| 摘要: |
| 目的：了解吉林大学第一医院儿科门诊微生态制剂使用现状及存在的问题。方法：通过医院信息系统（HIS）调取我院2019年1-12月儿科门诊使用微生态制剂处方。参照药品说明书，对患儿的基本信息、微生态制剂使用品种及超说明书用药情况进行统计分析。结果：共抽取含微生态制剂处方10 372张，涉及品种包括布拉氏酵母菌活菌制剂（2 580张，24.87%）、酪酸梭菌肠球菌三联活菌片（2 648张，25.53%）、酪酸梭菌活菌散（4 564张，44.01%）、双歧杆菌三联活菌肠溶胶囊（144张，1.39%）及双歧杆菌四联活菌片（436张，4.2%）；微生态制剂超说明书用药主要表现为超适应证用药（6 272张，60.47%）、超用法用量用药（4 504张，43.42%）及超适应人群用药（450张，4.34%）。结论：微生态制剂在儿科用药中超说明书用药的比例较高，应规范医务人员的处方行为。此外，国家相关部门应敦促药品生产企业及时完善修订微生态制剂药品说明书中儿童用药的相关信息，以保障患儿用药的合理性和安全性 |
| 关键词: 微生态制剂 儿科门诊 超说明书用药 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2022.03.009 |
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| 基金项目: |
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| Investigation and Analysis of Off-Label Drug Use Prescriptions of Microecological Preparations in Pediatric Clinics |
| Liu Yajuan, Liu Xin, Cao Yidan |
| (The First Hospital of Jilin University, Changchun 130021, China) |
| Abstract: |
| Objective: To investigate the current status and problems of microecological preparations in the pediatric clinics of the First Hospital of Jilin University. Methods: Prescription of microecological preparations in the pediatric clinics of our hospital from Jan. to Dec. 2019 was retrieved through the hospital information system (HIS). The general information, varieties of microecological preparations and off-label drug use were statistically analyzed according to the drug instructions. Results: A total of 10,372 prescriptions of microecological preparations were extracted, including Saccharomyces boulardii preparations (2,580 pieces, 24.87%), triple live bacteria of Clostridium butyricum enterococcus triple viable bacterial tablet (2,648 pieces, 25.53%), Clostridium typhimurium powders (4,564 pieces, 44.01%), Bifidobacterium triplet enteric-coated capsules (144 pieces, 1.39%) and Bifidobacterium quadruple live bacteria (436 pieces, 4.2%). Off-label use of microecological preparations mainly included off-label indications (6,272 pieces, 60.47%), off-label usage and dosage (4,504 pieces, 43.42%) and off-label adaptation population (450 pieces, 4.34%). Conclusion: Microecological preparations have a higher percentage of off-label use in pediatric medicines, and the prescription behavior of medical personnel should be standardized. Meanwhile, relevant national departments should inspire the drug manufacturers to complete and revise the relevant information on children’s medication in the drug instructions of microecological preparations in a timely manner, so as to ensure the rationality and safety of medication for children |
| Key words: microecological preparations pediatric clinics off-label drug use |
