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伊曲康唑治疗皮肤孢子丝菌病-645 例患者研究。

Treatment of cutaneous sporotrichosis with itraconazole--study of 645 patients.

机构信息

Evandro Chagas Clinical Research Institute, Rio de Janeiro, Brazil.

出版信息

Clin Infect Dis. 2011 Jun 15;52(12):e200-6. doi: 10.1093/cid/cir245.

Abstract

BACKGROUND

Itraconazole has become the first choice for treatment of cutaneous sporotrichosis. However, this recommendation is based on case reports and small series. The safety and efficacy of itraconazole were evaluated in 645 patients who received a diagnosis on the basis of isolation of Sporothrix schenckii in Rio de Janeiro, Brazil.

METHODS

A standard regimen of itraconazole (100 mg/day orally) was used. Clinical and laboratory adverse events were assessed a grades 1-4. A multivariate Cox model was used to analyze the response to treatment.

RESULTS

The median age was 43 years. Lymphocutaneous form occurred in 68.1% and fixed form in 23.1%. Six hundred ten patients (94.6%) were cured with itraconazole (50-400 mg/day): 547 with 100 mg/day, 59 with 200-400 mg/day, and 4 children with 50 mg/day. Three patients switched to potassium iodide, 2 to terbinafine, and 4 to thermotherapy. Twenty-six were lost to follow-up. Clinical adverse events occurred in 18.1% of patients using 100 mg/day and 21.9% of those using 200-400 mg/day. The most frequent clinical adverse events were nausea and epigastric pain. Laboratory adverse events occurred in 24.1%; the most common was hypercholesterolemia, followed by hypertriglyceridemia. Four hundred sixty-two patients (71.6%) completed clinical follow-up, and all remained cured. Only 2 variables were significant in explaining the cure: patients with erythema nodosum healed faster, and lymphocutaneous form took longer to cure.

CONCLUSIONS

In the current series, the therapeutic response was excellent with the minimum dose of itraconazole, and there was a low incidence of adverse events and treatment failure.

摘要

背景

伊曲康唑已成为治疗皮肤孢子丝菌病的首选药物。然而,这一推荐是基于病例报告和小系列研究。本研究在巴西里约热内卢基于申克孢子丝菌分离培养确诊的 645 例患者中评估了伊曲康唑的安全性和疗效。

方法

采用标准伊曲康唑(100 mg/天,口服)治疗方案。根据 1-4 级评估临床和实验室不良事件。采用多变量 Cox 模型分析治疗反应。

结果

中位年龄为 43 岁。淋巴管型占 68.1%,固定型占 23.1%。610 例(94.6%)患者经伊曲康唑治愈(50-400 mg/天):547 例用 100 mg/天,59 例用 200-400 mg/天,4 例儿童用 50 mg/天。3 例患者换用碘化钾,2 例换用特比萘芬,4 例换用热疗。26 例失访。100 mg/天组和 200-400 mg/天组的患者分别有 18.1%和 21.9%出现临床不良事件。最常见的临床不良事件为恶心和上腹痛。24.1%的患者出现实验室不良事件,最常见的是胆固醇升高,其次是甘油三酯升高。462 例(71.6%)患者完成了临床随访,均治愈。仅有 2 个变量对解释治愈有意义:结节性红斑患者愈合更快,淋巴管型治愈时间更长。

结论

在当前系列中,伊曲康唑最低剂量治疗反应极好,不良事件发生率低,治疗失败率低。

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