当前位置:科学网首页 > 小柯机器人 >详情
环形电切术可降低HIV感染及宫颈高级别病变患者的复发率
作者:小柯机器人 发布时间:2019/10/25 10:16:17

美国华盛顿大学和世界卫生组织国际癌症研究机构合作开展临床试验,分析了冷冻疗法与环形电切术对肯尼亚HIV感染及宫颈高级别病变患者宫颈疾病复发的影响。相关结果发表在2019年10月22日出版的《美国医学会杂志》上。

世界卫生组织建议对组织学确诊的宫颈上皮内瘤样病变(CIN)2级及以上的患者采用冷冻疗法或宫颈环形电切术(LEEP)进行治疗,而不论其是否感染HIV。冷冻疗法在资源匮乏的地区可行性更高,但对HIV感染妇女可能疗效较差。
 
2011年6月至2016年9月,研究组对肯尼亚的HIV感染妇女进行宫颈筛查,并进行了巴氏试验和确认性活检。对HIV感染和CIN 2级或3级的妇女按1:1随机分组,进行干预治疗。其中200名接受冷冻治疗,200名接受LEEP治疗,之后每6个月随访一次,进行巴氏试验和确认性活检,持续24个月。
 
400名妇女中有339名(85%)完成了试验。术后2年,冷冻治疗组中有60名(30%)患者CIN 2级及以上复发,LEEP组中有37名(19%),差异显著。冷冻治疗组中有40名妇女发生不良事件,包括病理改变和其他原因引起的死亡,LEEP组中有30名,包括病理改变和治疗无关的妇科并发症。
 
总之,在这项针对HIV感染和CIN 2、3级妇女的单中心研究中,LEEP治疗与冷冻治疗相比,显著降低了24个月内宫颈肿瘤的复发率。但在资源匮乏地区必须进行成本效益分析,以确定LEEP的额外获益建立在对资源充分利用的基础上。
 
附:英文原文
 
Title: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
Author:Sharon A. Greene, PhD, MPH1,2; Hugo De Vuyst, MD, PhD3; Grace C. John-Stewart, MD, PhD1,2,4,5; et al
 
Issue&Volume:October 22/29
 
Abstract:
 
Importance  The World Health Organization recommends cryotherapy or loop electrosurgical excision procedure (LEEP) for histologically confirmed cervical intraepithelial neoplasia (CIN) grade 2 or higher regardless of HIV status. Cryotherapy is more feasible in resource-limited settings but may be less effective for women living with HIV.

Objective  To evaluate whether cryotherapy or LEEP is a more effective treatment for high-grade cervical lesions among women with HIV.

Design, Setting, and Participants  Single-center randomized trial conducted among women with HIV and CIN grade 2 or 3. From June 2011 to September 2016, women with HIV in Kenya underwent cervical screening with Papanicolaou testing and confirmatory biopsy. The final date on which a study procedure was administered was September 7, 2016.

Interventions  Women with HIV infection and CIN grade 2 or 3 were randomized 1:1 to receive cryotherapy (n = 200) or LEEP (n = 200) and were followed up every 6 months for 24 months with a Papanicolaou test and confirmatory biopsy.

Main Outcome and Measures  The primary outcome was disease recurrence, defined as CIN grade 2 or higher on cervical biopsy, during the 24-month follow-up period.

Results  Among 400 women who were randomized (median age, 37.4 [interquartile range, 31.9-43.8] years), 339 (85%) completed the trial. Over 2 years, 60 women (30%) randomized to cryotherapy had recurrent CIN grade 2 or higher vs 37 (19%) in the LEEP group (relative risk, 1.71 [95% CI, 1.12-2.65]; risk difference, 7.9% [95% CI, 1.9%-14.0%]; P = .01). Adverse events occurred in 40 women (45 events, including change in pathology and death due to other causes) in the cryotherapy group and in 30 women (38 events, including change in pathology and unrelated gynecological complications) in the LEEP group.

Conclusions and Relevance  In this single-center study of women with HIV infection and CIN grade 2 or 3, treatment with LEEP compared with cryotherapy resulted in a significantly lower rate of cervical neoplasia recurrence over 24 months. Cost-effectiveness analysis is necessary to determine whether the additional benefit of LEEP represents an efficient use of the additional resources that would be required.

DOI:10.1001/jama.2019.14969
 
Source: https://jamanetwork.com/journals/jama/article-abstract/2753370

期刊信息

JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex