862例肾移植患者应用他克莫司的临床经验

目的 探讨肾移植患者术后长期应用他克莫司（FK506）的疗效和安全性。方法 （1）选取1997至2005年肾移植术后长期应用FK506的患者862例，根据患者的年龄分为儿童组（〈18岁）18例，成人组（≥18岁，≤60岁）692例，高龄组（〉60岁）152例；根据术前是否有糖尿病分为糖尿病组（164例）和非糖尿病组（698例），比较各组间1、3、5年的人／肾存活率、排斥反应率及毒副反应发生率。（2）选择上述应用FK506的糖尿病患者164例（FK506组），另选同期肾移植术后应用环孢素A（CsA）的糖尿病患者126例（CsA组），比较两组1年内高血糖发生率及胰岛素的应用情况。结果 （1）儿童组、成人组和高龄组的1年人／肾存活率（％）分别为93．8／93．8、98．8／97．2和97．8／95．7；3年人／肾存活率（％）分别为91．7／83．3、96．5／87．3和94．7／93．3；儿童组1、3年人／肾存活率略低于成人组和高龄组，但三组间比较，差异均无统计学意义（P〉0.05）。儿童组有3例患者均带肾存活超过5年，成人组和高龄组的5年人／肾存活率（％）为87．5／84．4和90．4／85．7。糖尿病组1、3、5年人／肾存活率（％）分别为96．5／94．4、91．5／84．1和88．2／82．4，非糖尿病组为98．2／97．3、97．1／89．1和89．7／87．2，两组比较，差异无统计学意义（P〉0．05）。862例患者的1、3、5年的急性排斥反应发生率分别为9．9％、12．69％和16．07％；3、5年的慢性排斥反应发生率分别为5．25％和12．5%。FK506的毒副作用有肝功能损害、肾中毒、感染等，其发病率分别为7．54％、5．33％和12．41%，神经、精神毒性和脱发的发生率为15．89％和4．76％。非糖尿病组的糖代谢紊乱发生率为16．7％。（2）FK506组术后1个月有112例（68．3％）使用胰岛素，平均剂量为32．72IU／d，术后1年有63例（38．4%）使用胰岛素，平均剂量为13．46IU／d；CsA组术后1个月有78例（61．9％）使用胰岛素，平均剂量为29．08IU／d，术后1年有40例（31．79／）使用胰岛素，平均剂量为12．29IU／d。结论 肾移植术后长期应用FK506可降低排斥反应发生率，提高移植肾存活率。FK506是一种安会有效的基础免疫抑制剂，也适用于儿童和高龄患者。

Application of tacrolimus in 862 renal transplantation recipients

Objective To explore the long-term clinical effectiveness and safety of tacrolimus (FK506) used in kidney transplant recipients. Methods A total of 862 kidney transplant recipients were divided into pediatric recipients (PR), adult recipients (ADR) and old recipients (ER) according to the age, and into diabetic recipients (DR) and non-diabetic recipients (NDR) according to the complications with or without diabetic mellitus (DM). Survival of patients and grafts, incidence of rejection and side-effects were compared. To those patients with DM, the influence of FK506 and CsA on glycometabolism was compared also. Results The incidence of chronic rejection in 3 and 5 years were 5.25 % and 12.5%, respectively. The incidence of abnormal liver function, nephrotoxicity, infection, nervous system disturbance and alopecia was 7.54 %, 5.33 %, 12.41 %, 15.89 % and 4.76 % respectively. To those recipients without DM, the incidence of glycometabolism disorder was 16. 7 %. To those patients with DM, the incidence of insulin therapy in FK506 and CsA group was 68. 3 % and 61.9 % in a month, 38. 4 % and 31. 7 % in a year respectively (P>0. 05). The dose of insulin was 32.72 IU/d and 29.08 IU/d in a month, 13.46 IU/d and 12.29 IU/d (P>0. 05) in a year, respectively. Conclusions FK506 was an effective and high safe basic immunosuppressant in long-term application in renal transplant recipients, especially suitable for children and old recipients. To those patients with DM, FK506 had almost the same influence on the glucose metabolism as the CsA.