两种他克莫司制剂（progaf®和ADVAGRAF®）在马来西亚肾移植患者中的安全性和有效性比较研究

Q4 Medicine

Journal of the University of Malaya Medical Centre Pub Date : 2019-05-06 DOI:10.22452/JUMMEC.VOL22NO1.4

R. MacGuad, N. Zaharan, Wan Md Adnan Wah, Z. Chik, Ganji Sh

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引用次数: 0

摘要

目的：作为移植患者的标准免疫抑制剂，每天一次的他克莫司制剂Advagraf®正越来越多地取代每天两次的他克莫司Prograf®。在本研究中，在马来西亚多民族肾移植人群中，比较了Advagraf®与Prograf®的临床安全性和有效性。方法：这项回顾性研究确定了在马来亚大学医学中心（UMMC）从Prograf®转为Advagraf®的肾移植患者（n=69）。获得了一年、转换前后的临床记录和实验室记录，包括他克莫司的每日剂量和谷值。对疑似不良事件的因果关系评估是基于世界卫生组织-尤普萨拉监测中心的标准。根据更新的Banff 2007活检确诊急性排斥反应（BPAR）分类，重新评估肾活检记录。结果：转换为Advagraf®后，他克莫司的平均谷值和日剂量分别从6.11±2.15降至4.91±1.25 ng/mL和4.08±2.19降至3.48±1.79 mg/mL，显著降低（p<0.01）。血清肌酐和估计肾小球功能没有显著差异。高密度脂蛋白显著升高（p=0.005），甘油三酯显著降低（p=0.003）。BPAR的发生率为16%（Prograf®4例，Advagraf®7例）。在研究期间，没有患者死亡或丢失移植物。共有34例不良事件，分为确定（5%）、可能（36%）、可能的（23%）和不可能的（36%），各组之间没有显著差异。结论：Prograf®和Advagraf®他克莫司制剂在马来西亚肾移植患者中具有可比的安全性和有效性。Advagraf®可能在脂质分布方面具有优势。关键词：Prograf®，肾移植，Advagraf®，急性排斥反应，安全性

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SAFETY AND EFFICACY OF TWO TACROLIMUS FORMULATIONS (PROGRAF® AND ADVAGRAF®) IN MALAYSIAN RENAL TRANSPLANT PATIENTS: A COMPARATIVE STUDY

Aim: A once-daily formulation of tacrolimus, Advagraf®, is increasingly being used in place of twice-daily tacrolimus, Prograf®, as a standard immunosuppressive agent for transplant patients. In this study, the clinical safety and efficacy of Advagraf® were compared with Prograf®, among multi-ethnic Malaysian renal transplanted population. Method: This retrospective study identified renal transplant patients who were converted from Prograf® to Advagraf® at the University Malaya Medical Centre (UMMC) (n=69). Clinical notes and laboratory records, including tacrolimus daily dose and trough levels, were obtained for one-year, pre-and post-conversion. Causality assessment of suspected adverse events were based on the WHO-Uppsala Monitoring Center criteria. Renal biopsy records were re-evaluated based on the updated Banff 2007 classification for biopsy-confirmed acute rejection (BPAR). Results: Following conversion to Advagraf®, the mean tacrolimus trough level and daily dose decreased significantly (p<0.01) from 6.11±2.15 to 4.91±1.25 ng/mL and 4.08±2.19 to 3.48±1.79 mg/day, respectively. There was no significant difference in serum creatinine and estimated glomerular function. HDL was significantly increased (p=0.005) while triglycerides was significantly decreased following conversion to Advagraf® (p=0.003). The incidence of BPAR was 16% (4 cases in Prograf® and 7 cases in Advagraf®). No patients died or lost their grafts during the study period. There were 34 cases of adverse events which were classified as certain (5%), probable (36%), possible (23%) and unlikely (36%) with no significant difference between groups. Conclusion: Prograf® and Advagraf® tacrolimus formulations have comparable safety and efficacy profiles among Malaysian renal transplant patients. Advagraf® may have an advantage in terms of lipid profile. Keywords: Prograf®, Renal Transplant, Advagraf®, Acute Rejection, Safety

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Journal of the University of Malaya Medical Centre Medicine-Medicine (all)

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0.30

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0.00%

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