国产他克莫司防治肾移植排斥反应的临床研究

目的 观察国产他克莫司防治肾移植排斥反应的有效性及安全性. 方法 采用多中心、开放性的比较研究.同种异体肾移植术后患者80例.均为首次接受肾移植受者,分2组:①研究组:58例,接受国产他克莫司胶囊(福美欣)抗排斥反应治疗.男23例,女35例.年龄(39.1±9.6)岁.②对照组:22例,接受进口他克莫司胶囊(普乐可复)抗排斥反应治疗.男12例,女10例.年龄(41.3±8.5)岁.使用他克莫司(进口或国产)加吗替麦考酚酯加泼尼松三联用药方案,其中进口或国产他克莫司的用药剂量均为0.10～015 mg·kg-1·d-1,最初60 d血药谷浓度维持8～12ng/ml,之后维持5～10 ng/ml,12 h给药1次,直至观察终点(术后3个月).体质量≥70 kg受者吗替麦考酚酯剂量1.5～2.0 g/d,50～69 kg受者1.5 g/d,≤49 kg受者1.0 g/d,分2次121服.泼尼松起始剂量亦按照各中心的常规方案.2组间不同时相点的药物使用剂量以及血药谷浓度值的比较行方差分析;2组急性排斥反应及不良事件发生率比较行秩和检验. 结果 2组供者年龄、性别、供肾冷热缺血时间等比较差异均无统计学意义(P>0.05).研究组2例和对照组3例发生急性排斥反应.研究组和对照组包括高血压、高血脂、高血糖和轻度肝功能异常等的不良事件发生率分别为36.2%(21/58)和36.36%(8/22),2组间比较差异无统计学意义(P>0.05).2组移植物和受者存活率均为100%.研究组术后8、12周时药物使用剂量明显低于对照组,分别为(4.83±2.05)和(5.64±1.47)mg、(4.57±1.91)和(5.44±61.43)mg,组间比较差异有统计学意义(P<0.05).2组术后各时相点血药谷浓度比较差异无统计学意义(P>0.05). 结论 国产他克莫司胶囊防治同种异体肾移植急性排斥反应有效、安全.

Clinical research of domestic tacrolimus in management of rejection following renal transplant

Objective To evaluate the efficacy and safety of domestic taerolimus in the manage-ment of acute rejection in renal transplantation reeipienta. Methods A multieeneter, open and com-parative study for domestic Taerolimua and Prograf was performed. Eighty reeipienta of first allogenie renal transplantation were randomized into 2 groups: ①Experimental group (accepting Fumeixin ad-ministration, n=58) included 23 males and 35 females with the mean age of(39.1±9.6)years. ②Control group(accepting Prograf administration, n=22) included 12 males and 10 females with the mean age of(41.34±8.5)years. There was no significant difference in the volume, warm and cold is-chemia time of donor renal, age and sex of donor. All of the 80 cases accepted tacrolimus (domestic or foreign made, at the dose of 0. 10～0. 15 mg·kg-1·d-1 , q 12 h) treatment that combined with MMF and prednisone posttransplantation. Tacrolimus CO was aimed to 8-12 ng/ml in the first 60 days and 5-10 ng/ml later. The dose of MMF was according to the rule of each transplantation center based on the following recommendation: 1.5-2.0 g/d for the weight above 70 kg, 1.5 g/d for the weight 50-69 kg, and 1.0 g/d for the weight below 49 kg, in two divided doses. Prednisone was ad- ministrated as per ruler of each center. Results Observation termination was 3 months. Morbility of actue rejection was 3.40% (2/58)and 13.6% (3/22) in experimental and control group(P>0.05). Ad-verse events including hypertension, hyperlipemia, hyperglycemia and slight abnormality of liver func-tion occurred in 36. 2%(21/58) and 36. 4% (8/22) cases of experimental and control group(P> 0. 05). The survival rate in the 2 groups was 100%. The dose of tacrolimus in experimental group was significantly lower than that in the control group at 8 and 12 weeks posttransplant, while drug valley concentration in serum was proximal in 2 groups during the whole observation period. Conclusion Domestic tacrolimus capsules can be used effectively and safely in the management of acute rejection in renal transplantation.