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低资源环境下热消融的应用:三项多中心非劣效性随机临床试验的经验

Use of Thermal Ablation in Low-Resource Settings: Experience From Three Multicenter Noninferiority Randomized Clinical Trials.

作者信息

Conzuelo Rodriguez Gabriel, Cremer Miriam L, Muwonge Richard, Basu Partha

机构信息

Basic Health International, Pittsburgh, PA.

Cleveland Clinic Lerner College of Medicine, Cleveland, OH.

出版信息

JCO Glob Oncol. 2025 Jun;11:e2500050. doi: 10.1200/GO-25-00050. Epub 2025 Jun 6.

DOI:10.1200/GO-25-00050
PMID:40479636
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12179886/
Abstract

PURPOSE

Thermal ablation (TA) is now a widely used treatment for cervical precancer in low- and middle-income countries. Over the past decade, TA devices have been redesigned to be more portable, user-friendly, and affordable. This analysis combines data from three large randomized clinical trials comparing the efficacy, safety, and acceptability of TA with those of the previous standard, gas-based cryotherapy.

METHODS

This analysis used Human Papillomavirus (HPV) test results at 1-year post-treatment as the primary outcome. Secondary outcomes included side effects and patient satisfaction.

RESULTS

Of the 2,948 participants treated with either TA or gas-based cryotherapy, 80.9% and 81.8% completed HPV testing at 1 year, respectively. Overall, 60.7% tested negative for HPV at follow-up, with slightly higher rates in the TA group (62.5%) compared with cryotherapy (58.7%), although the difference was not statistically significant ( value = .14). Side effects were minimal for both treatments. Severe pain was slightly more common with TA (7.6% 3.9% for cryotherapy), but vasovagal responses were less frequent (2.3% 7.6%). Satisfaction with treatment was high (approximately 98%) across both groups.

CONCLUSION

Our findings support the efficacy of TA in treating cervical precancer, offering an effective and practical alternative in low-resource settings. However, future research is urgently needed to address critical questions, including the standardization of treatment protocols and tailored approaches for women living with HIV.

摘要

目的

热消融(TA)目前在低收入和中等收入国家是一种广泛用于治疗宫颈上皮内瘤变的方法。在过去十年中,TA设备经过重新设计,变得更便于携带、用户友好且价格低廉。本分析结合了三项大型随机临床试验的数据,比较了TA与先前标准的基于气体的冷冻疗法在疗效、安全性和可接受性方面的差异。

方法

本分析将治疗后1年的人乳头瘤病毒(HPV)检测结果作为主要结局。次要结局包括副作用和患者满意度。

结果

在接受TA或基于气体的冷冻疗法治疗的2948名参与者中,分别有80.9%和81.8%在1年时完成了HPV检测。总体而言,随访时60.7%的人HPV检测呈阴性,TA组(62.5%)的比例略高于冷冻疗法组(58.7%),尽管差异无统计学意义(P值 = 0.14)。两种治疗的副作用都很小。TA治疗时严重疼痛略更常见(TA组为7.6%,冷冻疗法组为3.9%),但血管迷走反应较少见(TA组为2.3%,冷冻疗法组为7.6%)。两组对治疗的满意度都很高(约98%)。

结论

我们的研究结果支持TA治疗宫颈上皮内瘤变的疗效,在资源匮乏地区提供了一种有效且实用的替代方法。然而,迫切需要未来的研究来解决关键问题,包括治疗方案的标准化以及针对感染HIV女性的个性化方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c96/12179886/745db2ff3259/go-11-e2500050-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c96/12179886/ba00ab01d61d/go-11-e2500050-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c96/12179886/745db2ff3259/go-11-e2500050-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c96/12179886/ba00ab01d61d/go-11-e2500050-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c96/12179886/745db2ff3259/go-11-e2500050-g002.jpg

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本文引用的文献

1
A portable thermal ablation device for cervical cancer prevention in a screen-and-treat setting: a randomized, noninferiority trial.一种用于筛查和治疗环境下宫颈癌预防的便携式热消融设备:一项随机、非劣效性试验。
Nat Med. 2024 Sep;30(9):2596-2604. doi: 10.1038/s41591-024-03080-w. Epub 2024 Jun 25.
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Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.2022 年全球癌症统计数据:全球 185 个国家和地区 36 种癌症的发病率和死亡率全球估计数。
CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
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Design of the HPV-automated visual evaluation (PAVE) study: Validating a novel cervical screening strategy.
HPV 自动化视觉评估(PAVE)研究设计:验证一种新的宫颈癌筛查策略。
Elife. 2024 Jan 15;12:RP91469. doi: 10.7554/eLife.91469.
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Reproducible and clinically translatable deep neural networks for cervical screening.可重现且可临床转化的用于宫颈癌筛查的深度神经网络。
Sci Rep. 2023 Dec 8;13(1):21772. doi: 10.1038/s41598-023-48721-1.
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A rapid HPV typing assay to support global cervical cancer screening and risk-based management: A cross-sectional study.一种支持全球宫颈癌筛查和基于风险的管理的快速人乳头瘤病毒分型检测方法:一项横断面研究。
Int J Cancer. 2024 Jan 15;154(2):241-250. doi: 10.1002/ijc.34698. Epub 2023 Sep 29.
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Efficacy of thermal ablation for treatment of biopsy-confirmed high-grade cervical precancer among women living with HIV in Kenya.肯尼亚 HIV 感染者中经活检证实的高级别宫颈前病变热消融治疗的疗效。
Int J Cancer. 2023 Dec 15;153(12):1971-1977. doi: 10.1002/ijc.34737. Epub 2023 Sep 15.
7
Effect of Cryotherapy vs Loop Electrosurgical Excision Procedure on Cervical Disease Recurrence Among Women With HIV and High-Grade Cervical Lesions in Kenya: A Randomized Clinical Trial.肯尼亚一项随机临床试验:冷冻疗法与环形电切术对伴有 HIV 及高级别宫颈病变的女性宫颈疾病复发的影响。
JAMA. 2019 Oct 22;322(16):1570-1579. doi: 10.1001/jama.2019.14969.
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J Glob Oncol. 2018 Oct;4:1-10. doi: 10.1200/JGO.18.00093.
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J Low Genit Tract Dis. 2018 Jan;22(1):47-51. doi: 10.1097/LGT.0000000000000359.
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