Goodrich J M, Bowden R A, Fisher L, Keller C, Schoch G, Meyers J D
Fred Hutchinson Cancer Research Center, Seattle, Washington.
Ann Intern Med. 1993 Feb 1;118(3):173-8. doi: 10.7326/0003-4819-118-3-199302010-00003.
To study the efficacy and toxicity of ganciclovir prophylaxis given at engraftment to cytomegalovirus (CMV)-seropositive, allogeneic bone marrow transplant recipients.
A double-blind, placebo-controlled study.
The Fred Hutchinson Cancer Research Center, a referral marrow transplant center.
This study was conducted from November 1990 to August 1991. Ninety-three CMV-seropositive patients were entered into the study before marrow transplant, with 64 patients randomized to receive the study drug after marrow engraftment. Thirty-one patients received placebo, and 33 received ganciclovir. The dose was 5 mg/kg body weight administered intravenously twice daily for 5 days, followed by once daily until day 100 after transplant.
Outcome variables measured were CMV infection, monitored by weekly cultures, and neutropenia, defined as an absolute neutrophil count of 0.750 x 10(-9)/L for 2 consecutive days. Cytomegalovirus disease and mortality were secondary end points.
Fourteen (45%) placebo recipients developed CMV infection in the first 100 days after marrow transplant compared with one (3%) ganciclovir recipient (P < 0.001). Nine (29%) placebo recipients developed CMV disease compared with no cases in the ganciclovir group during the first 100 days (P < 0.001). Neutropenia occurred in 10 ganciclovir recipients (30%) compared with no cases in the placebo group during the period of observation (P = 0.001). In a separate analysis, patients on ganciclovir who became neutropenic were at greater risk (relative risk, 4.3; P = 0.02) for bacterial infection. Mortality between the two study groups did not differ statistically at 100 and 180 days.
Ganciclovir given prophylactically after engraftment is effective in suppressing CMV infection and disease. Neutropenia is an important side effect of ganciclovir use and is associated with an increased risk for bacterial infection.
研究移植时给予更昔洛韦预防对巨细胞病毒（CMV）血清学阳性的异基因骨髓移植受者的疗效和毒性。
一项双盲、安慰剂对照研究。
弗雷德·哈钦森癌症研究中心，一家转诊骨髓移植中心。
本研究于1990年11月至1991年8月进行。93名CMV血清学阳性患者在骨髓移植前进入研究，64名患者在骨髓植入后随机接受研究药物。31名患者接受安慰剂，33名患者接受更昔洛韦。剂量为5mg/kg体重，静脉注射，每日两次，共5天，然后每日一次，直至移植后第100天。
测量的结果变量为CMV感染（通过每周培养监测）和中性粒细胞减少症（定义为连续2天绝对中性粒细胞计数为0.750×10⁻⁹/L）。巨细胞病毒疾病和死亡率为次要终点。
14名（45%）接受安慰剂的患者在骨髓移植后的前100天内发生CMV感染，而接受更昔洛韦的患者中有1名（3%）发生感染（P<0.001）。9名（29%）接受安慰剂的患者在最初100天内发生CMV疾病，而更昔洛韦组无病例发生（P<0.001）。在观察期间，10名接受更昔洛韦的患者（30%）出现中性粒细胞减少症，而安慰剂组无病例发生（P=0.001）。在一项单独分析中，发生中性粒细胞减少症的更昔洛韦治疗患者发生细菌感染的风险更高（相对风险，4.3；P=0.02）。两个研究组在100天和180天时的死亡率在统计学上无差异。
移植后预防性给予更昔洛韦可有效抑制CMV感染和疾病。中性粒细胞减少症是使用更昔洛韦的重要副作用，且与细菌感染风险增加相关。
