妇产科专科医院门诊应用低剂量阿司匹林及超说明书情况分析

Clinical application and off-label use of aspirin in outpatients in tertiary specialized hospital of obstetrics and gynecology

目的 ：评价阿司匹林在妇产科领域的临床应用现状以及其超说明书用药分析。方法 ：调取我院2013年1月—2016年2月所有含有阿司匹林的处方数据,参考药品说明书、妇产科临床相关诊疗指南、专家共识及相关文献,对该药品在妇产科专业领域的临床使用情况进行处方分析与评价。结果 ：阿司匹林在30～39岁之间患者（n=1 691人,占54.39%）和在妇科门诊处方率（n=1 751张,占56.32%）中最多,应用阿司匹林均为超药品说明书用药;临床诊断依次为女性不育症（945人次,占26.10%）、月经失调（480人次,占13.26%）和自然流产（456人次,占12.59%）;频次最高的用法用量为每日2次,每次25 mg（占43.84%）。结论 ：本研究中阿司匹林超说明应用均有证据支持,但阿司匹林在妇产科领域特别是妊娠期患者的超说明书应用方面仍在探索阶段,未来需要进行更多的随机大样本试验以及长期随访其安全性来为临床应用提供依据。

Objective： To evaluate the current clinical application of aspirin in outpatients of obstetrics and gynecology hospital and its medication analysis of off-label use. Methods： The data of 38-month prescription about aspirin from 2013 to 2016 were extracted and the situation of its clinical use was analyzed based on the drug instruction,relevant guidelines,expert consensus, and literature. Results： In our hospital, the most off-label use of aspirin was in gynecological clinic（n=1 751, 56.32%） and in the female patients aged 30～39（n=1 691, 54.39%）. The most common off-label indication for aspirin was female infertility（n=945, 26.10%）, then menstrual disorders（n=480, 13.26%） and spontaneous abortion（n=456, 12.59%）. The highest dosage was twice a day at 25 mg each time（43.84%） specifically to deal with obstetrics and gynecology conditions. Conclusion：Off-label use of aspirin in this study is all based on scientific evidences but its off-label use in pregnancy patients is still at an exploratory stage. More large-scale randomized and controlled trials and the confirmation of its safety by long-term follow-up would be necessary in the future so as to provide a basis for clinical application.