Local Hyperthermia at 44°C Is Effective in Clearing Cervical High-Risk Human Papillomaviruses: A Proof-of-Concept, Randomized Controlled Clinical Trial
Local Hyperthermia at 44°C Is Effective in Clearing Cervical High-Risk Human Papillomaviruses: A Proof-of-Concept, Randomized Controlled Clinical Trial
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44°C 局部热疗可有效清除宫颈高危人乳头瘤病毒：概念验证、随机对照临床试验。
DOI：
10.1093/cid/ciab369
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发表时间：
2021-11-01
影响因子：
11.8
通讯作者：
Gao, Xing-Hua
中科院分区：
文献类型：
--
作者：
Yang, Yang;Zhang, Lan;Gao, Xing-Hua
背景高危型人乳头瘤病毒（HPV）的持续感染是宫颈上皮内瘤变和宫颈癌的主要原因。44摄氏度的局部热疗已被证明有效清除HPV感染引起的皮肤或肛门生殖器疣。本研究旨在评估44 ℃高温对高危HPV清除的影响。在4个医学中心进行了一项随机、患者盲、假治疗对照试验。我们招募了高危HPV阳性且细胞学检查结果正常或不显著（阴性/意义不明的非典型鳞状细胞/低度鳞状上皮内病变）的患者。参与者被随机分配（1：1）接受44摄氏度或37摄氏度的高温，每次30分钟。两组患者每天接受一次治疗，连续3天，10 +/- 3天后再接受2次治疗。主要结果是治疗后3个月HPV的清除率。经过3个月的随访，44 ℃和37 ℃的热疗治疗分别实现了85.19%（23/27）和50%（13/26）的HPV清除率（P = .014）。44 ℃热疗对单型和多型HPV感染者的疗效无显著性差异。两组治疗期间均未发生明显不良事件。44摄氏度的局部热疗安全而显著地有助于清除宫颈高危HPV，其效果有助于阻止宫颈转化和病毒传播的进展。
Background. Persistent infection by high-risk human papillomavirus (HPV) is the leading cause of cervical intraepithelial neoplasia and cervical carcinoma. Local hyperthermia at 44 degrees C has been proven efficacious to clear cutaneous or anogenital warts caused by HPV infection. This study aims to assess the effect of hyperthermia at 44 degrees C on the clearance of high-risk HPV.Methods. A randomized, patient-blind, sham treatment-controlled trial was conducted in 4 medical centers. We enrolled patients with positive high-risk HPVs and normal or insignificant cytological findings (negative/atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion). Participants were randomly assigned (1:1) to receive either hyperthermia at 44 degrees C or 37 degrees C, for 30 minutes in each session. Patients in both groups received treatment once a day for 3 consecutive days, plus 2 more sessions 10 +/- 3 days later. The primary outcome was clearance rate of HPV 3 months after treatment.Results. After a 3-month follow-up, hyperthermia treatment at 44 degrees C and 37 degrees C achieved HPV clearance rates of 85.19% (23/27) and 50% (13/26), respectively (P = .014). There was no significant difference of treatment response between patients with single and multiple type of HPV by 44 degrees C hyperthermia treatment. There were no significant adverse events recorded during the treatment period in both groups.Conclusions. Local hyperthermia at 44 degrees C safely and significantly aids in clearing cervical high-risk HPVs, the effect of which helps halt the progression of cervical transformation and transmission of the virus.