR)reports related to Guilong Kechuangning preparations from May 1,2008 to April 30,2023 were collected from the Shandong Province ADR database.The reporting institutions,annual trends,drug dosage forms,administration routes,usage and dosage,patients'demographic characteristics,past and family history,medication reasons,ADR occurrence time,and clinical manifestations of ADR reports were retrospectively analyzed.The drug instructions of various Guilong Kechuanning preparations were compared and analyzed,and the risk factors for ADR occurrence were analyzed.Results Among 293 ADR reports,293 patients were involved and 399 ADRs occurred.Among them,there were 285 new ADR reports(97.27%),of which 268 cases were obtained from medical institutions;eight severe ADR reports(2.73%)were obtained from medical institutions.Among the ADRs reported from 2009 to 2022,the highest number(47 cases)was in 2014,which gradually decreased and began to show an increasing trend in 2019;the dosage forms included tablets(240 cases),capsules(51 cases),and granules(2 cases);the administration route was oral administration,and 253 cases(86.35%)met the recommended dosage in the drug instructions;the patients'average age was 55.26 years old,mainly occurring in middle-aged and elderly patients aged≥60 years old(71.68%);the male to female ratio was 1.11∶1;203 cases(69.28%)had no history of adverse drug reactions(ADRs)or adverse drug events(ADEs),while 90 cases(30.72%)had an unknown history of ADRs or ADEs;the family ADR/ADE history of all patients was unknown;a total of 38 cases(12.97%)had a history of smoking.ADRs induced by Guilong Kechuanning preparations were reported in 123 cases(41.98%)for bronchitis,75 cases(25.60%)for cough,19 cases(6.48%)for anti-inflammatory and asthma relief,17 cases(5.80%)for upper respiratory tract infections,and 59 cases(20.14%)for other conditions.ADRs mostly occurred within 1 d after medication(79.18%).Among 399 cases of ADRs,16 cases were combined medication,involving 10 system/organ classifications,mainly including gastrointestinal system damage,skin and accessory damage,central and peripheral nervous system damage,heart rate and arrhythmia,etc.The main clinical manifestations were nausea,rash,diarrhea,itching,dizziness,abdominal pain,vomiting,headache,etc.Most patients had a good overall prognosis.In the drug instructions,only Guilong Kechuanning Honey Refining Cream was briefly labeled as ADR,while others were"not yet clear".Conclusion There are many new and severe ADRs in the clinical use of Guilong Kechuanning preparations,but the warning content in the drug instructions is not sufficient,and there is a lack of medication guidance for special populations.The indications and principles of medication should be strictly controlled,and ADRs should be closely monitored during medication.The marketing authorization holder(MAH)should actively improve the drug instructions to ensure drug safety.
作者
谷晓云
谢彦军
霍艳飞
袁明辉
王茜
王振东
李霞
GU Xiaoyun;XIE Yanjun;HUO Yanfei;YUAN Minghui;WANG Qian;WANG Zhendong;LI Xia(Weihai Institute of Drug and Food Inspection and Testing,Weihai,Shandong,China 264200;Shandong Adverse Drug Reaction Monitoring Center,Jinan,Shandong,China 250014)
出处
《中国药业》
CAS
2024年第19期31-34,共4页
China Pharmaceuticals
基金
山东省药品不良反应专业评价平台项目[2023SDADRKY37]。
关键词
桂龙咳喘宁
药品不良反应
安全用药
胸闷
心悸
Guilong Kechuanning
adverse drug reactions
safe medication
chest tightness
heart palpitations
