Department of Surgery, Ajou University School of Medicine, Suwon, South Korea.
Department of Surgery, Samsung Medical Center, Seoul, South Korea.
Asian J Surg. 2020 Jun;43(6):660-667. doi: 10.1016/j.asjsur.2019.07.011. Epub 2019 Jul 25.
Many immunosuppressive drugs are prescribed as twice-daily dosing. A simplified once-daily dosing of immunosuppressive drug regimen may improve medication adherence. We investigated medication adherence of simplified once-daily immunosuppressive regimen consisting of extended-release tacrolimus, sirolimus, and corticosteroids along with the efficacy and safety of this regimen.
This study was a prospective, multicenter, controlled and cohort trial. Stable kidney transplant recipients who had received transplantation at least 3 months before the study enrollment were eligible for the study. Participants were required to fill-out the self-reported immunosuppressant therapy barrier scale (ITBS) questionnaire before and after the conversion. Other clinical laboratory parameters and adverse events were evaluated until 6 months post-conversion.
A total of 160 kidney recipients comprised the intention-to-treat population. The mean total ITBS score was 19.5 ± 4.0 at pre-conversion and 6 months after converting, the mean total ITBS score was 16.6 ± 3.6 (p < 0.001). Particularly, the ITBS scores of 4 questions related to the frequency of medication dosing were significantly different between pre-conversion and post-conversion. Only 1 patient (0.62%) was diagnosed as biopsy-confirmed acute rejection in the study period. There was no significant change in the mean estimated glomerular filtration rate after the conversion. Overall 95 patients (59.4%) had an adverse event and 28 patients (17.5%) had a serious adverse event. No graft loss and 1 death were reported.
Medication adherence after the conversion to the once-daily immunosuppressive regimen was significantly improved with no additional risks of efficacy failure or adverse events.
许多免疫抑制剂药物被规定为每日两次给药。简化为每日一次的免疫抑制剂方案可能会提高药物依从性。我们研究了由延长释放他克莫司、西罗莫司和皮质类固醇组成的简化每日一次免疫抑制方案的药物依从性，以及该方案的疗效和安全性。
这是一项前瞻性、多中心、对照和队列研究。在研究入组前至少 3 个月接受过移植的稳定肾移植受者有资格参加研究。参与者在转换前后需要填写自我报告的免疫抑制剂治疗障碍量表（ITBS）问卷。在转换后 6 个月内评估其他临床实验室参数和不良事件。
共有 160 例肾移植受者构成意向治疗人群。转换前的平均总 ITBS 评分为 19.5±4.0，转换后 6 个月的平均总 ITBS 评分为 16.6±3.6（p<0.001）。特别是，与药物给药频率相关的 4 个问题的 ITBS 评分在转换前后有显著差异。在研究期间，仅 1 例（0.62%）患者被诊断为经活检证实的急性排斥反应。转换后平均估计肾小球滤过率无明显变化。总体而言，95 例（59.4%）患者发生不良事件，28 例（17.5%）患者发生严重不良事件。无移植物丢失和 1 例死亡报告。
转换为每日一次免疫抑制方案后，药物依从性显著提高，且没有疗效失败或不良事件增加的风险。
