麦考酚钠肠溶片仿制药与原研药在成人肾移植受者免疫抑制治疗中的对比分析  

Comparison of efficacy,safety and cost analysis between generic and branded enteric-coated mycophenolate sodium in adult recipients of renal transplantation

作　　者：陈好雨 李立志 孙平平 王佳丽 王卫 贾志缃 周华 Chen Haoyu;Li Lizhi;Sun Pingping;Wang Jiali;Wang Wei;Jia Zhixiang;Zhou Hua(Center of Kidney Transplantation&Dialysis,Second People's Hospital of Shanxi Province,Taiyuan 030012,China)

机构地区：[1]山西省第二人民医院肾移植透析中心,太原030012

出　　处：《中华器官移植杂志》2024年第12期885-891,共7页Chinese Journal of Organ Transplantation

基　　金：山西省卫生健康委员会科研课题(2022038)。

摘　　要：目的对比分析麦考酚钠肠溶片(mycophenolate sodium enteric-coated tablets,EC-MPS)仿制药与原研药在成人肾移植受者免疫抑制治疗中的疗效、安全性和经济成本。方法连续纳入2022年1月至2023年10月于山西省第二人民医院行肾移植并根据受者意愿选择EC-MPS仿制药(仿制药组,30例)和原研药(原研药组,30例)治疗受者。对比分析两组受者在基线期(手术日当天前后不超过3 d,W0),治疗后第1(W1)、4(W4)、8(W8)、12(W12)、24(W24)周时肝肾功能、血常规、药物浓度变化,不良事件发生情况以及药物成本等。结果不同时间点肝肾功能和血常规比较,仿制药组和原研药组仅W24时的尿蛋白[0.4(0~0.6)g/24 h比0(0~0.2)g/24 h]、W12时天冬氨酸转氨酶[(15.6±3.3)U/L比(20.3±9.7)U/L]、W1时的白细胞计数[(8.4±2.3)×10^(9)/L比(10.1±3.8)×10^(9)/L)]和血小板计数[(158.5±51.5)×10^(9)/L比(185.8±46.8)×10^(9)/L],差异有统计学意义(P=0.049、0.010、0.045、0.036)。仿制药组和原研药组麦考酚钠血药浓度、药时曲线下面积、各时间点他克莫司谷浓度比较,差异均无统计学意义(P值均>0.050)。仿制药组和原研药组在W4和W12的辅助性T细胞(helper T cell,Th)、抑制性T细胞(T Suppressor cell,Ts)、Th/Ts和B细胞水平比较,差异均无统计学意义(P值均>0.050)。用药成本方面,仿制药组和原研药组EC-MPS数和住院时间比较,差异均无统计学意义(P值均>0.050);药物费用[(1333.5±419.6)元比(2368.6±596.0)元]和住院期间总费用[(96403.3±29159.8)元比(117062.8±28782.1)元]比较,差异有统计学意义(P<0.001和P=0.001)。仿制药组主要不良事件包括反酸19例(63.3%)、低白蛋白血症16例(53.3%)、贫血12例(40.0%)和低钾血症11例(36.7%);原研药组常见不良事件为反酸20例(66.7%)、贫血14例(46.7%)和低白蛋白血症9例(30.0%)。两组所有不良事件发生率比较,差异均无显著差异(P值均>0.050)。结论EC-MPS仿制药和原研药具有相似的�Objective To compare the therapeutic efficacy,safety and drug cost between generic enteric-coated mycophenolate sodium(EC-MPS)and branded EC-MPS in immunosuppressive treatment for adult recipients of renal transplantation(RT).Methods From January,2022 to October,2023,60 adult RT patients were continuously enrolled and randomized into two groups.Patients receiving generic EC-MPS were selected as cohort 1(n=30)while those taking branded EC-MPS designated as cohort 2(n=30).Hepatic/renal function,blood routine parameters,drug concentrations,adverse events(AEs)and drug costs were recorded and compared between two cohorts at baseline(<3 days before/after day of RT,W0),week 1(W1),week 4(W4),week 8(W8),week 12(W12)and week 24(W24)post-RT.Results Only urine protein was elevated at W24[0.4(0-0.6)vs 0(0-0.2)g/24 h,P=0.049]in cohort 1 as compared with cohort 2.Aspartate aminotransferase at W12(15.6±3.3 vs 20.3±9.7 U/L,P=0.010),leucocyte count at W1(8.4±2.3 vs 10.1±3.8×10^(9)/L,P=0.045)and platelet count at W1(158.5±51.5 vs 185.8±46.8×10^(9)/L,P=0.036)all declined in cohort 1 as compared with cohort 2.However,these parameters at other timepoints did not vary between two cohorts(all P>0.050).In addition,blood concentration of MPS after dosing,area under the concentration-time curve and trough concentration of tacrolimus at different timepoints were not different between two cohorts(all P>0.050).Similarly,helper T cells(Th),suppressor T cells(Ts),Th/Ts and B cells at W4/12 did not vary between two cohorts(all P>0.050).Concerning drug cost,no difference existed in the number of tablets or length of stay between two cohorts(both P>0.050).However,cost of EC-MPS(￥1333.5±419.6 vs￥2368.6±596.0,P<0.001)and total cost during hospitalization(￥96403.3±29159.8 vs￥117062.8±28782.1,P=0.001)were lower in cohort 1 than cohort 2.The most common AEs in cohort 1 included acid regurgitation(n=19,63.3%),hypoalbuminemia(n=16,53.3%),anemia(n=12,40.0%)and hypokalemia(n=11,36.7%).And the most common AEs in cohort 2 included acid re

关 键 词：肾移植 免疫抑制剂 仿制药品 原研药品 疗效 安全性 麦考酚钠肠溶片 

分 类 号：R699.2[医药卫生—泌尿科学]