对比经阴道镜检查发现的宫颈病变中热消融(热凝固)与冷冻疗法的可接受性及疗效:一项初步研究。

Comparison of acceptability & efficacy of thermal ablation (thermocoagulation) & cryotherapy in VIA positive cervical lesions: A pilot study.

机构信息

Department of Obstetrics & Gynaecology, King George's Medical University, Lucknow, Uttar Pradesh, India.

出版信息

Indian J Med Res. 2023 Oct 1;158(4):423-431. doi: 10.4103/ijmr.ijmr_1166_22. Epub 2023 Sep 25.

Abstract

BACKGROUND OBJECTIVES

The World Health Organization (WHO) has endorsed thermal ablation (thermocoagulation) as an efficient and safe modality for treatment of cervical pre-cancer lesions. More evidence is being looked up by WHO through rigorous studies for health delivery models using screen-and-treat strategies incorporating thermal ablation and studies comparing it against the conventional standard modality cryotherapy. The objective of this study was to assess the acceptability of thermal ablation both among the providers and clients and compare the same with cryotherapy.

METHODS

A randomized control trial was conducted for one year from September 2019 to October 2020 after obtaining ethics approval. Computer-generated random number table was used for randomization, and eligible candidates were divided into two groups following informed consent. Women with visual inspection with acetic acid (VIA) positive cervical lesions in Group A received cryotherapy and Group B received thermal ablation. After the procedure, the acceptability of the provider and the client were assessed using the International Agency for Research on Cancer-validated questionnaire for both the procedures. Immediate side effects and problems at six weeks and at six months were assessed as well. Efficacy was decided by the absence of VIA positivity at six months.

RESULTS

The overall VIA positivity in this study was 11.8 per cent. Thermal ablation (thermocoagulation) had better provision and client acceptability than cryotherapy (significant difference). The efficacy of thermal ablation was 97.6 per cent, while, it was 92 per cent for cryotherapy (not significant).

INTERPRETATION CONCLUSIONS

In the context of screen-and-treat programme in settings such as India, thermal ablation appears to be a better method of treatment than cryotherapy for cervical pre-cancerous lesions particularly in terms of better provision and client acceptability.

摘要

背景

目的

世界卫生组织(WHO)已认可热消融(热凝固)作为治疗宫颈癌前病变的有效且安全的方法。WHO 通过严格的研究正在寻找更多证据,以寻找使用包括热消融在内的筛查-治疗策略的卫生提供模式,并研究将其与传统标准方法冷冻疗法进行比较。本研究的目的是评估热消融在提供者和患者中的可接受性,并将其与冷冻疗法进行比较。

方法

在获得伦理批准后,于 2019 年 9 月至 2020 年 10 月进行了为期一年的随机对照试验。使用计算机生成的随机数表进行随机分组,并在获得知情同意后将合格的参与者分为两组。A 组中 VIA 阳性宫颈病变的患者接受冷冻疗法,B 组接受热消融。治疗后,使用国际癌症研究机构(IARC)验证的问卷对两种方法的提供者和患者的可接受性进行评估。还评估了治疗后 6 周和 6 个月的即时副作用和问题。疗效决定于 6 个月时 VIA 阴性。

结果

本研究中 VIA 总阳性率为 11.8%。热消融(热凝固)的提供和患者接受程度优于冷冻疗法(差异有统计学意义)。热消融的疗效为 97.6%,冷冻疗法为 92%(差异无统计学意义)。

解释

结论

在印度等国家的筛查-治疗项目背景下,热消融似乎是治疗宫颈癌前病变的一种比冷冻疗法更好的方法,特别是在提供和患者接受程度方面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d31/10793829/685a9ac8a080/IJMR-158-423-g002.jpg

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