| 摘要: |
| 目的：回顾性调查郑州儿童医院2 350例癫痫患儿抗癫痫药物使用情况，分析其超说明书用药现状，为临床合理用药提供参考。方法：选取2019年2月至2020年3月郑州儿童医院门诊收治的2 350例癫痫患儿，并对患儿一般资料、药物使用情况、超说明书用药情况进行统计分析。对超说明书用药影响因素进行单因素χ2检验和多因素Logistic回归分析。结果：2 350例癫痫患儿中，年龄35 d~17岁，各年龄段男性患儿均多于女性。涉及抗癫痫药物8种，使用率最高为丙戊酸钠，其次为左乙拉西坦和奥卡西平。联合用药处方412张（17.5%）。超说明书用药处方337张（14.3%），超说明书用药医嘱363条（12.8%），其中超给药年龄149条（5.2%）、超给药剂量164条（5.8%）、超给药频次74条（2.6%）。婴幼儿期超说明书用药发生率最高，超给药年龄是婴幼儿期超说明书用药主要类型。超说明书用药发生率由高到低的抗癫痫药物分别为奥卡西平口服液、托吡酯片、卡马西平片和左乙拉西坦片。单因素和多因素Logistic分析显示，年龄、性别和用药品种数是超说明书用药的独立影响因素。结论：癫痫患儿用药基本遵循“首选单药治疗”原则。我院超说明书用药现象较普遍，主要发生于婴幼儿时期，以超给药年龄为主，在奥卡西平、托吡酯等新型抗癫痫药物中较常见。低龄男性患儿采用联合用药方案更易发生超说明书用药。 |
| 关键词: 儿童 抗癫痫药物 超说明书用药 |
| DOI：doi:10.13407/ j.cnki.jpp.1672.108X.2021.09.009 |
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| 基金项目:国家卫生健康委员会医管中心委托课题,医管中心药械处[2019]053 号。 |
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| Current Status and Off-Label Use of Antiepileptic Drugs in a Hospital |
| Chang Zhao, Ma Shuli, Li Yiqi, Zhang Shengnan |
| (Children’s Hospital Affiliated of Zhengzhou University, Henan Children’s Hospital, Zhengzhou Children’s Hospital, Henan Zhengzhou 450018, China) |
| Abstract: |
| Objective: To retrospectively investigate the use of antiepileptic drugs in 2,350 children with epilepsy in Zhengzhou Children’s Hospital, and to analyze the off-label use of antiepileptic drugs, so as to provide reference for rational drug use in clinic. Methods: A total of 2,350 children with epilepsy admitted to the outpatient department of Zhengzhou Children’s Hospital from Feb. 2019 to Mar. 2020 were extracted, and the general data, drug use and off-label drug use of the children were statistically analyzed. The influencing factors of off-label drug use were analyzed by univariate χ2 test and multivariate Logistic regression. Results: Of the 2,350 children with epilepsy, ages ranged from 35 d to 17 years, with more males than females in all age groups. Eight kinds of antiepileptic drugs were involved, and the highest use rate was sodium valproate, followed by levetiracetam and oxazepine. Totally 412 prescriptions (17.5%) of drug combination were collected. There were 337 prescriptions (14.3%) of off-label drug use and 363 medical orders of off-label drug use (12.8%), among which 149 prescriptions were off-label age (5.2%), 164 prescriptions were off-label dose (5.8%) and 74 prescriptions were off-label administration frequency (2.6%). The incidence of off-label drug use in infants was the highest, and the drug use of off-label age in infants was the main type. The incidence of off-label drug use from high to low were oxacaxipine oral liquid, topiramate tablets, carbamazepine tablets and levetiracetam tablets. Univariate and multivariate Logistic analysis showed that age, gender and categories of drugs were independent influencing factors of off-label drug use. Conclusion: The medication of children with epilepsy in our hospital basically follows the principle of “monotherapy”. Off-label drug use is widespread in infants, especially in off-label age, and is more common in new antiepileptic drugs such as oxacaxipine and topiramate. Drug combination in younger male children is more likely to occur with off-label drug use. |
| Key words: children antiepileptic drugs off-label drug use |
