Snydman D R, Werner B G, Heinze-Lacey B, Berardi V P, Tilney N L, Kirkman R L, Milford E L, Cho S I, Bush H L, Levey A S
Department of Medicine, Brigham and Women's Hospital, Boston, MA 02111.
N Engl J Med. 1987 Oct 22;317(17):1049-54. doi: 10.1056/NEJM198710223171703.
We undertook a prospective randomized trial to examine whether an intravenous cytomegalovirus (CMV) immune globulin would prevent primary CMV disease in renal-transplant recipients. Fifty-nine CMV-seronegative patients who received kidneys from donors who had antibodies against CMV were assigned to receive either intravenous CMV immune globulin or no treatment. The immune globulin was administered in multiple doses over the first four months after transplantation. The incidence of virologically confirmed CMV-associated syndromes was reduced from 60 percent in controls to 21 percent in recipients of CMV immune globulin (P less than 0.01). Fungal or parasitic superinfections were not seen in globulin recipients but occurred in 20 percent of controls (P = 0.05). Only 4 percent of globulin recipients had marked leukopenia (reflecting serious CMV disease), as compared with 37 percent of the controls (P less than 0.01). There was a concomitant but not statistically significant reduction in the incidence of CMV pneumonia (17 percent of controls as compared with 4 percent of globulin recipients). A significant reduction in serious CMV-associated disease was observed even when patients were stratified according to therapy for transplant rejection (P = 0.04). We observed no effect of immune globulin on rates of viral isolation or seroconversion, suggesting that treated patients often harbored the virus but that clinically evident disease was much less likely to develop in them. We conclude that CMV immune globulin provides effective prophylaxis in renal-transplant recipients at risk for primary CMV disease.
我们进行了一项前瞻性随机试验，以研究静脉注射巨细胞病毒（CMV）免疫球蛋白是否能预防肾移植受者的原发性CMV疾病。59名CMV血清阴性患者接受了来自有CMV抗体供体的肾脏，被分配接受静脉注射CMV免疫球蛋白或不接受治疗。免疫球蛋白在移植后的前四个月分多次给药。病毒学确诊的CMV相关综合征的发生率从对照组的60%降至CMV免疫球蛋白接受者的21%（P<0.01）。球蛋白接受者未出现真菌或寄生虫二重感染，而对照组中出现的比例为20%（P=0.05）。只有4%的球蛋白接受者有明显的白细胞减少（反映严重的CMV疾病），而对照组为37%（P<0.01）。CMV肺炎的发生率也有相应降低，但无统计学意义（对照组为17%，球蛋白接受者为4%）。即使根据移植排斥反应的治疗对患者进行分层，严重CMV相关疾病的发生率也显著降低（P=0.04）。我们观察到免疫球蛋白对病毒分离率或血清转化无影响，这表明接受治疗的患者通常携带病毒，但临床上明显的疾病在他们身上发生的可能性要小得多。我们得出结论，CMV免疫球蛋白对有原发性CMV疾病风险的肾移植受者提供了有效的预防作用。
