稳定期肾移植受者将他克莫司普通剂型转换为缓释剂型对移植肾功能的影响

目的观察稳定期肾移植受者由普通剂型他克莫司(Tac)转换为缓释剂型Tac后对移植肾功能的影响。方法回顾性分析山西省第二人民医院2011年12月至2019年6月由普通剂型Tac转换为缓释剂型Tac的83例稳定期肾移植受者,随访12~36个月,同时匹配83例继续服用普通剂型Tac的稳定期肾移植受者作为对照组。观察稳定期肾移植受者由普通剂型Tac转换为缓释剂型Tac后肾功能、谷值浓度个体内变异度(IPV)及依从性的变化、排斥反应的发生率及移植肾和移植受者的存活率。结果普通剂型Tac转换为缓释剂型Tac时间为移植后(42.76±30.50)个月,转换后24个月血清肌酐(SCr)明显低于转换前(P=0.013),估算肾小球滤过率(eGFR)明显高于转换前(P=0.005)。试验组较对照组在转换后36个月SCr明显降低(P=0.017),eGFR明显增高(P=0.038)。试验组转换前免疫抑制剂治疗障碍量表(ITBS)得分为(20.23±2.89)分,转换后为(17.63±3.08)分(P=0.000);Tac每日剂量转换前是(2.09±0.84)mg,转换后为(2.10±0.83)mg;Tac谷值浓度转换前为(7.22±2.84)ng/mL,转换后显著降低,人/肾均健康存活。结论稳定期肾移植受者由普通剂型Tac转换为缓释剂型Tac肾功能保持稳定且较普通剂型Tac相对更好,依从性明显改善,谷值浓度个体内变异度明显降低,长期服用的临床疗效和安全性良好。

Effect of conversion of tacrolimus dosage forms from immediate-release to extended-release on kidney function in stable kidney transplant recipients

Objective To observe the effect of conversion from immediate-release tacrolimus(Tac)to extended-release Tac on kidney function in stable kidney transplant recipients.Methods 83 stable kidney transplant recipients who were converted from immediate-release Tac to extended-release Tac in the second people's hospital of Shanxi province from December 2011 to June 2019 were followed up for 12-36 months,and 83 stable kidney transplant recipients who continued to take immediate-release Tac were selected as control group.The changes of kidney function indexes,Tac trough concentration intra-patient variability(IPV)and compliance,the incidence of rejection and the survival rate of grafts and recipients were observed after the conversion from immediate-release Tac to extended-release Tac in stable kidney transplant recipients.Results The conversion time from immediate-release Tac to extended-release Tac was(42.76±30.50)months after transplantation.At 24 months after conversion,the serum creatinine(SCr)was significantly lower than that before conversion(P=0.013),and the estimated glomerular filtration rate(eGFR)was significantly higher than that before conversion(P=0.005).In the experimental group,the SCr was significantly lower than that of the control group at 36 months after conversion(P=0.017),eGFR was significantly higher than that of the control group(P=0.038).In the experimental group,the score of Immunosuppressant Therapy Barrier Scale(ITBS)was(20.23±2.89)before conversion and(17.63±3.08)after conversion(P=0.000).The daily dose of Tac was(2.09±0.84)mg before conversion and(2.10±0.83)mg after conversion.The trough concentration of Tac before conversion was(7.22±2.84)ng/mL,which reduced significantly after conversion.No rejection occurred after conversion,and the recipients/grafts survived healthily during the follow-up period.Conclusions After conversion from immediate-release Tac to extended-release Tac in stable kidney transplant recipients,the kidney function is stable and better than that of before conversion,the compliance is significantly improved,the IPV of Tac trough concentration is significantly reduced,and long-term use of extended-release Tac has good clinical efficacy and safety.