First M R, Schroeder T J, Hariharan S, Alexander J W, Weiskittel P
Division of Nephrology and Hypertension, University of Cincinnati Medical Center, OH 45267-0585.
Transplantation. 1992 Jan;53(1):91-4. doi: 10.1097/00007890-199201000-00017.
Fifty renal transplant recipients with histologically documented acute allograft rejection were treated with OKT3 monoclonal antibody therapy. Group 1 (n = 25) received standard premedication with steroids, acetaminophen, and diphenhydramine. Group 2 (n = 25) received these agents plus indomethacin in an attempt to minimize the early adverse effects associated with OKT3. At 1 hr prior to the first dose of OKT3, 50 mg of indomethacin was administered orally followed by 25 mg every 6 hr for the next 48 hr. Demographics were similar in the two groups. Reversal of rejection occurred in 23 of 25 (92%) in group 1, and in 22 of 25 (88%) in group 2. Graft survival rates at six months after the rejection were 88% in group 1 and 80% in group 2. There was a single patient death in group 2, due to a suicide in a patient with a functioning kidney and pancreas graft. The maximum temperature was significantly diminished in the group receiving indomethacin during the first three days of OKT3 therapy. The percentage of patients with a maximum temperature less than 100 degrees F was significantly higher in group 2: day 1--16% vs. 36%, day 2--12% vs. 48%, day 3--52% vs. 68% for group 1 and group 2, respectively. No serious side effects occurred in either group--however, subjective side effects were less common in group 2. Serum creatinine levels were similar in the two groups prior to rejection, at the start of OKT3 therapy, at the peak during OKT3 therapy, at the end of OKT3 therapy, and 30 days and 180 days post OKT3. The data indicate that the concurrent use of indomethacin with OKT3 appears to significantly decrease the initial febrile response without compromising renal function or the efficacy of OKT3 therapy.
五十名经组织学证实发生急性移植肾排斥反应的肾移植受者接受了OKT3单克隆抗体治疗。第一组（n = 25）接受了标准的预处理，使用了类固醇、对乙酰氨基酚和苯海拉明。第二组（n = 25）除接受这些药物外还加用了吲哚美辛，试图将与OKT3相关的早期不良反应降至最低。在首次使用OKT3前1小时，口服50毫克吲哚美辛，随后在接下来的48小时内每6小时服用25毫克。两组的人口统计学特征相似。第一组25例中有23例（92%）排斥反应逆转，第二组25例中有22例（88%）排斥反应逆转。排斥反应发生后六个月时，第一组的移植肾存活率为88%，第二组为80%。第二组有1例患者死亡，是一名移植肾和胰腺功能正常的患者自杀所致。在OKT3治疗的前三天，接受吲哚美辛治疗的组体温最高值显著降低。最高体温低于100华氏度的患者百分比在第二组显著更高：第一天，第一组为16%，第二组为36%；第二天，第一组为12%，第二组为48%；第三天，第一组为52%，第二组为68%。两组均未出现严重副作用——然而，第二组的主观副作用较少见。在排斥反应发生前、OKT3治疗开始时、OKT3治疗高峰期、OKT3治疗结束时以及OKT3治疗后30天和180天，两组的血清肌酐水平相似。数据表明，吲哚美辛与OKT3同时使用似乎能显著降低初始发热反应，而不影响肾功能或OKT3治疗的疗效。
