摘要
目的了解中山大学孙逸仙纪念医院门诊阿司匹林超说明书用药现状,为制订超说明书用药政策提供基线数据。方法采用分层随机抽样的方法,收集2013年门诊阿司匹林的处方数据,采用卡方检验比较阿司匹林超说明书用药不同类型间发生率,采用logistic回归模型分析阿司匹林各类超说明书用药发生的影响因素。结果共抽取门急诊阿司匹林处方5 023张,超说明书用药率达17.7%。超说明书超适应证使用高达94.38%,超适应证前3分别为:复发性流产、不孕症和系统性红斑狼疮。年龄、性别、药品规格、处方开具科室均是超说明书用药风险因素。结论中山大学孙逸仙纪念医院2013年门诊阿司匹林超说明书用药情况普遍,以妇产科和生殖中心女性生殖超说明书用药现象最显著,提示仍需促进阿司匹林在生殖方面的临床试验以提供更多的用药证据,保障阿司匹林的用药安全和规避相关医疗风险。
Objective To understand the situation of off-label use of aspirin among outpatients in Sun Yat- sen Memorial Hospital, so as to provide baseline data for developing off-label drug use policy. Methods A stratified random sampling method was used to collected prescription data of aspirin among outpatients in 2013. The incidence rates between different types of off-label use of aspirin were determined by chi-square test, and the influence factors of off-label drug use were analyzed by logistic regression model. Results A total of 5 023 prescriptions with aspirin were collected and analyzed, with incidence rate of off-label use up to 17.7%. The major category of off-label use was no indication （94.38%）. The top 3 no indications were recurrent abortion, infertility and systemic lupus erythematosus. Drug specification, gender, age and prescribed department were the risk factors of off-label use. Conclusion Aspirin off-label use is common among outpatients in Sun Yat-sen Memorial Hospital in 2013, especially in obstetrics and gynecology department and assisted reproductive center. The results suggest that more clinical studies about aspirin for reproduction are needed to provide more evidence of drug use, so as to potential medical risk, ensure the safety of drug use in special populations and avoid potential medical risk.
出处
《中国循证医学杂志》
CSCD
2015年第12期1365-1371,共7页
Chinese Journal of Evidence-based Medicine
