Pham S M, Kormos R L, Hattler B G, Kawai A, Tsamandas A C, Demetris A J, Murali S, Fricker F J, Chang H C, Jain A B, Starzl T E, Hardesty R L, Griffith B P
Department of Surgery, University of Pittsburgh School of Medicine, PA, USA.
J Thorac Cardiovasc Surg. 1996 Apr;111(4):764-72. doi: 10.1016/s0022-5223(96)70336-7.
Between January 1, 1989, and December 31, 1994, we have treated 122 primary heart recipients with FK 506 (group I) and 121 with cyclosporine (group II). Fifty patients in the cyclosporine (CyA) group received no lympholytic induction (CyA alone) and 71 others received lympholytic induction with either rabbit antithymocyte globulin or OKT3 (CyA+LI). The mean follow-up was longer in the FK 506 group than in the CyA groups (3.2 +/- 1.3 vs 2.3 +/- 1.8 years; p< 0.01). Patient survival did not differ on the basis of the type of immunosuppression used. At 3 months after transplantation, the freedom from rejection in the FK 506 group was higher than that of the CyA-alone group (47% vs 22%, p < 0.01) but similar to that of the CyA+LI group (47% vs 53%). The linearized rejection rate (episodes/100 patient-days) of the FK 506 group (0.09 episodes) was lower (p < 0.05) than that of the CyA-alone group (0.26) and the CyA+LI group (0.13). The requirement for pulsed steroids to treat rejection was less in common in the FK 506 group than in either CyA group. Eighteen patients in the CyA group had refractory rejections; all resolved with FK 506 rescue. Two patients in the FK 506 group had refractory rejection that resolved with total lymphoid irradiation (n=1) and methotrexate therapy (n=1). Patients receiving FK 506 had a lower risk of hypertension and required a lower dose of steroids. Although the mean serum creatinine concentration at 1 year was higher in the FK 506 group, this difference disappeared after 2 years. No patients required discontinuation of FK 506 because of its side effects. Our intermediate-term results indicate that FK 506 compares favorably with CyA as a primary immunosuppressant in heart transplantation.
1989年1月1日至1994年12月31日期间，我们用FK 506治疗了122例心脏移植受者（I组），并用环孢素治疗了121例（II组）。环孢素（CyA）组中有50例患者未接受淋巴细胞溶解诱导治疗（仅使用CyA），另外71例接受了兔抗胸腺细胞球蛋白或OKT3的淋巴细胞溶解诱导治疗（CyA+LI）。FK 506组的平均随访时间比CyA组更长（3.2±1.3年对2.3±1.8年；p<0.01）。患者生存率在所用免疫抑制类型的基础上没有差异。移植后3个月，FK 506组的无排斥反应率高于仅使用CyA组（47%对22%，p<0.01），但与CyA+LI组相似（47%对53%）。FK 506组的线性化排斥率（事件数/100患者日）（0.09次事件）低于仅使用CyA组（0.26）和CyA+LI组（0.13）（p<0.05）。FK 506组中用于治疗排斥反应的脉冲类固醇的需求比任何一个CyA组都少。CyA组中有18例患者发生难治性排斥反应；所有这些患者均通过FK 506挽救治疗而缓解。FK 506组中有2例患者发生难治性排斥反应，分别通过全淋巴照射（n=1）和甲氨蝶呤治疗（n=1）而缓解。接受FK 506治疗的患者患高血压的风险较低，且所需的类固醇剂量较低。虽然FK 506组在1年时的平均血清肌酐浓度较高，但2年后这种差异消失。没有患者因FK 506的副作用而需要停药。我们的中期结果表明，在心脏移植中，FK 506作为一线免疫抑制剂与CyA相比具有优势。
