Randomised trial of efficacy and safety of oral ganciclovir in the prevention of cytomegalovirus disease in liver-transplant recipients
Randomised trial of efficacy and safety of oral ganciclovir in the prevention of cytomegalovirus disease in liver-transplant recipients
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DOI：
10.1016/s0140-6736(97)05535-9
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发表时间：
1997-12-13
期刊：
影响因子：
168.9
通讯作者：
Robinson, CA
中科院分区：
文献类型：
--
作者：
Gane, E;Saliba, F;Robinson, CA
背景巨细胞病毒（CMV）病是导致实体器官移植后严重并发症的常见原因。用于预防CMV感染和疾病的预防性方案在血清阴性受者中显示出有限的益处。我们研究了口服更昔洛韦的安全性和有效性，在预防CMV疾病后原位肝transplant.Methods 1993年12月，1995年4月，304肝移植受者随机接受口服更昔洛韦1000毫克或匹配安慰剂，每天三次。排除血清阴性肝脏的血清阴性受体。一旦患者能够口服药物（不晚于第10天），即给予研究药物，直至移植后第98天。结果Kaplan-Meier法估计安慰剂组6个月内154例患者中有29例（18.9%）发生CMV疾病，而更昔洛韦组150例患者中有7例（4.8%）发生CMV疾病（P < 0.05）。
Background Cytomegalovirus (CMV) disease is a frequent cause of serious morbidity after solid-organ transplantation. The prophylactic regimens used to prevent CMV infection and disease have shown limited benefit in seronegative recipients. We studied the safety and efficacy of oral ganciclovir in the prevention of CMV disease following orthotopic liver transplantation.Methods Between December, 1993, and April, 1995, 304 liver-transplant recipients were randomised to receive oral ganciclovir 1000 mg or matching placebo three times a day. Seronegative recipients of seronegative livers were excluded. Study drug was administered as soon as the patient was able to take medication by mouth (no later than day 10) until the 98th day after transplantation. Patients were assessed at specified times throughout the first 6 months after surgery for evidence of CMV infection, CMV disease, rejection, opportunistic infections, and possible drug toxicity.Findings The Kaplan-Meier estimate of the 6-month incidence of CMV disease was 29 (18.9%) of 154 in the placebo group, compared with seven (4.8%) of 150 in the ganciclovir group (p