A Randomized Controlled Trial of Local Heat Therapy Versus Intravenous Sodium Stibogluconate for the Treatment of Cutaneous Leishmania major Infection

医学 锑葡萄糖酸钠 皮肤利什曼病 红斑 随机对照试验 内科学 蜂窝织炎 病变 腹痛 临床试验 胃肠病学 靶病变 外科 皮肤病科 利什曼病 病理 心肌梗塞 经皮冠状动脉介入治疗
作者
Naomi Aronson,Glenn Wortmann,W. Russell Byrne,Robin Howard,Wendy B. Bernstein,Mary Marovich,Mark E. Polhemus,In‐Kyu Yoon,Kelly A. Hummer,Robert A. Gasser,Charles N. Oster,Paul Benson
出处
期刊:PLOS Neglected Tropical Diseases 卷期号:4 (3): e628-e628 被引量:98
标识
DOI:10.1371/journal.pntd.0000628
摘要

Background Cutaneous Leishmania major has affected many travelers including military personnel in Iraq and Afghanistan. Optimal treatment for this localized infection has not been defined, but interestingly the parasite is thermosensitive. Methodology/Principal Findings Participants with parasitologically confirmed L. major infection were randomized to receive intravenous sodium stibogluconate (SSG) 20mg/kg/day for ten doses or localized ThermoMed (TM) device heat treatment (applied at 50°C for 30 seconds) in one session. Those with facial lesions, infection with other species of Leishmania, or more than 20 lesions were excluded. Primary outcome was complete re-epithelialization or visual healing at two months without relapse over 12 months. Fifty-four/56 enrolled participants received intervention, 27 SSG and 27 TM. In an intent to treat analysis the per subject efficacy at two months with 12 months follow-up was 54% SSG and 48% TM (p = 0.78), and the per lesion efficacy was 59% SSG and 73% TM (p = 0.053). Reversible abdominal pain/pancreatitis, arthralgias, myalgias, headache, fatigue, mild cytopenias, and elevated transaminases were more commonly present in the SSG treated participants, whereas blistering, oozing, and erythema were more common in the TM arm. Conclusions/Significance Skin lesions due to L. major treated with heat delivered by the ThermoMed device healed at a similar rate and with less associated systemic toxicity than lesions treated with intravenous SSG. Clinical Trial Registration ClinicalTrials.gov NCT 00884377
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