摘要
目的:调查我国儿科质子泵抑制剂(PPIs)使用现状及存在问题,为儿童合理应用PPIs提供参考。方法:采用文本分析法,根据药品说明书、国内外临床诊疗指南/共识及文献资料编写PPIs儿科临床使用情况调查问卷,在全国六大行政区20个省市的24家医院发放问卷,并对调查结果进行统计分析。结果:共回收185份有效调查问卷,24家医院中21家使用奥美拉唑注射剂型,18家使用奥美拉唑口服剂型,8家使用艾司奥美拉唑口服剂型。较常见使用PPIs的疾病为消化道溃疡、幽门螺杆菌感染和胃食管反流病及反流性食管炎;存在超说明书适应证用药的调查问卷共156份(84.32%);儿童剂量在诊疗指南/共识推荐范围外的调查问卷96份(51.89%);与抗菌药物、胃黏膜保护剂、H_(2)受体拮抗剂和微生态制剂等药物联合使用的调查问卷159份(85.95%);PPIs曾发生不良反应的问卷为136份(73.51%)。结论:PPIs在我国用于儿童属于超说明书用药,儿科临床超说明书适应证用药以及诊疗指南/共识推荐的儿童剂量范围外用药的发生率较高,应规范临床医师处方行为,促进临床合理用药。同时应鼓励制药企业完善药品说明书中儿童用药信息,保证其用药的安全性和有效性。
Objective: To investigate the current status and problems of proton pump inhibitors(PPIs) in pediatrics in China, so as to provide reference for the rational use of PPIs in children. Methods: The questionnaire on clinical use of PPIs in pediatrics was compiled according to the drug instructions, clinical guidelines/consensus, and literature at home and abroad. The questionnaire was distributed to 24 hospitals in 20 provinces and cities of 6 administrative regions in China, and the survey results were statistically analyzed. Results: A total of 185 valid questionnaires were collected. Among the 24 hospitals, 21 used omeprazole(injection form), 18 used omeprazole(oral dosage form), and 8 used esomeprazole(oral dosage form). Peptic ulcer, Helicobacter pylori infection, gastroesophageal reflux disease and reflux esophagitis were the common diseases treated with PPIs. A total of 156 questionnaires(84.32%) were found to have off-label drug use. There were 96 questionnaires(51.89%) with off-label recommended range of diagnosis and treatment guidelines/consensus. Totally 159 questionnaires(85.95%) had drug combination with antibiotics, gastric mucosal protective agents, H_(2)receptor antagonists and probiotics. There were 136 questionnaires(73.51%) with adverse drug reactions to PPIs. Conclusion: PPIs used in children in China belongs to off-label drug use, and the incidence of off-label drug use in pediatrics and off-label dose recommended by the diagnosis and treatment guidelines/consensus is relatively high. Therefore, clinicians’ prescription behavior should be standardized to promote clinical rational drug use. Meanwhile, pharmaceutical enterprises should be encouraged to improve the drug information for children in the drug instructions to ensure the safety and effectiveness of drug use.
作者
魏婷
刘斌
曾庆威
张俐
佟岩
杨宁
王晓玲
Wei Ting;Liu Bin;Zeng Qingwei;Zhang Li;Tong Yan;Yang Ning;Wang Xiaoling(Harbin Children’s Hospital,Harbin 150010,China;Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China)
出处
《儿科药学杂志》
CAS
2022年第4期8-12,共5页
Journal of Pediatric Pharmacy
基金
黑龙江省卫生健康委科研课题,编号2020-041。
关键词
质子泵抑制剂
儿科
临床应用
调查问卷
proton pump inhibitors
pediatrics
clinical application
questionnaires
