Ally R, Schürmann D, Kreisel W, Carosi G, Aguirrebengoa K, Dupont B, Hodges M, Troke P, Romero A J
Department of Gastroenterology, Chris Hani, Baragwanath Hospital, Johannesburg, South Africa.
Clin Infect Dis. 2001 Nov 1;33(9):1447-54. doi: 10.1086/322653. Epub 2001 Sep 26.
The efficacy, safety, and tolerability of voriconazole and fluconazole were compared in 391 immunocompromised patients with mycology- and biopsy-proven esophageal candidiasis. Primary efficacy analysis (256 patients) of esophageal treatment as assessed by esophagoscopy revealed success rates of 98.3% with voriconazole and 95.1% with fluconazole. The 95% confidence interval for the difference in success rates ranged from -1.0% to 7.5%. The overall safety and tolerability of both antifungals were acceptable. Fewer patients discontinued voriconazole treatment because of insufficient clinical response (4 patients [2.0%] vs. 5 patients [2.6%]). More patients discontinued voriconazole than fluconazole treatment because of laboratory test abnormalities (7 patients [3.5%] vs. 2 patients [1.0%]) or treatment-related adverse events (5 patients [2.5%] vs. 1 patient [0.5%]). The most frequent adverse events (23%) with voriconazole were mild, transient visual disturbances. Voriconazole (200 mg, b.i.d.) was shown to be at least as effective as fluconazole in the treatment of biopsy-proven esophageal candidiasis in immunocompromised patients.
在391例经真菌学和活检证实为食管念珠菌病的免疫功能低下患者中，比较了伏立康唑和氟康唑的疗效、安全性和耐受性。通过食管镜评估食管治疗的主要疗效分析（256例患者）显示，伏立康唑的成功率为98.3%，氟康唑为95.1%。成功率差异的95%置信区间为-1.0%至7.5%。两种抗真菌药物的总体安全性和耐受性均可接受。因临床反应不足而停用伏立康唑治疗的患者较少（4例[2.0%]对5例[2.6%]）。因实验室检查异常（7例[3.5%]对2例[1.0%]）或治疗相关不良事件（5例[2.5%]对1例[0.5%]）而停用伏立康唑治疗的患者比氟康唑多。伏立康唑最常见的不良事件（23%）为轻度、短暂的视觉障碍。在治疗活检证实的免疫功能低下患者的食管念珠菌病方面，伏立康唑（200毫克，每日两次）显示出至少与氟康唑一样有效。
