我国儿科微生态制剂超说明书用药调查

Investigation of Off-Label Drug Use of Pediatric Microecological Preparations in China

目的:探讨我国儿科微生态制剂超说明书用药情况,为临床合理用药提供参考。方法:采用文本分析法,根据药品说明书及文献资料编制微生态制剂儿科临床使用情况调查问卷,在全国六大行政区21个省市的36家医院发放问卷,并对调查结果进行统计分析。结果:共回收213份有效调查问卷,36家医院中31家使用双歧杆菌四联活菌片,23家使用枯草杆菌二联活菌颗粒。使用微生态制剂较常见的适应证为急慢性腹泻、功能性消化不良及抗生素相关性腹泻;存在超说明书用药的调查问卷共207份(97.18%),其中超适应证用药184份(86.38%)、超给药途径用药4份(1.88%)、超用法用量191份(89.67%)、超人群用药134份(62.91%)。结论:微生态制剂在儿童中的超说明书用药发生率较高,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,保证其用药安全性和有效性。

Objective:To probe into the off-label drug use of pediatric microecological preparations in China,so as to provide reference for clinical rational drug use.Methods:Text analysis method was adopted,according to the drug instructions and literature,questionnaire on the clinical use of microecological preparations in pediatrics was prepared,distributed and recovered in 36 hospitals in 6 administrative regions,21 provinces and cities in China,and the survey results were statistically analyzed.Results:There were a total of 213 valid questionnaires,among which 31 hospitals had bifidobacteria quadruplicate viable tablets and 23 hospitals had bacillus subtilis diplicate viable tablets.The most common indications for the use of microecological preparations were respectively acute and chronic diarrhea,functional dyspepsia and antibiotic-related diarrhea.There were 207 questionnaires(97.18%)of off-label drug use,including 184 cases(86.38%)of off-label indications,4 cases(1.88%)of off-label administration route,191 cases(89.67%)of over usage and dosage and 134 cases(62.91%)of overuse.Conclusion:The incidence of off-label drug use in children with microecological preparations is relatively high.The prescribing behavior of clinical clinicians should be standardized to promote rational clinical use of drugs.Meanwhile,it is necessary to encourage and improve the information of children’s drug use in the drug instructions to ensure the safety and effectiveness of drug use.