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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32．72 IU／d,术后1年有63例(38．4％)使用胰岛素,平均剂量为13．46 IU／d;CsA组术后1个月有78例(61．9％)使用胰岛素,平均剂量为29．08 IU/d,术后1年有40例(31．7％)使用胰岛素,平均剂量为12．29 IU／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是一种安全有效的基础免疫抑制剂,也适用于儿童和高龄患者。
Objective To investigate the efficacy and safety of long-term use of tacrolimus (FK506) in renal transplant recipients. Methods A total of 862 patients with long-term FK506 after renal transplantation from 1997 to 2005 were selected. According to their age, 18 children (<18 years old) and 692 adults (≥18 years old, ≤60 years old) And 152 patients in the advanced age group (> 60 years old). According to the presence or absence of diabetes before surgery, they were divided into diabetic group (164 cases) and non-diabetic group (698 cases) , Rejection rate and the incidence of adverse reactions. (2) A total of 164 diabetic patients with FK506 (FK506 group) were enrolled. Another 126 patients (CsA group) with cyclosporine A (CsA) diabetes during the same period of renal transplantation were selected. The hyperglycemia Rate and insulin application. Results (1) The 1-year human / kidney survival rates (%) in children group, adult group and senior group were 93.8 / 93.8, 98.8 / 97.2 and 97.8 / 95.7, respectively; 3 The survival rate of human / kidney (%) was 91.7 / 83.3,96.5 / 87.3 and 94.7 / 93.3, respectively. The survival rate of human / kidney at 1 and 3 years in children was slightly lower than that of adults Group and advanced age group, but there was no significant difference between the three groups (P> 0.05). Three children in the child group survived with kidney more than 5 years, and the 5-year human / kidney survival rates (87.5 / 84.4 and 90.4 / 85.7) in the adult and advanced age groups. The 1, 3, 5 years of human / kidney survival rates (%) were 96.5 / 94.4, 91.5 / 84.1 and 88.2 / 82.4 respectively in diabetic group and 98.2 / 97.3,97.1 / 89.1 and 89.7 / 87.2, respectively. There was no significant difference between the two groups (P> 0.05). The incidences of acute rejection at 1, 3, and 5 years in 862 patients were 9.9%, 12.69% and 16.07% respectively. The rates of chronic rejection at 3 and 5 years were 5.25% and 12.5%. The toxic side effects of FK506 were liver damage, kidney poisoning, infection and so on. The incidence rate of FK506 was 7.54%, 5.33% and 12.41% respectively. The incidence of neurotoxicity, mental toxicity and alopecia was 15.89% and 4.76%. The incidence of glucose metabolism disorders in non-diabetic group was 16.7%. (2) In the FK506 group, 112 patients (68.3%) used insulin at one month after operation, with an average dose of 32.72 IU / d. 63 patients (38.4% (13.46 IU / d). In the CsA group, 78 patients (61.9%) were treated with insulin at a mean of 29.08 IU / d at 1 month after surgery, 40 (31.7% With insulin, the average dose was 12.29 IU / d. Conclusion Long-term application of FK506 after renal transplantation can reduce the incidence of rejection and improve the survival rate of renal allografts. FK506 is a safe and effective basic immunosuppressant, also applies to children and elderly patients.