儿科超说明书用药影响因素探讨  

Factors influencing the off-label use of medicine in the Pediatric Department

作　　者：冯秋荣[1] 李必坚[1] 刘静[1] 

机构地区：[1]南方医科大学南方医院药材科,广州510515

出　　处：《中南药学》2013年第11期860-862,共3页Central South Pharmacy

摘　　要：目的对本院儿科门诊和住院处方进行抽查分析,以探讨儿科超说明书用药影响因素,为临床合理用药提供依据。方法从本院随机抽取2010年1月至2012年9月儿科门诊和住院处方,按照年龄分为2组,婴幼儿组(<3岁组)和儿童组(≥3岁组),利用大医通软件"处方审核与点评系统"筛选所有处方,将超说明书用药处方进行分类统计分析。结果共抽取处方2 103张,含用药记录5 987条,超说明书用药记录2 033条,发生率33.96%;其中,容易发生超说明书用药的是给药剂量、给药频次和超年龄用药。婴幼儿组和儿童组在超说明书用药发生构成上差异有统计学意义(P=0.000),婴幼儿组发生比例高于儿童组;对所有涉及药物进行分析,超说明书用药发生率最高的是抗变态反应药(49.55%),其次为消化系统用药(44.75%),再次为外用药物(44.09%);在2 103张处方中,联合用药处方共2 097张(99.71%);婴幼儿组易出现超说明书用药的为抗变态反应药(50.32%)、外用药(45.21%)和消化系统用药(43.25%),儿童组易出现超说明书用药的为抗变态反应药(49.01%)、消化系统用药(45.28%)和中成药(43.69%)。2组患儿具体用药种类上超说明书用药发生率差异有统计学意义(P<0.05)。结论儿科用药风险高,超说明书用药现象普遍,用药时应注意给药剂量、给药频次,对婴幼儿用药和联合用药应谨慎,尽量减少超说明书用药行为。Objective To sample the outpatient department and hospital prescriptions in the Pediatric Department, Nanfang Hospital of Southern Medical University, and to explore the factors influencing the off-label use of medicine. Methods A total of 2 103 samples from January 2010 to September 2012 in Nanfang Hospital of Southern Medical University in the Outpatient Department and pediatric prescriptions were randomly divided into 2 groups according to age： an infant group（ 3 years old） and a children group（ ≥ 3 years old）. We used large medical software ＂Prescription Audit and Review System＂ to screen and analyze all prescriptions. Results A total of 2 103 prescriptions were collected in the study, including 5 987 medication administration records and 2033 off-label use records（33.96%）. The off-label use covered dosage, frequency and age. There was significant difference in the off-label use of medicine between the infant and the children group（χ2= 18.685, P = 0.000）, with higher rate in the infant group. Antiallergic drugs（49.55%） had the highest incidence rate, followed by the digestive system drugs（44.75%）, and topical drugs（44.09%）. In the 2 103 prescriptions, 2 097 prescriptions were combined drug use（99.71%）. In the infant group, the off-label use of antiallergic drugs accounted for 50.32%, followed by external use（45.21%） and digestive system drugs（43.25%）. In the children group, the off-label use of antiallergic drugs was 49.01%, followed by digestive system drugs（45.28%） and traditional Chinese medicine（43.69%）. The 2 groups had significant difference（P 0.05）. Conclusion It is highly risky in the off-label use of medicine. Doctors should pay much attention to the dosage and frequency of administration, infant medication and combined use of medications.

关 键 词：超说明书用药 儿科 给药剂量 联合用药 

分 类 号：R969.3[医药卫生—药理学]