目的 探索在真實世界中兒脾醒顆粒的用藥特征和臨床療效，為其臨床合理應(yīng)用和二次開發(fā)的研究設(shè)計提供依據(jù)。方法 基于 5家醫(yī)院的醫(yī)院信息系統(tǒng)（HIS），對兒脾醒顆粒患兒的用藥數(shù)據(jù)進行分析，包括：（1）年齡、性別、中西醫(yī)診斷、單次用藥劑量、療程、合并用藥信息等特征的描述性分析；（2）聯(lián)合用藥及其種類的關(guān)聯(lián)規(guī)則分析；（3）適用疾病痊愈時間的描述性分析。結(jié)果 用藥特征分析顯示：共納入5 351例患兒，平均年齡（4.16±3.41）歲，98.17%的患兒＜14歲；有14.86%患兒低于說明書用藥年齡的下限。適應(yīng)證的西醫(yī)診斷以消化系統(tǒng)疾病為主，包括小兒消化不良、小兒腹瀉病、小兒厭食癥，也可見便秘、免疫球蛋白A（IgA）血管炎、反復(fù)呼吸道感染等；中醫(yī)診斷常見積滯、厭食、紫癜等，單用與聯(lián)用在適應(yīng)證分布和構(gòu)成比上，無顯著區(qū)別。單次用藥劑量為（3.08±1.22）g，16.74%患兒出現(xiàn)超說明書用藥，主要為低于說明書用量下限，特別是＞5 歲患兒，其用量約為說明書的 1/2，單用與聯(lián)用間，無顯著性差異。用法主要為每天 3次（95.55%）。療程平均（7.76±2.6）d，97.23% 患兒的療程≤10 d（說明書），主要適應(yīng)證（前 3位）的療程約 7 d。合并用藥中，87.78% 患兒聯(lián)合 1 種藥物，關(guān)聯(lián)規(guī)則分析，主要藥物組合為“酪酸梭菌二聯(lián)活菌-神曲消食口服液”，化學(xué)分類法（ATC）治療學(xué)分類/中藥功能組合為“消導(dǎo)劑-止瀉藥，腸道抗炎/抗感染藥”。臨床療效觀察：共納入906例患兒，適應(yīng)證以小兒消化不良和小兒腹瀉病為主（83%），兩種疾病的平均病程均約11 d，治療7 d左右，疾病痊愈的中位時間，前者為21 d，后者為17 d，兩種疾病3周的治愈率均超過50%；不良反應(yīng)主要為皮疹、瘙癢和惡心。結(jié)論 兒脾醒顆粒在臨床實踐中的應(yīng)用廣泛，適應(yīng)證除消化系統(tǒng)的病癥外，也包括反復(fù)呼吸道感染、IgA血管炎等疾病，適用人群也可擴至嬰兒，臨床上常與同類中成藥或益生菌制劑聯(lián)合應(yīng)用，對于主適應(yīng)證，臨床療效尚佳，值得推廣應(yīng)用和深度開發(fā)。

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

中國人口福利基金會婦女兒童關(guān)愛工程計劃資助項目（GNB-6-20210304-68）