五酯胶囊在他克莫司缓释剂型转换中对个体变异度的影响  

Effect of Wuzhi Capsules on interpersonal variations in the conversion of twice-daily tacrolimus into once-daily sustained-release formulation in stable kidney transplantation recipients

作　　者：王振[1] 曹玉 乜兆玲 赵杰[1] 王辉[1] 冯刚[1] 莫春柏[1] 宋文利[1] 付迎欣[1] Wang Zhen;Cao Yu;Nie Zhaoling;Zhao Jie;Wang Hui;Feng Gang;Mo Chunbai;Song Wenli;Fu Yingxin(Department of Kidney Transplantation,First Central Municipal Hospital,Tianjin 300192,China)

机构地区：[1]天津市第一中心医院肾移植科,300192

出　　处：《中华器官移植杂志》2020年第10期619-622,共4页Chinese Journal of Organ Transplantation

基　　金：国家自然科学基金(81970654)。

摘　　要：目的探讨在肾功能稳定受者中,五酯胶囊在他克莫司普通剂型向缓释剂型转换中对个体内变异度(IPV)的影响。方法选取2010年1月至2019年10月在天津市第一中心医院行肾移植手术且由他克莫司普通剂型向缓释剂型转换的158例肾功能稳定的受者,药物转换前后随访3个月。根据药物转换时是否使用五酯胶囊,分为佐剂组53例和非佐剂组105例,比较两组药物转换前后的IPV[(血药浓度与平均值差值/血药浓度平均值)×100],他克莫司和五酯胶囊剂量变化。结果佐剂组和非佐剂组转换前后他克莫司使用剂量差异无统计学意义[佐剂组(3.6±1.1)mg/d和(3.5±1.2)mg/d,P=0.237;非佐剂组(2.7±1.2)mg/d和(2.7±1.3)mg/d,P=0.117],与转换前相比,转换后佐剂组IPV下降约29.2%,差异无统计学意义(P=0.061),非佐剂组IPV下降约31.7%,差异有统计学意义(P=0.0002)。佐剂组转换后五酯胶囊使用剂量增加2例(3.77%),无变化34例(64.15%),减少17例(32.08%),转换前后五酯胶囊使用变化与他克莫司剂量变化无相关性(r=0.230,P=0.097)。结论五酯胶囊的使用减弱了他克莫司缓释剂型转换对浓度变异度的改善效果,肾功能稳定受者不使用五酯胶囊在转换为他克莫司缓释剂型后获益更大。Objective To explore retrospectively the effect of Wuzhi Capsules on interpersonal variations(IPV)in the conversion of twice-daily tacrolimus into once-daily sustained-release formulation in stable kidney graft recipients.Methods From January 2010 to October 2019,a total of 158 renal transplant recipients with stable renal function underwent renal transplantation.According to the dosing status of Wuzhi Capsules,they were divided into two groups of adjuvant and non-adjuvant.During a follow-up period of 3 months,the changes of IPV,doses of tacrolimus and Wuzhi Capsules were compared between two groups.Results No significant inter-group difference existed in the dose of tacrolimus before and after conversion[(3.6±1.1)vs(3.5±1.2)mg/d in adjuvant group,P=0.237;(2.7±1.2)vs(2.7±1.3)mg/d in non-adjuvant group,P=0.117].As compared to IPV pre-conversion,IPV decreased by 29.2%in adjuvant group,there was no statistical difference(P=0.061);that of non-adjuvant group decreased by 31.7%,there was statistical difference(P=0.0002).In adjuvant group,the dose of Wuzhi Capsules was boosted(n=2,3.77%),unchanged(n=34,64.15%)and lowered(n=17,32.08%).No correlation existed between dose change of Wuzhi Capsules and tacrolimus before and after conversion(r=0.230,P=0.097).Conclusions The dosing of Wuzhi Capsules weakens the effect of tacrolimus sustained-release formulation on concentration variation.And patients taking no Wuzhi Capsules benefit more after a conversion into tacrolimus sustained-release formulation.

关 键 词：肾移植 钙调磷酸酶抑制剂 细胞色素P-450 

分 类 号：R699.2[医药卫生—泌尿科学]