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单剂量脂质体两性霉素B治疗孟加拉国内脏利什曼病患者的疗效与安全性:一项真实病例经验

Efficacy and safety of single-dose liposomal amphotericin B in patients with visceral leishmaniasis in Bangladesh: a real-life experience.

作者信息

Ekram Md Rezaul, Amin Mohammad Robed, Hasan Mohammad Jahid, Khan Md Abdullah Saeed, Nath Rajib, Mallik Pranab Kumar, Lister Alex, Rahman Monjur

机构信息

Department of Medicine, Dhaka Medical College, Dhaka, Bangladesh.

Pi Research Consultancy Center, Dhaka, Bangladesh.

出版信息

J Parasit Dis. 2021 Dec;45(4):903-911. doi: 10.1007/s12639-021-01379-w. Epub 2021 Mar 23.

Abstract

UNLABELLED

Liposomal amphotericin B (LAmB) is the drug of choice in Bangladesh to eliminate the burden of visceral leishmaniasis, also known as kala-azar, a fatal protozoan parasitic disease if left untreated. We aimed to assess efficacy and safety of a single-dose (10 mg/kg) LAmB in visceral leishmaniasis (VL) treatment among the visiting children and adults in a tertiary care setting. This prospective study includes 11 children and 19 adults with a confirmed diagnosis of kala-azar (total 30 cases). Intravenous infusion of LAmB (10 mg/kg body weight) was given to all of the patients. Clinical assessments were conducted during treatment, before hospital discharge, and on days 30 and 180 after treatment. Efficacy was estimated in terms of initial cure (at day 30) and the final cure (at 180 days). All information was recorded in a preformed case record form and analysis was performed in SPSS 22. The mean age was 27.13 ± 18.04 years (3-65) with male predominance (60%). Significant regression of spleen size was found following treatment with LAmB at 30 days and 180 days follow up visit (p < 0.05 for all). Overall, rate of initial cure was 90% (n = 27) (child 90.9% vs 89.47% adult) and final cure was 96.66% (n = 29) (child 100% vs 94.73% adult). Fourteen adverse events were recorded mostly including fever and/or shivering (85.71%). No case relapsed or were referred either due to management or Severe Adverse Event (SAE). In real-life experience, the LAmB treatment for visceral leishmaniasis is as safe and effective for treatment of kala-azar patients.

SUPPLEMENTARY INFORMATION

The online version contains supplementary material available at 10.1007/s12639-021-01379-w.

摘要

未标注

脂质体两性霉素B(LAmB)是孟加拉国消除内脏利什曼病(也称为黑热病)负担的首选药物,黑热病是一种致命的原生动物寄生虫病,若不治疗会导致死亡。我们旨在评估单剂量(10mg/kg)LAmB在三级医疗机构就诊的儿童和成人内脏利什曼病(VL)治疗中的疗效和安全性。这项前瞻性研究纳入了11名儿童和19名确诊为黑热病的成人(共30例)。所有患者均接受静脉输注LAmB(10mg/kg体重)。在治疗期间、出院前以及治疗后第30天和180天进行临床评估。根据初始治愈(第30天)和最终治愈(第180天)评估疗效。所有信息记录在预先制定的病例记录表中,并在SPSS 22中进行分析。平均年龄为27.13±18.04岁(3 - 65岁),男性占主导(60%)。在第30天和第180天随访时发现,LAmB治疗后脾脏大小有显著缩小(所有p值均<0.05)。总体而言,初始治愈率为90%(n = 27)(儿童为90.9%,成人为89.47%),最终治愈率为96.66%(n = 29)(儿童为100%,成人为94.73%)。记录了14起不良事件,主要包括发热和/或寒战(85.71%)。没有病例因管理或严重不良事件(SAE)而复发或转诊。在实际经验中,LAmB治疗内脏利什曼病对黑热病患者同样安全有效。

补充信息

在线版本包含可在10.1007/s12639-021-01379-w获取的补充材料。

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