Student Research Committee, Department of Epidemiology, Faculty of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Community Medicine, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.
Epidemiol Health. 2019;41:e2019011. doi: 10.4178/epih.e2019011. Epub 2019 Mar 31.
Cutaneous leishmaniasis (CL) is most common form of leishmaniasis and is characterized by ulcerative skin lesions. The objective of this study was to conduct a systematic review and meta-analysis of clinical trials that compared the efficacy of miltefosine and glucantime for the treatment of CL. We searched the following databases: Cochrane, PubMed, Embase, Scopus, Web of Science, ProQuest, Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform search portal of World Health Organization, Sid, Irandoc, Magiran, and clinicaltrials.gov. We used keywords including "miltefosine," "glucantime," and "Leishmania." The quality of studies was assessed using the Cochrane risk of bias tool. A random-effects model was employed for the analysis. We assessed heterogeneity by the chi-square test and the I2 index statistic. When heterogeneity was present, meta-regression analyses were performed. The Egger method was used to assess publication bias; when it was significant, the trim-and-fill method was used to test and adjust for publication bias. A total of 1,570 reports were identified, of which 10 studies were included in the meta-analysis. In the meta-analysis, there was no significant difference between the efficacy of miltefosine and glucantime; however, subgroup analysis showed that, regarding parasite species other than Leishmania braziliensis, miltefosine was significantly superior to glucantime (intention to treat; relative risk, 1.15; 95% confidence interval, 1.01 to 1.32). In the meta-regression, only the glucantime injection type was significant at the p=0.1 level. The Egger test found statistically significant publication bias; however, including the 3 missing studies in the trim-and-fill analysis did not change the results. This meta-analysis found that miltefosine seems to be more effective than glucantime, at least in species other than L. braziliensis, for treating CL.
皮肤利什曼病（CL）是利什曼病最常见的形式，其特征是溃疡性皮肤损伤。本研究的目的是对比较米替福新和葡萄糖酸锑钠治疗 CL 的疗效的临床试验进行系统评价和荟萃分析。我们搜索了以下数据库：Cochrane、PubMed、Embase、Scopus、Web of Science、ProQuest、Cochrane 对照试验中心注册库、世界卫生组织国际临床试验注册平台搜索门户、Sid、Irandoc、Magiran 和 clinicaltrials.gov。我们使用了包括“米替福新”、“葡萄糖酸锑钠”和“利什曼原虫”在内的关键词。使用 Cochrane 偏倚风险工具评估研究质量。采用随机效应模型进行分析。通过卡方检验和 I2 指数统计量评估异质性。当存在异质性时，进行 meta 回归分析。使用 Egger 方法评估发表偏倚；当存在显著发表偏倚时，使用修剪和填充方法进行检验和调整。共确定了 1570 份报告，其中有 10 项研究纳入荟萃分析。荟萃分析结果显示，米替福新和葡萄糖酸锑钠的疗效无显著差异；然而，亚组分析显示，对于除利什曼巴西利什曼原虫以外的寄生虫种类，米替福新明显优于葡萄糖酸锑钠（意向治疗；相对风险，1.15；95%置信区间，1.01 至 1.32）。在 meta 回归中，只有葡萄糖酸锑钠注射类型在 p=0.1 水平上具有统计学意义。Egger 检验发现存在统计学显著的发表偏倚；然而，在修剪和填充分析中纳入 3 项缺失研究并未改变结果。本荟萃分析发现，米替福新似乎比葡萄糖酸锑钠更有效，至少在除 L. braziliensis 以外的物种中，用于治疗 CL。
