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目的:了解我国儿科临床微生态制剂使用现状及存在问题,为儿童合理应用微生态制剂提供参考。方法:通过全国范围内5家“三甲”儿童医院的信息系统,检索2019年1-3月使用含微生态制剂的全部门/急诊处方,对微生态制剂使用的品种情况、患儿年龄分布、临床诊断、联合用药、超说明书用药等进行调查分析。结果: 共抽取门/急诊处方74 210张,涉及18种微生态制剂,其中酪酸梭菌二联活菌散处方数排序居第1位(31 146张,41.97%),其次为布拉氏酵母菌散(14 289张,19.25%)、复方嗜酸杆菌活菌片(10 281张、13.85%)等;患儿年龄为<18岁,以1~<3岁婴幼儿占比最大(33 753张,45.48%);临床诊断为消化道疾病的最多(54 009张,72.78%),其次为呼吸系统感染性疾病(11 744张,15.83%);与微生态制剂联用的有健脾胃类中成药(18 546张,24.99%)、抗菌药物(10 595张,14.28%)和口服补液盐Ⅲ(8 238张,11.10%);19 532张(26.32%)处方存在超说明书用药的情况,主要表现为超适应证用药(15 590张,21.01%)、超用法用量用药(8 098张,14.52%),少数处方存在超人群用药(48张,3.91%)。结论: 微生态制剂在儿童中超说明书用药的发生率较高,医务人员应规范处方行为,促进合理用药。同时应鼓励相关部门完善药品说明书中儿童用药信息,保证患儿用药的安全性和有效性。
OBJECTIVE: To investigate the situation and problems of clinical microecological preparations in pediatrics department of China, and to provide reference for rational application of microecological preparations in children. METHODS: Outpatient/emergency prescriptions of microecological preparations during Jan.-Mar. 2019 were retrieved from information system of 5 “Third Grade Class A” children hospitals, and were investigated and analyzed in respects of the type of microecological agents, age distribution, clinical diagnosis, drug combination, off-label medication, etc. RESULTS: A total of 74 210 outpatient/emergency prescriptions were collected, involving 18 kinds of microecological preparations. Among them, Clostridium butyricum combined viable powder ranked first (31 146, accounting for 41.97%), followed by Brucella yeast powder (14 289, accounting for 19.25%) and Compound Lactobacillus acidophilus tablets (10 281, 13.85%). The age of children was less than 18 years old, and the proportion of children aged 1-<3 years old was the highest (33 753, 45.48%). The most common clinical diagnosis was digestive tract diseases (54 009, 72.78%), followed by respiratory infectious diseases (11 744, 15.83%). In combination with microecological agents, there were Chinese patent medicine for invigorating the spleen and stomach (18 546, 24.99%), antibacterial medicine (10 595, 14.28%) and oral rehydration salt Ⅲ (8 238, 11.10%). Off-label drug use was found in 19 532 prescriptions (26.32%), mainly manifesting as super-indications (15 590, 21.01%), super-usage and dosage (8 098, 14.52%), super crowd medication (48, 3.91%) was found in a few prescriptions. CONCLUSIONS: There is a high incidence of off-label use of microecological agents in children. Medical staff should standardize prescription behavior and promote rational use of drugs. At the same time, the improvement of the information of children’s medication in drug instructions to ensure the safety and effectiveness of children’s medication should be encouraged.
微生态制剂儿童超说明书用药处方分析
Microecological preparationChildrenOff-label drug usePrescription analysis
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