Division of Transplant Surgery, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Division of Transplant Nephrology, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Clin Transplant. 2020 Apr;34(4):e13844. doi: 10.1111/ctr.13844. Epub 2020 Mar 16.
Medication non-adherence is common after transplant and a major contributor to graft loss. The objective of this pilot study was to obtain preliminary safety and adherence data of a complete once-daily immunosuppression regimen of Extended-release-tacrolimus (LCP-tac), everolimus, and prednisone vs LCP-tac, mycophenolate Twice daily (BID), and prednisone through a randomized controlled pilot study of 40 patients (20 in each arm). At 3 ± 2 months post-transplant, patients were randomized to receive LCP-tac and everolimus once daily or LCP-tac and mycophenolate BID (control arm) for 6 months; 80 met eligibility, and 40 were randomized. Mean age was 51 ± 14 years, 33% were female, 45% African American, and 55% had a Calculated panel reactive antibody (cPRA) >20%. Both regimens were well-tolerated, and medication side effect burden tended to be less severe in the intervention group. Self-reported high medication adherence decreased in the control arm from baseline to 6 months (80%-59%), while remaining the same in the intervention arm throughout the study (45%-47%). For safety assessment, there was no rejection, graft loss, or death in either arm. These results provide preliminary evidence of the safety of a novel once-daily immunosuppression regimen. The impact of this once-daily regimen on medication adherence requires a larger long-term study.
移植后药物依从性差是常见的，也是导致移植物丢失的主要原因。本研究旨在通过一项 40 例患者（每组 20 例）的随机对照研究，获得扩展释放他克莫司（LCP-他克莫司）、依维莫司和泼尼松与 LCP-他克莫司、吗替麦考酚酯每日两次（BID）和泼尼松的完整每日一次免疫抑制方案的初步安全性和依从性数据。在移植后 3±2 个月，患者被随机分为每日接受 LCP-他克莫司和依维莫司或 LCP-他克莫司和吗替麦考酚酯 BID（对照组）6 个月；80 名符合条件，40 名被随机分组。平均年龄为 51±14 岁，33%为女性，45%为非裔美国人，55%的计算群体反应抗体（cPRA）>20%。两种方案均耐受良好，干预组药物副作用负担倾向较轻。对照组自报高药物依从性从基线到 6 个月时下降（80%-59%），而干预组在整个研究过程中保持不变（45%-47%）。安全性评估方面，两组均无排斥反应、移植物丢失或死亡。这些结果为新型每日一次免疫抑制方案的安全性提供了初步证据。这种每日一次的方案对药物依从性的影响需要进行更大的长期研究。
