A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF ORAL ACYCLOVIR FOR THE PREVENTION OF CYTOMEGALO-VIRUS DISEASE IN RECIPIENTS OF RENAL-ALLOGRAFTS
A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF ORAL ACYCLOVIR FOR THE PREVENTION OF CYTOMEGALO-VIRUS DISEASE IN RECIPIENTS OF RENAL-ALLOGRAFTS
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DOI：
10.1056/nejm198905253202105
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发表时间：
1989-05-25
影响因子：
158.5
通讯作者：
FRYD, DS
中科院分区：
文献类型：
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作者：
BALFOUR, HH;CHACE, BA;FRYD, DS
巨细胞病毒是肾移植患者的主要病毒病原体，巨细胞病毒疾病很难治疗。因此，我们进行了一项阿昔洛韦预防尸体肾同种异体移植受者巨细胞病毒病的随机、安慰剂对照、双结合试验。根据患者估计的肾功能水平，每天口服阿昔洛韦 800 至 3200 mg。患者在移植前 6 小时服用第一剂阿昔洛韦或安慰剂，并继续服用指定药物 12 周。在参与该研究的 118 名患者中，104 名患者完成了至少 30 天的研究药物治疗，并被纳入我们的结果分析中。移植后第一年，阿昔洛韦组 53 名患者中有 4 名（7.5%）患有有症状的巨细胞病毒病，而安慰剂组 51 名患者中有 15 名（29%）患有症状性巨细胞病毒病（P = 0.002）。阿昔洛韦组有 1 例巨细胞病毒肺炎病例，而安慰剂组有 9 例。在接受血清阳性供体肾脏的血清阴性患者中观察到阿昔洛韦的最大预防益处。阿昔洛韦组中的六名患者中只有一名患有巨细胞病毒病，而安慰剂组中则有七名患者患有巨细胞病毒病。在接受安慰剂的患者中，阿昔洛韦将巨细胞病毒感染（有或没有症状性疾病）的发生率从 61% 降低到 36%（P = 0.011）。在接受阿昔洛韦治疗的患者中，血液和尿液中病毒的回收率显着降低，但咽部病毒排出率与安慰剂组没有显着差异。各组之间的不良事件发生频率或移植物或患者的存活率没有差异。我们的结论是，在移植同种异体肾移植物之前开始口服阿昔洛韦可以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存活率。
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-bind trial of acyclovir for the prevention of cytomegalovirus disease in recipients of renal allografts from cadvers. Acyclovir was given orally in doses of 800 of 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 porphylactic 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.