目的 了解在真实世界中热毒宁注射液治疗手足口病的临床用药特点，为临床应用提供借鉴和参考。方法 采用频数分析和关联规则方法，对来自江苏省3家三甲儿童专科医院信息系统（HIS）中使用热毒宁注射液的手足口病患者一般信息、临床用药信息及合并用药特征进行统计分析。结果 使用热毒宁注射液手足口病患者共3 486例，平均年龄为4.74岁，多为6岁以下儿童，占83.37%。主要分布在感染性疾病科，住院时间多集中于1～7 d，占86.40%。使用热毒宁注射液的手足口病患者常合并有上呼吸道感染、腹泻病、支气管炎等，中医证候多为湿热郁蒸证，其次为风热犯肺证；热毒宁注射液的给药途径主要为静脉滴注，单次用药剂量以4～7 mL最多，共1 725例患者，占49.58%；疗程分布最多的为4～7 d，占总人数的58.45%。热毒宁注射液的常见联合用药为开喉剑（支持度43.67%）、奥拉西坦（支持度35.40%）、苯扎氯胺（支持度26.82%）、利巴韦林（支持度24.53%），并常与抗病毒药物、清热解毒类中成药等具有相似药理作用的药物合并使用。结论 热毒宁注射液临床用药基本符合药品说明书及手足口病诊疗指南，部分患者存在超说明书用药情况，临床医生应注意用药规范，并评估合并用药的种类及其相互作用，预防儿科药品不良反应的发生。

Objective To investigate the medication characteristics of Reduning Injection in treating hand-foot-mouth disease (HFMD) in the real world, so that we can provide guidance for its clinical use. Methods Cases of hospital information system (HIS) data were collected from three grade A children hospitals. The basic description method and assosiation rules were used to analyze the data about patient information, clinical characteristics and combined medication. Results Of all the 3 486 case of HFMD patients, the average age was 4.74 years, and 83.37% of patients were aged below 6 years. Most patients came from the department of infectious diseases, and the hospitalization day between one and seven was most, accounting for 86.40%. The complications were the upper respiratory tract infection, diarrhea and bronchitis, and the traditional Chinese medicine syndrome was damp-heat with exuberance of virulence and wind-heat invading lung. The route of administration was mostly intravenous infusion, with 1 725 patients (49.58%) receiving a dosage of 4—7 mL per dose for between four and seven days, accounting for 58.45% of the total number of people. The main combination drugs were Kaihoujian, oxiracetam, benzalkonium chloride and ribavirin, with confidence of 43.67%, 35.40%, 26.82% and 24.53% respectively. And Reduning Injection was often combined with drugs with similar phamacological effects such as antiviral drugs and antipyretic-detoxicate drugs. Conclusion Reduning Injection was basically complied with the drug instructions and guidelines of HFMD in practice. However, off-label use still existed, doctors should realize the hiding risks, observe the conconmitant medications and interactions so as to prevent adverse drug reactions in pediatrics.

R974

十三五南京市卫生青年人才培养工程第三层次（QRX17173）；南京药学会—常州四药医院药学科研基金（2019YX026）