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脂质体两性霉素 B 治疗人类利什曼病。

Liposomal amphotericin B as a treatment for human leishmaniasis.

机构信息

Drugs for Neglected Diseases Initiative, Geneva, Switzerland.

出版信息

Expert Opin Emerg Drugs. 2012 Dec;17(4):493-510. doi: 10.1517/14728214.2012.748036. Epub 2012 Nov 20.

Abstract

INTRODUCTION

Leishmaniasis is a parasitic disease transmitted by phlebotomine sandflies. Between 700,000 and 1.2 million cases of cutaneous leishmaniasis and between 200,000 and 400,000 cases of visceral leishmaniasis (VL), which is fatal if left untreated, occur annually worldwide. Liposomal amphotericin B (LAMB), alone or in combination with other drugs, has been extensively studied as VL treatment, but data on routine field use are limited, and several challenges to patients' access to this life-saving drug remain.

AREAS COVERED

This article provides a review of clinical studies on LAMB for VL and other forms of leishmaniasis. The current development of generic versions of LAMB and related challenges are also discussed.

EXPERT OPINION

LAMB proved to be highly efficacious and safe in over 8000 VL patients treated by MÉdecins Sans Frontières in South Asia, and its use was feasible even at primary healthcare level. Despite requiring higher doses, LAMB is the drug of choice to treat vulnerable groups (e.g., pregnant or HIV positive) and relapsing VL patients in East Africa. LAMB should be included in national VL guidelines and registered in all VL endemic countries. Its cost should be further reduced and regulatory pathways to prove bioequivalence for generic LAMB products should be implemented.

摘要

简介

利什曼病是一种由白蛉传播的寄生虫病。每年在全球范围内都会发生 70 万至 120 万例皮肤利什曼病和 20 万至 40 万例内脏利什曼病(VL)病例,如果不治疗,VL 是致命的。单独使用或与其他药物联合使用脂质体两性霉素 B(LAMB)已被广泛研究用于治疗 VL,但关于常规现场使用的数据有限,并且患者获得这种救命药物仍然存在一些挑战。

涵盖领域

本文回顾了 LAMB 治疗 VL 和其他形式利什曼病的临床研究。还讨论了 LAMB 通用版本的当前开发情况和相关挑战。

专家意见

无国界医生组织在南亚为 8000 多名 VL 患者使用 LAMB 治疗,结果证明其疗效高且安全,即使在初级保健水平也可以使用。尽管需要更高的剂量,但 LAMB 是治疗弱势群体(例如孕妇或 HIV 阳性)和东非复发性 VL 患者的首选药物。LAMB 应被纳入国家 VL 指南,并在所有 VL 流行国家注册。应进一步降低其成本,并实施用于证明通用 LAMB 产品生物等效性的监管途径。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52c1/3518293/22ebf9092a48/EMD-17-493-g001.jpg

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