Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis - A randomized, double-blind trial
Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis - A randomized, double-blind trial
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DOI：
10.7326/0003-4819-133-9-200011070-00009
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发表时间：
2000-11-07
影响因子：
39.2
通讯作者：
Rinaldi, MG
中科院分区：
文献类型：
--
作者：
Galgiani, JN;Catanzaro, A;Rinaldi, MG
背景：在之前的开放标签非比较性临床试验中，浴氟康唑和伊曲康唑是治疗进行性球孢子菌病的有效疗法。目的：确定氟康唑或伊曲康唑在治疗非脑膜进行性球孢子菌感染方面是否优越。设计：随机、双盲、安慰剂对照试验。地点：加利福尼亚州、亚利桑那州和德克萨斯州的 7 个治疗中心。患者：198 名患有慢性肺部、软组织、干预：口服氟康唑，400 mg/d，或伊曲康唑，200 mg，每天两次。测量：4、8 和 12 个月后，使用预定义的评分系统评估感染的严重程度。将结果与基线进行比较。结果：总体而言，50% 的患者（94 名中的 47 名）和 63% 的患者（97 名中的 67 名）分别对氟康唑和伊曲康唑 8 个月的治疗有反应（差异，13 个百分点 [95% CI，-2 至 28 个百分点]；P = 0.08）。骨骼感染患者对伊曲康唑的反应频率是氟康唑的两倍。到 12 个月时，57% 的患者对氟康唑有反应，72% 的患者对伊曲康唑有反应（差异，15 个百分点 [CI，0.003 至 30 个百分点]；P = 0.05）。正如之前的研究一样，软组织疾病与缓解可能性增加相关。除 3 名患者外，所有患者的血清标本中均检测到唑类药物；然而，药物浓度对预测结果没有帮助。停止治疗后的复发率在各组之间没有显着差异（氟康唑治疗后为 28%，伊曲康唑治疗后为 18%）。两种药物的耐受性良好。结论：氟康唑和伊曲康唑在治疗非脑膜球孢子菌病方面均未表现出统计学上优越的疗效，尽管在研究剂量下伊曲康唑的疗效有稍高的趋势。
Background: In previous open-label noncomparative clinical trials, bath fluconazole and itraconazole were effective therapy for progressive forms of coccidioidomycosis.Objective: To determine whether fluconazole or itraconazole is superior for treatment of nonmeningeal progressive coccidioidal infections.Design: Randomized, double-blind, placebo-controlled trial.Setting: 7 treatment centers in California, Arizona, and Texas.Patients: 198 patients with chronic pulmonary, soft tissue, or skeletal coccidioidal infections.Intervention: Oral fluconazole, 400 mg/d, or itraconazole, 200 mg twice daily.Measurements: After 4, 8, and 12 months, a predefined scoring system was used to assess severity of infection. Findings were compared with those at baseline.Results: Overall, 50% of patients (47 of 94) and 63% of patients (67 of 97) responded to 8 months of treatment with fluconazole and itraconazole, respectively (difference, 13 percentage points [95% CI, -2 to 28 percentage points]; P = 0.08). Patients with skeletal infections responded twice as frequently to itraconazole as to fluconazole. By 12 months, 57% of patients had responded to fluconazole and 72% had responded to itraconazole (difference, 15 percentage points [CI, 0.003 to 30 percentage points]; P = 0.05). Soft tissue disease was associated with increased likelihood of response, as in previous studies. Azole drug was detected in serum specimens from all but 3 patients; however, drug concentrations were not helpful in predicting outcome. Relapse rates after discontinuation of therapy did not differ significantly between groups (28% after fluconazole treatment and 18% after itraconazole treatment). Both drugs were well tolerated.Conclusions: Neither fluconazole nor itraconazole showed statistically superior efficacy in nonmeningeal coccidioidomycosis, although there is a trend toward slightly greater efficacy with itraconazole at the doses studied.