微生态制剂治疗儿童功能性便秘的临床用药现状调查

Clinical medication of probiotics for functional constipation in children

目的探索临床应用微生态制剂治疗儿童功能性便秘(FC)的用药现状,推动微生态制剂安全合理用药。方法调研5家三级甲等儿童专科医院2019年1-3月应用微生态制剂治疗儿童FC的门/急诊处方,结合国内外指南及共识中相关推荐意见,分析微生态制剂治疗儿童FC的用药品种分布、合并用药及超说明书用药情况。结果 共调研处方4928张,涉及微生态制剂品种16种,处方数排名前三位的为酪酸梭菌二联活菌散(47.24%)、复方嗜酸乳杆菌片(14.14%)以及酪酸梭菌活菌散剂(9.19%)。其中合并用药处方2423张(49.17%),合并药物主要包括健脾消食类中成药、乳果糖、清热解毒类中成药等。微生态制剂超说明书用药的发生率为66.13%(3259/4928),其中超适应证处方占比最高(61.43%),其次为超适应人群处方(35.62%)及超用法用量处方(21.51%)。共梳理15项国内外指南及共识,仅5项指南/共识推荐微生态制剂用于治疗儿童FC,推荐品种包括双歧杆菌、酪酸梭菌、枯草杆菌等;各指南/共识均未提及应用微生态制剂治疗儿童FC的安全性。结论目前国内临床应用微生态制剂治疗儿童FC较普遍,但超说明书用药情况较多,临床医师需规范处方行为,药师应加强审方能力,共同推动儿科合理用药。

Objective To explore the application of probiotics for children’s functional constipation (FC),and to promote the safe and rational use of probiotics.Methods The outpatient/emergency prescriptions on children’s FC with probiotics in 5 children’s hospitals from January to March,2019 were investigated.We also analyzed the drug varieties,drug use and off-label drug use of probiotics in treating children’s FC in combination with the relevant recommendations from domestic and foreign guidelines/consensus.Results Totally 4928 prescriptions were investigated,and 16 species of probiotics were involved.The top three probiotics prescriptions were clostridium caseinate with live bacteria powder (47.24%),compound lactobacillus acidophilus tablets (14.14%) and clostridium caseinate with live bacteria powder (9.19%).There were 2423 prescriptions in combination with other drugs (49.17%),including proprietary Chinese medicines for strengthening the spleen and improving digestion,lactose,clearing heat and detoxifying,etc.The overall incidence of off-label use of probiotics was high,reaching 66.13% (3259/4928),with off-lable of indication accounting for the highest proportion (61.43%),followed by over-population prescriptions (35.62%) and over-use and dosage prescriptions (21.51%).We reviewed 15 domestic and foreign guidelines and consensus.Only 5 guidelines/consensus recommended the use of microecological agents for FC in children,including bifidobacteria,clostridium caseinate,and bacillus subtilis.All the guidelines/consensus did not mention the safety of microecologic agents for FC in children.Conclusion Probiotics for FC in children is widely used in clinical practice in China.However,the off-label use of drugs is common.Clinicians should regulate prescribing behaviors and pharmacists should promote rational use of pediatric drugs.