三剂赛尼哌在肝移植中应用的临床研究

摘要/Abstract

摘要： 目的探讨三剂赛尼哌在预防同种异体原位肝移植术后早期急性排斥反应(AR)发生的作用,以及联合他克莫斯(FKS06)、霉酚酸酯(MMF)、皮质类固醇的效果、安全性。方法原位肝移植患者13例,手术前后应用三剂赛尼哌并联合三联免疫治疗,观察术后30d内AR的发生次数及反应程度,移植肝功能的恢复时间,FK506用量及血药浓度变化,感染性疾病及不良反应。将上述结果与国内外同类研究结果相对照。结果本组病人共发生AR1例,发生时间分别为术后17d,应用甲基强地松龙(MP)冲击治疗好转;死亡3例,分别于术后14、19、23d死于肺部真菌感染、移植肝动脉狭窄所致肝衰竭、多器官衰竭;移植肝功能的恢复时间在16.56±10.40d;共10例病人发生各种类型的感染FK506谷值血药浓度维持在(10.25±1.99)×10^-3mg/L(W/V)未发生AR,未发现过敏反应及明显的不良反应。结论三剂赛尼哌结合三联免疫抑制剂治疗或预防AR安全有效且无并发症。联合应用FK506时其谷值血药浓度维持在(10.25±1.99)×10^-3mg/Lg,用药量为5±2mg/d。

Abstract: Objective To observe the clinical efficacy and safety of three-dose regimen of Zenapax combined with tacrolimus (FK506), mycophenolate mofetil (MMF), and steroid in the early-stage management of liver transplantation. Method Thirteen liver transplantation recipients received the same immunosuppression regimen with three-dose Zenapax combined with FK506, MMF, and steroid. The incidence of acute allograft rejection (AR), blood concentration and dosage of FK506, and the liver graft function were observed in the 30 d after liver transplantation and compared with the results documented in literature. Results One patient developed AR 17 d after transplantation and 3 patients died on the postoperative days 14, 19 and 23, respectively, due to pulmonary fungal infection, acute hepatic failure or multiple organ failure resulting of stenosis and thrombosis of hepatic artery respectively. Ten recipients had various infections. An average of 16.5±10.40 d was taken for functional recovery of the liver graft, and the blood concentration of FK506 was maintained at (10.25±1.99)×10^-3 mg/L. Anaphylaxis, post-transplant lymphoproliferative disorder (PTLD), or other adverse effects were not observed. Conclusion Three-dose regimen of Zenapax in combination with FK506, MMF and steroid is safe and effective in the postoperative management of orthotopic liver transplantation.

中图分类号:

R982

何刚, 于立新, 邓文锋. 三剂赛尼哌在肝移植中应用的临床研究[J]. 南方医科大学学报, 2004, 24(07): 729-732.

HE Gang, YU Li-xing, DENG Wen-feng. Clinical study of three-dose regimen of Zenapax in orthotopic liver transplantation[J]. Journal of Southern Medical University, 2004, 24(07): 729-732.

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