Ranawaka Ranthilaka R, Weerakoon Hema S, de Silva S H Padmal
Department of Dermatology, Anuradhapura Teaching Hospital, Anuradhapura, Sri Lanka.
Int J Dermatol. 2015;54(5):555-63. doi: 10.1111/ijd.12685. Epub 2015 Jan 20.
Intralesional 7% hypertonic saline (HS) has been shown to be effective and safe against Leishmania donovani and Leishmania major cutaneous leishmaniasis (CL), with cure rates of 92% and 96%, respectively. This study was designed to assess the efficacy and safety of 10% and 15% HS in CL.
A total of 444 patients (643 lesions) were randomly allocated to sodium stibogluconate (SSG), 10% HS and 15% HS at a ratio of 2 : 2 : 1, taking into consideration any unwanted side effects that might arise with 15% HS. The follow-up period was 18 months. Survival analysis using Cox proportional hazard regression was performed to assess the effectiveness of the three treatment modalities. The clinical trial was registered at the Sri Lanka Clinical Trial Registry (SLCTR/2013/024).
Treatment with SSG resulted in a cure rate of 96.3% within one to seven injections (mean: 3.6 injections); the mean (median) duration of treatment was six weeks (6 weeks) per lesion. Treatment with 10% HS showed a cure rate of 93.0% within one to 10 injections (mean: 5.28 injections); the mean (median) duration of treatment was 9.3 weeks (9 weeks) per lesion. Treatment with 15% HS showed a cure rate of 93.6% within two to 10 injections (mean: 5.3 injections); the mean (median) duration of treatment was 11.3 weeks (10.0 weeks) per lesion. Treatment with 10% HS and 15% HS caused cutaneous necrosis in 3.1% and 30.6% of lesions, respectively. Despite continuous data collection for 14 months, we were unable to recruit a sample of sufficient size. Seventeen (3.8%) patients were lost to follow-up, and 24 (5.4%) were partial or non-responders.
This study found 10% HS to be an effective and safe alternative to SSG. Treatment with HS at concentrations of 15% or above was not safe as a result of cutaneous necrosis. Safety was not studied for concentrations of 11-14%, and these concentrations should be avoided pending further evidence. Hypertonic saline is very cheap (< US$1 per 100 ml, whereas SSG is priced at US$160 per 100 ml), is prepared locally and has no systemic side effects and minimal local side effects.
病灶内注射7%高渗盐水（HS）已被证明对杜氏利什曼原虫和大型利什曼原虫引起的皮肤利什曼病（CL）有效且安全，治愈率分别为92%和96%。本研究旨在评估10%和15%高渗盐水治疗皮肤利什曼病的疗效和安全性。
共444例患者（643个病灶）按照2∶2∶1的比例随机分配接受葡萄糖酸锑钠（SSG）、10%高渗盐水和15%高渗盐水治疗，同时考虑到15%高渗盐水可能出现的任何不良副作用。随访期为18个月。采用Cox比例风险回归进行生存分析，以评估三种治疗方式的有效性。该临床试验已在斯里兰卡临床试验注册中心注册（SLCTR/2013/024）。
葡萄糖酸锑钠治疗1至7次注射（平均：3.6次注射）后的治愈率为96.3%；每个病灶的平均（中位数）治疗持续时间为6周（6周）。10%高渗盐水治疗1至10次注射（平均：5.28次注射）后的治愈率为93.0%；每个病灶的平均（中位数）治疗持续时间为9.3周（9周）。15%高渗盐水治疗2至10次注射（平均：5.3次注射）后的治愈率为93.6%；每个病灶的平均（中位数）治疗持续时间为11.3周（10.0周）。10%高渗盐水和15%高渗盐水治疗分别导致3.1%和30.6%的病灶出现皮肤坏死。尽管连续收集数据14个月，但我们未能招募到足够规模的样本。17例（3.8%）患者失访，24例（5.4%）为部分缓解或无反应者。
本研究发现10%高渗盐水是葡萄糖酸锑钠的一种有效且安全的替代药物。由于皮肤坏死，15%及以上浓度的高渗盐水治疗不安全。未对11%至14%浓度的安全性进行研究，在有进一步证据之前应避免使用这些浓度的高渗盐水。高渗盐水非常便宜（每100毫升<1美元，而葡萄糖酸锑钠每100毫升售价为160美元），可在当地配制，且无全身副作用，局部副作用也极小。
