Graybill J R, Stevens D A, Galgiani J N, Dismukes W E, Cloud G A
Medical Service, Audie Murphy Veterans Administration Hospital, San Antonio, Texas 78284.
Am J Med. 1990 Sep;89(3):282-90. doi: 10.1016/0002-9343(90)90339-f.
The purpose of this study was to assess the tolerance and efficacy of itraconazole in the treatment of coccidioidomycosis.
Fifty-one patients with nonmeningeal coccidioidomycosis were considered for treatment with intraconazole. Forty-nine patients who met study criteria were treated with itraconazole given orally in doses of 100 to 400 mg/day for periods up to 39 months. Of these patients, 12 had osteoarticular disease, 23 had chronic pulmonary disease, and 14 had skin or soft tissue disease. Clinical response was evaluated using a scoring system accounting for lesion number and size, symptoms, culture, and serologic titer. Remission was defined as reduction of the pretreatment score by 50% or more.
Patients with osteoarticular, chronic pulmonary, and soft tissue disease improved at similar rates. Because two patients had no scoring assessment for efficacy, they were considered inassessable for efficacy. Forty-seven patients are evaluable. Of these patients, 44 have completed therapy, and three are still receiving itraconazole. Of the 44 patients no longer receiving therapy, 25 (57%) achieved remission. Of the 25 patients achieving remission, four later experienced a relapse. Therapy failed in 19 patients (43%). Of these cases, 16 (36%) were clinical failures and three (7%) developed drug intolerance that precluded continuation of treatment. Evaluation of culture conversions was of limited value in the osteoarticular patients, fewer than half of whom had follow-up biopsies. However, culture conversions were a useful index of response in patients with chronic pulmonary disease. During the course of treatment, serologic titers declined in the two groups with extrapulmonary disease, but not in patients with pulmonary coccidioidomycosis. Possible toxicities were generally mild.
Itraconazole appears efficacious and very well tolerated in patients with coccidioidomycosis.
本研究旨在评估伊曲康唑治疗球孢子菌病的耐受性和疗效。
51例非脑膜球孢子菌病患者被考虑用伊曲康唑治疗。49例符合研究标准的患者接受伊曲康唑口服治疗,剂量为100至400mg/天,疗程长达39个月。其中,12例患有骨关节炎疾病,23例患有慢性肺部疾病,14例患有皮肤或软组织疾病。使用一个考虑病变数量和大小、症状、培养及血清学滴度的评分系统评估临床反应。缓解定义为预处理评分降低50%或更多。
骨关节炎、慢性肺部和软组织疾病患者的改善率相似。由于两名患者未进行疗效评分评估,故认为其疗效不可评估。47例患者可评估。其中,44例已完成治疗,3例仍在接受伊曲康唑治疗。在44例不再接受治疗的患者中,25例(57%)实现缓解。在实现缓解的25例患者中,4例后来复发。19例患者(43%)治疗失败。其中,16例(36%)为临床失败,3例(7%)出现药物不耐受而无法继续治疗。在骨关节炎患者中,培养转阴评估价值有限,不到一半的患者进行了随访活检。然而,培养转阴是慢性肺部疾病患者反应的有用指标。在治疗过程中,肺外疾病两组的血清学滴度下降,但肺部球孢子菌病患者的血清学滴度未下降。可能的毒性一般较轻。
伊曲康唑在球孢子菌病患者中似乎有效且耐受性良好。