Norman D J, Kahana L, Stuart F P, Thistlethwaite J R, Shield C F, Monaco A, Dehlinger J, Wu S C, Van Horn A, Haverty T P
Division of Nephrology, Oregon Health Sciences University, Portland 97201.
Transplantation. 1993 Jan;55(1):44-50. doi: 10.1097/00007890-199301000-00009.
A randomized, prospective multicenter trial was conducted to compare the safety and efficacy of OKT3 as an induction therapy with that of conventional immunosuppressive therapy administered to cadaveric renal allograft recipients. Two hundred fifteen patients were treated either with OKT3 plus azathioprine and steroids for 14 days with the delayed addition of cyclosporine on day 11, or with conventional immunosuppression (steroids, azathioprine, and cyclosporine). OKT3 patients had significantly fewer rejection episodes (51% vs. 66%, P = 0.032), a longer time to initial rejection (46 days vs. 8 days, P = 0.001), and fewer rejection episodes per patient (0.82 vs. 1.14, P = 0.014) than conventionally treated patients. Kaplan-Meier estimates of two-year graft and patient survival rates were 84% and 95%, respectively, for the OKT3-treated group, and 75% and 94%, respectively, for the conventionally treated group. Following a subsequent first rejection episode, OKT3 reversed 93% of the rejections in patients receiving OKT3 induction therapy and 94% in patients receiving conventional therapy. Adverse experiences reported during OKT3 induction therapy were similar to those seen when the drug was used for rejection. Following initial exposure, 40.3% of the patients tested were positive for anti-OKT3 antibody, only 6.7% of which were of high titer (1:1000). In the presence of low titer (1:100 or less) antibody, OKT3 was successful in reversing rejection in five of six retreated patients tested. In conclusion, treatment with OKT3 (in combination with azathioprine, steroids, and the delayed addition of cyclosporine) is an effective approach for renal allograft maintenance.
开展了一项随机、前瞻性多中心试验，以比较OKT3作为诱导疗法与给予尸体肾移植受者的传统免疫抑制疗法的安全性和有效性。215例患者接受了如下治疗：OKT3联合硫唑嘌呤和类固醇治疗14天，并在第11天延迟加用环孢素；或接受传统免疫抑制治疗（类固醇、硫唑嘌呤和环孢素）。与传统治疗的患者相比，接受OKT3治疗的患者排斥反应显著减少（51%对66%，P = 0.032），首次发生排斥反应的时间更长（46天对8天，P = 0.001），且每位患者的排斥反应次数更少（0.82对1.14，P = 0.014）。接受OKT3治疗组的两年移植肾和患者生存率的Kaplan-Meier估计值分别为84%和95%，而传统治疗组分别为75%和94%。在随后首次发生排斥反应后，接受OKT3诱导治疗的患者中93%的排斥反应得到逆转，接受传统治疗的患者中这一比例为94%。OKT3诱导治疗期间报告的不良经历与该药用于治疗排斥反应时观察到的情况相似。初次接触后，40.3%的检测患者抗OKT3抗体呈阳性，其中只有6.7%为高滴度（1:1000）。在存在低滴度（1:100或更低）抗体的情况下，OKT3成功逆转了6例再次检测患者中5例的排斥反应。总之，OKT3（联合硫唑嘌呤、类固醇以及延迟加用环孢素）治疗是维持肾移植的有效方法。
