应用卫生技术评估遴选第三代抗癫痫发作药吡仑帕奈和拉考沙胺

Application of health technology assessment in selection of third-generation antiseizure medications perampanel and lacosamide

目的通过对吡仑帕奈、拉考沙胺的综合评价,为医疗机构遴选和临床合理使用第三代抗癫痫发作药提供参考。方法以《中国医疗机构药品评价与遴选快速指南(第二版)》为依据制定百分制评估体系,参考药品说明书、临床指南及相关文献,从药学特性、有效性、安全性、经济性和其他属性五个维度对吡仑帕奈和拉考沙胺进行量化评分。结果最终评估总分吡仑帕奈77.41分,拉考沙胺69.06分。吡仑帕奈的得分大于70分,在医疗机构药品使用目录品种引进时的建议为“强推荐”。两药在有效性和经济性方面得分差异较大。吡仑帕奈治疗药物难治性癫痫的循证证据和适应证较多,日均治疗费用较低,有效性和经济性略优于拉考沙胺。但在安全性方面,吡仑帕奈存在美国食品和药物管理局关于严重精神和行为反应的黑框警告,且在妊娠及肝功能不全患者中的使用推荐不如拉考沙胺。结论吡仑帕奈和拉考沙胺在不同属性方面各有优势,医疗机构可根据患者人群特点及是否有可替代药品决定是否引进。

AIM To provide reference for selection and clinical rational use of third-generation anti-seizure medications in medical institutions through a comprehensive evaluation of perampanel and lacosamide.METHODS A percentage based evaluation system was developed based on the Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition).Referring to drug instructions,clinical treatment guidelines,and relevant literature,perampanel and lacosamide were quantitatively scored from five dimensions of pharmaceutical characteristics,effectiveness,safety,economy,and other attributes.RESULTS The final evaluation score was 77.41 for perampanel and 69.06 for lacosamide.The score of perampanel was higher than 70,so the recommendation for entering the drug use catalog of medical institutions was“strong recommendation”.There was a significant difference in effectiveness and economy between the two drugs.Perampanel had more evidence-based proofs and indications for the treatment of drug-resistant epilepsy and lower average daily treatment cost,so the effectiveness and economy of perampanel was slightly better than that of lacosamide.However,in terms of safety,perampanel had a Boxed Warning from the U.S.Food and Drug Administration about severe psychiatric and behavioral reactions,and it was not as recommended as lacosamide in patients with pregnancy or liver dysfunction.CONCLUSION Perampanel and lacosamide each have advantages in different attributes,and medical institutions can decide whether to introduce them based on the characteristics of patient population and the availability of alternative drugs.