大剂量兔抗人胸腺细胞免疫球蛋白推注给药对肾移植患者血管重建的安全性和有效性——长期结果

Safety and efficacy of high dose ATG bolus administration on rewascularization in kidney graft patients--long term results.

作者信息

Samsel Radosław, Pliszczyński Jacek, Chmura Andrzej, Korczak Grazyna, Włodarczyk Zbigniew, Cieciura Tomasz, Lagiewska Beata, Glyda Maciej, Wyzgal Janusz, Paczek Leszek, Durlik Magdalena, Rowiński Wojciech

机构信息

Department of General and Transplantation Surgery - Warsaw Medical University, Warsaw, Poland.

出版信息

Ann Transplant. 2008;13(1):32-9.

PMID:18344941

Abstract

BACKGROUND

Various preparations of ALG/ATG have been used in clinical transplantation for more than 30 years. In recent years the number of high immunological risk patients has increased and biological agents are being used as induction therapy. The aim of this prospective, randomized study was to asses the safety and efficacy of a single high dose of antithymocyte globulin (9 mg/kg ATG Fresenius S) in cadaveric renal transplantation. The maintenance immunosuppressive regimen consisted of steroids, mycophenolate mofetil (converted after the fourth month to azathioprine), and cyclosporine.

MATERIAL/METHODS: Between November 1997 and April 1999, 79 recipients were included into the study. Patients were randomized to ATG (n=40) or the standard treatment group (n=39) with a follow up period of 5 years.

RESULTS

The incidence of acute rejection was lower in the ATG group--9 patients (22.5%) compared to 14 in the control group (35.9%) (p=NS). The total number of all acute rejections episodes in the ATG group was 11 and 23 in the control group. Steroid resistant rejections occurred in 4 (10%) and 8 (20.5%) patients respectively. The number of infectious complications was similar in both groups (65% - ATG, 67.5% - control, p=NS). Graft survival was 70% for the ATG and 69.23% for the control group. Death censored graft survival was 85% in the ATG and 74.43% in the control group (p=NS).

CONCLUSIONS

Induction Therapy with high single dose of ATG seems to be safe and efficacious in kidney transplantation.

摘要

背景

各种抗淋巴细胞球蛋白（ALG）/抗胸腺细胞球蛋白（ATG）制剂已在临床移植中使用了30多年。近年来，高免疫风险患者的数量有所增加，生物制剂正被用作诱导治疗。这项前瞻性随机研究的目的是评估单次高剂量抗胸腺细胞球蛋白（9mg/kg费森尤斯ATG S）在尸体肾移植中的安全性和有效性。维持免疫抑制方案包括类固醇、霉酚酸酯（第四个月后转换为硫唑嘌呤）和环孢素。

材料/方法：1997年11月至1999年4月期间，79名受者纳入研究。患者被随机分为ATG组（n=40）或标准治疗组（n=39），随访期为5年。

结果

ATG组急性排斥反应的发生率较低——9例患者（22.5%），而对照组为14例（35.9%）（p=无统计学意义）。ATG组所有急性排斥反应发作的总数为11次，对照组为23次。分别有4例（10%）和8例（20.5%）患者发生类固醇抵抗性排斥反应。两组感染并发症的数量相似（ATG组65%，对照组67.5%，p=无统计学意义）。ATG组移植物存活率为70%，对照组为69.23%。死亡校正移植物存活率ATG组为85%，对照组为74.43%（p=无统计学意义）。