A Controlled Trial of Ganciclovir to Prevent Cytomegalovirus Disease after Heart Transplantation

作者：Thomas C. Merigan, Dale G. Renlund, SUSAN K. KEAY, Michael R. Bristow, Vaughn A. Starnes, John B. O’Connell, Silvia C. Resta, Diane Dunn, P. Gamberg, Ranae M. Ratkovec, Wayne E. Richenbacher, Roger C. Millar, Charles DuMond, Bernadette DeAmond, Veronica Sullivan, Tricia Cheney, William C. Buhles, Edward B. Stinson · 发表于：New England Journal of Medicine · 年份：1992 · DOI：10.1056/nejm199204303261803 · 被引用次数：382 · 研究领域：Cytomegalovirus and herpesvirus research、Transplantation: Methods and Outcomes、Hepatitis Viruses Studies and Epidemiology

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 less than 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-treat...