肾移植术后将环孢素A切换为他克莫司缓释胶囊的临床研究  

Conversion from cyclosporine A to once-daily tacrolimus in stable kidney transplant recipients： a multicenter prosepctive study

作　　者：石炳毅 韩文科[2] 张小东[3] 季曙明[4] 马潞林[5] 刘航[6] 徐达[7] 孙煦勇 林涛[9] 陈知水[10] 刘龙[11] 潘光辉[12] 陈莉萍 

机构地区：[1]解放军第三O九医院全军器官移植研究所,北京100091 [2]北京大学第一医院 [3]首都医科大学附属北京朝阳医院 [4]南京军区南京总医院 [5]北京大学第三医院 [6]北京武警总医院 [7]上海交通大学医学院附属瑞金医院 [8]解放军第三O三医院 [9]四川大学华西医院 [10]华中科技大学同济医学院附属同济医院 [11]沈阳军区总医院 [12]广州医学院第二附属医院

出　　处：《中华器官移植杂志》2014年第2期77-81,共5页Chinese Journal of Organ Transplantation

摘　　要：目的评价稳定的肾移植受者将环孢素A（CsA）切换为他克莫司缓释胶囊（商品名：新普乐可复）的有效性和安全性。方法采用多中心、开放、无对照、非随机、非双盲的临床前瞻性研究。符合纳入标准的接受CsA治疗的稳定的肾移植受者，按0．05～0．1mg·kg-1·d-1，或为CsA剂量的1／30～1／50为起始剂量，将CsA切换为新普乐可复。观察切换后24周内肾功能变化及CsA相关不良反应的改善情况。结果自2010年11月至2012年11月，共人组受者105例，纳入全因分析集101例，符合方案分析集85例，安全性分析集102例。研究期间全部受者均存活，未发生急性排斥反应。切换前以及切换后24周内肾功能均保持稳定状态。总胆固醇、三酰甘油和低密度脂蛋白较切换前降低，差异有统计学意义（P〈0．05）；入组时患多毛症且要求采取干预治疗的受者51例（52．0％），切换24周时21例（41．2％）痊愈，25例（49．0%）明显改善，5例（9．8％）无明显变化。入组时有牙龈增生且提出治疗要求者52例（53．1％），切换后24周时有8例（15．4％）痊愈，39例（75．0％）明显改善，5例（9．6％）无明显变化。结论在稳定的肾移植受者中将CsA切换为新普乐可复是安全有效的，并能使肾功能以及与CsA相关的高血压、高血脂、多毛症和牙龈增生等得到明显改善。Objective To evaluate the safety and efficacy of switch from cyclosporine A （CsA） to prolonged-release tacrolimus in adult stable kidney transplant recipients. Method This multicenter, open-lable, single arm, and uncontroled study in stable adult kidney transplant recipients who had been immunosuppresively treated with CsA and met the inclusion/exclusion creteria were eligible for enrollment. CsA was switched to prolonged-release （once daily） tacrolimus at the initial dose of 0. 05 -0. 1 mg. kg-1 d-1. Change of serum creatinine level （primary endpoint）, as well as serume creatinine, acute rejection, tacrolimus trough concentration, blood pressure, blood lipid, ALT, AST, HDL, TC, TG, LDL, TBIL, fasting blood glucose, gingival hyperplasia and hypertrichosis （second endpoint） during the 24-week of study time were assessed. Result From November 2010 to November 2012, there were 105 patients enrolled with similar baseline characteristics. There was no death and acute rejection during the 24-week follow-up. Serum creatinine remained stable after conversion to taerolimus QD from CsA. TC, TG and LDL after conversion were significantly reduced. HDL, ALT and AST showed no significant change, and TBIL levels were lower at 1st, 2nd, 4th, 8th, and 12th week after conversion than those at the baseline. Hypertrichosis and gingival hyperplasia in more than 90% of recipients were alleviated at week 24 after conversion. Conclusion The conversion from CsA to Tacrolimus QD was safe and effective in stable kidney transplant recipients. Compared with the baseline, renal function was improved significantly （P〈0. 01） at week 24 after conversion, gingivalhyperplasia and hypertrichosis improved sigtlificantly （P〈0. 01 ）, and no acute rejection episodes occurred.

关 键 词：他克莫司缓释胶囊 环孢素 肾移植 有效性 安全性 

分 类 号：R699.2[医药卫生—泌尿科学]