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首页> 外文期刊>Japanese journal of infectious diseases >Clinical study on the efficacy and safety of intravenous itraconazole infusion for the treatment of invasive fungal infection in china.
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Clinical study on the efficacy and safety of intravenous itraconazole infusion for the treatment of invasive fungal infection in china.

机译：中国静脉注射伊曲康唑输注治疗侵袭性真菌感染的疗效和安全性的临床研究。

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摘要

Itraconazole has a broad spectrum of activity against the most common fungal pathogens. Prior problems with absorption in severely ill patients have been overcome with the introduction of an oral solution and an intravenous preparation. An open-labeled, non-competitive, multicenter phase IV study was conducted to investigate the efficacy and safety of itraconazole administered intravenously for the treatment of invasive fungal infections in Chinese patients. Patients were treated with itraconazole intravenously for 2 weeks (200 mg twice daily for 2 days, then 200 mg once daily for 12 days) followed by 28 days of oral capsules (200 mg twice daily). Efficacy evaluation included an assessment of the clinical efficacy, fungal efficacy and total efficacy on days 14 and 42. Of 156 evaluable patients, 35 patients had proven and 62 suspected invasive fungal infections, and 59 patients were treated empirically. On day 14 the total efficacy rate in patients with proven infection was 54.3% (19/35; 95% confidence interval [CI], 37-71%) and on day 42 it was 65.7% (23/35; 95% CI, 48-81%). The most common adverse events were hypokalemia (13.5%), gastrointestinal disorders (12.8%), elevation of liver enzymes (10.9%) and increase of bilirubin (8.3%). Itraconazole intravenously followed by oral capsules is thus tolerated and effective in severely ill patients with proven invasive fungal infection.
机译：伊曲康唑对最常见的真菌病原体具有广泛的活性。通过引入口服溶液和静脉内制剂已经克服了重症患者吸收的先前问题。进行了一项开放标签，非竞争性，多中心IV期研究，以研究静脉注射伊曲康唑治疗中国患者侵袭性真菌感染的有效性和安全性。患者接受伊曲康唑静脉内治疗2周（每天200 mg，连续2天，然后每天200 mg，连续12天），然后口服28天（200 mg，每天两次）。疗效评估包括对第14天和第42天的临床疗效，真菌功效和总功效的评估。在156例可评估患者中，有35例确诊和62例可疑侵袭性真菌感染，并对59例患者进行了经验治疗。在第14天，已证实感染的患者的总有效率为54.3％（19/35; 95％置信区间[CI]，37-71％），在第42天为65.7％（23/35; 95％CI， 48-81％）。最常见的不良事件是低血钾（13.5％），胃肠道疾病（12.8％），肝酶升高（10.9％）和胆红素升高（8.3％）。因此，在经证实的侵袭性真菌感染的重症患者中，静脉注射伊曲康唑并口服口服胶囊有效。

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