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肝移植中每日 1 次与每日 2 次长时释放他克莫司的比较。

Once-daily prolonged-release tacrolimus versus twice-daily tacrolimus in liver transplantation.

出版信息

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.

Abstract

OBJECTIVE

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).

DESIGN

Meta-analysis.

SETTING AND PARTICIPANTS

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.

OUTCOME MEASURES

Results were reported as odds ratios (ORs) with 95% CIs.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

设计

荟萃分析。

设置和参与者

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。

结果测量

结果以比值比(OR)及其 95%置信区间(CI)报告。

结果

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。

结论

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。

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