Reed E C, Bowden R A, Dandliker P S, Lilleby K E, Meyers J D
Fred Hutchinson Cancer Research Center, Seattle, Washington.
Ann Intern Med. 1988 Nov 15;109(10):783-8. doi: 10.7326/0003-4819-109-10-783.
To determine if the combination of ganciclovir and intravenous cytomegalovirus immunoglobulin is effective in patients with cytomegalovirus pneumonia after bone marrow transplant.
Consecutive entry trial with treatment for a minimum of 14 days.
Consecutive sample of 25 patients with bone marrow transplants and cytomegalovirus pneumonia after transplant proven by open lung biopsy or bronchoalveolar lavage. Patients with abnormal renal function or concomitant infectious causes of pneumonia, or who were respirator-dependent at diagnosis, were not eligible.
Induction treatment consisted of ganciclovir, 2.5 mg/kg body weight every 8 hours for 14 days, and cytomegalovirus immunoglobulin, 400 mg/kg on days 1, 2, and 7 and 200 mg/kg on day 14. Ganciclovir dosage was adjusted for renal function. Patients who were improved but still symptomatic after 14 days were given maintenance treatment consisting of ganciclovir, 5 mg/kg once daily for an additional 14 days, and immunoglobulin, 200 mg/kg on day 21. Patients with clinical deterioration continued to receive induction doses. Ganciclovir therapy was discontinued if the neutrophil count fell below 500 X 10(6)/L for 2 consecutive days.
Serial tests of renal and liver function, blood counts, and viral cultures of blood, throat, and urine were obtained 3 times a week. Thirteen of twenty-five (52%) patients (95% CI, 31 to 72) survived the initial episode of pneumonia. Viral excretion ceased in 17 of 23 (74%) patients treated more than 96 hours. Proven recurrences of pneumonia occurred in 3 patients and possible recurrences in 2 after treatment was stopped. Three patients developed neutropenia during induction therapy and 6 patients during maintenance therapy.
Survival of 13 (52%) of 25 patients from the initial episode of cytomegalovirus pneumonia with the regimen of ganciclovir and cytomegalovirus immunoglobulin is significantly better (P less than 0.001) than the survival of 13 of 89 (15%) patients using previous antiviral regimens.
确定更昔洛韦与静脉注射巨细胞病毒免疫球蛋白联合应用对骨髓移植后发生巨细胞病毒肺炎的患者是否有效。
连续入组试验，治疗至少14天。
连续选取25例骨髓移植且移植后发生巨细胞病毒肺炎的患者，经开胸肺活检或支气管肺泡灌洗确诊。肾功能异常、伴有肺炎的其他感染病因或诊断时依赖呼吸机的患者不符合入选标准。
诱导治疗包括更昔洛韦，体重2.5mg/kg，每8小时1次，共14天；巨细胞病毒免疫球蛋白，第1、2和7天400mg/kg，第14天200mg/kg。更昔洛韦剂量根据肾功能调整。14天后病情改善但仍有症状的患者给予维持治疗，包括更昔洛韦，5mg/kg，每日1次，再用14天，免疫球蛋白，第21天200mg/kg。临床病情恶化的患者继续接受诱导剂量治疗。如果中性粒细胞计数连续2天低于500×10⁶/L，则停用更昔洛韦治疗。
每周3次进行肾功能、肝功能、血细胞计数以及血液、咽喉和尿液病毒培养的系列检测。25例患者中有13例（52%）（95%CI，31%至72%）在肺炎初始发作期存活。接受治疗超过96小时的23例患者中有17例（74%）病毒排泄停止。治疗停止后，3例患者确诊肺炎复发，2例可能复发。3例患者在诱导治疗期间出现中性粒细胞减少，6例患者在维持治疗期间出现中性粒细胞减少。
采用更昔洛韦和巨细胞病毒免疫球蛋白方案治疗，25例巨细胞病毒肺炎初始发作期患者中有13例（52%）存活，这显著优于（P<0.001）使用先前抗病毒方案治疗的89例患者中的13例（15%）的存活率。
