Refai Wardha F, Madarasingha Nayani P, Sumanasena Buthsiri, Weerasingha Sudath, De Silva Amala, Fernandopulle Rohini, Satoskar Abhay R, Karunaweera Nadira D
Postgraduate Institute of Medicine, Colombo, Sri Lanka.
Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka.
Am J Trop Med Hyg. 2017 Oct;97(4):1120-1126. doi: 10.4269/ajtmh.16-0879. Epub 2017 Aug 18.
causes cutaneous leishmaniasis (CL) in Sri Lanka. Standard treatment is multiple, painful doses of intralesional sodium stibogluconate (IL-SSG). Treatment failures are increasingly reported, hence the need to investigate alternatives. Efficacy, safety, and cost-effectiveness of thermotherapy were assessed for the first time for . CL. A single blinded noninferiority randomized controlled trial was conducted on new laboratory-confirmed CL patients with single lesions ( = 213). Selected patients were randomly assigned to 1) test group ( = 98; single session of radiofrequency-induced heat therapy (RFHT) given at 50°C for 30 seconds) and 2) control group ( = 115; 1-3 mL IL-SSG given weekly, until cure/10 doses). Patients were followed-up fortnightly for 12 weeks to assess clinical cure. Cost of treatment was assessed using scenario building technique. Cure rates by 8, 10, and 12 weeks in RFHT group were 46.5%, 56.5%, and 65.9% as opposed to 28%, 40.8%, and 59.4% in IL-SSG group, with no major adverse events. Cure rate by RFHT was significantly higher at 8 weeks ( = 0.009, odds ratio [OR]: 2.236, confidence interval [CI]: 1.217-4.108) and 10 weeks ( = 0.035, OR: 1.881, CI: 1.044-3.388), but comparable thereafter. Cost of RFHT was 7 times less (USD = 1.54/patient) than IL-SSG (USD = 11.09/patient). A single application of RFHT is safe, cost-effective, and convenient, compared with multiple doses of IL-SSG in the treatment of CL. Therefore, RFHT would be considered noninferior as per trial outcome when compared with standard IL-SSG therapy with multiple benefits for the patient and the national health care system.
在斯里兰卡引发皮肤利什曼病（CL）。标准治疗方法是多次注射病灶内葡萄糖酸锑钠（IL - SSG），会带来疼痛。治疗失败的报告日益增多，因此需要研究替代方法。首次评估了热疗法对CL的疗效、安全性和成本效益。对新确诊的单发实验室确诊CL患者（n = 213）进行了单盲非劣效随机对照试验。选定的患者被随机分为两组：1）试验组（n = 98；单次射频诱导热疗（RFHT），温度为50°C，持续30秒）和2）对照组（n = 115；每周注射1 - 3 mL IL - SSG，直至治愈/注射10剂）。每两周对患者进行一次为期12周的随访以评估临床治愈情况。使用情景构建技术评估治疗成本。RFHT组在8周、10周和12周的治愈率分别为46.5%、56.5%和65.9%，而IL - SSG组分别为28%、40.8%和59.4%，且无重大不良事件。RFHT在8周时的治愈率显著更高（p = 0.009，优势比[OR]：2.236，置信区间[CI]：1.217 - 4.108），在10周时也更高（p = 0.035，OR：1.881，CI：1.044 - 3.388），但此后两者相当。RFHT的成本比IL - SSG低7倍（每位患者1.54美元）（IL - SSG每位患者11.09美元）。与多次注射IL - SSG治疗CL相比，单次应用RFHT安全、具有成本效益且方便。因此，根据试验结果，与标准的多次IL - SSG疗法相比，RFHT对患者和国家医疗保健系统有多重益处，可被视为非劣效。
