Department of Nephrology and Transplantation Medicine, Wroclaw Medical University, Wroclaw, Poland.
Medical Department, Chiesi Poland Sp z o.o., Warsaw, Poland.
Transplant Proc. 2024 May;56(4):776-780. doi: 10.1016/j.transproceed.2024.01.060. Epub 2024 Mar 6.
BACKGROUND/AIM: Tremor is common with tacrolimus treatment and is linked with peak blood drug concentrations. We investigated the effect of switching from immediate-release tacrolimus (IR-TAC) to MeltDose prolonged-release tacrolimus (LCPT) on tremor in kidney transplant recipients experiencing tremor at therapeutic levels of IR-TAC.
The Activities of Daily Living Subscale (ADL, range 0-48, lower = better) of the Essential Tremor Rating Scale was used to assess the effect of therapy change on speech, occupational impairment and social activities over a 12-month follow-up period.
The study included 18 patients (mean age = 45.6 y, range 26-73; median (IQR) time from transplant = 1.1 y (0.6-1.5), with baseline IR-TAC trough concentrations (C) ranging from 4.2 to 9.4 ng/mL (mean C = 6.7 ± 1.3 ng/mL). After the switch to LCPT, the mean ADL score improved from baseline 11.2 to 8.4 after 7 to 14 days (an 18% improvement, P < .001). This improvement was sustained after 3 months (ADL score = 5.0, 46% improvement vs baseline), 6 months (ADL score = 4.4, 48% improvement vs baseline), and 12 months (ADL score = 3.6, 63% improvement vs baseline); all P < .001. Despite a 40% reduction in LCPT daily doses (mean -1.9 mg/day compared to IR-TAC), the achieved C was constant during the course of the 12-month observation (P = .755). The renal function remained stable after conversion (eGFR 12 months vs baseline = +1.1 mL/min/1.73 m, 95% CI: -5.6 to +7.9).
Conversion to LCPT may alleviate symptom burden and improve daily activities in kidney transplant recipients experiencing tremor within therapeutic IR-TAC concentrations.
背景/目的:震颤是他克莫司治疗中的常见现象,与血药峰浓度有关。我们研究了将即时释放他克莫司(IR-TAC)转换为MeltDose 缓释他克莫司(LCPT)对在治疗性 IR-TAC 浓度下出现震颤的肾移植受者震颤的影响。
使用原发性震颤评定量表的日常生活活动量表(ADL,范围 0-48,得分越低表示情况越好)评估治疗变化对 12 个月随访期间言语、职业障碍和社会活动的影响。
研究纳入 18 例患者(平均年龄 45.6 岁,范围 26-73;从移植到研究开始的中位数(IQR)时间为 1.1 年(0.6-1.5),IR-TAC 谷浓度(C)范围为 4.2 至 9.4ng/ml(平均 C = 6.7±1.3ng/ml)。转换为 LCPT 后,ADL 评分从基线的 11.2 分改善至 7-14 天后的 8.4 分(改善 18%,P<.001)。这种改善在 3 个月(ADL 评分=5.0,与基线相比改善 46%)、6 个月(ADL 评分=4.4,与基线相比改善 48%)和 12 个月(ADL 评分=3.6,与基线相比改善 63%)时持续存在;所有 P<.001。尽管 LCPT 日剂量减少了 40%(与 IR-TAC 相比平均减少 1.9mg/天),但在 12 个月的观察过程中,C 保持不变(P=0.755)。转换后肾功能保持稳定(eGFR 12 个月与基线相比增加 1.1ml/min/1.73m,95%CI:-5.6 至+7.9)。
对于在治疗性 IR-TAC 浓度下出现震颤的肾移植受者,转换为 LCPT 可能减轻症状负担并改善日常活动。