Snydman D R, Werner B G, Dougherty N N, Griffith J, Rubin R H, Dienstag J L, Rohrer R H, Freeman R, Jenkins R, Lewis W D, Hammer S, O'Rourke E, Grady G F, Fawaz K, Kaplan M M, Hoffman M A, Katz A T, Doran M
New England Medical Center, Boston, Massachusetts.
Ann Intern Med. 1993 Nov 15;119(10):984-91. doi: 10.7326/0003-4819-119-10-199311150-00004.
To study the effect of cytomegalovirus immune globulin (CMVIG) on prevention of cytomegalovirus (CMV) disease and its complications in patients receiving liver transplants.
Randomized, multicenter, placebo-controlled, double-blind trial.
Four university-affiliated transplant centers in Boston (Boston Center for Liver Transplantation).
One hundred forty-one liver transplant recipients completed the study.
CMVIG or placebo (1% albumin) given in a dose of 150 mg/kg body weight within 72 hours of the transplant, then at weeks 2, 4, 6, and 8, and at 100 mg/kg at weeks 12 and 16.
Patients were observed for 1 year after transplantation for the development of CMV infection, disease, pneumonia, as well as for opportunistic fungal infections, graft survival, and mortality. Weekly cultures were taken of urine, buffy coat, and throat wash for CMV for 2 months, then monthly, and at any clinical illness.
Using a Cox proportional hazards model, CMVIG was shown to reduce severe CMV-associated disease (multi-organ CMV disease, CMV pneumonia, or invasive fungal disease associated with CMV infection) from 26% to 12% (relative risk, 0.39; 95% CI, 0.17 to 0.89). When we controlled for the use of monoclonal antibodies to T cells (OKT3), CMVIG use was still protective (relative risk, 0.39; CI, 0.17 to 0.90). Rates of CMV disease were reduced from 31% to 19% (relative risk, 0.56; CI, 0.3 to 1.1) in CMVIG recipients although no effect on rates of CMV infection, graft survival, or patient survival at 1 year were shown. When we controlled for the urgency of transplantation and OKT3 use, a reduction in CMV disease (relative risk, 0.22; CI, 0.06 to 0.81) was shown for globulin recipients for all serologic groups except for the highest risk group (the CMV-seropositive donor, CMV-seronegative group).
CMVIG reduced the rate of severe CMV-associated disease in patients undergoing orthotopic liver transplantation. No effect of CMVIG on CMV donor-positive, recipient-negative liver transplant recipients was shown, suggesting a need for additional prophylactic strategies.
研究巨细胞病毒免疫球蛋白（CMVIG）对预防肝移植患者巨细胞病毒（CMV）疾病及其并发症的效果。
随机、多中心、安慰剂对照、双盲试验。
波士顿的四个大学附属移植中心（波士顿肝移植中心）。
141例肝移植受者完成了该研究。
在移植后72小时内给予CMVIG或安慰剂（1%白蛋白），剂量为150mg/kg体重，然后在第2、4、6和8周给药，在第12和16周给药100mg/kg。
移植后观察患者1年，观察CMV感染、疾病、肺炎的发生情况，以及机会性真菌感染、移植物存活情况和死亡率。在2个月内每周采集尿液、血沉棕黄层和咽漱液进行CMV培养，然后每月采集一次，以及在任何临床疾病发生时采集。
使用Cox比例风险模型，CMVIG可将严重CMV相关疾病（多器官CMV疾病、CMV肺炎或与CMV感染相关的侵袭性真菌疾病）的发生率从26%降至12%（相对风险，0.39；95%置信区间，0.17至0.89）。当我们控制了T细胞单克隆抗体（OKT3）的使用时，CMVIG的使用仍然具有保护作用（相对风险，0.39；置信区间，0.17至0.90）。CMVIG接受者的CMV疾病发生率从31%降至19%（相对风险，0.56；置信区间，0.3至1.1），尽管未显示对1年时的CMV感染率、移植物存活率或患者存活率有影响。当我们控制移植的紧迫性和OKT3的使用时，除最高风险组（CMV血清学阳性供体、CMV血清学阴性组）外，球蛋白接受者的所有血清学组的CMV疾病均有所减少（相对风险，0.22；置信区间，0.06至0.81）。
CMVIG降低了原位肝移植患者严重CMV相关疾病的发生率。未显示CMVIG对CMV供体阳性、受体阴性的肝移植受者有影响，提示需要额外的预防策略。
