CAJ | 학술논문

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0.05～0.1 mg·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,共入组受者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.
목적 평개은정적신이식수자장배포소A(CsA)절환위타극막사완석효낭(상품명:신보악가복)적유효성화안전성.방법 채용다중심、개방、무대조、비수궤、비쌍맹적림상전첨성연구.부합납입표준적접수CsA치료적은정적신이식수자,안0.05～0.1 mg·kg-1·d-1,혹위CsA제량적1/30～1/50위기시제량,장CsA절환위신보악가복.관찰절환후24주내신공능변화급CsA상관불량반응적개선정황.결과 자2010년11월지2012년11월,공입조수자105례,납입전인분석집101례,부합방안분석집85례,안전성분석집102례.연구기간전부수자균존활,미발생급성배척반응.절환전이급절환후24주내신공능균보지은정상태.총담고순、삼선감유화저밀도지단백교절환전강저,차이유통계학의의(P＜0.05)；입조시환다모증차요구채취간예치료적수자51례(52.0％),절환24주시21례(41.2％)전유,25례(49.0％)명현개선,5례(9.8％)무명현변화.입조시유아간증생차제출치료요구자52례(53.1％),절환후24주시유8례(15.4％)전유,39례(75.0％)명현개선,5례(9.6％)무명현변화.결론 재은정적신이식수자중장CsA절환위신보악가복시안전유효적,병능사신공능이급여CsA상관적고혈압、고혈지、다모증화아간증생등득도명현개선.
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 tacrolimus 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,gingival hyperplasia and hypertrichosis improved significantly (P＜0.01),and no acute rejection episodes occurred.