在艾滋病毒感染率高的埃塞俄比亚人群中，米替福新与葡萄糖酸锑钠治疗内脏利什曼病的比较。

A comparison of miltefosine and sodium stibogluconate for treatment of visceral leishmaniasis in an Ethiopian population with high prevalence of HIV infection.

作者信息

Ritmeijer Koert, Dejenie Abren, Assefa Yibeltal, Hundie Tadesse Beyene, Mesure Jo, Boots Gerry, den Boer Margriet, Davidson Robert N

机构信息

Médecins Sans Frontières-Holland, Amsterdam, The Netherlands.

出版信息

Clin Infect Dis. 2006 Aug 1;43(3):357-64. doi: 10.1086/505217. Epub 2006 Jun 20.

DOI:10.1086/505217

PMID:16804852

Abstract

BACKGROUND

Antimonials are the mainstay of visceral leishmaniasis (VL) treatment in Africa. The increasing incidence of human immunodeficiency virus (HIV) coinfection requires alternative safe and effective drug regimens. Oral miltefosine has been proven to be safe and effective in the treatment of Indian VL but has not been studied in Africa or in persons with HIV and VL coinfection.

METHODS

We compared the efficacy of miltefosine and sodium stibogluconate (SSG) in the treatment of VL in persons in Ethiopia. A total of 580 men with parasitologically and/or serologically confirmed VL were randomized to receive either oral miltefosine (100 mg per day for 28 days) or intramuscular SSG (20 mg/kg per day for 30 days).

RESULTS

The initial cure rate was 88% in both treatment groups. Mortality during treatment was 2% in the miltefosine group, compared with 10% in the SSG group. Initial treatment failure was 8% in the miltefosine group, compared with 1% in the SSG group. Among the 375 patients (65%) who agreed to HIV testing, HIV seroprevalence was 29%. Among patients not infected with HIV, initial cure, mortality, and initial treatment failure rates were not significantly different (94% vs. 95%, 1% vs. 3%, and 5% vs. 1% for the miltefosine and SSG groups, respectively). Initial treatment failure with miltefosine occurred in 18% of HIV-coinfected patients, compared with treatment failure in 5% of non-HIV-infected patients. At 6 months after treatment, 174 (60%) of the 290 miltefosine recipients and 189 (65%) of the 290 SSG recipients experienced cure; 30 (10%) of 290 in the miltefosine group and 7 (2%) of 290 in the SSG group experienced relapse, and the mortality rate was 6% in the miltefosine group, compared with 12% in the SSG group. HIV-infected patients had higher rates of relapse (16 [25%] of 63 patients), compared with non-HIV-infected patients (5 [5%] of 131).

CONCLUSIONS

Treatment with miltefosine is equally effective as standard SSG treatment in non-HIV-infected men with VL. Among HIV-coinfected patients, miltefosine is safer but less effective than SSG.

摘要

背景

锑剂是非洲内脏利什曼病（VL）治疗的主要药物。人类免疫缺陷病毒（HIV）合并感染发病率的上升需要替代的安全有效药物方案。口服米替福新已被证明在治疗印度VL中安全有效，但尚未在非洲或HIV与VL合并感染的患者中进行研究。

方法

我们比较了米替福新和葡萄糖酸锑钠（SSG）治疗埃塞俄比亚患者VL的疗效。共有580名经寄生虫学和/或血清学确诊为VL的男性被随机分组，分别接受口服米替福新（每日100毫克，共28天）或肌肉注射SSG（每日20毫克/千克，共30天）。

结果

两个治疗组的初始治愈率均为88%。米替福新组治疗期间的死亡率为2%，而SSG组为10%。米替福新组的初始治疗失败率为8%，而SSG组为1%。在同意进行HIV检测的375名患者（65%）中，HIV血清阳性率为29%。在未感染HIV的患者中，初始治愈率、死亡率和初始治疗失败率无显著差异（米替福新组和SSG组分别为94%对95%、1%对3%、5%对1%）。米替福新治疗的初始失败在18%的HIV合并感染患者中出现，而非HIV感染患者中为5%。治疗后6个月，290名接受米替福新治疗的患者中有174名（60%）治愈，290名接受SSG治疗的患者中有189名（65%）治愈；米替福新组290名患者中有30名（10%）复发，SSG组290名患者中有7名（2%）复发，米替福新组的死亡率为6%，而SSG组为12%。HIV感染患者的复发率较高（63名患者中有16名[25%]），而非HIV感染患者为（131名患者中有5名[5%]）。