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热疗法治疗葡聚糖钠锑治疗失败的皮肤利什曼病的疗效:一项随机对照的原理临床验证试验。

Therapeutic Response to Thermotherapy in Cutaneous Leishmaniasis Treatment Failures for Sodium Stibogluconate: A Randomized Controlled Proof of Principle Clinical Trial.

机构信息

1Department of Parasitology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.

2Base Hospital, Tangalle, Sri Lanka.

出版信息

Am J Trop Med Hyg. 2021 Jan 25;104(3):945-950. doi: 10.4269/ajtmh.20-0855.


DOI:10.4269/ajtmh.20-0855
PMID:33534750
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7941834/
Abstract

Treatment failure to intralesional sodium stibogluconate (IL-SSG) is a health challenge for cutaneous leishmaniasis (CL) in Sri Lanka. A randomized controlled proof of principle clinical trial, with two arms (viz., radio frequency-induced heat therapy [RFHT] by a ThermoMed™ device (Model 1.8, Thermosurgery Technologies, Inc., Phoenix, AZ) and thermotherapy by a handheld exothermic crystallization thermotherapy for CL [HECT-CL] device) was conducted on 40 CL treatment failures to IL-SSG, from three hospitals in Tangalle, Hambantota, and Anuradhapura, from January 2017 to January 2018, followed up for 180 days post-thermotherapy with a final follow-up in February 2020. Intention-to-treat cure rates were calculated at day 90 (initial cure rate) and at day 180 (final cure rate) posttreatment. Radio frequency-induced heat therapy group: the initial cure rate was 100% (20/20) and the final cure rate was 95% (19/20), with one patient relapsing. The HECT-CL group: both the initial and final cure rates were 80% (16/20), with no relapses and one excluded from the trial. In February 2020 (1.6-3 years posttreatment), 27 traceable patients (RFHT = 16, HECT-CL = 11) remained healed. Second-degree burns were observed with RFHT in 65% (13/20), with HECT-CL in 15% (3/20), which completely resolved subsequently. The cure rates between the two treatment groups were comparable (P = 0.15). Radio frequency-induced heat therapy consumed less time and required only a single hospital visit. Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG. This study is the first proof that thermotherapy is an efficacious and safe treatment for CL patients in Sri Lanka, complicated by treatment failure to IL-SSG.

摘要

局部注射葡萄糖酸锑钠(IL-SSG)治疗失败是斯里兰卡皮肤利什曼病(CL)面临的一个健康挑战。一项随机对照的原理性临床试验,设有两个治疗组(即 ThermoMed™ 设备(型号 1.8,Thermosurgery Technologies,Inc.,凤凰城,亚利桑那州)产生的射频诱导热疗(RFHT)和用于治疗 CL 的手持热致结晶热疗(HECT-CL)设备),于 2017 年 1 月至 2018 年 1 月在 Tangalle、Hambantota 和 Anuradhapura 的三家医院对 40 例 IL-SSG 治疗失败的 CL 患者进行了治疗,在热疗后 180 天进行随访,并于 2020 年 2 月进行最终随访。在治疗后第 90 天(初始治愈率)和第 180 天(最终治愈率)计算意向治疗治愈率。射频诱导热疗组:初始治愈率为 100%(20/20),最终治愈率为 95%(19/20),1 例患者复发。HECT-CL 组:初始和最终治愈率均为 80%(16/20),无复发,1 例患者因试验排除。2020 年 2 月(治疗后 1.6-3 年),27 例可追踪患者(RFHT=16,HECT-CL=11)仍痊愈。射频热疗组有 65%(13/20)出现二度烧伤,HECT-CL 组有 15%(3/20)出现二度烧伤,随后完全缓解。两组治疗结果无差异(P=0.15)。射频热疗消耗的时间更少,只需单次医院就诊。CL 的手持热致结晶热疗具有潜在的社区应用价值,两者的成本均低于 IL-SSG。这项研究首次证明,热疗是治疗斯里兰卡因局部注射葡萄糖酸锑钠治疗失败而导致的 CL 患者的一种有效且安全的治疗方法。

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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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