Oinincal study on increased Mood concentration of cyclosporin A influenced by nicadipine in renal transplantation recipients

Objective To study the effect of nicadipine on blood pressure (BP) and blood trough level concentration of cyclosporin A ( CsA) in renal transplantation recipients. Methods Sixty-two cases of renal transplantation recipients in the study group whose renal function had recovered to be normal were treated with CsA. and nicadipine, and 23 cases of renal transplantation recipients in the control group were treated with CsA and nifedipine. Hood trough levels and dose of CsA.serum creatinine(SCr) and BP were determined and served as indicators of clinical evaluation. Results After the treatment of nicadipine, the blood trough level of CsA was increased significantly, and BP was decreased and kept within normal range. Furthermore, the dose of CsA was reduced by 34.2% 6 months later compared with that before the treatment(P<0.01). No significant effects on renal function were observed before and after the treatment. Conclusion Nicadipine is safe and effective for the treatment and prevention of hypertension aft     

The effects of diltiazem in renal transplantation patients treated with cyclosporine A

Objective： To investigate the effects of diltiazem and cyclosporine A （CsA） combination therapy on protecting the kidney, promoting graft functioning and improving post-transplanted kidney recovery. Methods： The blood con- centrations of CsA, the condition of the post-transplant kidney, the rate of acute rejection （AR）, as well as hepatic and renal toxicity in 636 cases of renal transplant recipients were determined after being treated by CsA, with or without diltiazem. Results： Compared with the control group which received CsA, mycophenolate mofetil （MMF） and prednisolone （Pred） but lacked diltiazem, the group receiving these agents together with diltiazem required reduced dosage of CsA （P 〈 0.01）, while blood concentrations of CsA were significantly increased （P 〈 0.01）; the recovery time of graft function was reduced from （6.2± 1.5） d to （3.9± 1.4） d （P 〈 0.01）, and the rate of AR was decreased from 13.2% to 7.9% （P 〈 0.01）. Conclusion： In renal transplantation patients treated with CsA and diltiazem, blood concentrations of CsA were increased while the dosage was decreased. This efficient combination therapy reduced patients economic burden, at the same time retained kidney function, promoted graft function recovery and decreased hepatic and renal toxicity and the rate of AR.     

Use of PCR and PCR-SSP for detection of urinary donor-origin DNA in renal transplant recipients with acute rejection

Objective To analyze the urine of renal recipients for the pressence of donor DNA in an attempt to establish an alternative diagnostic means of acute rejection.Methods Sixty-four renal transplant recipients were examined.Thirty-seven were normal after transplantation,while 22 others developed acute rejection,based on serum creatinine levels and/or needle biopsy findings of the graft.Five developed drug-induced renal dysfunction.In female recipients with a male graft,we examined urine for the presence of Ychromosome(SRY and DYZ-1) and in recipients receiving and HLA mismatched graft,we looked for HLA-DR gene(DRB1)using PCR.Results Among the 14 female recipients with male grafte demonstrating stable renal function,only one was positive for SRY and DYZ-1 on the Y chromosome.However,sry AND DYZ-1 were found in the urine of four female patients with acute rejection,but these DNA fragments were not detected in 3 of the 4 after anti-rejection therapy.The last patient was referred to hemodialysis.Of 23 recipients of a graft from HLA mismatch donors with stable renal function,DRB1 was negative in 21(91%).Of 18 patients with acute rejection,DRB1 was positive in 16(89%)and negative in 2.these ENA fragments were no longer found in 13 patients after anti-rejection therapy.In all patients with drug induced renal dysfunction,donor-derived DNA was negative.Conclusions Presence of door specific DNA in the urine of the recipient is strongly associated with acute rejection.Analysis of dna DNA derived from donor cells in urine was an effective and accurate method for the diagnosis of acute rejection of a renal transplant.     

Establishment of a sensitized canine model for kidney transplantation

Objective:To establish a sensitized canine model for kidney transplantation. Methods: 12 male dogs were averagely grouped as donors and recipients. A small number of donor canine lymphocytes was infused into different anatomic locations of a paired canine recipient for each time and which was repeated weekly. Specific immune sensitization was monitored by means of Complement Dependent Cytotoxicity (CDC) and Mixed Lymphocyte Culture (MLC) test. When CDC test conversed to be positive and MLC test showed a significant proliferation of reactive lymphocytes of canine recipients, the right kidneys of the paired dogs were excised and transplanted to each other concurrently. Injury of renal allograft function was scheduled determined by ECT dynamic kidney photography and pathologic investigation. Results:CDC test usually conversed to be positive and reactive lymphocytes of canine recipients were also observed to be proliferated significantly in MLC test after 3 to 4 times of canine donor lymphocyte infusions. Renal allograft function deterioration occurred 4 d post-operatively in 4 of 6 canine recipients, in contrast to none in control dogs. Pathologic changes suggested antibody-mediated rejection (delayed) or acute rejection in 3 excised renal allograft of sensitized dogs. Seven days after operation, all sensitized dogs had lost graft function, pathologic changes of which showed that the renal allografts were seriously rejected. 2 of 3 dogs in control group were also acutely rejected. Conclusion：A convenient method by means of repeated stimulation of canine lymphocyte may induce specific immune sensitization in canine recipients. Renal allografts in sensitized dogs will be earlier rejected and result in a more deteriorated graft function.     

TWO-YEAR OBSERVATION OF A RANDOMIZED TRIAL ON TACROLIMUS-BASED THERAPY WITH WITHDRAWAL OF STEROIDS OR MYCOPHENOLATE MOFETIL AFTER RENAL TRANSPLANTATION

Objective To evaluate the safety and feasibility of steroid or mycophenolate mofetil (MMF) withdrawal from tacrolimus-based immunosuppressant regimen in renal allograft recipients. Methods A cohort of 45 patients following cadaveric renal allograft transplantation were randomly divided into 3 groups based on the regimen of combination of tacrolimus, steroid, and MMF: triple therapy group, steroid withdrawal group, and MMF withdrawal group. During 2 years, survival of patients and allografts, clinical acute rejection, adverse events, hepatic and renal allograft function, and blood lipids were monitored to evaluate the safety and feasibility of steroid or MMF withdrawal after renal transplantation. Results During two-year observation, steroid or MMF was successfully withdrawn from immunosuppressant regimen based on tacrolimus without any clinical acute rejection. Patient and graft survival rates were 100% and all the renal allografts kept excellent function. Some adverse events occurred and there were no significant differences among groups. Conclusion Withdrawal of steroid or MMF in low-immunological-risk renal allografts treated with tacrolimus-based immunosuppressant regimen can be achieved with no increased risk of acute rejection.     

Influence of pregnancy on graft after renal transplantation

Objective To investigate the influence of pregnancy on graft after renal transplantation. Methods Clinic data from 13 female transplant recipients with pregnant duration more than 5 months from May 1978 to March 2002 were retrospectively analyzed. Results Immunosuppresive programs: 4 patients received CsA plus Pred, 5 CsA, MMF plus Pred, and 4 FK506, MMF plus Pred. Among the 13 cases, 10 had successful pregnancies with stable graft function; one died of pulmonary infection and cardiac insufficiency with functioning graft after delivery ( the bady was safe); 2 experienced chronic rejection proven by biopsy, getting graft lost and pregnancy terminated: one returened to hemodialysis till now and one received successful retransplantation after 1-year hemodialysis. 11 offerings are healthy by now. Conclusion Patient/kidney survival in our study was 76.9 %. Our data and literature have demonstrated that pregnancy has no effect on graft long-term survival or function. It is advisable in a woman of childbearing     

Strong additive effect of calcitriol and cyclosporine A on lymphocyte proliferation in vitro and rat liver allotransplantations in vivo

Background Vitamin D3 and its metabolites have been found to exert immunosuppressive effects both in vivo and in vitro. We investigated the synergistic effect of calcitriol and cyclosporine A (CsA) on lymphocyte proliferation in vitro and graft rejection following rat liver allotransplantations in vivo.Methods Alloantigen driven, human peripheral mononuclear cells’ proliferation and cytokine production capacity were tested in the presence or absence of various concentrations of calcitriol or CsA. In vivo, liver allografts were transplanted in a high responder strain combination (SD to Wistar) rats and combination of subtherapeutical dose of CsA and calcitriol was administered in recipients, whereas the control recipients received single or no immunosuppressant. Proliferation of splenocyte from recipient was tested with mixed lymphocyte reaction. Serum interleukin-2 (IL-2) and interferon gamma (IFN-γ) concentrations were measured with enzyme linked immunosorbent assay. Results Combined medication of 10(-9) mol/L calcitriol and 100 ng/ml CsA inhibited human peripheral mononuclear cells’ proliferation to alloantigen and the production of IL-2 and IFN-γ but promoted that of IL-4 and IL-10. Similarly, combination of 250 ng·kg(-1)·d(-1) calcitriol and 1.0 mg·kg(-1)·d(-1) CsA showed an additive effect in liver transplant model. It restrained splenocyte proliferation to alloantigen from donor and significantly reduced serum concentration of IL-2 and IFN-γ in recipients. Consequently, allograft rejection in combined medication group was minor (median William’s grade was 1.0 vs 3.0 in combined medication group and in the control group, P&lt;0.05) and the recipients’ survival was evidently prolonged [(93.7±5.8) days vs (12.6±1.4) days in combined medication group and in the control group, P&lt;0.01].Conclusion A combination of calcitriol and CsA has an additive effect on limiting lymphocyte proliferation and prolonging liver graft survival. With its additional immunomodulating property, calcitriol is a potent immunosuppressant that can extend the therapeutic window of classical immunomodulators in prevention and treatment of liver graft rejection.     

Anti-CD3 and -CD4 monoclonal antibody in the treatment of steroid-resistant renal allograft rejection.

Between November 1987 and October 1991, 40 consecutive cadaveric renal recipients immunosuppressed with cyclosporine (CsA) who developed renal allograft rejection were treated with domestically prepared muromonab CD3 (Wu 338) and CD4 (Wu167). CD3 and CD4 monoclonal antibodies (McAb) as rescue treatment (n = 34) successfully reversed 29 cases of (85.3%) intractable renal allograft rejection (steroid resistant rejection 32 and anti-human thymocyte globulin [AHTG] resistant rejection 2) and completely reversed 4 cases of acute renal rejection episodes CD3 McAb as first-line treatment (n = 4). Two cases of chronic rejection failed in the treatment of McAb. Rejection episodes were reversed from 4 to 11 days (mean 6 days). Combined use of CD3 and CD4 McAb seemed to yield better results. Peripheral blood T lymphocyte subsets showed that CD3+, CD4+ and CD8+ decreased significantly after the treatment of McAb. No severe side-effects were observed in the treatment of McAb. The McAb could be administered safely. Pulmonary infection rate was 15%. The yearly graft survival rate was increased significantly (87.8% vs 80.0%).

     

TWO-YEAR OBSERVATION OF A RANDOMIZED TRIAL ON TACROLIMUS-BASED THERAPY WITH WITHDRAWAL OF STEROIDS OR MYCOPHENOLATE MOFETIL AFTER RENAL TRANSPLANTATION

Objective To evaluate the safety and feasibility of steroid or mycophenolate mofetil （MMF） withdrawal from tacrolimus-based immunosuppressant regimen in renal allograft recipients.
Methods A cohort of 45 patients following cadaveric renal allograft transplantation were randomly divided into 3 groups based on the regimen of combination of tacrolimus, steroid, and MMF： triple therapy group, steroid withdrawal group, and MMF withdrawal group. During 2 years, survival of patients and allografts, clinical acute rejection, adverse events, hepatic and renal allograft function, and blood lipids were monitored to evaluate the safety and feasibility of steroid or MMF withdrawal after renal transplantation.
Results During two-year observation, steroid or MMF was successfully withdrawn from immunosuppressant regimen based on tacrolimus without any clinical acute rejection renal allografts kept excellent function. Some adverse events among groups. Patient and graft survival rates were 100% and all the occurred and there were no significant differences
Conclusion Withdrawal of steroid or MMF in low-immunological-risk renal allografts treated with tacrolimus-based immunosuppressant regimen can be achieved with no increased risk of acute rejection.     

Rapamycin instead of mycophenolate mofetil or azathioprine in treatment of post-renal transplantation urothelial carcinoma

Background Malignant tumor is the most common complication occurred in transplant recipients. It is widely recognized that immunosuppressive treatments increase the risk of cancer in transplant recipients. The efficacy and safety of rapamycin （RPM） in combination with low-dose calcineurin inhibitor （CNI） in treating 15 renal allograft recipients which developed urothelial carcinoma were observed.
Methods Immunosuppressive regimen in all recipients was altered with rapamycin to replace mycophenolate mofetil （MMF） or azathioprine （Aza）. The initial loading dosage was 2 mg/d, and the next dosage was 1 mg/d. The dosage of rapamycin was carefully adjusted according to the blood drug level and concentration of the drug was maintained at 4-6 μg/L. In all the 15 patients, the calcineurin inhibitor was reduced down to one third of the original dosage after the rapamycin blood concentration became stable. Surgical treatment and intravesical instillation chemotherapy were carried out in all patients. Recurrence of the tumor was monitored throughout the study. Post-transplant renal function and side effects were also closely monitored.
Results Among the 15 patients, 9 had no tumor recurrence in 2 years, 2 had tumor recurrences twice, and 4 had once. There was no acute rejection observed during RPM treatment. Post-transplant renal function in 11 patients was improved with a decreased creatinine level. Hyperlipoidemia and thrombocytopenia were the most frequent adverse events which responded well to corresponding treatments.
Conclusion Among the renal allograft recipients with urothelial carcinoma, combination of rapamycin and low dose calcineurin inhibitor treatment is effective and safe.     

普乐可复在肾移植中的临床应用探讨

目的:评价普乐可复(FK506)对肾移植患者免疫抑制作用的疗效和安全性。方法:将70例肾移植患者分为两组。普乐可复组(n=35):主要用药为普乐可复+硫唑嘌呤(Aza)+泼尼松(Pred);环孢素A(CsA)组(n=35):主要用药为CsA+Aza+Pred。结果:观察6个月,普乐可复组急性排斥发生率为0,而CsA组有9例(25.7%)发生急性排斥反应(P<0.05);普乐可复组的肝毒性和神经毒性反应发生率均比CsA组低(P<0.05);普乐可复组有3例(8.6%)发生高血糖反应(P>0.05)。结论:普乐可复在肾移植中排斥发生率低,毒副作用小,是一种安全高效的新型免疫抑制剂。     

乙型肝炎病毒携带者肾移植术后应用他克莫司和环孢霉素A的临床研究

目的 比较他克莫司和环孢霉素A在乙型肝炎病毒携带者肾移植术后的疗效和安全性.方法 符合入选标准的109例肾移植患者,随机分成他克莫司(FK506)治疗组(52例)和环孢霉素A(CsA)治疗组(57例),随访2年,比较两组的人肾存活率、急性排斥反应(AR)发生率、肝功能异常发生率和药物转换率等.结果 CsA和FK506组的2年人肾存活率分别为86.0%/73.7%和94.2%/90.3%(P＜0.05).AR发生率分别为10.5%和9.6%(P＞0.05).CsA组和FK506组的肝功能异常发生率分别为26.3%和15.4%(P＜0.05).CsA组有21.1%的患者接受静脉护肝药物治疗,而FK506组为9.6%(P＜0.05).CsA组有14.4%的患者转换为FK506,而FK506组没有病人转成CsA(P＜0.05).转换后,谷丙转氨酶/谷草氨酶在10～50 d内由[(255.13±31.38/201.88±21.25)U/L)]降至[(31.25±11.50/25.13±9.68)U/L](P＜0.01).结论 对乙型肝炎病毒携带者肾移植患者,FK506比CsA有更好的疗效和更高的安全性,可作为首选的基础免疫抑制剂.     

肾移植术后早期应用不同免疫抑制治疗方案的疗效-成本分析

目的　寻找适合国人肾移植受者术后早期的免疫抑制治疗方案。方法　 4 5 3例肾移植受者按不同免疫抑制治疗方案分成国产环孢素A(CyclosporineA ,CsA)组和他克莫司 (Tarclolimus,FK5 0 6 )组 ,并将两组病例临床资料进行统计及比较。结果　FK5 0 6组肝炎携带受者及高危移植受者多于CsA组 (P <0 0 0 1) ;两组病例在年龄、男女比例、体重、住院时间、术后第 10天血肌酐值、术后并发症发生率等方面差异无显著性 (P >0 0 5 ) ;CsA组治疗费用低于FK5 0 6组 (P <0 0 0 1)。结论　肾移植受者术后早期应用国产CsA疗效好、费用低 ;肝炎携带受者及高危移植受者术后早期应用FK5 0 6疗效较佳。     

肝移植受者服用FK506期间T淋巴细胞亚群、NK、CIK细胞的分析

目的分析肝移植受者服用FK506期间外周血T淋巴细胞亚群、NK细胞及CIK细胞的变化,探讨其在移植排异监测中的作用。方法采用流式细胞仪(FCM)检测技术对17例服用FK506的肝移植受者及25例健康对照者进行外周血的K506QIJIANT淋巴细胞亚群、NK细胞及CIK细胞检测,然后以健康体检者为对照进行统计学分析。FK506血药浓度的测定采用酶联免疫分析法测定。结果肝移植受者术后3个月组的T淋巴细胞亚群CD3值高于健康对照组(TamhaneT2法P=0.004),术后1个月组的T淋巴细胞亚群CD4值高于健康对照组(TamhaneT2法P=0.040),术后2周组、术后1个月组、术后3个月组的NK值均低于健康对照组(LSD-t检验P≤0.023),术后1个月组的CIK值低于健康对照组(TamhaneT2法P=0.005)。结论肝移植受者在服用FK506期间,外周血中T淋巴细胞亚群、NK细胞、CIK细胞可作为移植排异反应的监测指标。当FK506血药浓度恒定时,可使T淋巴细胞亚群、NK细胞、CIK细胞的值保持在正常水平。     

环孢素A和他克莫司对1型糖尿病肾移植受者血糖的影响

目的 观察和比较环孢素A与他克莫司对1型糖尿病肾移植受者血糖的影响,为1型糖尿病肾移植受者术后早期选择合理的免疫抑制剂提供参考.方法 收集1型糖尿病肾移植受者40例,随机分为CsA组和FK506组.同种异体肾移植术后,CsA组予环孢素A（CsA）＋吗替麦考酚脂（MMF）＋强的松（Pred）行免疫抑制治疗,共20例;FK506组予他克莫司（FK506）＋MMF＋Pred行免疫抑制治疗,共20例.各组受者术前均用胰岛素控制空腹血糖（FBG）和糖化血红蛋白（HbA1c）至基本正常,术后降糖方案与术前相同.观察和比较两组肾移植受者术前和术后第1、3、6个月的FBG浓度和HbA1c含量.结果 治疗的6个月内,CsA组有3例退出,FK506组有4例退出.CsA组和FK506组的FBG、HbA1c水平逐渐升高.CsA组的FBG在术后第6个月比术前显著升高（P〈0.05）,而CsA组HbA1c含量在术后各时间段与术前比较差异均无统计学意义（P〉0.05）.FK506组FBG水平在术后第3、6个月比术前显著升高（P〈0.05）,FK506组HbA1c水平在术后第6个月比术前显著升高（P〈0.05）.FK506组FBG水平在术后第3、6个月比CsA组显著升高（P〈0.05）,FK506组HbA1c水平在术后第6个月比CsA组显著升高（P〈0.05）.结论 FK506对I型糖尿病肾移植受者术后早期升高血糖的影响比CsA大.     

肾移植术后普乐可复应用的临床研究

目的研究肾移植术后应用普乐可复免疫抑制治疗的临床疗效和毒副作用。方法随机将62例肾移植受者分成两组：（1）FK506组（n=24）：应用FK506＋骁悉（MMF）＋强的松（Pred）治疗方案;（2）环孢素A（CsA）组（n=38）：应用CsA＋MMF＋Pred治疗方案。结果随访24个月,FK506组有2例（8.3%）、CsA组有9例（23.7%）发生急性排斥反应（P〈0.05）;两组肾功能恢复指标血清肌酐值无明显差异（P〉0.05）;FK506组和CsA组分别有3例（12.5%）和14例（36.8%）发生肝功能损害（P〈0.05）;分别有13例（54.2%）和22例（57.9%）血压升高（P〉0.05）;分别有4例（16.67%）和6例（15.79%）血糖升高（P〉0.05）。结论 FK506具有强效的免疫抑制作用,对于发生急性排斥反应、严重肝功能损害等肾移植术后患者由CsA切换成FK506治疗是安全有效的;应用时须根据血药浓度调整剂量,以减少不良反应的发生。     

肾移植术后应用普乐可复(FK506)逆转环孢素A(CsA)引起肝功能损害的临床研究

目的 :观察普乐可复 (FK5 0 6 )替换环孢素A(CsA)在防治尸肾移植术后药物性肝损害的有效性和安全性。方法 :选择 2 5例尸肾移植术后应用CsA出现肝功能异常而肾功能正常患者 (移植术后 2个月～ 36个月 ,年龄 2 3岁～ 5 8岁 ) ,以FK5 0 6切换CsA ,FK5 0 6初始剂量及维持剂量以患者体重、移植后时间、病情及全血FK5 0 6血药浓度进行相应调整 ,同时予以保肝治疗。结果 :将CsA切换成FK5 0 6治疗 2周～ 4周后 ,患者肝功能指标 (血清ALT、D BIL及I BIL)呈明显下降趋势。 8周～ 10周后 ,19例患者肝功能恢复正常 ,6例接近正常 ,换药前后比较差异有显著性 ,P <0 0 5。肾功能 (血清Cr、BUN)换药前后比较差异无显著性 ,P >0 0 5。以上病例继续随访 3个月～ 6个月 ,肝功能、肾功能全部维持正常。结论 :对CsA引起肝功能损害的尸肾移植患者应用FK5 0 6替换治疗是安全有效的。     

恬尔心对大鼠FK506肾毒性的防治作用

目的探讨肾移植术后首剂治疗剂量他克莫司（FKS06）对大鼠肾脏的毒性作用以及地尔硫革（恬尔心,Dil）对FKS06肾毒性的防治作用。方法按公式将肾移植术后FKS06、环孢素A（CsA）和Dil的首剂治疗剂量换算成大鼠的治疗剂量。SD大鼠24只随机分成对照组、CsA组（25mg·kg^-1·d^-1）、FKS06组（0．8mg·kg^-1·d^-1）和FKS06＋Dil组（0．8mg·kg^-1·d^-1及8mg·kg^-1·d^-1）,用药4周后建立起各组大鼠肾毒性模型。检测各组大鼠的体重、尿标本、肾功能,以及观察肾组织的病理改变。结果CsA组与FKS06组均出现明显的血肌酐上升、肌酐清除率下降、肾小管细胞浊肿及空泡变性。FKS06＋Dil组上述各项指标的变化明显减轻或接近正常。结论肾移植术后首剂治疗剂量FKS06与CsA一样,对大鼠肾脏均具有毒性作用。恬尔心可以防治FKS06的肾毒性。     

三剂赛尼哌在肝移植中应用的临床研究

OBJECTIVES: 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 days after liver transplantation and compared with the results documented in literatures. RESULTS: One patient developed AR 17 days 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 from stenosis and thrombosis of hepatic artery respectively. Ten recipients had various infections. An average of 16.56+/-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)x10(-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.     

他克莫司对终末期糖尿病肾病肾移植的术后治疗

OBJECTIVE: To compare the efficacy and safety of tacrolimus (FK506)- versus cyclosporine (CsA)-based immunosuppression protocol in the treatment of patients with renal transplantation for diabetic end-stage renal disease. METHODS: A total of 64 patients with end-stage renal disease were randomized into FK506 (n=33) and CsA (n=31) group after cadaveric renal transplantation, the former group adopting small-dose FK506 therapy with low trough concentration, and the latter receiving CsA therapy. The dose of insulin was adjusted according to blood glucose level of the patients after the operation. The incidence of acute rejections, blood glucose level, the dose of insulin and changes in blood pressure, lipid metabolism and liver function were compared between the two groups. RESULTS: The 1-year patient/graft survival rates were 96.97%/93.94% in FK506 group and 96.77%/90.32% in CsA group. Four patients (12.12%) developed acute rejection in the FK506 group, while 11 (35.48%) did in the CsA group during the first year after the operation (P<0.05). The dose of the insulin of the FK506 group (34.35 U/d, 14.09 U/d) was not significantly different from that in the CsA group (28.15 U/d, 13.05 U/d) at the first month and 1 year after the operation (P>0.05). One year after the operation, 21 patients (63.63%) required anti-hypertension treatment, 5 (15.15%) needed anti-hyperlipidemia treatment and 3 (9.09%) had abnormal liver function in FK506 group, while in the CsA group, 28 patients (90.32%) needed anti-hypertension therapy, 13 (41.94%) received anti-hyperlipidemia treatment and 11 (35.48%) showed signs of abnormal liver function, with significant differences between the two groups. CONCLUSIONS: Small-dose FK506 therapy with low concentrations is effective in the postoperative management of patients with renal transplantation for diabetic end-stage renal disease, with only mild adverse effect. FK506 is comparable with CsA in terms of the effect on glucose metabolism of the patients.