100249例热毒宁注射液儿童用药临床安全性的前瞻性、多中心、大样本医院集中监测  

Prospective,multi-center,and large-scale hospital centralized monitoring of clinical safety of Reduning Injection in 100249 children cases

作　　者：王连心[1] 杨硕 王萌萌 刘福梅[1] 李军[2] 林爱伟 向龙[4] 王孟清[5] 雷洁 钟柔 张宏艳 张爱华[2] 谢雁鸣[1] WANG Lian-xin;YANG Shuo;WANG Meng-meng;LIU Fu-mei;LI Jun;LIN Ai-wei;XIANG Long;WANG Meng-qing;LEI Jie;ZHONG Rou;ZHANG Hong-yan;ZHANG Ai-hua;XIE Yan-ming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Children's Hospital of Nanjing Medical University,Nanjing 210008,China;Qilu Children's Hospital of Shandong University,Ji'nan 250022,China;Chengdu First People's Hospital,Chengdu 610095,China;the First Hospital of Hunan University of Chinese Medicine,Changsha 410007,China;the First Bethune Hospital of Jilin University,Changchun 130061,China;School of Statistics,Renmin University of China,Beijing 100872,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]南京医科大学附属儿童医院,江苏南京210008 [3]山东大学齐鲁儿童医院,山东济南250022 [4]成都市第一人民医院,四川成都610095 [5]湖南中医药大学第一附属医院,湖南长沙410007 [6]吉林大学白求恩第一医院,吉林长春130061 [7]中国人民大学统计学院,北京100872

出　　处：《中国中药杂志》2024年第12期3396-3403,共8页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划“中医药现代化研究”项目(2022YFC3502004);国家药品监督管理局项目(RS2024Z008);国家自然科学基金面上项目(81973982);中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003)。

摘　　要：采用前瞻性、大样本、多中心、注册登记式医院重点专科监测法,从热毒宁注射液上市后真实世界使用情况出发,监测100 249例使用热毒宁注射液的14岁及以下儿童患者,共发生不良事件83例,判定为不良反应(adverse drug reactions, ADR)76例,ADR发生率0.076%,属于罕见不良反应。ADR症状主要为皮肤瘙痒、腹泻、腹痛、呕吐、高热、呼吸困难、抽搐和浑身发冷,报告类型均为首次报告,其中新发不良反应3例,已知不良反应73例;不良反应类别均为一般不良反应;严重程度均为轻度不良反应。ADR患者男性多于女性,1例患者既往有药品不良反应史,不良反应药品为布洛芬混悬液。热毒宁注射液用量5~10 mL、滴速每分钟30滴及以下、溶媒类型5%葡萄糖注射液等情况下发生ADR例数最多。ADR患者表现最多的是皮肤瘙痒,其次为腹泻、腹痛、呕吐、高热、呼吸困难、抽搐、浑身发冷等,72例(占ADR患者94.74%)停药,3例(占ADR患者3.95%)给予吸氧。47例(占ADR患者61.84%)用药处理,其中用药最多的是地塞米松(24例,占ADR患者46.15%),76例ADR患者结局均为痊愈或好转。当西医诊断为急性支气管炎,中医诊断为咳嗽,中医证型为风热证,合并用药为盐酸氨溴索和注射用盐酸溴己新、抗坏血酸/维生素C注射液时,发生ADR可能性较大,为热毒宁注射液在14岁及以下广泛儿童患者中应用时进行主动药物警戒提供安全性循证依据。This study utilized a prospective,large-sample,multi-center,and registered key specialty approach of hospitals to monitor the application of Reduning Injection.A total of 100249 adolescent patients aged 14 years and below who received Reduning Injection were monitored,resulting in 83 cases of adverse events,with 76 of them being classified as adverse drug reaction(ADR).The calculated incidence rate of ADR for Reduning Injection was 0.076%,indicating a very rare ADR.The main symptoms of ADR were pruritus,diarrhea,abdominal pain,vomiting,high fever,dyspnea,convulsion,and chills.All ADR cases were reported for the first time,including three new ADR cases and 73 known ADR cases.The categories of ADR was general ADR.All ADR was mild in severity.There were more males than females in ADR patients.One patient had a history of ADR,and the drug causing ADR was buprofen.The largest number of ADR cases occurred when the dosage of Reduning injection was 5-10 mL.The dropping speed was 30 drops or less per min,and the solvent type was 5%glucose injection.The most common manifestation of ADR patients was pruritus,followed by diarrhea,abdominal pain,vomiting,high fever,dyspnea,convulsions,and chills.72 patients(94.74%of ADR patients)discontinued the drug,and three patients(3.95%of ADR patients)were given oxygen inhalation.47 cases(61.84%of ADR patients)were treated with medication,of which dexamethasone was the most used(24 cases,46.15%of ADR patients).76 ADR patients were cured or improved.ADRs are more likely to occur when diagnosed with acute bronchitis by western medicine and cough by traditional Chinese medicine(TCM),TCM syndrome type is wind heat syndrome,and the combination medicine is ambroxol hydrochloride and bromhexine hydrochloride injection,ascorbic acid/vitamin C injection.This result provides an evidence-based safety basis for active pharmacovigilance of Reduning Injection in adolescents aged 14 years and below.

关 键 词：热毒宁注射液 儿童 安全性 大样本 医院集中监测 

分 类 号：R285.6[医药卫生—中药学]