转换使用他克莫司缓释胶囊对肾移植受者治疗有效性及安全性的影响

EFFECT OF CONVERSION TO TACROLIMUS SUSTAINED-RELEASE CAPSULES ON TREATMENT EFFICACY AND SAFETY IN KIDNEY TRANSPLANT RECIPIENTS

目的探究由他克莫司普通剂型胶囊转换为他克莫司缓释胶囊治疗后对肾移植受者有效性及安全性的影响。方法选取2019年2月-2020年2月于我院将他克莫司普通剂型等量更换为他克莫司缓释胶囊的患者39例(转换组),以同期行肾移植术后持续服用他克莫司普通剂型的患者100例为对照组,均随访1年,观察分析换药前与换药后3、6、12个月患者肾功能水平、生化指标水平、排斥反应情况、他克莫司血药浓度及浓度个体变异度(IPV)、药物相关不良反应等。结果转换组患者换药后3、6、12个月时的空腹血糖、胆固醇、三酰甘油、低密度脂蛋白、高密度脂蛋白及他克莫司血药浓度分别与换药前比较差异无显著性(P>0.05);但换药后3、6、12个月的IPV及换药后12个月的肌酐水平分别与换药前比较差异有显著性(t=2.228~3.101,P<0.05)。转换组换药后不良反应和排斥反应发生情况与对照组比较差异无显著性(P>0.05)。结论他克莫司缓释胶囊安全性与普通剂型相比差异无显著性,但在改善移植术后患者肾功能及维持他克莫司血药稳态浓度方面优于普通剂型他克莫司。

Objective To investigate the effect of conversion from the ordinary dosage form of tacrolimus to tacrolimus sustained-release capsules on treatment efficacy and safety in kidney transplant recipients.Methods A total of 39 patients who converted from the ordinary dosage form of tacrolimus to tacrolimus sustained-release capsules with the same dose in our hospital from February 2019 to February 2020 were enrolled as conversion group,and 100 patients who received the ordinary dosage form of tacrolimus after kidney transplantation during the same period of time were enrolled as control group.All patients were followed up for 1 year,and related indices were observed before conversion and at 3,6,and 12 months after conversion,including renal function,biochemical parameters,rejection reaction,plasma concentration and intra-patient variability(IPV)of tacrolimus,and drug-related adverse reactions.Results There were no significant differences in fasting blood glucose,cholesterol,triacylglyce-rol,low-density lipoprotein,high-density lipoprotein and tacrolimus between the patients in the conversion group at 3,6 and 12 months after conversion and those before conversion(P>0.05).However,there were significant differences in IPV at 3,6 and 12 months after conversion and creatinine level at 12 months after conversion compared with these before conversion(t=2.228-3.101,P<0.05).There were no significant differences in adverse reactions and rejection reaction after conversion between the two groups(P>0.05).Conclusion There is no significant diffe-rence in safety between tacrolimus sustained-release capsules and the ordinary dosage form of tacrolimus,but tacrolimus sustained-release capsules are superior to the ordinary dosage form of tacrolimus in improving renal function and maintaining the steady-state concentration of tacrolimus in patients after transplantation.