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带有阴茎切除术和阴茎切除术与高级PACG的阴茎切除术:一个随机临床试验

Fengbin Lin¹, Aiguo Lv², Fei Li¹

¹State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.

JAMA ophthalmology

|April 17, 2025

概括

通过手术外围皮膜切除术与阴透析和阴切除术 (SPI+GSL+GT) 显示,在先进的初级闭角光眼瘤中降低眼内压力时,与轨道切除术相比,效果不差. 这种青光眼治疗需要更少的干预,提供了潜在的替代方案.

科学领域:

眼科医生眼科眼科
玻璃眼的手术玻璃眼的手术
临床试验临床试验

背景情况:

外科外围虹膜切除术 (SPI) 结合阴透析 (GSL) 和阴切除术 (GT) 与用于降低眼内压力 (IOP) 的眼切除术在先进的初级关闭角度玻璃眼瘤 (PACG) 中的相对安全性和疗效尚未得到充分证实.
如果IOP没有得到有效的管理,先进的PACG会导致显著的视力丧失.
管切除术是一种常见的外科手术,但正在探索替代手术.

研究的目的:

评估SPI+GSL+GT的安全性和有效性,与1年随访后在没有白内障的高级PACG患者中进行带切除术相比.
为了确定SPI+GSL+GT是否在减少IOP方面不劣于轨道切除术.

主要方法:

一个非劣势随机临床试验,涉及88名中国患者,患有没有白内障的高级PACG.
参与者被随机分配1:1接受SPI+GSL+GT或轨道切除术.
主要结局是12个月内心压力,其非劣势率为4mmHg. 二级结局包括手术成功率,并发症和药物使用.

主要成果:

在12个月后,SPI+GSL+GT在降低内皮压方面表现出与带切除术相比的非劣势 (平均内皮压:15.6与14.9毫米升).
在SPI+GSL+GT中,完全成功率较低 (60.5%),而在轨道切除术 (82.2%).
SPI+GSL+GT组所需的术后干预显著减少 (7.0%与55.6%相比),药物使用没有差异.

结论:

SPI+GSL+GT是一种非劣质的替代品,用于治疗晚期PACG患者的IOP减轻,其特点是对术后干预的需求较低.
虽然完全成功率较低,但整体安全概况和减少的干预要求表明SPI+GSL+GT是可行的选择.
建议在更大的研究中进行进一步验证,以较小的非劣势差额.

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