Hansen R M, Reinerio N, Sohnle P G, Abrams R A, Ritch P S, Libnoch J A, Anderson T
Arch Intern Med. 1987 Apr;147(4):710-2.
A prospective, randomized, controlled, double-blind study was performed between 1982 and 1985 to assess the ability of ketoconazole to prevent fungal infections in selected patients with cancer. Fifty-six patients receiving induction chemotherapy for acute leukemia, autologous bone marrow transplant for refractory nonhematopoietic malignant neoplasms, multidrug chemotherapy for malignant lymphoma, or corticosteroids for brain metastases were randomized to receive either oral ketoconazole, 400 mg/d, or placebo and observed until leukopenia resolved or corticosteroid therapy was stopped. Oral candidiasis developed in eight (28%) of 29 patients receiving placebo compared with none of 27 receiving ketoconazole. However, ketoconazole failed to prevent Candida esophagitis and vulvovaginitis in two patients and one patient, respectively. Furthermore, prophylactic use of ketoconazole did not significantly alter the total number of hospital days, febrile days, or antibiotic days or the requirement for amphotericin B in patients with acute leukemia and autologous bone marrow transplant. Since oral candidiasis can be successfully managed by several different treatment modalities when it does occur, we do not think that the routine prophylactic use of ketoconazole is justified.
1982年至1985年间进行了一项前瞻性、随机、对照、双盲研究，以评估酮康唑预防特定癌症患者真菌感染的能力。56例接受急性白血病诱导化疗、难治性非造血恶性肿瘤自体骨髓移植、恶性淋巴瘤多药化疗或脑转移瘤皮质类固醇治疗的患者被随机分为两组，分别接受每日400毫克口服酮康唑或安慰剂，并进行观察，直至白细胞减少症缓解或皮质类固醇治疗停止。接受安慰剂的29例患者中有8例（28%）发生口腔念珠菌病，而接受酮康唑的27例患者中无一例发生。然而，酮康唑分别未能预防2例患者的念珠菌食管炎和1例患者的念珠菌外阴阴道炎。此外，对于急性白血病和自体骨髓移植患者，预防性使用酮康唑并未显著改变住院天数、发热天数或使用抗生素天数，也未改变两性霉素B的使用需求。由于口腔念珠菌病发生时可通过几种不同的治疗方式成功处理，我们认为常规预防性使用酮康唑并无道理。
