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[摘要]
目的 调查河南省人民医院重组人干扰素-α(INF-α)在儿童患者群体的超说明书使用情况,为临床合理使用提供理论依据。方法 抽取河南省人民医院2018年1月-2018年12月使用INF-α的门诊处方,对18岁以下的患者进行疾病和用药情况分析。结果 共抽取患者747例,其中IFN-α 1b 514例,IFN-α 2b 233例,超说明书类型主要有超给药途径给药,超适应症以及超剂量用药,其中超适应症处方数684例,占91.56%;其次是超给药途径和超剂量给药,处方数分别为583、24例,构成比分别为78.05%、3.21%。结论 INF-α在儿科的使用多数属于超说明书使用,应规范该药的使用流程和加强使用管理,并告知患者签订知情同意书。
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[Abstract]
Objective To investigate the off-label use of recombinant human interferon (IFN)-α in children, and to provide theoretical basis for the rational use of recombinant human IFN-α in clinical practice. Methods The outpatient prescriptions of IFN-α were used from January 2018 to December 2018, and the information on diseases and medication for patients under 18 years old were analyzed. Results A total of 747 patients were selected, including 514 cases of IFN-α 1b and 233 cases of IFN-α 2b. The off-label types of IFN-α included ultra-indication, ultra-dosage, and ultra-administration route. There were 684 cases of ultra-indication prescriptions of IFN-α, accounting for 91.56%. The number of prescription of ultra-administration route and ultra-dosage of recombinant human interferon-α were 583 and 24, accounting for 78.05% and 3.21%. Conclusion In the clinical practice, most of the use of recombinant human interferon are administered beyond the routine medical standards. The use process of IFN-α should be managed and standardized. And the patients should be informed to sign the informed consent form.
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