Kaufman Dixon B, Burke George W, Bruce David S, Johnson Christopher P, Gaber A Osama, Sutherland David E R, Merion Robert M, Gruber Scott A, Schweitzer Eugene, Leone John P, Marsh Christopher L, Alfrey Edward, Concepcion Waldo, Stegall Mark D, Schulak James A, Gores Paul F, Benedetti Enrico, Smith Craig, Henning Alice K, Kuehnel Fernando, King Sarah, Fitzsimmons William E
Feinberg School of Medicine at Northwestern University, Chicago, IL, USA.
Am J Transplant. 2003 Jul;3(7):855-64. doi: 10.1034/j.1600-6143.2003.00160.x.
A randomized, multicenter, prospective study was conducted at 18 pancreas transplant centers in the United States to determine the role of induction therapy in simultaneous pancreas-kidney (SPK) transplantation. One hundred and 74 recipients were enrolled: 87 recipients each in the induction and noninduction treatment arms. Maintenance immunosuppression consisted of tacrolimus, mycophenolate mofetil, and corticosteroids. There were no statistically significant differences between treatment groups for patient, kidney, and pancreas graft survival at 1-year. The 1-year cumulative incidence of any treated biopsy-confirmed or presumptive rejection episodes (kidney or pancreas) in the induction and noninduction treatment arms was 24.6% and 31.2% (p = 0.28), respectively. The 1-year cumulative incidence of biopsy-confirmed, treated, acute kidney allograft rejection in the induction and noninduction treatment arms was 13.1% and 23.0% (p = 0.08), respectively. Biopsy-confirmed kidney allograft rejection occurred later post-transplant and appeared to be less severe among recipients that received induction therapy. The highest rate of Cytomegalovirus (CMV) viremia/syndrome was observed in the subgroup of recipients who received T-cell depleting antibody induction and received organs from CMV serologically positive donors. Decisions regarding the routine use of induction therapy in SPK transplantation must take into consideration its differential effects on risk of rejection and infection.
在美国的18个胰腺移植中心进行了一项随机、多中心、前瞻性研究，以确定诱导治疗在同期胰腺-肾脏（SPK）移植中的作用。共纳入174名受者：诱导治疗组和非诱导治疗组各87名受者。维持免疫抑制包括他克莫司、霉酚酸酯和皮质类固醇。治疗组之间在1年时的患者、肾脏和胰腺移植物存活率无统计学显著差异。诱导治疗组和非诱导治疗组中任何经活检证实或推定的排斥反应发作（肾脏或胰腺）的1年累积发生率分别为24.6%和31.2%（p = 0.28）。诱导治疗组和非诱导治疗组中经活检证实、治疗的急性肾移植排斥反应的1年累积发生率分别为13.1%和23.0%（p = 0.08）。经活检证实的肾移植排斥反应在移植后出现较晚，在接受诱导治疗的受者中似乎不那么严重。在接受T细胞清除抗体诱导且接受来自巨细胞病毒（CMV）血清学阳性供体器官的受者亚组中，观察到最高的CMV病毒血症/综合征发生率。关于SPK移植中诱导治疗常规使用的决策必须考虑其对排斥反应风险和感染的不同影响。
