Pinson C W, Chapman W C, Wright J K, Hunter E B, Awad J A, Raiford D S, Payne J L, Geevarghese S, Blair T K, Van Buren D H
Department of Surgery, Vanderbilt University Transplant Center, Nashville, Tennessee 37232-4753, USA.
Transpl Int. 1998;11 Suppl 1:S278-83. doi: 10.1007/s001470050479.
We compared results using Neoral versus Sandimmune, each in combination with steroid and azathioprine immunosuppression, in primary liver transplantation recipients. There were 15 patients in each group with similar demographic distributions. Intravenous cyclosporine was stopped at 4.3 +/- 1.9 days in the Neoral group vs 7.8 +/- 4.9 days in the Sandimmune group. (P < 0.025). Cyclosporine levels in the first 10 days were higher (mean 306 ng/ml vs 231 ng/ml) in the Neoral group than the Sandimmune group (P < 0.05). The Neoral dose was less than the Sandimmune dose (mean 5.5 ng/kg per day vs 7.9 ng/kg per day) to achieve these levels in that time period (P < 0.05). Two patients (13%) experienced three episodes of biopsy-proven rejection in the Neoral group compared to nine patients (60%) with 12 episodes of rejection in the Sandimmune group (P < 0.025). Incidences of neurological and renal complications were similar between the groups. Infections requiring treatment were also similar. Liver function, renal function, and marrow function, evaluated at days 7, 14, 21, 28, and 2, 4, 6, and 12 months post-transplant, were not different between the groups. In summary, shorter use of intravenous cyclosporine and quicker stabilization of trough cyclosporine levels was achieved with Neoral than with Sandimmune. In the early post-transplant period, higher levels with lower doses were achieved with Neoral than with Sandimmune. In our experience, the incidence of rejection was lower with Neoral than with Sandimmune. There were similar lengths of hospitalization, mortality, adverse events, retransplantation, and similar liver, renal, and marrow function up to 1 year post-transplantation. Because of this experience, we continued to use Neoral in a total of 59 primary liver transplant recipients. We have not used intravenous cyclosporine in the last 44 patients. Follow-up was a mean of 11.4 months, ranging from 1 to 27 months. The incidence of rejection was 24% in these 59 patients compared to our historical experience of 70% using Sandimmune.
我们比较了在初次肝移植受者中使用新山地明（Neoral）与环孢素（Sandimmune）分别联合类固醇和硫唑嘌呤进行免疫抑制的效果。每组有15例患者，人口统计学分布相似。新山地明组静脉注射环孢素在4.3±1.9天停用，而环孢素组为7.8±4.9天停用。（P<0.025）。新山地明组前10天的环孢素水平高于环孢素组（平均306 ng/ml对231 ng/ml）（P<0.05）。在该时间段内，为达到这些水平，新山地明的剂量低于环孢素的剂量（平均每天5.5 ng/kg对7.9 ng/kg）（P<0.05）。新山地明组有2例患者（13%）发生3次经活检证实的排斥反应，而环孢素组有9例患者（60%）发生12次排斥反应（P<0.025）。两组神经和肾脏并发症的发生率相似。需要治疗的感染情况也相似。在移植后第7、14、21、28天以及2、4、6和12个月评估的肝功能、肾功能和骨髓功能，两组之间没有差异。总之，与环孢素相比，新山地明静脉注射环孢素的使用时间更短，谷值环孢素水平更快稳定。在移植后早期，新山地明比环孢素能以更低剂量达到更高水平。根据我们的经验，新山地明的排斥反应发生率低于环孢素。移植后长达1年的住院时间、死亡率、不良事件、再次移植情况以及肝、肾和骨髓功能相似。基于这一经验，我们继续在总共59例初次肝移植受者中使用新山地明。在最后44例患者中我们未使用静脉注射环孢素。随访平均为11.4个月，范围从1至27个月。这59例患者的排斥反应发生率为24%，而我们使用环孢素的历史经验发生率为70%。
