Zucker M J, Baran D A, Arroyo L H, Goldstein D J, Neacy C, Mele L, Weinberg A D, Prendergast T W, Ribner H S
Cardiothoracic Transplantation Program, Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, NJ 07112, USA.
Transplant Proc. 2005 Jun;37(5):2231-9. doi: 10.1016/j.transproceed.2005.03.086.
Limited data exist regarding the safety and efficacy of sirolimus in combination with a calcineurin inhibitor in heart transplant recipients.
From January 2001 to June 2002, 31 de novo heart transplant recipients (treatment group) received a combination of sirolimus, tacrolimus, low-dose rabbit antithymocyte globulin, and glucocorticoids. Outcomes, such as actuarial survival, rate of rejection, incidence of infection, probability of developing diabetes mellitus, renal function, platelet and white blood cell counts, and incidence of coronary artery disease at 1 year, were compared with a cohort of 25 patients (control group) who underwent transplantation primarily in 2000 and in early 2002 treated with cyclosporine, mycophenolate mofetil, and glucocorticoids. All patients were followed up for at least 12 months.
Kaplan-Meier actuarial 1-year survival rates were equivalent between groups (97% for the treatment group and 88% for the control group), as was freedom from allograft rejection (48% and 42% for treatment and control groups, respectively). No cases of transplant arteriopathy were noted within the first posttransplantation year. Renal function was not significantly affected in either group. There was a striking increased incidence of mediastinitis in the treatment group (19%) versus 0% in the control group (P = .02). Tacrolimus-sirolimus therapy was associated with a nearly 11-fold increased incidence of new-onset diabetes mellitus as well (P = .004).
Tacrolimus, sirolimus, and steroids (following low-dose rabbit antithymocyte globulin) were associated with an increased incidence of mediastinitis and posttransplantation diabetes mellitus. No obvious long-term benefit on survival, arteriopathy, or renal function was noted.
关于西罗莫司与钙调神经磷酸酶抑制剂联合应用于心脏移植受者的安全性和有效性的数据有限。
2001年1月至2002年6月，31例初次接受心脏移植的受者（治疗组）接受了西罗莫司、他克莫司、低剂量兔抗胸腺细胞球蛋白和糖皮质激素的联合治疗。将1年时的实际生存率、排斥反应发生率、感染发生率、发生糖尿病的概率、肾功能、血小板和白细胞计数以及冠状动脉疾病发生率等结果，与25例主要于2000年及2002年初接受移植并接受环孢素、霉酚酸酯和糖皮质激素治疗的患者队列（对照组）进行比较。所有患者均随访至少12个月。
两组的Kaplan-Meier法计算的1年实际生存率相当（治疗组为97%，对照组为88%），移植后无排斥反应的比例也相当（治疗组和对照组分别为48%和42%）。移植后第1年内未观察到移植血管病病例。两组的肾功能均未受到显著影响。治疗组纵隔炎的发生率显著增加（19%），而对照组为0%（P = 0.02）。他克莫司-西罗莫司治疗还与新发糖尿病的发生率增加近11倍相关（P = 0.004）。
他克莫司、西罗莫司和类固醇（在低剂量兔抗胸腺细胞球蛋白之后使用）与纵隔炎和移植后糖尿病的发生率增加相关。未观察到对生存、血管病或肾功能有明显的长期益处。
