J Am Pharm Assoc (2003). 2019 Nov-Dec;59(6):816-823.e2. doi: 10.1016/j.japh.2019.08.002. Epub 2019 Sep 11.
For patients who have received a kidney transplant, studies have shown that once-daily prolonged-release tacrolimus (TAC) has similar efficacy and safety to standard twice-daily dosing. The purpose of this study was to perform a meta-analysis to compare the effectiveness and safety of daily TAC (TAC qd) versus standard twice-daily TAC (TAC bid) administration in liver transplantation (LT).
Meta-analysis.
We systematically searched the PubMed/MEDLINE, Web of Science, and Cochrane Library databases for studies comparing outcomes of LT patients who received TAC qd versus TAC bid.
Results were reported as odds ratios (ORs) with 95% CIs.
Six studies, which included 5179 LT recipients (TAC qd = 951; TAC bid = 4228) were included in the analysis. The TAC qd group had a low 1-year graft loss rate (OR 0.70 [95% CI 0.54-0.91], P = 0.008) and lower rate of biopsy-proven acute rejection (BPAR) at 90 days (OR 0.46 [95% CI 0.24-0.89], P = 0.02) compared with the TAC bid group. There was no significant difference in 1-year mortality or the incidence of adverse events after LT between the 2 groups.
Current evidence suggests that TAC qd is safe and effective for LT patients during the first year after transplantation. Longer-term follow-up studies are necessary to determine if TAC qd is safe and effective beyond the first year after LT.
对于已接受肾移植的患者，研究表明，每日一次的延长释放他克莫司（TAC）与标准每日两次剂量的疗效和安全性相当。本研究的目的是进行荟萃分析，以比较肝移植（LT）中每日一次 TAC（TAC qd）与标准每日两次 TAC（TAC bid）给药的有效性和安全性。
荟萃分析。
我们系统地检索了 PubMed/MEDLINE、Web of Science 和 Cochrane 图书馆数据库，以查找比较接受 TAC qd 与 TAC bid 的 LT 患者结局的研究。
结果以比值比（OR）及其 95%置信区间（CI）报告。
共有 6 项研究，包括 5179 例 LT 受者（TAC qd=951；TAC bid=4228）纳入分析。TAC qd 组 1 年移植物丢失率较低（OR 0.70 [95% CI 0.54-0.91]，P=0.008），90 天活检证实的急性排斥反应（BPAR）发生率也较低（OR 0.46 [95% CI 0.24-0.89]，P=0.02）。两组在 1 年死亡率或 LT 后不良事件发生率方面无显著差异。
目前的证据表明，TAC qd 对 LT 患者在移植后第一年是安全有效的。需要进行更长期的随访研究，以确定 TAC qd 在 LT 后第一年之外是否安全有效。
