痛风患者使用别嘌醇或非布司他治疗前行HLA-B~*58:01基因多态性检测的成本-效果分析

Cost-effectiveness Analysis of HLA-B~*58:01 Gene Polymorphism Detection before Gout Patients Using Allopurinol or Febuxostat

目的:为痛风患者优选药物治疗方案提供参考。方法:收集莆田学院附属医院2016年7月1日-2017年7月1日收治的符合痛风临床诊断标准的患者107例,按照是否进行人类白细胞抗原B(HLA-B)~*58:01基因检测将受试者分为A、B组。A组患者按照基因检测结果分为阳性、阴性2个亚组,阳性亚组给予非布司他40 mg,qd;阴性亚组给予别嘌醇300 mg,tid,2周为1个疗程,1个疗程后检测尿酸水平,若未达标则改用非布司他40 mg,qd治疗。B组患者给予别嘌醇治疗,1个疗程后检测尿酸水平,若未达标则改用非布司他治疗,用法用量与A组相同。两组患者均治疗6个月。考察两组患者治疗前后的尿酸水平,评价治疗达标情况;并电话随访两组患者的欧洲五维健康量表评分,以质量调整生命年(QALY)评价治疗效果;计算两组患者的成本-效果,并进行敏感度分析。结果:治疗前,两组患者的尿酸水平比较,差异无统计学意义(P>0.05);治疗后,两组患者尿酸水平显著低于同组治疗前,差异有统计学意义(P<0.05)。A组的治疗效果为0.818 QALY,B组为0.808 QALY,两组比较差异无统计学意义(P>0.05)。A组患者的治疗成本为3 932.46元,B组为2 174.92元,两组的成本-效果比分别为4 807.41和2 691.73,A组明显高于B组,表明B组方案更具成本-效果优势。敏感性分析支持此结果。两组患者的不良反应发生率比较,差异无统计学意义(P>0.05)。结论:痛风患者不进行基因检测直接选用别嘌醇治疗的方案更具成本-效果优势。

OBJECTIVE：To provide reference for optimizing gout drug therapy plan. METHODS：A total of 107 patients met gout clinical diagnosis criteria in the Affiliated Hospital of Putian University during Jul. 1 st,2016-Jul. 1 st,2017 were divided into group A and B according to carrying out HLA-B＊58：01 gene detection or not. Group A was divided into positive and negative subgroup according to the results of gene detection. Positive subgroup was given febuxostat 40 mg,qd. Negative subgroup was given allopurinol 300 mg,tid with a treatment course for 2 weeks,the level of uric acid was detected after a treatment course;febuxostat was given instead if the level of uric acid was not up to the standard. Group B was given allopurinol;after a treatment course,the level of uric acid was detected;febuxostat was given instead（usage and dosage as group A）if the level of uric acid was not up to the standard. Both groups were treated for 6 months. The levels of uric acid were investigated in 2 groups before and after treatment so as to evaluate up-to-standard rate of treatment. European 5-D health scale of 2 groups were followed up with telephone to calculate therapeutic efficacy by QALY. Cost-effectiveness of 2 groups were calculated,and sensitivity analysis was conducted. RESULTS：Before treatment,there was no statistical significance in urine acid levels between 2 groups（P0.05）.After treatment,urine acid levels of 2 groups were significantly lower than before treatment with statistical significance（P0.05）.Therapeutic effectiveness was 0.818 QALY in group A and 0.808 QALY in group B,without statistical significance between 2 groups（P0.05）. The cost of group A was 3 932.46 yuan,and that of group B was 2 174.92 yuan. Cost-effectiveness ratio of 2 groups were 4 807.41 and 2 691.73,and group A was significantly higher than group B. The therapy plan of group B showed that cost-effectiveness advantage. Sensitivity analysis supported the results. There was no statistical significance in the incidence of ADR between 2 groups（P0.05）. CONCLUSIONS：It shows costeffectiveness advantage to directly use allopurinol without gene detection in gout patients.