我院门诊患儿眼用制剂超说明书用药分析

Off-Label Drug Use in Ophthalmic Preparations of Outpatient Children

目的:调查眼用制剂在儿科患儿中的超说明书用药情况,规范儿童局部用药,促进合理用药。方法:抽取2015年我院儿童门诊眼用制剂处方,依据药品说明书,分析用药年龄段、超说明书用药类型和各类药品超说明书用药情况,了解儿童眼用制剂的超说明书用药。结果:眼科门诊患儿主要的超说明书用药类型以未提及儿童用药信息为主,超说明书用药药物涉及8大类共34种眼用制剂,超说明书用药发生率前3位的药物种类分别为免疫抑制剂、抗干眼症药和降眼压药,且超说明书用药发生率均>50%,同时婴幼儿(0~3岁)及青少年(12~18岁)超说明书用药发生率高于学龄期儿童(3~12岁)。结论:儿科眼用制剂超说明书用药普遍,应加强监管并促进和规范儿童药物临床试验,为儿童用药提供更多的证据,保障儿童用药安全。

Objective：To investigate the situation of off-label drug use in ophthalmic preparations of outpatient children and regularize the topical application of children,so as to promote rational drug use.Methods：To select prescriptions of ophthalmic preparations of outpatient children in 2015.According to drug instructions,the off-label drug use of prescriptions was analyzed in age,the category of off-label drug use and the category of drugs.Results：The main categories of off-label drug use were with no pediatric information.The off-label drugs include 8 categories and 34 kinds of ophthalmic preparations.The top 3 drugs of off-label use were immunosuppressants,antixerophthalmic and ocular hypotensive agents,and all the rate of off-label use was more than 50%.Also infants（age from 0 to 3） and teenagers（age from 12 to 18） had higher rates of off-label drug use than school-aged children（age from 3 to 12）.Conclusion：The offlabel drug use in ophthalmic preparations of children is common in our hospital.The regulator should be strengthened,the clinical trials research of children should be promoted to provide more evidence for children medication and ensure the safety of the drug use in children.