【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。更多还原

【Abstract】 ObjectiveTo provide a reference for the clinical rational and safe use of Guilong Kechuanning preparations.MethodsAtotal of 293 new and severe adverse drug reaction(ADR) reports related to Guilong Kechuangning preparations from May 1,2008to April 30,2023 were collected from the Shandong Province ADR database. The reporting institutions,annual trends,drug dosageforms,administration routes,usage and dosage,patients’ demographic characteristics,past and family history,medication reasons,ADRoccurrence time,and clinical manifestations of ADR reports were retrospectively analyzed. The drug instructions of various GuilongKechuanning preparations were compared and analyzed,and the risk factors for ADR occurrence were analyzed.ResultsAmong293 ADR reports,293 patients were involved and 399 ADRs occurred. Among them,there were 285 new ADR reports(97. 27%),ofwhich 268 cases were obtained from medical institutions;eight severe ADR reports(2. 73%) were obtained from medicalinstitutions. Among the ADRs reported from 2009 to 2022,the highest number(47 cases) was in 2014,which gradually decreasedand 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 druginstructions;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 GuilongKechuanning 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%) forother 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 druginstructions,only Guilong Kechuanning Honey Refining Cream was briefly labeled as ADR,while others were "not yet clear".ConclusionThere are many new and severe ADRs in the clinical use of Guilong Kechuanning preparations,but the warningcontent in the drug instructions is not sufficient,and there is a lack of medication guidance for special populations. The indicationsand principles of medication should be strictly controlled,and ADRs should be closely monitored during medication. The marketingauthorization holder(MAH) should actively improve the drug instructions to ensure drug safety.更多还原