冷冻疗法联合外用刺柏乳膏与冷冻疗法联合安慰剂治疗旧大陆皮肤利什曼病的疗效：一项三盲随机对照临床试验。

Efficacy of cryotherapy plus topical Juniperus excelsa M. Bieb cream versus cryotherapy plus placebo in the treatment of Old World cutaneous leishmaniasis: A triple-blind randomized controlled clinical trial.

作者信息

Parvizi Mohammad Mahdi, Handjani Farhad, Moein Mahmoodreza, Hatam Gholamreza, Nimrouzi Majid, Hassanzadeh Jafar, Hamidizadeh Nasrin, Khorrami Hamid Reza, Zarshenas Mohammad Mehdi

机构信息

Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

PLoS Negl Trop Dis. 2017 Oct 5;11(10):e0005957. doi: 10.1371/journal.pntd.0005957. eCollection 2017 Oct.

DOI:10.1371/journal.pntd.0005957

PMID:28981503

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5655399/

Abstract

BACKGROUND

Cutaneous leishmaniasis is one of the highly prevalent endemic diseases in the Middle East and North Africa. Many treatment modalities have been recommended for this condition but success rates remain limited. Herbal remedies have also been used for treatment but evidence-based clinical trials with these products are sparse. In-vitro and in-vivo studies have shown the anti-leishmanial and curative effects of extract of fruits and leaves of Juniperus excelsa (J. excelsa). The aim of this study was to determine the efficacy of topical J. excelsa M. Bieb extract as an adjuvant to cryotherapy for the treatment of human CL.

MATERIALS AND METHODS

This study was designed as a two-arm triple-blind randomized placebo-controlled clinical trial using a parallel design. Seventy-two patients with clinical diagnosis of CL confirmed by leishmania smears were allocated to receive either a topical formulation of leaf of J. excelsa extract (group A) or placebo (group B) for 3 months. Both groups received cryotherapy as baseline standard treatment. Patients were evaluated before and weekly after the intervention was initiated until complete cure.

RESULTS

Overall, 82% of patients in group A, experienced complete cure and 9% of them had partial cure. On the other hand, 34% in group B reported complete cure, while 14% of them had partial cure at the end of treatment protocol with a significant difference between the two groups (P< 0.001). The mean duration to healing of the lesions in patients who received J. excelsa extract was statistically significantly shorter than the placebo group (p = 0.04). No significant side effect was seen in the J. excelsa extract group except for mild to moderate local irritation after a few weeks in a few numbers of patients.

CONCLUSION

The results of this study showed that topical J. excelsa extract can be used as an adjuvant treatment modality in addition to cryotherapy for accelerating the time to cure in addition to increasing the complete cure rate in CL.

TRIAL REGISTRATION

ClinicalTrials.gov IRCT2015082523753N1.

摘要

背景

皮肤利什曼病是中东和北非地区高度流行的地方病之一。针对这种疾病推荐了多种治疗方法，但成功率仍然有限。草药疗法也被用于治疗，但针对这些产品的循证临床试验较少。体外和体内研究表明，刺柏（Juniperus excelsa）果实和叶子提取物具有抗利什曼原虫和治疗作用。本研究的目的是确定外用刺柏提取物作为冷冻疗法辅助手段治疗人类皮肤利什曼病的疗效。

材料与方法

本研究设计为双臂三盲随机安慰剂对照临床试验，采用平行设计。72例经利什曼涂片确诊为皮肤利什曼病的患者被分配接受刺柏叶提取物局部制剂（A组）或安慰剂（B组）治疗3个月。两组均接受冷冻疗法作为基线标准治疗。在干预开始前及开始后每周对患者进行评估，直至完全治愈。

结果

总体而言，A组82%的患者完全治愈，9%部分治愈。另一方面，B组34%的患者报告完全治愈，14%部分治愈，两组之间存在显著差异（P<0.001）。接受刺柏提取物治疗的患者皮损愈合的平均时间在统计学上显著短于安慰剂组（p = 0.04）。除少数患者在几周后出现轻度至中度局部刺激外，刺柏提取物组未观察到明显副作用。