Dressings Combined with Injection of Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial
Dressings Combined with Injection of Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial
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DOI：
10.1371/journal.pone.0066123
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发表时间：
2013-06-24
期刊：
影响因子：
3.7
通讯作者：
Firooz, Alireza
中科院分区：
文献类型：
--
作者：
Khatami, Alireza;Talaee, Rezvan;Firooz, Alireza
背景：皮肤利什曼病（CL）是一种被忽视的传染病，在一些发展中国家是一个主要的健康问题。尽管对敷料的潜在益处有一些合理的解释，但关于敷料在CL治疗中的作用只有微量证据。这项随机、评估者盲法、对照、在伊朗的一个流行区进行了一项由利什曼原虫引起的CL的临床试验，以评估每周一次病灶内注射锑酸葡甲胺的疗效（i.l.MA）单独或与银或非银聚酯敷料联合应用于其病变6周。筛选241例CL病变患者后，将83例合格患者（158处病变）随机分配至研究的3个组。合格标准包括经寄生虫学证实的CL，年龄12 - 60岁;愿意参与，病变持续时间3个月，病变数量5个，最大溃疡直径5 cm。排除妊娠或哺乳期女性。主要结局是基于完全愈合比例的绝对风险降低（ARR），完全愈合定义为治疗终止时和1个月后各组病灶大小与基线相比减少75%以上。ARR i.l.MA与i.l.MA+非银敷料组的95%置信区间[CI]为5.98%（-7.07%至20.25%），i.l.MA与i.l.MA+银敷料组之间为-0.23%治疗6周后，i.l.MA+非银敷料组与i.l.MA+银敷料组之间为-6.21%（-18.28%至6.52%）。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+银敷料组之间为3.64%（-15.36%至22.82%），i.l.MA+非银敷料组与i.l.MA+银敷料组之间的差异为5.86% 1个月后（-12.86%至24.31%）。结论：不能证明任何一种敷料都能提高i.l.MA的疗效。
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.