5种给药方案治疗精神分裂症的成本效果分析

Safety evaluation of the novel antiseizure medication perampanel in the treatment of epilepsy in children

目的:评价不同药物给药方案治疗精神分裂症的经济性,为我国临床用药选择提供参考依据。方法:基于Markov模型模拟一组精神分裂症患者在3种健康状态(稳定、复发、死亡)中的进展,从中国医疗系统角度,收集药品价格和复发患者住院成本费用数据。估算每日口服药物(奥氮平)以及每隔0.5个月(注射用利培酮微球Ⅱ)、1个月(棕榈酸帕利哌酮注射液1M)、3个月(棕榈酸帕利哌酮注射液3M)、6个月(棕榈酸帕利哌酮注射液6M)注射1次药物,共5种给药方案治疗精神分裂症的5年累积成本和健康效果,并计算增量成本效果比,通过敏感性分析评估结果的稳健性。结果:每日口服给药治疗精神分裂症是成本最低的方案,每1个月注射1次的治疗方案效果最好。每0.5和6个月注射1次的方案比每1个月注射1次成本更高但效果更差。与每日口服给药相比,每3个月注射1次每挽救1个质量调整生命年(quality adjusted life year, QALY)需花费66 078.9元,每1个月注射1次每挽救1个QALY需花费143 417.8元,敏感性分析提示模型结果具有较好的稳定性。结论:在2022年中国人均3倍GDP(257 094.0元)的支付意愿阈值下,每1个月注射1次和每3个月注射1次的治疗方案均具成本效果,其中每3个月注射1次的治疗方案最具成本效果,本研究可为我国精神分裂症的临床治疗提供证据。

Objective:To evaluate the safety of perampanel(PER)adjuvant therapy in children with epilepsy.Methods:The safety of 3 months of perampanel treatment in children with epilepsy was retrospectively collected and evaluated.To assess the safety of perampanel using adverse events by the type and frequency during epilepsy treatment in all children.Results:A total of 88 children with epilepsy were included in this study.During the entire PER treatment period,41(46.59%)children with epilepsy experienced at least one adverse drug reaction.The most common adverse reactions were drowsiness(26.14%),dizziness(19.32%),mental and behavioral abnormalities(9.09%),and nausea/vomiting(4.55%).4 children discontinued PER treatment due to adverse effects.The plasma drug concentrations in the adverse drug reaction group after taking PER were significantly higher than that those in the group without adverse reactions[(0.56±0.46)μg·mL^(-1) vs(0.39±0.27)μg·mL^(-1),P<0.05].The proportion of children with epilepsy at a PER plasma trough concentration>0.98μg·mL^(-1) was significantly higher in the adverse drug reaction group than that in the group without adverse drug reactions(21.95%vs 4.26%,P<0.05).Conclusion:The safety of PER is relatively poor.The proportion of adverse reactions is high.It is very necessary to monitor the plasma drug concentration of PER treatment at any time during the drug process.