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静脉曲张治疗随机试验的五年结局
作者:小柯机器人 发布时间:2019/9/6 13:58:55

英国格拉斯哥大学的Julie Brittenden与合作者,分析了腔内激光消融和超声引导下泡沫硬化治疗原发性静脉曲张的长期效果。2019年9月5日出版的《新英格兰医学杂志》发表了这一成果。

这项随机对照试验在英国的11个中心招募了798名原发性静脉曲张患者,研究组通过调查问卷的形式比较了激光消融、泡沫硬化治疗和手术的5年后结局。共有595名(75%)患者完成了生活质量问卷调查。

在调整了基线得分和其他协变量后,接受激光消融或手术的患者阿伯丁静脉曲张问卷得分(得分越低,生活质量越好)低于接受泡沫硬化治疗的患者。各治疗组的一般生活质量指标没有差异。依据每质量调整生命年(QALY) 20000英镑(28433美元)的支付意愿门槛,77.2%的成本效益模型迭代倾向于激光消融。而在泡沫硬化治疗和手术的双向比较中,54.5%的模型迭代倾向于手术。

综上,激光消融或手术治疗静脉曲张5年后的疾病特异性生活质量优于泡沫硬化治疗。大概率成本效益模型迭代倾向于激光消融,每QALY的支付意愿门槛为 20000英镑(28433美元)。

据悉,腔内激光消融和超声引导下泡沫硬化治疗是手术治疗原发性静脉曲张的首选,但其长期疗效仍不确定。

附:英文原文

Title: Five-Year Outcomes of a Randomized Trial of Treatments for Varicose Veins

Author: Julie Brittenden, M.D., David Cooper, Ph.D., Maria Dimitrova, M.Sc., Graham Scotland, Ph.D., Seonaidh C. Cotton, Ph.D., Andrew Elders, M.Sc., Graeme MacLennan, M.Sc., Craig R. Ramsay, Ph.D., John Norrie, M.Sc., Jennifer M. Burr, M.D., Bruce Campbell, M.B., B.S., Paul Bachoo, M.B., Ch.B., Ian Chetter, M.B., Ch.B., M.D., Michael Gough, M.B., Ch.B., Jonothan Earnshaw, D.M., Tim Lees, M.B., Ch.B., M.D., Julian Scott, M.B., Ch.B., M.D., Sara A. Baker, M.Sc., Emma Tassie, M.Sc., Jill Francis, Ph.D., and Marion K. Campbell, Ph.D.

Issue&Volume: Vol 381 No 10

Abstract: 

BACKGROUND
Endovenous laser ablation and ultrasound-guided foam sclerotherapy are recommended alternatives to surgery for the treatment of primary varicose veins, but their long-term comparative effectiveness remains uncertain.

METHODS
In a randomized, controlled trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of laser ablation, foam sclerotherapy, and surgery. Primary outcomes at 5 years were disease-specific quality of life and generic quality of life, as well as cost-effectiveness based on models of expected costs and quality-adjusted life-years (QALYs) gained that used data on participants’ treatment costs and scores on the EuroQol EQ-5D questionnaire.

RESULTS
Quality-of-life questionnaires were completed by 595 (75%) of the 798 trial participants. After adjustment for baseline scores and other covariates, scores on the Aberdeen Varicose Vein Questionnaire (on which scores range from 0 to 100, with lower scores indicating a better quality of life) were lower among patients who underwent laser ablation or surgery than among those who underwent foam sclerotherapy (effect size [adjusted differences between groups] for laser ablation vs. foam sclerotherapy, −2.86; 95% confidence interval [CI], −4.49 to −1.22; P<0.001; and for surgery vs. foam sclerotherapy, −2.60; 95% CI, −3.99 to −1.22; P<0.001). Generic quality-of-life measures did not differ among treatment groups. At a threshold willingness-to-pay ratio of £20,000 ($28,433 in U.S. dollars) per QALY, 77.2% of the cost-effectiveness model iterations favored laser ablation. In a two-way comparison between foam sclerotherapy and surgery, 54.5% of the model iterations favored surgery.

CONCLUSIONS
In a randomized trial of treatments for varicose veins, disease-specific quality of life 5 years after treatment was better after laser ablation or surgery than after foam sclerotherapy. The majority of the probabilistic cost-effectiveness model iterations favored laser ablation at a willingness-to-pay ratio of £20,000 ($28,433) per QALY. (Funded by the National Institute for Health Research; CLASS Current Controlled Trials number, ISRCTN51995477. opens in new tab.)

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home