McDiarmid S V, Millis M J, Terasaki P I, Ament M E, Busuttil R W
Department of Pediatrics, UCLA School of Medicine.
Dig Dis Sci. 1991 Oct;36(10):1418-26. doi: 10.1007/BF01296809.
In a randomized prospective study of liver transplant recipients, we compared prophylaxis with OKT3, steroids, and azathioprine to cyclosporine, steroids, and azathioprine. Seventy-two percent of patients receiving OKT3 prophylaxis were rejection free in the first 14 days compared to 41% in the cyclosporine group (P = 0.02). However, after 14 days through a mean of 6.3 months, the overall incidence of rejection did not differ between the two groups (74% for the cyclosporine group and 48% for the OKT3 group). There was no increase in the rate of infectious complications noted in the OKT3-treated group. Thirty-nine percent of the OKT3-treated patients developed anti-OKT3 antibodies. Eight patients in the OKT3 group required reuse of OKT3 for rejection. Six of these continued to have greater than 10% CD3-positive cells with retreatment. Five were rescued successfully. With a mean survival of greater than 674 +/- 209 days in the OKT3-treated group and 626 +/- 242 days in the cyclosporine-treated group, no overall differences in graft and patient survival, liver function, renal function, late rejection incidence, or infectious complications were evident between the two groups. We conclude that OKT3 offers no long-term benefit compared to cyclosporine prophylaxis and should be reserved for treatment of rejection in patients in whom cyclosporine may be contraindicated.
在一项针对肝移植受者的随机前瞻性研究中，我们将使用OKT3、类固醇和硫唑嘌呤进行预防与使用环孢素、类固醇和硫唑嘌呤进行预防做了比较。接受OKT3预防的患者中，72%在最初14天内未发生排斥反应，而环孢素组为41%（P = 0.02）。然而，在14天后至平均6.3个月期间，两组的总体排斥反应发生率并无差异（环孢素组为74%，OKT3组为48%）。OKT3治疗组的感染并发症发生率没有增加。39%接受OKT3治疗的患者产生了抗OKT3抗体。OKT3组中有8名患者因排斥反应需要再次使用OKT3。其中6名患者再次治疗后CD3阳性细胞仍大于10%。5名患者成功获救。OKT3治疗组的平均生存期大于674 +/- 209天，环孢素治疗组为626 +/- 242天，两组在移植物和患者生存率、肝功能、肾功能、晚期排斥反应发生率或感染并发症方面均无明显总体差异。我们得出结论，与环孢素预防相比，OKT3没有长期益处，应仅用于治疗环孢素可能禁忌的患者的排斥反应。
