西地那非超说明书用药回顾性调查

摘要

目的 了解西地那非超说明书用药现状,为制订超说明书用药政策提供参考.方法 采用分层随机抽样的方法,收集广东省妇幼保健院2015年西地那非的处方数据,按照药品说明书判断其超说明书用药情况.对各科室用药情况进行统计,分析其超说明书用药发生率.结果 共抽取处方1044张,其中超说明书用药处方726张,占69.54%.西地那非超说明书用药处方发生率最高的前3位科室依次为生殖健康不孕症科、心脏中心及新生儿科;超说明书用药类型中居前三位的是:超适应证(50.35%)、超用药人群(31.76%)和超给药途径(17.89%).其中西地那非的超适应证用药包括不孕症、肺动脉高压、先天性心脏病等.结论 该院2015年西地那非超说明书用药情况普遍,以生殖健康不孕症科、心脏中心、新生儿科最显著,提示仍需促进西地那非在心血管方面的临床试验以提供更多的用药证据,保障西地那非的用药安全和规避相关医疗风险.%Objective To understand the situation of off-label use of sildenafil, so as to provide reference for developing off-label drug use policy. Methods A stratified random sampling method was used to collect prescription data of sildenafil in Guangdong Women and Children Hospital in 2015. The off-label drug use situation was analyzed according to drug labels. The situations of drug use in all departments were summarized, and off-label drug use occurrences were analyzed.Results A total of 1044 prescriptions with sildenafil were collected and analyzed to discover the occurrence of off-label use was up to 69. 54%. The top 3 departments of off-label use of sildenafil were assisted reproductive center, heart center and neonatal intensive care unit (NICU). The top 3 types of off-label use were non-indication(50. 35%), over drug population(31. 76%) and over drug administration(17. 89%). The top 3 diseases for non-indications were infertility, pulmonary hypertension and congenital heart disease. Conclusion Sildenafil off-label use was common in Guangdong Women and Children Hospital in 2015, especially in assisted reproductive center, heart center, and NICU. The result suggests that more clinical studies about sildenafil on cardiovascular system are expected to provide more evidence for drug use, so as to ensure the safety of drug use in special populations and avoid potential medical risk.