A randomized clinical trial comparing meglumine antimoniate, pentamidine and amphotericin B for the treatment of cutaneous leishmaniasis by Leishmania guyanensis
A randomized clinical trial comparing meglumine antimoniate, pentamidine and amphotericin B for the treatment of cutaneous leishmaniasis by Leishmania guyanensis
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DOI：
10.1590/s0365-05962011000600005
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发表时间：
2011-12-01
影响因子：
1.7
通讯作者：
Talhari, Sinésio
中科院分区：
文献类型：
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作者：
Neves, Leandro Ourives;Talhari, Anette Chrusciak;Talhari, Sinésio
基础知识：美国表皮利什曼病（ATL）的治疗仍然是一个挑战，因为大多数可用的药物是注射，只有少数比较，随机临床试验已经进行，以支持他们的使用。此外，治疗结果可能取决于利什曼原虫的致病种属。结论：评价和比较锑酸葡甲胺、羟乙基磺酸喷他脒和阿替霉素B治疗圭亚那利什曼原虫引起的ATL的疗效和耐受性。根据合格标准选择了185名患者，并随机分为三组-两组，每组74名患者，对照组37例，分别用葡甲胺、喷他脒和阿替霉素B治疗。剂量、给药方式和治疗时间均遵循每种药物的当前建议。患者在完成治疗后1、2、6个月进行复查。结果：治疗组之间在性别、年龄、病变数量或部位方面无差异。意向治疗（ITT）分析显示，喷他脒的疗效为58.1%，葡甲胺为55.5%（p = 0.857）。对阿替霉素B组进行单独分析，因为该组中有28名患者（75.7%）拒绝继续参与研究。轻度或中度不良反应74例（40%），尤以葡甲胺组关节痛（20.3%）和喷他脒组注射部位疼痛（35.1%）或硬结（10.8%）为多。guyanensis。鉴于这两种药物的低疗效，迫切需要新的治疗方法。
Fundamentals: American tegumentary leishmaniasis (ATL) treatment remains a challenge, since most available drugs are injectable and only a small number of comparative, randomized clinical trials have been performed to support their use. Moreover, treatment outcome may depend on the causative species of Leishmania.OBJECTIVES: To evaluate and compare the efficacy and tolerability of meglumine antimoniate, pentamidine isethionate, and amphotericin B in the treatment of ATL caused by Leishmania (Viannia) guyanensis.METHODS: 185 patients were selected according to the eligibility criteria and randomly allocated into three groups - two groups with 74 patients each, and one group with 37 patients, which underwent meglumine, pentamidine and amphotericin B treatment, respectively. Doses, mode of administration and time periods of treatment followed the current recommendations for each drug. Patients were re-examined one, two and six months after completion of treatment.RESULTS: No differences were observed among the therapeutic groups in relation to gender, age, number or site of lesions. Intention-to-treat (ITT) analysis showed efficacy of 58.1% for pentamidine and 55.5% for meglumine (p=0.857). The amphotericin B group was analyzed separately, since 28 patients (75.7%) in this group refused to continue participating in the study. Mild or moderate adverse effects were reported by 74 (40%) patients, especially arthralgia (20.3%) in the meglumine group, and pain (35.1%) or induration (10.8%) at the site of injection in the pentamidine group.CONCLUSION: Pentamidine and meglumine show similar efficacy in the treatment of ATL caused by L. guyanensis. Given the low efficacy of both drugs, there is an urgent need for new therapeutical approaches.