Long-term efficacy of single-dose radiofrequency-induced heat therapy vs. intralesional antimonials for cutaneous leishmaniasis in India
Long-term efficacy of single-dose radiofrequency-induced heat therapy vs. intralesional antimonials for cutaneous leishmaniasis in India
复制标题
DOI：
10.1111/bjd.12205
复制
发表时间：
2013-05-01
影响因子：
10.3
通讯作者：
Satoskar, A. R.
中科院分区：
文献类型：
--
作者：
Bumb, R. A.;Prasad, N.;Satoskar, A. R.
背景射频热疗（RFHT）已被发现在短期内对皮肤利什曼病（CL）安全有效，但其长期疗效尚不清楚。目的比较RFHT与葡萄糖酸锑钠（SSG）病灶内注射治疗印度CL的长期疗效。方法将100例确诊为CL的患者按1：1的比例随机分为两组，一组接受局部RFHT治疗3060 s，另一组接受SSG病灶内注射7次（50 mgcm ~ 2）。治疗4个月后每15天监测一次病情改善和复发情况，并分别于治疗后5、6、9、12、18个月进行随访，比较两组患者的完全治愈率。结果12周时，RFHT组50例患者中有47例（94%）病变愈合，SSG组50例患者中有46例（92%）病变愈合。两组的完全愈合时间相当。治疗后6个月，RFHT和SSG组的治愈率分别为98% [95%置信区间（CI）94 - 100%]和94%（95% CI 86 - 100%）。年龄、性别和病灶大小或数量对治愈率没有影响。在开始治疗后的12 - 18个月内，两组治愈患者均未记录感染复发。在12个月时，RFHT组8/8（100%）例患者和SSG组3/3例患者的治愈病灶皮肤活检显示最小纤维化，聚合酶链反应试验显示热带利什曼原虫阴性。结论RFHT是一种安全、可接受、长期有效的治疗CL的方法。
Background Radiofrequency-induced heat therapy (RFHT) has been found to be safe and effective against cutaneous leishmaniasis (CL) in the short term, but its long-term efficacy is unclear. Objectives To compare the long-term efficacy of RFHT vs. intralesional sodium stibogluconate (SSG) injections in the treatment of CL in India. Methods One hundred patients with a confirmed diagnosis of CL were randomly assigned in a 1:1 ratio to receive topical RFHT for 3060s or seven intralesional injections of SSG (50mgcm2 of lesion). Improvement and recurrence were monitored every 15days after the initiation of treatment for 4months and then at 5, 6, 9, 12 and 18months post-treatment; the rates of complete cure were compared. Results Lesions were healed in 47 out of 50 patients (94%) in the RFHT group and in 46 out of 50 patients (92%) in the SSG group at week 12. Time to complete healing was comparable in the two groups. At 6months post-treatment, cure rates in the RFHT and SSG groups were 98% [95% confidence interval (CI) 94100%] and 94% (95% CI 86100%), respectively. Age, sex and lesion size or number had no effect on cure rates. No relapse of infection was recorded in cured patients in either group up to 1218months after initiation of treatment. Skin biopsies of cured lesions in eight out of eight (100%) patients from the RFHT group and three of three from the SSG group at 12months showed minimal fibrosis and were negative for Leishmania tropica by polymerase chain reaction test. Conclusions A single application of RFHT is safe, cosmetically acceptable and effective in inducing a long-term cure of CL.