飛秒激光辅助治療白內障的療效和成本均不优于超声乳化術
法國波尔多大學病院Cedric Schweitzer小组的一項最新钻研比力了飛秒激光辅助與超声乳化術醫治白內障的结果與本钱效益。2020年1月18日出书的《柳叶刀》颁發了這項功效。白內障手術是醫療保健中最多见的手術之一。飛秒激光辅助白內障手術（FLACS）與白內障超声乳化手術（PCS）比拟，眼暗语和晶状體劈開更切确。虽然FLACS的本钱较高，但與PCS比拟，它有望改良白內障手術的终局。
2013年10月9日至2015年10月30日，钻研组举行了一項介入者盲、随機、优胜性、临床實驗，在法國的5所大學病院招募了907例22岁及以上患者，均合适单侧或两侧白內障手術的尺度，将其随機分派，别离接管FLACS或PCS醫治。
除疤藥膏，
870例患者纳入终极阐發，此中FLACS组704眼，PCS组685眼。FLACS组的手術樂成率為41.1%，PCS组為43.6%，差别不显著。與FLACS比拟，利用PCS醫治樂成的患者每增长一位，可节流增量本钱效益比為10703欧元。FLACS组未察看到紧张的不良反响，大部門并發症與重要醫治辦法有關，且均產生在超声乳化阶段或術後。
总之，FLACS固然技能先辈，但醫治白內障的療效其實不优于PCS，且本钱较高，不值得临床推行。
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 按摩器推薦,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 co妹妹on 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 unilater孩子節日禮物,al case去除黃褐斑,s 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% ; PCS: 43·6% ); 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足療養生,
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: (19)32481-X/fulltext
LANCET：《柳叶刀》，創刊于1823年。從属于爱思唯尔出书社，最新IF：59.102
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