聚维酮碘乳膏联合注射用二巯丁二酸治疗皮肤利什曼病的随机对照临床试验。
Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial.
机构信息
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
PLoS One. 2013 Jun 24;8(6):e66123. doi: 10.1371/journal.pone.0066123. Print 2013.
BACKGROUND
Cutaneous leishmaniasis (CL) is a neglected infectious disease and a major health problem in several developing countries. Despite some reasonable explanation for their potential benefits, there is only trace evidence regarding the role of dressings in the treatment of CL.
METHODS
This randomized, assessor-blind, controlled, clinical trial was conducted in an endemic area for CL caused by Leishmania major in Iran to assess the efficacy of administration of weekly intralesional meglumine antimoniate (i.l.MA) either alone or combined with application of a silver or a non-silver polyester dressing on their lesions for 6 weeks. After screening of 241 patients with CL lesions, 83 eligible patients with 158 lesions were randomly allocated in three arms of the study. Eligibility criteria included parasitologically confirmed CL, age of 12 to 60 years; willingness to participate, duration of lesion<3 months, number of lesions<5, largest ulcer diameter<5 cm. Pregnant or lactating women were excluded. The primary outcome was absolute risk reduction (ARR) based on the proportion of complete healing, which was defined as more than 75% reduction in the size of the lesion compared with baseline in each group at the termination of treatment and 1 month later.
FINDINGS
ARR (95% Confidence Interval [CI]) in i.l.MA versus i.l.MA+non-silver dressing groups was 5.98% (-7.07% to 20.25%), between i.l.MA versus i.l.MA+silver dressing groups was -0.23% (-13.53% to 14.82%), and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was -6.21%(-18.28% to 6.52%) after 6 weeks of treatment. ARR (95% CI) in i.l.MA versus i.l.MA+non-silver dressing groups was -2.22% (-22.12% to 18.10%), between i.l.MA versus i.l.MA+silver dressing groups was 3.64% (-15.36% to 22.82%), and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was 5.86% (-12.86% to 24.31%) 1 month later.
CONCLUSION
It could not be demonstrated that the efficacy of i.l.MA was improved by either dressing.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials (IRCT.ir) IRCT138707201166N2.
背景
皮肤利什曼病（CL）是一种被忽视的传染病，也是几个发展中国家的主要卫生问题。尽管有一些合理的解释表明其具有潜在的益处，但关于敷料在 CL 治疗中的作用，只有一些零星的证据。
方法
本随机、评估者盲、对照、临床试验在伊朗一个由利什曼原虫引起的 CL 流行地区进行，旨在评估每周一次的肌肉内氨苯砜（i.l.MA）单独使用或与银或非银聚酯敷料联合应用于其病变 6 周对治疗 CL 的疗效。在对 241 例 CL 病变患者进行筛查后，将 83 例符合条件的患者（158 处病变）随机分配到研究的三个组中。纳入标准包括寄生虫学证实的 CL、年龄在 12 至 60 岁之间；愿意参与、病变持续时间<3 个月、病变数<5、最大溃疡直径<5cm。排除孕妇或哺乳期妇女。主要结局是基于完全愈合的绝对风险降低（ARR），定义为与治疗结束和 1 个月后每组的基线相比，病变大小减少超过 75%。
结果
i.l.MA 与 i.l.MA+非银敷料组的 ARR（95%置信区间[CI]）为 5.98%（-7.07%至 20.25%），i.l.MA 与 i.l.MA+银敷料组的 ARR 为-0.23%（-13.53%至 14.82%），i.l.MA+非银敷料与 i.l.MA+银敷料组的 ARR 为-6.21%（-18.28%至 6.52%）。治疗 6 周后。i.l.MA 与 i.l.MA+非银敷料组的 ARR（95%CI）为-2.22%（-22.12%至 18.10%），i.l.MA 与 i.l.MA+银敷料组的 ARR 为 3.64%（-15.36%至 22.82%），i.l.MA+非银敷料与 i.l.MA+银敷料组的 ARR 为 5.86%（-12.86%至 24.31%）。1 个月后。
结论
不能证明 i.l.MA 的疗效因任何敷料而得到改善。
试验注册
伊朗临床试验注册处（IRCT.ir）IRCT138707201166N2。
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