A CONTROLLED TRIAL OF GANCICLOVIR TO PREVENT CYTOMEGALOVIRUS DISEASE AFTER HEART-TRANSPLANTATION
A CONTROLLED TRIAL OF GANCICLOVIR TO PREVENT CYTOMEGALOVIRUS DISEASE AFTER HEART-TRANSPLANTATION
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DOI：
10.1056/nejm199204303261803
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发表时间：
1992-04-30
影响因子：
158.5
通讯作者：
STINSON, EB
中科院分区：
文献类型：
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作者：
MERIGAN, TC;RENLUND, DG;STINSON, EB
背景资料。由于所需的免疫抑制，心脏移植受者经常出现巨细胞病毒(CMV)引起的并发症，包括肺炎、食管炎、胃炎以及发热、肝炎和白细胞减少综合征。我们进行了一项对照试验，以评价预防性应用更昔洛韦预防心脏移植后巨细胞病毒引起的疾病。这项随机、双盲、安慰剂对照试验在四个中心进行。在随机分组之前，患者被分成两组：移植前CMV血清阳性的患者和血清阴性但接受血清阳性捐赠者的心脏的患者。术后第1~14天，更昔洛韦5 mg/kg体重静脉滴注，每12小时1次，后改为6 mg/kg/d，每周5天，至28天。在血清阳性的患者中，服用安慰剂的56名患者中有26名(46%)在心脏移植后的头120天内发生巨细胞病毒病，而接受更昔洛韦治疗的56名患者中有5名(9%)(P<；0.001)。在37名血清阴性患者中，CMV疾病在两组中都很常见(安慰剂，29%；更昔洛韦，35%；P不显著)。从第15天到第60天，服用更昔洛韦的患者尿培养中CMV阳性的患者明显较少，但到第90天时没有差异。接受更昔洛韦治疗的患者中，有更多患者的血肌酐浓度大于或等于每升220微克摩尔(每升2.5毫克)(18%比安慰剂组的4%)，但这些升高是暂时的。心脏移植后预防性应用更昔洛韦是安全的，在CMV血清阳性的患者中，它降低了CMV引起的疾病的发生率。
Background. Because of the immunosuppression required, heart-transplant recipients frequently have complications caused by cytomegalovirus (CMV), including pneumonia, esophagitis, gastritis, and a syndrome of fever, hepatitis, and leukopenia. We undertook a controlled trial to evaluate the prophylactic administration of ganciclovir to prevent CMV-induced disease after heart transplantation.Methods. This randomized, double-blind, placebo-controlled trial was conducted at four centers. Before randomization, the patients were stratified into two groups: those who were seropositive for CMV before transplantation and those who were seronegative but who received hearts from seropositive donors. Ganciclovir was given intravenously at a dose of 5 mg per kilogram of body weight every 12 hours from postoperative day 1 through day 14, then at a dose of 6 mg per kilogram each day for 5 days per week until day 28.Results. Among the seropositive patients, CMV illness occurred during the first 120 days after heart transplantation in 26 of 56 patients given placebo (46 percent), as compared with 5 of 56 patients treated with ganciclovir (9 percent) (P < 0.001). Among 37 seronegative patients, CMV illness was frequent in both groups (placebo, 29 percent; ganciclovir, 35 percent; P not significant). From day 15 through day 60, the patients who took ganciclovir had significantly fewer urine cultures positive for CMV, but by day 90 there was no difference. More of the ganciclovir-treated patients had serum creatinine concentrations greater-than-or-equal-to 220-mu-mol per liter (2.5 mg per deciliter) (18 percent vs. 4 percent in the placebo group), but those elevations were transient.Conclusions. The prophylactic administration of ganciclovir after heart transplantation is safe, and in CMV-seropositive patients it reduces the incidence of CMV-induced illness.