Galgiani J N, Catanzaro A, Cloud G A, Johnson R H, Williams P L, Mirels L F, Nassar F, Lutz J E, Stevens D A, Sharkey P K, Singh V R, Larsen R A, Delgado K L, Flanigan C, Rinaldi M G
Valley Fever Center for Excellence, 3601 South Sixth Avenue, Tucson, AZ 85723, USA.
Ann Intern Med. 2000 Nov 7;133(9):676-86. doi: 10.7326/0003-4819-133-9-200011070-00009.
In previous open-label noncomparative clinical trials, both fluconazole and itraconazole were effective therapy for progressive forms of coccidioidomycosis.
To determine whether fluconazole or itraconazole is superior for treatment of nonmeningeal progressive coccidioidal infections.
Randomized, double-blind, placebo-controlled trial.
7 treatment centers in California, Arizona, and Texas.
198 patients with chronic pulmonary, soft tissue, or skeletal coccidioidal infections.
Oral fluconazole, 400 mg/d, or itraconazole, 200 mg twice daily.
After 4, 8, and 12 months, a predefined scoring system was used to assess severity of infection. Findings were compared with those at baseline.
Overall, 50% of patients (47 of 94) and 63% of patients (61 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.
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.
在之前的开放标签非对照临床试验中，氟康唑和伊曲康唑对进行性球孢子菌病均为有效的治疗药物。
确定氟康唑或伊曲康唑在治疗非脑膜性进行性球孢子菌感染方面是否更具优势。
随机、双盲、安慰剂对照试验。
加利福尼亚州、亚利桑那州和得克萨斯州的7个治疗中心。
198例患有慢性肺部、软组织或骨骼球孢子菌感染的患者。
口服氟康唑，400mg/天，或伊曲康唑，200mg，每日两次。
在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。将结果与基线时的结果进行比较。
总体而言，分别有50%（94例中的47例）和63%（97例中的61例）的患者在接受8个月的氟康唑和伊曲康唑治疗后有反应（差异为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对氟康唑的两倍。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（差异为15个百分点[CI，0.003至30个百分点]；P = 0.05）。与既往研究一样，软组织疾病患者有反应的可能性增加。除3例患者外，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并无帮助。停药后的复发率在两组之间无显著差异（氟康唑治疗后为28%，伊曲康唑治疗后为18%）。两种药物耐受性均良好。
在非脑膜性球孢子菌病中，氟康唑和伊曲康唑在统计学上均未显示出更优的疗效，尽管在所研究的剂量下，伊曲康唑有疗效略高的趋势。
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