微生态制剂治疗儿童功能性消化不良的门/急诊处方分析  

Analysis on the outpatient and emergency prescriptions of probiotics for the treatment of functional dyspepsia in children

作　　者：尉耘翠 都赛飞 张俐 魏婷 贾露露 马津京[4] 金彦 王晓玲[4] YU Yuncui;DU Saifei;ZHANG Li;WEI Ting;JIA Lulu;MA Jinjing;JIN Yan;WANG Xiaoling(Clinical Research Center,National Center for Children′s HealthBeijing Children′s Hospital,Capital Medical University,Beijing100045,China;Department of Clinical Pharmacology,Harbin Children′s Hospital,Heilongjiang Province,Harbin150010,China;Department of Gastroenterology,Harbin Children′s Hospital,Heilongjiang Province,Harbin150010,China;Department of Pharmacy,National Center for Children′s HealthBeijing Children′s Hospital,Capital Medical University,Beijing100045,China)

机构地区：[1]国家儿童医学中心首都医科大学附属北京儿童医院临床研究中心,北京100045 [2]哈尔滨市儿童医院临床药学部,黑龙江哈尔滨150010 [3]哈尔滨市儿童医院消化内科,黑龙江哈尔滨150010 [4]国家儿童医学中心首都医科大学附属北京儿童医院药学部,北京100045

出　　处：《中国医药导报》2020年第29期56-61,共6页China Medical Herald

基　　金：国家重大新药创制专项项目(2017ZX09304029);中国医药质量管理协会课题(药质协字〔2019〕20号)。

摘　　要：目的了解我国临床应用微生态制剂治疗儿童功能性消化不良(FD)的现状及问题,为合理应用微生态制剂治疗儿童FD提供依据。方法回顾性抽取全国5所三甲儿童医院(首都医科大学附属北京儿童医院、哈尔滨市儿童医院、河南省儿童医院、湖南省儿童医院、江西省儿童医院)2019年1—3月使用微生态制剂治疗儿童FD的所有门/急诊处方。同时梳理国内外微生态制剂及FD相关指南/共识,对微生态制剂治疗儿童FD情况进行调研分析。结果共抽取使用微生态制剂治疗儿童FD处方14099张,其中男性占比56.43%(7956/14099),女性占比43.57%(6143/14099),年龄分布以1~3岁患儿占比最高,达到28.58%。处方共涉及微生态制剂17种,其中酪酸梭菌二联活菌散的处方数占比最高,达到64.65%(9115/14099)。存在合并用药的处方占比59.69%(8415/14099),合并使用的药物主要包括健脾消食类中成药、清热解毒类中成药、抗菌药等。超说明书用药处方发生率为27.68%(3903/14099),主要存在超适应证、超人群、超用法用量等情况。共梳理15项国内外微生态制剂及FD相关临床指南/共识,在有效性方面,仅有2项国内的专家共识建议可以使用微生态制剂作为治疗FD的辅助用药,推荐使用的品种主要包括双歧杆菌、乳杆菌等。在安全性方面,7项指南及共识提及并总体肯定微生态制剂的安全性,但均未单独提及微生态制剂治疗儿童FD的安全性。结论应用微生态制剂治疗儿童FD在临床上较常见,但仍存在超说明书用药等情况,且相关循证医学证据较少,临床医生应规范其处方行为。同时,未来仍需开展大量基于儿科群体的多中心前瞻性研究,为合理应用微生态制剂治疗儿童FD提供更多支持。Objective To understand the current status and problems of the clinical application of microecological preparations in the treatment of children with functional dyspepsia(FD)in China,and to provide the basis for the rational application of microecological preparations in the treatment of children with FD.Methods A retrospective selection of five Grade A children′s hospitals across the country(Beijing Children′s Hospital of Capital Medical University,Harbin Children′s Hospital,He′nan Children′s Hospital,Hu′nan Children′s Hospital,Jiangxi Provincial Children′s Hospital)would use microecological preparations to treat children from January to March 2019,while all outpatient/emergency prescriptions for FD were extracted.At the same time,the relevant guidelines/consensus of probiotics and FD at home and abroad were sorted out,and the treatment of children with FD by probiotics were investigated and analyzed.Results A total of 14099 FDprescriptions for the treatment of children with microecological preparations were drawn,of which 56.43%were males(7956/14099)and females accounted for 43.57%(6143/14099).The proportion of children aged one to three years was the highest,reaching 28.58%.A total of 17 kinds of microecological preparations were involved in the prescriptions.Among them,the prescription number of Clostridium Butyricum Duojun San was the highest,reaching 64.65%(9115/14099).The proportion of prescriptions with combined drugs accounted for 59.69%(8415/14099).The combined drugs mainly included Chinese patent medicines for strengthening the spleen and eliminating food,Chinese patent medicines for clearing away heat and detoxification,and antibacterial drugs.The incidence of off-label medication prescriptions was 27.68%(3903/14099),and there were mainly cases of over-indications,over-population,over-usage and dosage.A total of 15 domestic and foreign microecological preparations and FD-related clinical guidelines/consensus have been sorted out.In terms of effectiveness,only two domestic expert consen

关 键 词：微生态制剂 功能性消化不良 处方分析 儿童 

分 类 号：R725.7[医药卫生—儿科]