摘要
目的 比较阿利西尤单抗和依洛尤单抗用于治疗高脂血症的临床综合价值,以期为临床合理用药提供参考。方法 根据《药品临床综合评价管理指南(2021年版试行)》,围绕技术评价与政策评价两条主线,从安全性、有效性、经济性、创新性、适宜性、可及性6个维度开展科学规范的定性定量相结合的数据整合分析与综合研判,通过文献回顾性分析、专家访谈,以此来确定各维度评价指标。结果 在安全性方面,依洛尤单抗除在注射部位反应发生率更低外,其他安全性指标两药品差异均无统计学意义。在有效性方面,阿利西尤单抗在全因死亡方面显著低于依洛尤单抗,其余有效性指标两者差异均无统计学意义。在经济性方面,阿利西尤单抗与依洛尤单抗经济性相当。在创新性方面,阿利西尤单抗与依洛尤单抗基本一致。在适宜性方面,阿利西尤单抗与依洛尤单抗均提升了患者的依从性,但阿利西尤单抗的药动学结果更好。在可及性方面,阿利西尤单抗与依洛尤单抗在中国的价格均为国际最低价,两种药品的配备率大致相同,可负担性方面也相当。通过德尔菲法结果显示,依洛尤单抗总得分为7.88分,阿利西尤单抗总得分为8.11分。结论 阿利西尤单抗与依洛尤单抗在各维度表现相近,综合评价,阿利西尤单抗略优于依洛尤单抗。
Objective To compare the clinical comprehensive value of alirocumab and evolocumab in the treatment of hyperlipidemia,aiming to provide references for clinical rational drug use.Methods According to the Guidelines for the Comprehensive Clinical Evaluation of Drugs(Trial Implementation,2021),focusing on the two main lines of technical evaluation and policy evaluation,a scientific and standardized data integration analysis and comprehensive research and judgment were carried out based on the six dimensions of safety,efficacy,economy,innovation,suitability,and accessibility through qualitative and quantitative methods.Evaluation indicators for each dimension were determined through literature retrospective analysis and expert interviews.Results In terms of safety,there was no significant difference in safety indicators between the two drugs except for a lower incidence of injection site reactions of evolocumab.In terms of efficacy,alirocumab showed significantly lower all-cause mortality than evolocumab,and no significant difference between the two drugs in other efficacy indicators.In terms of economy,alirocumab and evolocumab had similar economic value.In terms of innovation,alirocumab and evolocumab were basically the same.In terms of suitability,both drugs improved patient compliance,but alirocumab had better pharmacokinetic results.In terms of accessibility,the prices of alirocumab and evolocumab in China are among the lowest in the world,and the availability of the two drugs is roughly the same,and they were also equally affordable.The results from the Delphi method showed a total score of 7.88 for evolocumab and a total score of 8.11 for alirocumab.Conclusion Alirocumab and evolocumab have similar performance in each dimension.Overall,alirocumab is slightly better than evolocumab.
作者
查镜凯
何琼
王丽娜
徐伟
ZHA Jing-kai;HE Qiong;WANG Li-na;XU Wei(International Pharmaceutical Business,School of China Pharmaceutical University,Nanjing 211198,China)
出处
《临床药物治疗杂志》
2023年第8期46-50,共5页
Clinical Medication Journal
