当前位置:科学网首页 > 小柯机器人 >详情
飞秒激光辅助治疗白内障的疗效和成本均不优于超声乳化术
作者:小柯机器人 发布时间:2020/1/23 9:51:36

法国波尔多大学医院Cedric Schweitzer小组的一项最新研究比较了飞秒激光辅助与超声乳化术治疗白内障的效果与成本效益。2020年1月18日出版的《柳叶刀》发表了这项成果。

白内障手术是医疗保健中最常见的手术之一。飞秒激光辅助白内障手术(FLACS)与白内障超声乳化手术(PCS)相比,眼切口和晶状体劈开更精确。尽管FLACS的成本较高,但与PCS相比,它有望改善白内障手术的结局。

2013年10月9日至2015年10月30日,研究组进行了一项参与者盲、随机、优越性、临床试验,在法国的5所大学医院招募了907例22岁及以上患者,均符合单侧或双侧白内障手术的标准,将其随机分配,分别接受FLACS或PCS治疗。

870例患者纳入最终分析,其中FLACS组704眼,PCS组685眼。FLACS组的手术成功率为41.1%,PCS组为43.6%,差异不显著。与FLACS相比,使用PCS治疗成功的患者每增加一名,可节省增量成本效益比为10703欧元。FLACS组未观察到严重的不良反应,大部分并发症与主要治疗措施有关,且均发生在超声乳化阶段或术后。

总之,FLACS虽然技术先进,但治疗白内障的疗效并不优于PCS,且成本较高,不值得临床推广。

附:英文原文

Title: Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial

Author: Cedric Schweitzer, Antoine Brezin, Beatrice Cochener, Dominique Monnet, Christine Germain, Stephanie Roseng, Remi Sitta, Aline Maillard, Nathalie Hayes, Philippe Denis, Pierre-Jean Pisella, Antoine Benard, Cati Albou-Ganem, Jean-Louis Arné, Emilie Bardet, Antoine Benard, Catherine Bourreau, Antoine Brezin, Olivier Chatoux, Catherine Cochard, Beatrice Cochener, Joseph Colin, Philippe Denis, Vincent Fortoul, Jerome Galet, Florence Galliot, Nicolas Georges, Christine Germain, Anne Gimbert, Margaux Guillard, Thomas Habay, Nathalie Hayes, Laurent Kodjikian, Aline Maillard, Emilie Merce, Dominique Monnet, Minh Nguyen, Romain Nicolau, Laurent Piazza, Pierre-Jean Pisella, Jean Rateau, Sophie Regueme, Stephanie Roseng, Jean-Jacques Sarragoussi, Cedric Schweitzer, Remi Sitta, David Touboul, Guillaume Vandenmeer

Issue&Volume: 2020/01/18

Abstract:

Background

Cataract surgery is one of the most common operations in health care. Femtosecond laser-assisted cataract surgery (FLACS) enables more precise ocular incisions and lens fragmentation than does phacoemulsification cataract surgery (PCS). We hypothesised that FLACS might improve outcomes in cataract surgery compared with PCS despite having higher costs.

Methods

We did a participant-masked randomised superiority clinical trial comparing FLACS and PCS in two parallel groups (permuted block randomisation stratified on centres via a centralised web-based application, allocation ratio 1:1, block size of 2 or 4 for unilateral cases and 2 or 6 for bilateral cases). Five French University Hospitals enrolled consecutive patients aged 22 years or older who were eligible for unilateral or bilateral cataract surgery. Participants, outcome assessors, and technicians carrying out examinations were masked to the surgical treatment allocation until the last follow-up visit and a sham laser procedure was set up for participants randomly assigned to the PCS arm. The primary clinical endpoint was the success rate of surgery, defined as a composite of four outcomes at a 3-month postoperative visit: absence of severe perioperative complication, a best-corrected visual acuity (BCVA) of 0·0 LogMAR (logarithm of the minimum angle of resolution) or better, an absolute refractive error of 0·75 dioptres or less, and unchanged postoperative corneal astigmatism power (≤0·5 dioptres) and axis (≤20°). The primary economic endpoint was the incremental cost per additional patient who had treatment success at 3 months. Primary outcomes were assessed in all randomly assigned patients who met all eligibility criteria (missing data considered as failure). We used mixed logistic regression models or mixed linear regression models for statistical comparisons, adjusted on centres and whether cataract surgery was bilateral or unilateral. The study is registered with ClinicalTrials.gov, NCT01982006.

Findings

Of the 907 patients (1476 eyes) randomly assigned between Oct 9, 2013, and Oct 30, 2015, 870 (704 eyes in FLACS group and 685 eyes in the PCS group) were analysed. We identified no significant difference in the success rate of surgery between the FLACS and PCS groups (FLACS: 41·1% [289 eyes]; PCS: 43·6% [299 eyes]); adjusted odds ratio 0·85, 95% CI 0·64–1·12, p=0·250). The incremental cost-effectiveness ratio was €10?703 saved per additional patient who had treatment success with PCS compared with FLACS. We observed no severe adverse events during the femtosecond laser procedure, and most of the complications in the FLACS group related to the primary outcome measures occurred during the phacoemulsification phase or postoperatively.

Interpretation

Despite its advanced technology, femtosecond laser was not superior to phacoemulsification in cataract surgery and, with higher costs, did not provide an additional benefit over phacoemulsification for patients or health-care systems.

DOI: 10.1016/S0140-6736(19)32481-X

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32481-X/fulltext

 

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet