目的 探索在真实世界中儿脾醒颗粒的用药特征和临床疗效，为其临床合理应用和二次开发的研究设计提供依据。方法 基于 5家医院的医院信息系统（HIS），对儿脾醒颗粒患儿的用药数据进行分析，包括：（1）年龄、性别、中西医诊断、单次用药剂量、疗程、合并用药信息等特征的描述性分析；（2）联合用药及其种类的关联规则分析；（3）适用疾病痊愈时间的描述性分析。结果 用药特征分析显示：共纳入5 351例患儿，平均年龄（4.16±3.41）岁，98.17%的患儿＜14岁；有14.86%患儿低于说明书用药年龄的下限。适应证的西医诊断以消化系统疾病为主，包括小儿消化不良、小儿腹泻病、小儿厌食症，也可见便秘、免疫球蛋白A（IgA）血管炎、反复呼吸道感染等；中医诊断常见积滞、厌食、紫癜等，单用与联用在适应证分布和构成比上，无显著区别。单次用药剂量为（3.08±1.22）g，16.74%患儿出现超说明书用药，主要为低于说明书用量下限，特别是＞5 岁患儿，其用量约为说明书的 1/2，单用与联用间，无显著性差异。用法主要为每天 3次（95.55%）。疗程平均（7.76±2.6）d，97.23% 患儿的疗程≤10 d（说明书），主要适应证（前 3位）的疗程约 7 d。合并用药中，87.78% 患儿联合 1 种药物，关联规则分析，主要药物组合为“酪酸梭菌二联活菌-神曲消食口服液”，化学分类法（ATC）治疗学分类/中药功能组合为“消导剂-止泻药，肠道抗炎/抗感染药”。临床疗效观察：共纳入906例患儿，适应证以小儿消化不良和小儿腹泻病为主（83%），两种疾病的平均病程均约11 d，治疗7 d左右，疾病痊愈的中位时间，前者为21 d，后者为17 d，两种疾病3周的治愈率均超过50%；不良反应主要为皮疹、瘙痒和恶心。结论 儿脾醒颗粒在临床实践中的应用广泛，适应证除消化系统的病症外，也包括反复呼吸道感染、IgA血管炎等疾病，适用人群也可扩至婴儿，临床上常与同类中成药或益生菌制剂联合应用，对于主适应证，临床疗效尚佳，值得推广应用和深度开发。

Objective To explore the medication characteristics and efficacy of Erpixing Granules in the real world, and to provide a basis for their rational clinical application and the design of studies for secondary development.Methods The data of Erpixing Granules were analysed based on the hospital information system (HIS) of five hospitals, including: (i) descriptive analysis of characteristics such as age, gender, Chinese and Western medical diagnosis, single dose, duration of treatment and information on combined medication, (ii) analysis of association rules for combined medication and its types, and (iii) descriptive analysis of recovery time of applicable diseases.Results Analysis of the dosing characteristics showed that 5 351 children were included, with a mean age of (4.16 ±3.41) years, 98.17% of whom were < 14 years old, 14.86% were below the lower age limit for dosing in the instructions. The Western medicine diagnosis was mainly digestive system diseases, including paediatric dyspepsia, paediatric diarrhoeal disease, paediatric anorexia, but also constipation, IgA vasculitis, RRIT; Chinese medicine diagnosis was commonly Jizhi, Yanshi, Zidian, etc. There was no significant difference in the distribution and composition ratio of indications between single use and combination use. The single dose was (3.08 ±1.22) g. 16.74% of the children were over-indicated, mainly below the lower limit of dosage, especially in children > five years of age, whose dosage was about half of the instruction, and there was no significant difference between single and combination use. The dosage was mainly 3 times/d (95.55%).The average duration of treatment was (7.76 ±2.6) d, with 97.23% of children having a duration of treatment of less than 10 days (instruction) and the duration of treatment for the main indications (top three) being around seven days. The main combination of drugs was " Combined Clostridium Butyricum and Bifidobacterium Powders-Shenquxiaoshi Liquid" and the ATC therapeutic classification/Chinese medicine functional combination was " prescriptions for resol ving food stagnancy-antidiarrhoeal, intestinal anti-inflammatory/anti-infective agent ". Clinical efficacy observation: There were 906 children included. The indications were mainly pediatric dyspepsia and pediatric diarrheal disease (83%). The mean duration of illness was about 11 d for both diseases and about seven days for treatment. The median time to disease healing was 21 d for the former and 17 d for the latter. The cure rate at three weeks was more than 50% for both diseases. Adverse effects were mainly rash, pruritus and nausea.Conclusion Erpixing granules are widely used in clinical practice. The indications can be seen in recurrent respiratory tract infections, IgA vasculitis and other diseases in addition to those of the digestive system. The applicable population can also be extended to infants. It is often used in combination with similar proprietary Chinese medicines or probiotic preparations in clinical practice. For the main indications, the clinical efficacy is still good, and it is worth to promote the application and in-depth development.

R287.5；R969.3

中国人口福利基金会妇女儿童关爱工程计划资助项目（GNB-6-20210304-68）