Cosimi A B, Cho S I, Delmonico F L, Kaplan M M, Rohrer R J, Jenkins R L
Transplantation. 1987 Jan;43(1):91-5. doi: 10.1097/00007890-198701000-00020.
A multiinstitutional randomized trial was undertaken comparing OKT3 with steroids for treatment of hepatic allograft rejection. All patients received baseline immunosuppression with Cyclosporine (CsA) and steroids. At the time of biopsy-confirmed rejection, up to 2 intravenous boluses (250-1000 mg) of methylprednisolone were initially administered. Twenty-eight patients who failed to respond were then randomly assigned to OKT3 or continued steroid therapy. Rescue therapy with the opposite treatment arm was added after 6 days if the primarily allocated protocol failed. Three of 13 patients assigned to the steroid group responded promptly, and continue with good function 7-12 months later. OKT3 rescue was required in 10 patients who failed to improve despite receiving up to 6 g of methylprednisolone (mean: 3.3 g/patient). One patient died of sepsis and hepatic failure. Rejection was reversed in 9 OKT3-rescue patients, 7 of whom are well 1-17 months later. In the OKT3 group, improved allograft function was observed within 72 hr in 11 of 15 patients. Two patients with inadequate response were successfully rescued with steroids; 1 patient underwent retransplantation; and 1 patient developed a biliary fistula that eventually resulted in sepsis and death. In summary, 23 of 28 hepatic recipients (82%) are alive with the original allograft 1-17 (mean 7.8) months after treatment for acute rejection. Another patient is alive 14 months following retransplantation. Eighteen (78%) of the survivors required OKT3 as initial (11) or rescue (7) therapy, whereas only 5 were successfully managed with steroids. OKT3 is superior to steroids for reversing liver allograft rejection and has greatly reduced the need for retransplantation even in recipients selected on the basis of having failed initial steroid therapy.
开展了一项多机构随机试验，比较OKT3与类固醇治疗肝移植排斥反应的效果。所有患者均接受环孢素（CsA）和类固醇进行基础免疫抑制。在活检确诊排斥反应时，最初先给予高达2次静脉推注（250 - 1000毫克）的甲泼尼龙。28例无反应的患者随后被随机分配接受OKT3或继续类固醇治疗。如果最初分配的方案失败，6天后加用另一治疗组的挽救治疗。分配到类固醇组的13例患者中有3例迅速产生反应，并在7至12个月后仍保持良好功能。10例尽管接受了高达6克甲泼尼龙（平均：3.3克/患者）但仍无改善的患者需要OKT3挽救治疗。1例患者死于败血症和肝衰竭。9例接受OKT3挽救治疗的患者排斥反应得到逆转，其中7例在1至17个月后情况良好。在OKT3组中，15例患者中有11例在72小时内观察到移植肝功能改善。2例反应不足的患者成功接受类固醇挽救治疗；1例患者接受了再次移植；1例患者发生胆瘘，最终导致败血症和死亡。总之，28例肝移植受者中有23例（82%）在治疗急性排斥反应后1至17个月（平均7.8个月）仍带着原移植肝存活。另1例患者在再次移植后14个月存活。18例（78%）幸存者需要OKT3作为初始（11例）或挽救（7例）治疗，而仅5例通过类固醇成功治疗。对于逆转肝移植排斥反应，OKT3优于类固醇，即使在因初始类固醇治疗失败而入选的受者中，也大大减少了再次移植的需求。
