奋乃静超说明书用药合理性与风险因素分析:一项真实世界研究

Rationality and Risk Factors of Off-label Prescriptions of Perphenazine:A Real-world Study

目的研究真实世界中全国多家医院奋乃静使用情况并分析其合理性。方法抽取全国42家医院2017年至2019年门诊患者使用奋乃静的处方,以奋乃静说明书为依据判断是否超说明书用药,从各数据库中搜集循证证据,分析用药合理性,并采用二元logistics回归方法,分析奋乃静超说明书用药影响因素。结果共抽取含奋乃静的处方5556张,其中超适应证用药率43.3%(2404/5556),主要超适应证为精神障碍;12~17岁(50.0%,54/108)、>65岁(56.3%,976/1735)患者超说明书用药率较18~65岁患者(37.0%,1372/3710)高;非精神心理科超说明书用药率(82.8%,891/1076)较精神心理科(33.8%,1513/4480)高,非一线城市超说明书用药率(72.1%,444/616)较一线城市(39.7%,1960/4940)高;回归分析显示,地区、时间、科室、报销与否和类型、年龄、药物费用、联合用药数量和性别都会影响超说明书用药的发生;单独使用奋乃静时,超说明书用药率最高(63.3%,826/1304);最常见联合用药方案为抗精神病药物+另一种抗精神病药物。结论奋乃静超说明书用药较普遍,应规范管理,超说明书使用是否有效尚需观察和研究,以便为临床提供支持使用的证据,促进奋乃静安全合理用药。

Objective To investigate the utilization and rationality of perphenazine in many hospitals in China by real-world study methods.Methods A total of 5556 prescriptions of perphenazine for outpatients in 42 hospitals from 2017 to 2019 were selected to analyze whether the utilization of perphenazine corresponded to the indications based on the instructions.We collected supporting pieces of evidences from various databases to analyze the rationality and influencing factors of off-label utilization of perphenazine by binary logistic regression.Results The rate of off-label utilization was 43.3%.The most frequent off-label diagnosis was the mental disorder.The prevalence of off-label medication in patients aged 12-17(50.0%)and over 65(56.3%)was higher than that in patients aged 18-65(37.0%).The prevalence of off-label medication in non-psychiatric departments(82.8%)was higher than that in the psychiatric department(33.8%).The prevalence of off-label prescriptions in non-first tier cities(72.1%)was higher than that in first-tier cities(39.7%).Regression analysis showed that region,time,department,insurance and insurance category,age,number of diagnoses,number of combined drugs and gender would affect the occurrence of off-label prescriptions.When perphenazine was used alone,the prevalence of off-label medication was the highest among all the prescriptions,which was 63.3%.The most common poly-pharmacy was an antipsychotic with another antipsychotic.Conclusion The perphenazine is often off-label prescribed,which must be standardized managed.In addition,the off-label prescription must be monitored and studied to provide more pieces of evidence for the rational use of perphenazine.