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印度比哈尔邦常规规划条件下脂质体两性霉素 B 治疗内脏利什曼病的疗效和安全性。

Effectiveness and safety of liposomal amphotericin B for visceral leishmaniasis under routine program conditions in Bihar, India.

机构信息

Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India.

出版信息

Am J Trop Med Hyg. 2010 Aug;83(2):357-64. doi: 10.4269/ajtmh.2010.10-0156.


DOI:10.4269/ajtmh.2010.10-0156
PMID:20682882
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2911185/
Abstract

We evaluated, through the prospective monitoring of 251 patients at Sadar Hospital in Bihar, India, the effectiveness and safety of 20 mg/kg body weight of liposomal amphotericin B for the treatment of visceral leishmaniasis. The treatment success rates for the intention-to-treat, per protocol, and intention-to-treat worse-case scenario analyses were 98.8%, 99.6%, and 81.3%, respectively. Nearly one-half of patients experienced mild adverse events, but only 1% developed serious but non-life-threatening lips swelling. The lost to follow-up rate was 17.5%. Our findings indicate that the 20 mg/kg body weight treatment dosage is effective and safe under routine program conditions. Given that the exorbitant cost of liposomal amphotericin B is a barrier to its widespread use, we recommend further study to monitor and evaluate a lowered dosage and a shorter treatment course.

摘要

我们通过对印度比哈尔邦萨达尔医院的 251 名患者进行前瞻性监测,评估了 20 毫克/公斤体重的脂质体两性霉素 B 治疗内脏利什曼病的疗效和安全性。意向治疗、符合方案和意向治疗最差情况分析的治疗成功率分别为 98.8%、99.6%和 81.3%。近一半的患者出现轻度不良反应,但只有 1%的患者出现严重但无生命威胁的嘴唇肿胀。失访率为 17.5%。我们的研究结果表明,在常规项目条件下,20 毫克/公斤体重的治疗剂量是有效和安全的。鉴于脂质体两性霉素 B 的高昂成本是其广泛使用的障碍,我们建议进一步研究以监测和评估较低的剂量和较短的疗程。

相似文献

[1]
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[5]
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[6]
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本文引用的文献

[1]
Single-dose liposomal amphotericin B for visceral leishmaniasis in India.

N Engl J Med. 2010-2-11

[2]
Nifurtimox plus Eflornithine for late-stage sleeping sickness in Uganda: a case series.

PLoS Negl Trop Dis. 2007-11-7

[3]
Injectable paromomycin for Visceral leishmaniasis in India.

N Engl J Med. 2007-6-21

[4]
Liposomal amphotericin B for the treatment of visceral leishmaniasis.

Clin Infect Dis. 2006-10-1

[5]
Development of miltefosine as an oral treatment for leishmaniasis.

Trans R Soc Trop Med Hyg. 2006-12

[6]
Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980-2004.

Lancet Infect Dis. 2005-12

[7]
Magnitude of unresponsiveness to sodium stibogluconate in the treatment of visceral leishmaniasis in Bihar.

Natl Med J India. 2005

[8]
Availability of miltefosine for the treatment of kala-azar in India.

Bull World Health Organ. 2005-5

[9]
Effectiveness of a 10-day melarsoprol schedule for the treatment of late-stage human African trypanosomiasis: confirmation from a multinational study (IMPAMEL II).

J Infect Dis. 2005-6-1

[10]
Epidemiological, clinical & pharmacological study of antimony-resistant visceral leishmaniasis in Bihar, India.

Indian J Med Res. 2004-9

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