肝移植术后激素24小时撤离的安全性

目的探讨肝移植术后激素24小时撤离的安全性及可行性.方法 76例成人肝移植患者随机分为激素3个月（3 m）撤离组（40例）和24 h撤离组（36例）,所有患者随访至2009年12月,前瞻性比较两组患者术后生存、感染、急性排斥反应、切口愈合不良、肝炎和肝癌复发、新发糖尿病、高脂血症及高血压的发生情况.结果两组间患者术后生存、急性排斥反应、高脂血症、乙肝复发及肝癌复发无明显区别,24 h撤离组的术后切口愈合不良、高血压、感染及新发糖尿病发生率明显低于3 m撤离组.结论肝移植术后采用IL-2单克隆抗体诱导下的以FK506为基础的免疫抑制方案时,激素24 h撤离是安全的,而且可以明显减少激素相关的副作用.     

肝移植术后激素七天撤离方案的临床疗效评价

目的 评价肝移植术后激素7 d撤离方案的临床有效性及安全性.方法 将2005年10月至2007年10月收治的76例供受者血型相同的首次肝移植患者动态随机法分为两组:术后7 d激素撤离组(7 d组,40例)和术后3个月激素撤离组(3个月组,36例),两组均采用以他克莫司(FK506)为基础的免疫抑制方案.7 d组激素用法:术中静脉滴注1000 mg甲泼尼龙,术后按500、240、200、160、80、40和20 mg依次递减,7 d后停用;3个月组激素用法:按7 d组方案静脉滴注甲泼尼龙7 d后,改用甲泼尼龙口服,每隔3 d依次按48、40、32、24、16、8和4 mg递减18 d,然后4 mg口服至术后3个月.随访6个月并评价术后急性排斥反应发生率和不良反应发生率.结果 共有69例完成全部随访,7例患者因死亡和严重细菌感染等原因于相应时间终止实验.两组患者在术后急性排斥反应、高脂血症、高血压发生率方面的差异均无统计学意义(P>0.05);7 d组术后糖尿病的发生率(17.5%比38.9%,X2=4.335,P=0.047)明显低于3个月组.结论 供受者血型相同的肝移植采用以FK506为基础的免疫抑制方案时,术后7 d激素撤离是安全有效的,不增加急性排斥反应发生率,并可以明显降低术后糖尿病发生率.     

两剂激素联合两剂达利珠单抗及他克莫司的免疫抑制方案在肝移植中的应用

目的 探讨两剂激素联合两剂达利珠单抗及他克莫司(FK506)的免疫抑制方案在肝移植中应用的安全性及有效性.方法 中山大学附属第一医院器官移植中心2006年9月至2008年3月共实施成人肝移植74例,排除3例血型不合、4例围手术期死亡外,余67例纳人本研究,其中男性54例,女性13例,年龄28～66岁,平均(46.9±8.7)岁.将67例成人肝移植患者随机分为两组:传统免疫抑制方案(激素3个月撤离)组(n=35)和两剂激素免疫抑制方案组(n=32),比较两组术后代谢并发症、感染(含细菌、真菌及巨细胞病毒感染)及排斥反应的发生率的差异.结果 两组患者的术后早期高血糖发生率,高血糖患者使用胰岛素的平均剂量,随访期内糖尿病、高血压及感染的发生率的差异有统计学意义(P<0.05);术后早期高血压发生率及随访期内排斥反应的发生率和高脂血症发生率无明显差异(P0.05).结论 两剂激素的免疫抑制方案是安全有效的,其不增加急性排斥反应的发生率,并可显著减少长期使用激素引起的各种不良反应及并发症的发生.     

肝移植术后早期激素撤离的临床观察

目的探讨肝移植术后免疫抑制治疗方案中激素的撤离。方法58例肝移植患者,术后采用环孢素A和激素预防排斥反应,10例患者加用霉酚酸酯。术后2～3周,患者的肝功能正常,无排斥反应发生时,试行逐步撤离激素。结果术后随访(9.3±5.5)个月,存活54例,死亡4例,死亡原因为非免疫因素。存活的54例中,术后3个月的激素撤离率为72.2%(39/54),6个月时为76.2%(32/42),12个月为77.8%(21/27)。3例在激素撤离过程中出现排斥反应,恢复减量前剂量,排斥逆转后再次撤离激素;10例加用霉酚酸酯者,术后3～4个月均成功撤离激素。结论术后采用以环孢素A为基础的免疫抑制方案的肝移植患者,部分患者能安全撤离激素。     

肝移植后应用巴利昔单抗同时撤减激素的免疫抑制治疗方案

目的 探讨肝移植后加用巴利昔单抗的情况下采用撤减激素的免疫抑制方案的临床效果.方法 首次肝移植患者60例,术后采用他克莫司和霉酚酸酯预防排斥反应,并分别于术中和术后第4天各给予1剂巴利昔单抗,其中20例不用激素,40例仅术中开放血流前使用甲泼尼龙1次,术后不再使用激素,此60例为撤减激素组.以同期完成的、术后采用含甲泼尼龙的免疫抑制方案的60例肝移植患者为对照组.观察两组患者及移植物的存活情况以及急性排斥反应、巨细胞病毒磷蛋白(CMV pp65)阳性及术后新发糖尿病的发生情况.结果 术后随访12个月,不用激素者、单次使用激素者及对照组的患者存活率分别为95.0%、92.5%和91.7%,移植肝存活率分别为95%、90%和90%,急性排斥反应发生率分别为10.0%、12.5%及11.7%,三者间两两比较,患者存活率、移植肝存活率和急性排斥反应发生率的差异均无统计学意义.不用激素者、单次使用激素者及对照组的CMV pp65阳性率分别为15.0%、20.0%和43.3%,新发糖尿病发生率分别为5.0%、7.5%和30.0%,撤减激素组明显低于对照组(P<0.05).结论 肝移植后,在加用巴利昔单抗的情况下采用撤减激素的免疫抑制方案,并不增加排斥反应的发生率,并能降低CMV pp65阳性率和新发糖尿病发生率.     

移植肾肾炎复发与新发患者的存活情况及影响因素分析

目的分析移植肾肾炎复发与新发患者的存活情况及影响因素。方法回顾性分析接受移植肾穿刺病理活组织检查(活检)的95例患者的临床资料。根据活检结果分为复发组(28例)、新发组(33例)、无肾炎组(34例)。统计并分析3组患者术后1、3、5年生存情况并计算相应生存率,采用Kaplan-Meier生存曲线分析患者5年生存情况。对复发组和新发组患者的临床资料进行单因素分析,再采用Logistic回归分析移植肾肾炎复发和新发患者预后的影响因素。结果 3组患者术后1年生存率比较,差异无统计学意义(均为P0.05)。新发组及无肾炎组患者术后3年生存率分别为97%和100%,均显著高于复发组的86%(均为P0.05)。新发组及无肾炎组患者术后5年生存率分别为82%和91%,均显著高于复发组的61%(均为P0.05)。Logisitic回归分析结果显示,移植肾肾炎复发患者的生存率与肾移植次数、冷缺血时间(≥12 h)、免疫抑制方案、术后血清肌酐(Scr)恢复时间(≥14 d)、术后1个月内情况(急性肾小管坏死、超急性排斥反应、急性排斥反应)及肾炎类型(IgA肾病、局灶节段性肾小球硬化、溶血性尿毒综合征)相关(均为P0.05);移植肾肾炎新发患者的生存率与冷缺血时间(≥12 h)、免疫抑制方案、术后Scr恢复时间(≥14 d)及术后1个月内情况(急性肾小管坏死、超急性排斥反应、急性排斥反应)相关(均为P0.05)。结论移植肾肾炎复发患者的生存率低于新发患者与无肾炎者,冷缺血时间、免疫抑制方案、术后Scr恢复时间及术后1个月内情况是影响移植肾肾炎复发与新发患者预后的重要因素。     

肝癌患者肝移植术后早期激素撤离对肿瘤复发的影响

目的 探讨肝癌患者肝移植术后激素撤离对肿瘤复发的影响。方法 对54例中、晚期原发性肝癌患者施行了肝移植，术后根据3个月内是否撤离激素分为激素撤离组（28例）和激素维持组（26例）。比较两组间排斥反应发生率、半年及1年的肿瘤复发率、1年存活率、血他克莫司（FK506）浓度及生化指标的平均值，运用统计学方法分析两组间差异。结果 激素撤离组和激素维持组排斥反应发生率、半年肿瘤复发率、1年存活率相比，差异无统计学意义；激素维持组1年肿瘤复发率明显高于激素撤离组，差异有统计学意义（P〈0．05）。术后半年，两组FK506浓度的差异无统计学意义。术后1周及术后半年，两组丙氨酸转氨酶、胆红素总量及肌酐分别相比，差异均无统计学意义。术后半年，两组胆固醇总量、中餐前血糖水平相比，差异均有统计学意义（P〈0．05）。结论 肝癌患者肝移植术后3个月内撤离激素是安全的，并不增加排斥反应的发生率，也不需要增加其它免疫抑制剂的用量，可明显降低肿瘤复发率，提高患者的长期存活率。     

恒河猴肝移植术后急性排斥反应时肝组织中转化生长因子-β1的表达

目的检测转化生长因子(TGF)-β1在恒河猴肝移植术后急性排斥反应时肝组织中的表达水平,以评价其作为肝移植术后急性排斥反应早期诊断指标的价值。方法采用改良血管袖套+胆道支撑管+动脉吻合法建立稳定的恒河猴肝移植模型,将其随机分为实验组(围手术期不给予免疫抑制治疗)和对照组(围手术期给予免疫抑制治疗)。继而分别在肝移植术后6 h、12 h、24 h和72 h四个时间点分别收集血清及肝组织,通过肝功能指标检测及移植肝组织苏木精-伊红染色Banff评分评价其移植排斥反应情况,并应用免疫组织化学、Western blot法分别检测TGF-β1蛋白表达情况。结果 1 2组恒河猴肝移植术后12 h、24 h和72 h均有急性排斥反应发生,尤其肝移植后72 h时实验组肝组织急性排斥反应重于对照组,Banff分级水平高于对照组(P<0.05)。2 2组术后ALT、AST和TBIL水平均随着时间的延长呈上升趋势(P<0.05),在移植术后6 h和12 h时2组ALT、AST和TBIL水平比较差异无统计学意义(P>0.05);在移植术后24 h和72 h时实验组ALT、AST和TBIL水平均明显高于对照组,差异有统计学意义(P<0.05)。3免疫组织化学检测TGF-β1蛋白表达结果:实验组肝移植术后12 h后肝组织中TGF-β1免疫组织化学染色阳性面积百分率随着时间延长不断升高,且均明显高于对照组相应时相(P<0.05)。4 Western blot检测TGF-β1蛋白表达的半定量结果:实验组和对照组均在6 h即开始随着时间的延长呈现上调趋势,而实验组上调的幅度较对照组大,在6 h、12 h、24 h和72 h时实验组均分别明显高于对照组相应时相,差异有统计学意义(P值分别是0.003、0.001、0.001、0.001)。结论肝移植术后肝组织中TGF-β1水平升高提示机体细胞免疫功能增强,对肝移植术后急性排斥反应的早期诊断可能有一定意义。     

以西罗莫司为主的免疫抑制方案在肝癌肝移植受者中的应用

目的 探讨肝癌肝移植受者术后采用以西罗莫司联合两剂激素为主的免疫抑制方案的安全性和有效性.方法 2004年3月至2006年10月间,共为92例超出米兰标准的中晚期肝癌患者施行了肝移植.其中89例纳入研究.前54例患者采用以他克莫司为主的免疫抑制方案,后35例患者采用以西罗莫司为主的新免疫抑制方案.术后对两组受者均进行了随访.随访时检测受者的肝肾功能、血糖和血脂水平等生化指标,监测受者感染、急性排斥反应、肿瘤复发、存活率及药物副作用等表现,并对两组免疫抑制方案的效果进行了分析和比较.结果 两组间1年肿瘤复发率、3个月内感染发牛率、术后1个月高血糖发生率及术后1年肾功能损害和高脂血症发生率的比较,差异均有统计学意义(P<0.05);其它指标的比较,无显著性差异.结论 肝癌肝移植受者采用以西罗莫司联合两剂激素为主的免疫抑制方案是安全和有效的.该方案在有效抑制排斥反应的同时可显著降低受者的肿瘤复发率,还可减少感染发生率、高血糖及.肾功能损害,但增加了高脂血症发生率.     

肝移植中应用巴利昔单抗诱导治疗的免疫抑制方案的疗效

目的 探讨肝移植中应用巴利昔单抗诱导治疗的免疫抑制方案的疗效。方法 2007年8月至2009年7月间139例成人肝移植受者接受含巴利昔单抗诱导的免疫抑制方案（诱导组）。以2006年1月至2006年12月间接受常规免疫抑制方案的106肝移植受者为对照组。术后随访12个月,记录两组受者排斥反应、代谢并发症的发生情况,以及患者的存活情况。结果 诱导组术后1个月内急性排斥反应、糖尿病、高血压及感染的发生率分别为7.9％、33.8％、21.6％和22.3％,对照组分别为15.1％、72.6％、40.6％和43.4％,差异有统计学意义(P＜0.05)。术后12个月内,诱导组急性排斥反应、移植后新发糖尿病、高血压以及高脂血症的发生率分别为10.8％、5.0％、4.3％和7.9％,而对照组分别为19.8％、9.4％、8.5％和14.2％,差异有统计学意义(P＜0.05)。诱导组和对照组术后1年的存活率分别为92.1％和88.7％(P＞0.05)。结论 免疫抑制方案中应用巴利昔单抗诱导治疗可以早期撤除皮质激素,并可降低急性排斥反应的发生率及减少使用皮质激素引起的不良反应。     

A Randomized Double-Blind, Placebo Controlled Trial of Steroid Withdrawal after Pediatric Renal Transplantation

In an effort to reduce rejection, extend allograft survival and minimize complications, we hypothesized that robust immunosuppression during the first 6 months after transplantation would allow for the safe withdrawal of steroids. A total of 274 pediatric subjects were enrolled and received an anti-CD25 antibody, sirolimus, calcineurin inhibitor and steroids. At 6 months after transplantation, subjects were randomized to steroid withdrawal (n = 73) versus continued low-dose steroids (n = 59). This study was stopped prior to target enrollment because of the incidence of post-transplant lymphoproliferative disorder. At the time of study termination, 132 subjects had been randomized and were available for analysis. At 18 months after transplantation, there was no difference in the standardized height z score; however, the standardized height velocity was greater in the steroid withdrawal group compared to the control group (p = 0.033). There were no differences in acute rejection episodes between treatment groups. The 3-year allograft survival rate was 84.5% in the control group and 98.6% in the steroid withdrawal group (p = 0.002). The immunosuppressive protocol utilized in this study allowed for the withdrawal of steroids without an increased risk of rejection or allograft loss. However, the complications associated with the use of this immunosuppressive protocol were too high to recommend its routine use in pediatric patients.     

Steroid withdrawal in adult liver transplantation: occurrence at a single center

Backgrounds

Steroids are the predominant immunosuppressive agent used after liver transplantation even though patients may experience steroid-related side effects.

Aims

The objective of this study was to determine whether steroid use influenced the outcomes of liver transplantations.

Methods

Three hundred forty-four adult patients underwent liver transplantation between May 2002 and December 2007. We reviewed the medical records of these patients, excluding those younger than 18 years old or those who died within the first month. The protocol withdrawal group (group 1) ceased steroid use within 5 months after transplantation, while the late withdrawal group (group 2) continued steroid use beyond this 5-month posttransplantation period.

Results

All patients were classified according to the onset of steroid withdrawal (group 1: n = 243; group 2: n = 99). The incidences of biopsy-confirmed and treated acute rejection episodes (ARE) at 12 and 24 months posttransplantation were 7.8% and 12.3% in group 1, but 25.3% and 27.3% in group 2, respectively (P = .001). The incidence of hepatitis B virus (HBV) recurrence in group 2 was higher than that in group 1 (P = .007). The HBV-free survival rates at 1 and 2 years posttransplantation were 99.0% and 97.1% in group 1 and 96.1% and 92.1% in group 2, respectively. New-onset diabetes, avascular necrosis of the femoral head, corticosteroid-resistant ARE, hepatocellular carcinoma recurrence, as well as graft and patient survivals did not differ between the two groups.

Conclusions

Acute rejection episodes and HBV recurrence occurred less frequently when steroids were discontinued within 5 months after liver transplantation.     

Minimization of immunosuppressive therapy and immunological monitoring of kidney transplant recipients with long-term allograft survival

Incidence of cardiovascular complications, cancers and chronic allograft nephropathy (CAN) suggests reduction of immunosuppressive dosages. Some studies analyzed the effects of minimization of immunosuppression until the avoidance of immunosuppressive drugs. However minimization seems to be related to a higher incidence of acute rejection. Induction of tolerance after transplantation and use of immunological tests that could monitor the immune reactivity are required. The aim of this study is to evaluate immunological state in a group of recipients after deceased and living donor kidney transplantation and to minimize immunosuppressive therapy monitoring simultaneously clinical and immunological parameters. We analyzed 41 patients, 38 from deceased donors and 3 from living donor kidney transplantation. All patients were treated with triple immunosuppressive therapy: cyclosporine or sirolimus or tacrolimus, mycophenolate mofetil and steroids. In all recipients the presence of CD8+CD28- T suppressor cells (Ts) was analyzed. Patients were divided in 2 groups, according to the presence of Ts. In patients with Ts, (Group A, n=19), mycophenolate mofetil (MMF) was progressively reduced and then stopped. Steroids were subsequently reduced and then interrupted, maintaining an immunosuppressive therapy with low doses of calcineurin inhibitors (CNI) or sirolimus (SIR). 22 patients were without presence of Ts: we enrolled for the study only patient acute rejection free, without proteinuria and with creatinine levels stable (Group B, n=19). In these patients, MMF was reduced and then stopped, while steroids were decreased to 5 mg at alternate days, maintaining CNI or SIR at medium therapeutic dosages (minimized therapy). Patient and graft overall survival in Group A and in Group B were respectively at 100% and 94.7%. Incidence of acute rejection was respectively at 0% in group A and 15.7% in Group B. Presence of episodes of acute rejection in Group B confirms risk of later minimization of steroids and the relevance of the analysis of recipient immunological reactivity before modification of immunosuppressive therapy. A careful evaluation of recipient immune reactivity with the presence of T regulatory cells can allow adequate and personalized immunosuppressive regimens, without high risks of acute rejection.     

肾移植中2剂舒莱和2剂赛尼哌对外周血可溶性白细胞介素-2受体水平的影响及意义

目的:探讨2剂舒莱和2剂赛尼哌在尸体肾移植中对外周血可溶性白细胞介素2受体(sIL2R)水平的影响及意义。方法:105例首次接受尸体肾移植的受者随机分为舒莱组、赛尼哌组和对照组,所有受者术后均接受普乐可复或环孢素A加骁悉加泼尼松三联疗法。另外舒莱组在术前2h、术后4天静脉滴注20mg舒莱,赛尼哌组在前24h、术后7天静脉滴注50mg赛尼哌。检测各组术前及术后每周共8周外周血中sIL2R水平变化,记录2个月内急性排斥(AR)的例数。结果:舒莱和赛尼哌组外周血中sIL2R水平分别在术后8周和3周内比对照组低(P<0.05)。术后第4～6周舒莱组比赛尼哌组低(P<0.05)。在术后2个月内,舒莱组、赛尼哌组和对照组发生急性排斥反应的例次分别为1、9、17例,各组比较差异有统计学意义(P<0.05)。结论:2剂舒莱对外周血中sIL2R的抑制及抗急性排斥反应效果比2剂赛尼哌好。     

肝移植后采用巴利昔单抗进行免疫诱导治疗

目的 探讨肝移植后采用巴利昔单抗进行免疫诱导治疗预防急性排斥反应的有效性和安全性.方法 160例肝移植患者中,47例术后给予两剂巴利昔单抗(20 mg/剂)进行免疫诱导治疗(研究组),另外113例为对照组,不使用巴利昔单抗.所有患者术后均采用他克莫司、霉酚酸酯和糖皮质激素预防排斥反应.结果 术后1年内,研究组的急性排斥反应发生率为8.5%(4/47),对照组为22.1%(25/113),二者间的差异有统计学意义(P＜0.05);研究组排斥反应活动指数平均为4,对照组为6,两组间的差异无统计学意义(P＞0.05).研究组术后感染发生率为31.9 %(15/47),对照组为26.5%(30/113),两组间的差异无统计学意义(P＞0.05).研究组患者及移植肝1年存活率分别为95.7%和95.7%,对照组分别为96.5%和94.7%,两组间的差异均无统计学意义(P＞0.05).两组间其它不良反应发生率的差异也无统计学意义.结论 在以他克莫司为基础的免疫抑制治疗方案中,采用巴利昔单抗进行诱导治疗可明显降低肝移植后急性排斥反应发生率,且不增加感染和其它不良反应发生率.     

肺移植术后免疫治疗方案的探讨

目的总结肺移植术后急性排斥反应的诊断和治疗,探讨优化的免疫抑制方案对提高肺移植术后排斥反应的疗效。方法2002年11月至2006年6月,行肺移植手术16例,其中单肺移植7例、双肺移植9例,免疫抑制方案采用他克莫司（FK506）、霉酚酸酯（骁悉）和泼尼松为主的新三联和（或）辅以赛尼哌治疗。结果本组中除早期2例双肺移植术中因出现严重的肺水肿和早期移植肺失功能死亡外,其余14例手术成功,术后急性排斥反应发生率为21．4％（3／14）。应用赛尼哌辅助方案的8例患者术后6个月内无移植后急性排斥反应。在三联方案的6例中,术后有3例出现急性排斥反应。结论他克莫司、骁悉和泼尼松为主的新三联和（或）辅以赛尼哌治疗方案,在预防肺移植后患者早期急性排斥反应有较好疗效。     

Multicenter Randomized Prospective Trial of Steroid Withdrawal in Renal Transplant Recipients Receiving Basiliximab, Cyclosporine Microemulsion and Mycophenolate Mofetil

Corticosteroids withdrawal from immunosuppressive regimens has thus far been associated with increased risk of acute rejection episodes. In this study, basiliximab, a chimeric monoclonal interleukin-2 receptor antagonist, added to a maintenance regimen consisting of cyclosporine microemulsion and mycophenolate mofetil was studied for its effectiveness in allowing early corticosteroid withdrawal in de novo renal allograft recipients. Primary renal transplant recipients receiving basiliximab, cyclosporine-microemulsion, and mycophenolate mofetil, were randomized to either corticosteroid withdrawal at day four post-transplantation (n = 40) or standard steroid therapy (n = 43). The primary endpoint was the incidence of biopsy-proven acute rejection episodes. Randomized subjects who underwent transplantation and received at least one dose of basiliximab were analyzed in an intent-to-treat fashion. The incidence of biopsy-proven acute rejection at 12 months was not significantly different between the steroid withdrawal group (20%) and the standard treatment group (16%). Patient and graft survival was 100% in the steroid withdrawal group while one death in a patient with a functioning graft occurred in the standard steroid group. Seventy-two percent of the steroid withdrawal group remained off steroids at 6 months post-transplant. Allograft function and incidence of adverse events and infections were similar between the two groups. Rapid and early corticosteroid withdrawal among renal transplant recipients receiving basiliximab induction and daily therapy with cyclosporine-microemulsion and mycophenolate mofetil was not associated with an increased risk of acute rejection.     

以西罗莫司为主的免疫抑制方案在肝细胞癌肝移植术后的应用

目的:评估西罗莫司为主的免疫抑制方案在肝细胞癌行肝移植术后应用的安全性及对术后肿瘤复发和生存的影响。方法:回顾性分析2006年1月至2013年1月在本院肝移植中心因肝细胞癌行肝移植手术的64例病人的临床资料,根据术后是否应用西罗莫司分为西罗莫司组和他克莫司组,比较两组移植术后急性排异、肝动脉栓塞、胆道并发症、切口并发症、代谢疾病、肿瘤复发和病人生存等情况。结果:两组在急性排异、肝动脉栓塞、胆道并发症和切口并发症的发生率方面差异无统计学意义(P>0.05),西罗莫司组新发糖尿病的发生率显著低于他克莫司组,而高血脂的发生率则高于他克莫司组(P<0.05)。与他克莫司组比,西罗莫司组肿瘤1年复发率明显降低,累积生存率明显升高(P<0.05)。结论:肝细胞癌肝移植术后西罗莫司为主的免疫抑制方案并不增加移植术后急性排异、肝动脉栓塞、胆道并发症和切口并发症的发生率,且可延迟肿瘤的复发,提高病人的生存率。     

Three-year observational follow-up of a multicenter, randomized trial on tacrolimus-based therapy with withdrawal of steroids or mycophenolate mofetil after renal transplant

BACKGROUND: The challenge in renal transplantation is to improve long-term patient and graft survival without increasing early acute rejection by minimizing immunosuppression. METHODS: This multicenter, observational study investigated the effects of withdrawal of steroids or mycophenolate mofetil (MMF) from a tacrolimus-based triple regimen (tac/MMF/steroids) 3 months posttransplant at 3 years; no additional interventions or assessments were undertaken. Adult patients, included in the intent-to-treat population of the THOMAS study, participated. Patient and graft survival, adverse events, rejection episodes, and immunosuppressive and concomitant medications were assessed. RESULTS: Data at Year 3 was available for 718 patients (triple therapy, n=237; steroid stop, n=235; MMF stop, n=246). The original randomized regimen was maintained in 45.6% of patients in the triple, 62.6% in the steroid stop, and 53.9% in the MMF stop groups. Graft survival rates were 88.1% (triple), 86.4% (steroid stop), and 85.8% (MMF stop); patient survival was 96.1%, 95.9%, and 95.7%, respectively. The incidence of biopsy-proven acute rejection was similar in all groups between Month 7 and Year 3: 1.2% (triple), 2.0% (steroid stop) and 2.0% (MMF stop). Patients in the steroid stop group had less hypertension and significantly lower mean total cholesterol and LDL-cholesterol at Year 3 compared with Month 3 (P=0.02). Median serum creatinine levels remained stable throughout the follow-up and were comparable between groups. CONCLUSION: Immunosuppression minimization initiated at Month 3 was maintained at Year 3 in over half of the patients. Steroid withdrawal was advantageous in reducing the cardiovascular risk factors hyperlipidemia, hypertension and diabetes mellitus. Renal function was stable in all groups.