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两性霉素 B 治疗内脏利什曼病患儿:每日与隔日治疗的随机试验。

Amphotericin B therapy in children with visceral leishmaniasis: daily vs. alternate day, a randomized trial.

机构信息

Department of Pediatrics and Child Care Center, Nalanda Medical College, Patna 800016, Bihar, India.

出版信息

J Trop Pediatr. 2010 Oct;56(5):321-4. doi: 10.1093/tropej/fmp132. Epub 2010 Jan 11.

DOI:10.1093/tropej/fmp132
PMID:20065047
Abstract

A randomized study was carried out to compare the efficacy and adverse reactions of daily vs. alternate day regimens of amphotericin B in children with visceral leishmaniasis (VL). Six hundred and five children of VL below 14 years of age were randomized into two groups; Group A (302), who received amphotericin B at a dose of 1 mg kg(-1) day(-1) for 15 days and Group B (303); same doses but on alternate days. All patients in both groups were cured, who had completed course of amphotericin B therapy. None had relapsed at 1 and 6 months of follow-up. Adverse reactions in both groups were non-significant. The duration of stay and cost of therapy was significantly lower in Group A children who left the hospital against medical advice, which was also significantly more in Group B. Thus, daily regimen of amphotericin B is equally effective, well tolerated, not more toxic and cost-effective than alternate day regimen, which is currently practiced.

摘要

一项随机研究比较了两性霉素 B 每日方案与隔日方案治疗内脏利什曼病(VL)患儿的疗效和不良反应。605 例 14 岁以下 VL 患儿随机分为两组;A 组(302 例)接受 1mg/kg-1 天-1 的两性霉素 B 治疗 15 天,B 组(303 例)相同剂量但隔日给药。两组均完成了两性霉素 B 治疗疗程的所有患者均治愈,无一例在 1 个月和 6 个月随访时复发。两组的不良反应均无显著差异。A 组因医源性原因提前出院的患儿住院时间和治疗费用明显较低,B 组则明显较高。因此,与目前采用的隔日方案相比,两性霉素 B 每日方案同样有效、耐受良好、毒性不增加且更具成本效益。

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