再次肾移植受者和移植肾长期预后影响因素分析

目的探究再次肾移植受者和移植肾存活情况及长期预后影响因素。 方法回顾性分析1991年1月1日至2017年12月31日于浙江大学医学院附属第一医院肾脏病中心接受肾移植受者临床资料。共纳入再次肾移植受者37例,首次肾移植受者5 374例。根据再次肾移植受者移植肾存活时间长短,将其分为长期存活组(19例,>5年)和短期存活组(18例,≤5年)。采用成组t检验比较长期和短期存活组供受者年龄、首次与再次肾移植间隔时间、HLA错配数和再次移植供肾冷/热缺血时间。采用卡方检验比较长期和短期存活组受者性别、再次移植供肾类型、再次移植前后群体反应性抗体阳性比例、首次移植失功移植肾切除比例、再次移植前免疫诱导比例及再次移植后移植肾功能延迟恢复(DGF)和急性排斥反应发生比例。采用Kaplan-Meier法分析再次和首次肾移植受者/移植肾1、5和10年存活率。采用Cox比例风险模型分析影响再次肾移植术后移植肾长期存活影响因素。P<0.05为差异有统计学意义。 结果截至2018年3月1日,37例再次肾移植受者中位随访时间为152个月(11～323个月),2例死亡,18例发生移植肾失功,17例移植肾功能稳定。5 374例首次肾移植受者中位随访时间为108.9个月(0.1～350.0个月),459例死亡,1 343例发生移植肾失功。再次移植组受者/移植肾1、5和10年存活率分别为86%/81%、86%/62%和82%/36%,首次移植组受者/移植肾1、5和10年存活率分别为99%/98%、93%/89%和88%/80%。再次移植组移植肾1、5和10年存活率均低于首次移植组(χ²＝60.816、25.110和43.900,P均<0.05);再次移植组受者1年存活率低于首次移植组,差异有统计学意义(χ²＝40.409,P<0.05)。长期和短期存活组受者再次移植后移植肾DGF和急性排斥反应发生比例差异均有统计学意义(χ²＝4.039和4.748,P均<0.05)。Cox回归分析结果示DGF和急性排斥反应是影响再次肾移植受者移植肾长期存活的独立危险因素,差异有统计学意义(RR＝4.317和4.571,P均<0.05)。 结论再次肾移植受者移植肾存活率低于首次肾移植受者,DGF和急性排斥反应是影响再次移植受者移植肾存活的独立危险因素。     

中西医结合治疗在防治肾移植排异反应中的作用和机制

目的 :探讨中西医结合方法在防治肾移植急性排异反应中的作用和机制。方法 :81例肾移植患者随机分为西医治疗组和中西医结合治疗组 ,观察和分析两组急性排异反应和感染并发症发生率、治疗方法、血和尿IL -6水平等情况。结果 :中西医结合治疗组在急性排异反应发生率、巨细胞病毒感染发生率、血和尿IL - 6水平等方面均较西医治疗组有显著的降低 (P <0 0 5 )。结论 :中西医结合方法在防治肾移植急性排异反应中具有可降低急性排异反应发生率、减少巨细胞病毒感染并发症、减少治疗费用等优点。其机制可能与合并中药的使用能更好地降低机体IL - 6水平有关     

移植肾功能延迟恢复对长期存活的影响

目的 探讨移植肾功能延迟恢复对肾移植受者人／肾长期存活的影响。方法 回顾分析５７３例肾移植中发生的７０例移植肾功能延迟恢复受者的人／肾存活情况及其相关危险因素。结果 ７０例患者总的１、３、５年人存活率分别为７７．１％、４７．６％、３７．５％,肾存活率分别为７１．４％、４０．５％、１５．０％,明显低于同期未发生肾功能延迟恢复的受者,但未合并排斥反应的移植肾功能延迟恢复者存活率并不受影响,合并排斥反应     

胰肾联合移植53例术后长期存活的临床观察

目的 分析53例胰肾联合移植长期存活情况及其影响因素.方法 回顾性分析2000年1月至2009年6月间施行的53例胰肾联合移植受者和移植物长期存活情况,分析受者死亡原因和移植物功能丧失原因.结果 3、5和8年受者存活率分别为90.1％、89.1％和80.0％,3、5和8年移植胰腺存活率分别为84.9％、84.8％和60.0％,3、5和8年移植肾存活率分别为83.0％、82.6％和53.3％.受者死亡原因分别为感染(4例)、移植肾功能丧失(2例)、心血管急症(1例)和脑卒中(1例).移植胰腺功能丧失的主要原因为带功能受者死亡、排斥反应和外科并发症.移植肾功能丧失的主要原因为排斥反应和带功能受者死亡.结论 胰肾联合移植治疗终末期糖尿病肾病远期效果良好,感染、排斥反应和外科并发症是受者死亡和移植物功能丧失的主要原因.     

丙型肝炎病毒阳性患者肾移植术后临床分析(附9例报告)

目的:探讨丙型肝炎病毒(HCV)阳性肾移植受者肾移植术后的疗效和安全性。方法:回顾性分析9例HCV阳性肾移植患者2.5~11.8年的临床随访资料,观察HCV阳性受者肾移植术后肾功能、肝功能和移植术后并发症。结果:9例患者随访至今,7例人/肾存活,其中4例已超过10年;移植肾失功恢复血液透析2例,其中1例术后15个月发生急性排斥反应,合并移植后新发糖尿病,另1例术后46个月发生急性排斥反应,此2例排斥反应经治疗未逆转。2例出现血清肌酐上升,将环孢素切换成他克莫司后,移植肾功能恢复正常。1例患者服用索菲布韦后,血清肌酐上升,减少索菲布韦剂量后,血清肌酐逐渐恢复正常。3例患者术后2周内出现肝功能异常,4例术后长期随访过程中多次出现肝功能异常,以还原性谷胱甘肽等保肝药物治疗后,肝功能均恢复正常。结论:HCV阳性终末期肾病患者接受肾移植安全可行,术前肝脏病变的评估,移植后密切随访,早期诊断和治疗移植后相关并发症是提高HCV阳性肾移植受者人/肾长期存活的关键。     

肝肾联合移植36例的预后分析

目的 分析肝肾联合移植36例的治疗效果及存活情况.方法 回顾性分析20022011年单中心施行的36例肝肾联合移植的临床资料.受者的年龄为(47.4±13.1)岁,术前4例曾接受过肝移植,7例曾接受肾移植.统计术后并发症发生情况及受者和移植物的存活情况.结果 存活受者随访47.9个月(29.1～115.7个月).术后1、3和5年受者存活率分别为88.7％、85.4％和81.4％;1、3和5年移植肝存活率分别为79.8％、76.3％和72.3％;1、3和5年移植肾存活率分别为85.7％、82.4％和78.2％.3例受者因严重胆道并发症进行了再次肝移植,1例受者因移植肾功能丧失进行了再次肾移植.结论 肝肾联合移植是治疗终末期肝病伴肾功能衰竭的有效方法,受者和移植物可获得良好的预后.     

夫妻活体供肾移植的相关问题分析

目的 探讨夫妻供肾移植的临床效果及安全性.方法63例活体供肾移植供者分夫妻供肾组(n=12)和亲属供肾组(n=51)2组.总结夫妻活体供肾肾移植的临床资料,并与同期基础条件相近、免疫抑制剂方案相同、基因相关亲属供肾组的临床资料进行对比.观察指标选择平均住院时间、急性肾小管坏死发生率、1年内急性排斥反应发生率和移植后7、30 d和1年血肌酐(SCr)水平.结果 夫妻供肾组和亲属供肾组受者年龄分别为(39±3)和(37±3)岁,P=0.05;透析时间分别为(4.7±3.2)和(4.4±2.9)个月,P=0.78;平均住院时间分别为(20.9±8.3)和(23.0±7.8)d,P=0.41.2组1年内急性排斥反应发生率分别为33.3%4/12),3.9%(2/51),P=0.01.急性肾小管坏死发生率分别为16.7%(2/12),3.9%(2/51)(P=0.31).夫妻供肾组术后7、30 d SCr值分别为(206.47±47.22)和(163.75±25.91)μmol/L,亲属供肾组分别为(142.79±89.42)和(119.99±15.03)μmol/L,P=0.02,P=0.00.术后1年夫妻供肾组获随访9例,亲属供肾组40例;SCr分别为(133.40±6.11)和(121.00±34.12)μmol/L,P=0.25.结论 术前对夫妻供、受者进行全面综合评估是夫妻供肾移植成功的保证.夫妻供肾移植的近期急性排斥反应发生率略高于亲属活体供肾移植,但术后1年夫妻供肾移植受者的移植肾功能与亲属活体供移植受者比较并无区别.     

84例50岁以上尿毒症患者尸体肾移植的临床总结

对84例(92人次)50岁以上尿毒症患者的尸体肾移植资料进行分析总结。受者年龄50～67岁。供肾热缺血时间6～12分,冷缺血时间4～12小时,淋巴细胞毒性试验均<0.01,HLA配型82例。手术均较为顺利,术后常规免疫抑制治疗1例,三联疗法83例。术后一年人/肾存活率分别为80.9％/73.9％。认为供肾质量、HLA配型、术中技巧、免疫抑制剂的合理应用、术后并发症的防治及患者的长期随访对患者长期存活非常重要。     

不同免疫抑制方案对肾移植受者和移植肾存活的影响

目的回顾单中心近28年肾移植受者资料,分析探讨不同免疫抑制方案对移植受者和移植肾存活的影响。方法1977年10月至2004年12月,中国人民解放军总医院总共为1804例终末期肾病患者施行了2037例肾移植手术。根据临床资料和截止2005年底的随访结果,采用Kaplan-Meier方法计算人、肾存活率,并按照Terasaki公式计算移植物的半数生存期,分析各种免疫抑制方案对移植肾和移植受者存活的影响。结果以钙调素抑制剂（CNI）为基础的免疫抑制药物治疗显著提高了移植受者和移植肾的存活率,术后1、5、10和15年受者存活率分别为95．9％、89．1％、80．5％和73．0％;移植肾存活率分别为92．7％、80．4％、64．9％和54．1％。与无CNI类药物治疗相比,受者和移植肾的同期存活率差异具有统计学意义（均P〈0．0001）。在CNI为基础的三联药物治疗方案中,采用环孢素＋霉酚酸酯＋泼尼松方案者移植肾1、5、10年存活率高于采用环孢素＋硫唑嘌呤＋泼尼松方案者（1年94．3％比86．4％,5年90．9％比70．6％,10年71．3％比56．5％,均P〈0．0001）。结论以CNI为基础的三联药物治疗方案显著改善了肾移植受者和移植物的存活,特别是以他克莫司为基础的或包含霉酚酸酯的治疗方案对改善肾移植受者和移植物的存活具有重要作用。     

活体肾移植前对致敏患者的处理经验及疗效分析

目的 总结活体肾移植前对致敏患者的处理经验,并对移植效果进行分析.方法 回顾性分析609例活体肾移植受者的临床资料.根据移植前群体反应性抗体(PRA)水平将受者分为高致敏组(41例,PRA≥30％),低致敏组(102例,PRA为0～30％)和非致敏组(466例,PRA为0).所有受者经HLA抗体检测和淋巴细胞毒交叉配合试验(CDC)确认没有针对供者的HLA抗体后进行肾移植.高致敏组给予抗胸腺细胞球蛋白诱导治疗,低致敏组给予抗白细胞介素2受体单抗诱导治疗.随访1年以上,观察各组术后移植肾功能、急性排斥反应发生率、受者和移植肾存活率及并发症发生率.结果 高致敏组、低致敏组和非致敏组受者术后移植肾恢复正常的时间和1年时肾小球滤过率均无明显差异;3组均未发生超急性排斥反应,急性排斥反应发生率分别为9.76％(4/41)、8.82％(9/102)和8.15％(38/466),术后1年移植肾存活率分别为97.6％(40/41)、97.1％(99/102)和98.1％(457/466),受者存活率分别为97.6％(40/41)、98.0％(100/102)和98.9％(461/466),3组间上述指标的差异均无统计学意义(P＞0.05).高致敏组的感染发生率为31.7％(13/41),明显高于低致敏组的26.5％(27/102)和非致敏组的21.6％ (101/466) (P＜0.05).结论 致敏受者肾移植前经HLA抗体检测和CDC配型,避开受者体内供者特异性抗体针对的供肾,并给予免疫诱导治疗,可以获得与非致敏受者相似的良好效果.     

Flow cytometry crossmatching as a predictor of acute rejection in sensitized recipients of cadaveric renal transplants

Flow cytometry crossmatching (FCXM) was developed as a more sensitive assay than the standard complement-dependent cytotoxicity crossmatch (CDCXM) for the detection of anti-donor antibodies, that mediate hyperacute rejection and graft loss in the early post-transplant period in renal transplant recipients. The role of FCXM in predicting long-term clinical outcome in renal allograft recipients is unclear. This study examines the role of FCXM in predicting long-term clinical outcome in highly sensitized recipients of cadaveric renal transplants. All patients (n = 100) with peak panel reactive antibody (PRA) levels > 30%, who received cadaveric renal transplants between 1/1/'90 and 12/31/'95 at our institution, were divided into FCXM + and FCXM - groups. The incidence of acute rejection was determined for each group during the first yr after transplant. Graft survival rates at 1, 2, and 3 yr, and creatinine levels were also compared between groups. FCXM + patients experienced a higher incidence of acute rejection during the first yr after transplant (69 vs. 45%), and a higher percentage of FCXM + patients had more than one episode of acute rejection during the first yr after transplant (34 vs. 8%) when compared to FCXM - patients. There was no statistically significant difference in 1-, 2-, or 3-yr graft survival between FCXM + and FCXM - patients (76 vs. 83, 62 vs. 80, 62 vs. 72%, respectively). These results suggest that sensitized FCXM + cadaveric renal transplant recipients have a higher incidence of acute rejection episodes in the first yr after transplant. Given the association of multiple rejection episodes with poor long-term allograft survival, FCXM may be a useful predictor of long-term clinical outcome in this sub-group of renal transplant recipients.     

Cytomegalovirus infection and graft rejection in renal transplantation

BACKGROUND: Cytomegalovirus (CMV) infection and CMV disease have been associated with acute and chronic graft rejection. The introduction of the sensitive CMV antigenemia pp65 assay for detection of CMV infection allowed us to study the time course of CMV infection and acute rejection and the long-term outcome in renal transplant recipients with and without a CMV risk constellation. METHODS: Prospective single center study including 48 renal transplant recipients at risk for CMV infection (donor and/or recipient CMV seropositive) and a control group of 36 CMV seronegative recipients of CMV seronegative kidney donors. Evidence of CMV infection was monitored by the CMV antigenemia pp65 assay every 1 to 2 weeks and compared with the occurrence of acute rejection in the posttransplant period and graft function at 5 years. RESULTS: CMV infection developed in 83% (40/48) of patients of the CMV risk group within 4 months posttransplant. A total of 18 of patients experienced an acute rejection episode (control group 16/36; P=0.65). In 12/18 CMV infection followed rejection and in three patients antigenemia preceded the diagnosis of rejection. In three patients CMV antigenemia remained negative. Five-year follow up: Patient survival (44/48 vs. 31/36; P=0.48), graft survival (38/48 vs. 27/36; P=0.79), number of patients with at least one acute rejection episode: CMV risk group: 42.1%, control group 51% (P=0.46), serum creatinine: CMV risk group:130 +/- 66 micromol/iter, control group: 126 +/- 37 micromol/ liter (P=0.56), proteinuria: CMV risk group: 0.02 +/- 0.02 g/mmol creatinine, control group: 0.02 +/- 0.02 g/mmol creatinine (P=1.0). CONCLUSION: CMV infection within 4 months posttransplant, as defined by a positive antigenemia assay was not found to be a risk factor for acute graft rejection or chronic graft dysfunction at 5 years.     

一剂赛尼哌对肾移植急性排斥反应的预防作用

目的 探讨1剂赛尼哌在预防同种异体肾移植急性排斥反应中的作用。方法 回顾性分析50例应用1剂赛尼哌的肾移植患者资料，同期30例未应用赛尼哌患者作为对照，随访6个月。分析比较2组患者急性排斥反应、移植肾功能、感染及赛尼哌不良反应发生情况。结果 赛尼哌组发生急性排斥反应13例（26％），对照组为17例（57％），差异有统计学意义（P〈0．05），2组患者药物不良作用方面、血液系统损害、肝功能损害、感染发生率及人／肾存活率差异无统计学意义（P〉0．05）。结论 联合应用1剂赛尼哌免疫抑制方案可以降低肾移植急性排斥反应发生率，改善移植肾功能，不良反应轻。     

Improved freedom from rejection after a loading dose of sirolimus

BACKGROUND: Sirolimus (SIR) in combination with cyclosporine reduces the incidence of acute rejection in renal transplant recipients. Limited data are available regarding SIR in combination with tacrolimus (TAC). METHODS: A single-center, retrospective review of renal transplant recipients receiving SIR, TAC, and corticosteroids postoperatively was conducted. A total of 118 consecutive renal transplant recipients were included on the basis of availability of day 1 SIR dose information. Seventy-seven patients received an SIR loading dose (SIR-LD) immediately posttransplantation, and 41 patients did not (SIR no loading dose [SIR-NLD]). RESULTS: The two groups showed similar demographic and transplant characteristics. SIR doses and trough levels were significantly higher in the SIR-LD patients at 1 and 7 days posttransplantation; however, no differences occurred beyond day 7. Patients receiving an SIR-LD experienced significantly better freedom from rejection at 1, 3, and 6 months posttransplantation (P<0.05). This rejection benefit in the SIR-LD group was independent of donor source and use of antibody induction. SIR-LD patients experienced fewer serious infections (12% SIR-LD vs. 27% SIR-NLD, P=0.04) and a lower incidence of delayed graft function (21% SIR-LD vs. 39% SIR-NLD, P<0.05). No significant differences in serum creatinine, hemoglobin, and platelet counts occurred in the first 180 days posttransplantation, but the patients in the SIR-NLD group experienced lower hemoglobin levels at day 30 than those in the SIR-LD group (10.8 g/dL SIR-LD vs. 9.7 g/dL SIR-NLD, P=0.03). CONCLUSION: SIR-LD significantly improves early posttransplantation freedom from rejection in renal transplant recipients without increasing other complications.     

Corticosteroid elimination in simultaneous liver–kidney transplantation recipients

Abstract: Background: Simultaneous liver–kidney transplantation (SLK) has more than doubled since 2002. While less common in kidney transplant alone recipients (KTA), corticosteroid discontinuation is performed routinely in liver transplantation, raising the question of optimal immunosuppression for SLK recipients. Methods: A retrospective case series of 16 SLK recipients under a steroid withdrawal protocol was performed to compare short‐term outcomes to a contemporaneous cohort of 32 KTA recipients. Results: In 69% of SLK recipients, corticosteroids were eliminated compared to 3% of KTA recipients, p < 0.0001. When comparing SLK and KTA recipients one yr post‐transplant, there were no significant differences in renal graft rejection (23.1% vs. 6.3%), death‐censored renal graft survival (100% vs. 97%), estimated glomerular filtration rate (74.4 vs. 62.6 mL/min), serum creatinine (1.10 vs. 1.39 mg/dL), or maintenance immunosuppression, respectively. Conclusions: Corticosteroids may be withdrawn safely in SLK recipients with one‐yr renal outcomes comparable to a KTA cohort.     

Tacrolimus plus low-dose mycophenolate mofetil in renal transplant recipients: better 2-year graft and patient survival than with a higher mycophenolate mofetil dose

OBJECTIVES: Mycophenolate mofetil (MMF) has become more widely prescribed in recent years, but its adverse effects on the gastrointestinal system and bone marrow restrict its use in certain settings. The aim of this study was to compare the demographic features and clinical data for 173 renal transplant recipients who received tacrolimus (TAC) plus 1 g/d MMF (group I, n = 112) versus TAC plus 2 g/d MMF (group II, n = 61 patients) over a 2-year period. Each patient received similar TAC doses. METHODS: We compared demographic data and clinical data for each case: acute rejection (AR) episodes, chronic rejection (CR) episodes, death, graft loss, development of posttransplantation diabetes mellitus (PTDM), and posttransplantation hypertension rates. RESULTS: Demographic features were similar. There were also no significant differences between groups I and II with respect to number of AR episodes (17/112 vs 12/61, respectively), number of CR episodes (4/112 vs 1/61, respectively), PTDM, and hypertension rate (P > .05). Kaplan-Meier survival analysis revealed 2-year graft survival rates of 94% in group I versus 83% in group II. The corresponding 2-year patient survival rates were 100% in group I versus 91% in group II. The graft survival and patient survival rates in group I were significantly higher than those in group II (log-rank 0.005 and 0.001, respectively). CONCLUSIONS: The 2-year graft and patient survival rates for the renal transplant recipients in this study suggest that the combination of a full TAC dose with 1 g/d MMF is a better choice than 2 g/d MMF.     

Should living-unrelated renal transplant recipients receive antibody induction? Results of a clinical experience trial

BACKGROUND: Living-donor kidney transplant recipients generally do not receive antibody induction. Induction avoidance may not be appropriate, particularly for living-unrelated renal transplant (LURT) recipients, in whom matching may not be optimal. We compared the incidence of acute rejection and graft outcome of LURT recipients who were administered no induction and cadaveric renal transplant (CRT) recipients who were administered anti-CD25 antibody. These groups both had immediate graft function and similar maintenance immunosuppression. METHODS: This retrospective analysis included patients who received kidney transplants between 1999 and 2000. CRT recipients received basiliximab, corticosteroids, mycophenolate mofetil (MMF), and delayed tacrolimus (serum creatinine <3 mg/dL). LURT recipients received tacrolimus (initiated pretransplantation), MMF, and corticosteroids. RESULTS: The analysis included 136 LURT recipients and 126 CRT recipients. CRT recipients included more African Americans (52.4% vs. 30.9%, P<0.01). LURT recipients included more patients with at least one human leukocyte antigen mismatch (97.8% vs. 85.7%, P<0.01). A higher acute rejection rate was observed in LURT recipients at both 6 months (LURT recipients 19.1% vs. CRT recipients 3.2%, P<0.01) and 1 year (21.3% vs. 4.0%, P<0.0004); a higher rate also was observed in African American LURT recipients compared with African American CRT recipients (35.7% vs. 4.5%, P<0.0015) at 1 year. LURT recipients demonstrated a threefold greater rejection risk than CRT recipients who were administered basiliximab (relative risk: 3.6, P<0.002). Graft survival was similar at 1 year. CONCLUSION: The higher rejection rates in LURT recipients (no induction) compared with CRT recipients (basiliximab induction), despite similar chronic immunosuppression (tacrolimus, MMF, and steroids) and immediate graft function, indicate the potential advantage of anti-CD25 induction in LURT protocols to reduce the risk of acute rejection.     

中西医结合治疗糖尿病肾病临床观察

目的 :探讨中西医结合疗法对糖尿病肾病的临床疗效。方法 :2型糖尿病、糖尿病肾病患者 6 4例 ,中西医结合组 34例、单纯西医治疗组 30例 ,观察治疗前、后尿白蛋白排泄率、肾功能及血液流变学等临床指标改变。结果 :(1)西医组显效率 2 0 .0 % ,总有效率 6 3.3% ;中西医组显效率 5 2 .9% ,总有效率 88.2 % ,明显高于西医组 ;(2 )与西医组相比 ,中西医组治疗后血液流变学指标和血脂代谢明显改善 ;(3)中西医组较西医组尿白蛋白排泄率和尿 β2 -微球蛋白的降低程度明显增加。结论 :中西医结合治疗糖尿病肾病较单纯西医治疗疗效优越。     

Treatment of renal transplant rejection episodes in patients receiving prednisone and azathioprine. A cost-effective approach

Antilymphocyte globulin (ALG) has been advocated for the treatment of renal transplant rejection episodes in patients maintained on prednisone and azathioprine. Treatment with steroids (outpatient) is considerably less expensive than with ALG (inpatient), so we studied whether routine ALG was necessary. Between 3/82 and 11/83, 54 cadaver transplant recipients maintained on prednisone and azathioprine who developed a first rejection episode were randomized to receive--for treatment of their first, and if necessary second, rejection--methylprednisolone (MP) plus ALG (n = 24), or MP alone, with ALG added if treatment failed (n = 30). Treatment failure was defined as continuing deterioration on T131 iodohippuran scan, rising serum creatinine level, or lack of improvement within 7 days. There was no significant difference in patient survival, graft survival, mean number of rejections, and infection rate between the two groups: 60% (18/30) of first and 50% (10/10) of second rejection episodes responded to MP alone. We conclude that patients are not penalized by initial rejection treatment with MP. Many rejection episodes respond to steroids alone; elimination of routine ALG use will save hospitalization time and expense.     

Double-blind comparison of two corticosteroid regimens plus mycophenolate mofetil and cyclosporine for prevention of acute renal allograft rejection

BACKGROUND: Renal transplant recipients experience adverse events attributed to corticosteroid therapy. METHODS: This was a multicenter, randomized, double-blind, 6-month, controlled steroid dose-reduction study in renal transplant recipients with an unblinded 6-month follow-up. In the low/stop arm, corticoste. roids were given at half the dosage of control for 3 months from the date of transplantation, and then withdrawn. Both arms received mycophenolate mofetil and cyclosporine. The primary endpoint was the incidence of biopsy-proven acute rejection at 6 months posttransplantation. RESULTS: There were 248 patients in the control group and 252 in the low/stop group. At 6 months the low/stop group had more biopsy-proven acute rejection episodes than the control (23% vs. 14%; P=0.008). At 12 months this increased to 25% vs. 15%. Most rejections were Banff grade I. Twelve-month graft loss was 5% in the low/stop group vs. 4% in the control. At 6 and 12 months serum cholesterol (P<0.01, P<0.01), triglycer. ides (P<0.01, P<0.01), and systolic blood pressure (P<0.001, P<0.001) were lower in the low/stop group. Diastolic pressure was lower (P<0.01) and lumbar spine bone density was greater (P<0.01) in the low/ stop group at 12 months. CONCLUSIONS: In renal transplant recipients treated with mycophenolate mofetil and cyclosporine, reduction and early withdrawal of the prophylactic corticosteroid dose is feasible without an unacceptable increase in serious rejection episodes. This is accompanied by a significant reduction of steroid-related adverse events.