Balfour H H, Chace B A, Stapleton J T, Simmons R L, Fryd D S
Department of Laboratory Medicine, University of Minnesota Health Sciences Center, Minneapolis 55455.
N Engl J Med. 1989 May 25;320(21):1381-7. doi: 10.1056/NEJM198905253202105.
Cytomegalovirus is a major viral pathogen in patients who undergo renal transplantation, and cytomegalovirus disease is difficult to treat. We therefore conducted a randomized, placebo-controlled, double-blind trial of acyclovir for the prevention of cytomegalovirus disease in recipients of renal allografts from cadavers. Acyclovir was given orally in doses of 800 to 3200 mg per day, according to the patients' estimated level of renal function. Patients took the first dose of either acyclovir or placebo six hours before transplantation and continued to take the assigned medication for 12 weeks. Of 118 patients enrolled in the study, 104 completed at least 30 days on the study medication and were included in our analysis of the results. During the first year after transplantation, 4 of 53 patients (7.5 percent) in the acyclovir group had symptomatic cytomegalovirus disease, as compared with 15 of 51 (29 percent) in the placebo group (P = 0.002). There was a single case of cytomegalovirus pneumonia in the acyclovir group, as compared with nine in the placebo group. The greatest prophylactic benefit of acyclovir was observed among seronegative patients who had received a kidney from a seropositive donor; only one of six such patients in the acyclovir group had cytomegalovirus disease, as compared with all seven in the placebo group. Acyclovir decreased the incidence of documented cytomegalovirus infection (with or without symptomatic disease) to 36 percent from 61 percent among the patients who received the placebo (P = 0.011). Among the patients who received acyclovir, the rates of recovery of virus from the blood and urine were significantly reduced, but the rate of viral shedding from the pharynx was not significantly different from that in the placebo group. There were no differences between the groups in the frequency of adverse events or in the rate of survival of either grafts or patients. We conclude that the oral administration of acyclovir, beginning before the transplantation of a renal allograft from a cadaver, reduces the rate of cytomegalovirus infection and disease without affecting the survival rate of either grafts or patients.
巨细胞病毒是接受肾移植患者的一种主要病毒病原体，且巨细胞病毒病难以治疗。因此，我们进行了一项随机、安慰剂对照、双盲试验，以研究阿昔洛韦对预防来自尸体供肾的同种异体肾移植受者巨细胞病毒病的效果。根据患者估计的肾功能水平，阿昔洛韦以每日800至3200毫克的剂量口服给药。患者在移植前6小时服用第一剂阿昔洛韦或安慰剂，并持续服用指定药物12周。在纳入该研究的118名患者中，104名至少服用研究药物30天，并被纳入我们的结果分析。移植后的第一年，阿昔洛韦组53名患者中有4名（7.5%）出现有症状的巨细胞病毒病，而安慰剂组51名患者中有15名（29%）出现（P = 0.002）。阿昔洛韦组有1例巨细胞病毒肺炎，而安慰剂组有9例。在接受血清反应阳性供者肾脏的血清反应阴性患者中，观察到阿昔洛韦具有最大的预防益处；阿昔洛韦组6名此类患者中只有1例出现巨细胞病毒病，而安慰剂组7名患者全部出现。阿昔洛韦使接受安慰剂的患者中记录的巨细胞病毒感染（无论有无症状疾病）发生率从61%降至36%（P = 0.011）。在接受阿昔洛韦的患者中，血液和尿液中病毒的恢复率显著降低，但咽部病毒脱落率与安慰剂组无显著差异。两组在不良事件发生频率或移植物及患者生存率方面无差异。我们得出结论，在来自尸体的同种异体肾移植前开始口服阿昔洛韦，可降低巨细胞病毒感染和疾病的发生率，而不影响移植物或患者的生存率。
