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Grafalon®与Thymoglobulin®作为肾移植诱导剂的对比——一项回顾性研究

Grafalon® vs. Thymoglobulin® as an Induction Agent in Renal Transplantation - A Retrospective Study.

作者信息

Jha Pranaw Kumar, Rana Abhyudaysingh, Kher Ajay, Bansal Shyam Bihari, Sethi Sidharth, Nandwani Ashish, Jain Manish, Bansal Dinesh, Yadav Dinesh Kumar, Gadde Ashwini, Mahapatra Amit Kumar, Sodhi Puneet, Kher Vijay

机构信息

Department of Nephrology, Medanta Institute of Kidney and Urology, Medanta - The Medicity, Sector 38, Gurugram, Haryana, India.

Department of Nephrology, Max Super Specialty Hospital, Vaishali, Ghaziabad, Uttar Pradesh, India.

出版信息

Indian J Nephrol. 2021 Jul-Aug;31(4):336-340. doi: 10.4103/ijn.IJN_205_20. Epub 2020 Nov 11.

DOI:10.4103/ijn.IJN_205_20
PMID:34584347
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8443089/
Abstract

INTRODUCTION

Antihuman thymocyte immunoglobulin, used as an induction agent in renal transplantation, is of two types - thymoglobulin and grafalon (formerly ATG-Fresenius). In this study, we compared outcomes with these two agents.

METHODS

This was a single-center retrospective study of patients transplanted from January 2017 to October 2019, who received either grafalon or thymoglobulin induction. Grafalon or thymoglobulin was given at 6 and 3 mg/kg, respectively, followed by standard triple immunosuppression of tacrolimus, MMF, and prednisolone.

RESULTS

Median follow up was 22 (3-36) months. Thymoglobulin was given to 255 patients, whereas 78 patients received grafalon. Baseline demographics were similar between the two groups although significantly more patients in the grafalon group received ABO incompatible transplant (15% vs. 4.3%; = 0.002). Patient survival was similar between the two groups (99% in grafalon vs. 98.8% in thymoglobulin; = 1.0). Death censored graft survival was also similar (99% in grafalon vs. 100% in thymoglobulin; = 0.23). Biopsy proven acute rejection (BPAR) was significantly higher in the grafalon group (12.8% vs. 5.1%, = 0.04). The significance persisted after multivariable regression analysis ( = 0.02). Other outcomes such as infection rate and estimated glomerular filtration rate on last follow up were comparable between the two groups.

CONCLUSIONS

Grafalon (6 mg/kg dose) when used as an induction agent was associated with significantly higher rate of BPARs as compared to thymoglobulin (3 mg/kg dose) although with comparable short-term patient and death censored graft survival, graft function, and infection rates.

摘要

引言

抗人胸腺细胞免疫球蛋白在肾移植中用作诱导剂,有两种类型——即胸腺球蛋白和格拉伏龙(以前称为ATG-费森尤斯)。在本研究中,我们比较了使用这两种药物的结果。

方法

这是一项单中心回顾性研究,研究对象为2017年1月至2019年10月接受移植的患者,这些患者接受了格拉伏龙或胸腺球蛋白诱导治疗。格拉伏龙或胸腺球蛋白分别以6mg/kg和3mg/kg的剂量给药,随后进行他克莫司、霉酚酸酯和泼尼松龙的标准三联免疫抑制治疗。

结果

中位随访时间为22(3-36)个月。255例患者接受了胸腺球蛋白治疗,而78例患者接受了格拉伏龙治疗。两组的基线人口统计学特征相似,尽管格拉伏龙组接受ABO血型不相容移植的患者明显更多(15%对4.3%;P=0.002)。两组患者的生存率相似(格拉伏龙组为99%,胸腺球蛋白组为98.8%;P=1.0)。死亡截尾的移植物生存率也相似(格拉伏龙组为99%,胸腺球蛋白组为100%;P=0.23)。格拉伏龙组活检证实的急性排斥反应(BPAR)明显更高(12.8%对5.1%,P=0.04)。多变量回归分析后,这种显著性仍然存在(P=0.02)。两组的其他结果,如感染率和最后一次随访时的估计肾小球滤过率相当。

结论

与胸腺球蛋白(3mg/kg剂量)相比,格拉伏龙(6mg/kg剂量)用作诱导剂时,BPAR发生率明显更高,尽管短期患者和死亡截尾的移植物生存率、移植物功能和感染率相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/811c/8443089/ebaa3afa1d12/IJN-31-336-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/811c/8443089/ed9ef1121201/IJN-31-336-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/811c/8443089/d96037b31564/IJN-31-336-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/811c/8443089/ebaa3afa1d12/IJN-31-336-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/811c/8443089/ed9ef1121201/IJN-31-336-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/811c/8443089/d96037b31564/IJN-31-336-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/811c/8443089/ebaa3afa1d12/IJN-31-336-g003.jpg

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本文引用的文献

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Thymoglobulin vs. ATG-Fresenius as Induction Therapy in Kidney Transplantation: A Bayesian Network Meta-Analysis of Randomized Controlled Trials.胸腺球蛋白与 ATG-Fresenius 在肾移植中的诱导治疗:随机对照试验的贝叶斯网状荟萃分析。
Front Immunol. 2020 Apr 3;11:457. doi: 10.3389/fimmu.2020.00457. eCollection 2020.
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Efficacy and Safety of ATG-Fresenius as an Induction Agent in Living-Donor Kidney Transplantation.
ATG-费森尤斯作为活体供肾移植诱导剂的疗效与安全性
Transplant Proc. 2017 Apr;49(3):481-485. doi: 10.1016/j.transproceed.2017.02.005.
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