单纯压迫疗法与压迫联合手术治疗慢性静脉溃疡的长期结果（ESCHAR）：随机对照试验
Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial.
作者信息
Gohel Manjit S, Barwell Jamie R, Taylor Maxine, Chant Terry, Foy Chris, Earnshaw Jonothan J, Heather Brian P, Mitchell David C, Whyman Mark R, Poskitt Keith R
机构信息
Cheltenham General Hospital, Cheltenham, Gloucester GL53 7AN.
出版信息
BMJ. 2007 Jul 14;335(7610):83. doi: 10.1136/bmj.39216.542442.BE. Epub 2007 Jun 1.
OBJECTIVE
To determine whether recurrence of leg ulcers may be prevented by surgical correction of superficial venous reflux in addition to compression.
DESIGN
Randomised controlled trial.
SETTING
Specialist nurse led leg ulcer clinics in three UK vascular centres.
PARTICIPANTS
500 patients (500 legs) with open or recently healed leg ulcers and superficial venous reflux.
INTERVENTIONS
Compression alone or compression plus saphenous surgery.
MAIN OUTCOME MEASURES
Primary outcomes were ulcer healing and ulcer recurrence. The secondary outcome was ulcer free time.
RESULTS
Ulcer healing rates at three years were 89% for the compression group and 93% for the compression plus surgery group (P=0.73, log rank test). Rates of ulcer recurrence at four years were 56% for the compression group and 31% for the compression plus surgery group (P<0.01). For patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). For patients who had superficial with segmental deep reflux, recurrence rates at three years were 52% for the compression group and 24% for the compression plus surgery group (P=0.04). For patients with superficial and total deep reflux, recurrence rates at three years were 46% for the compression group and 32% for the compression plus surgery group (P=0.33). Patients in the compression plus surgery group experienced a greater proportion of ulcer free time after three years compared with patients in the compression group (78% v 71%; P=0.007, Mann-Whitney U test).
CONCLUSION
Surgical correction of superficial venous reflux in addition to compression bandaging does not improve ulcer healing but reduces the recurrence of ulcers at four years and results in a greater proportion of ulcer free time.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN07549334 [controlled-trials.com].
目的
确定除加压治疗外，通过手术纠正浅静脉反流是否可预防腿部溃疡复发。
设计
随机对照试验。
地点
英国三个血管中心由专科护士主导的腿部溃疡诊所。
参与者
500例患有开放性或近期愈合的腿部溃疡且伴有浅静脉反流的患者（500条腿）。
干预措施
单纯加压治疗或加压治疗加隐静脉手术。
主要观察指标
主要结局为溃疡愈合和溃疡复发。次要结局为无溃疡时间。
结果
三年时，加压治疗组的溃疡愈合率为89%，加压治疗加手术组为93%（P = 0.73，对数秩检验）。四年时，加压治疗组的溃疡复发率为56%，加压治疗加手术组为31%（P < 0.01）。对于单纯浅静脉反流患者，四年时加压治疗组的复发率为51%，加压治疗加手术组为27%（P < 0.01）。对于伴有节段性深静脉反流的浅静脉反流患者，三年时加压治疗组的复发率为52%，加压治疗加手术组为24%（P = 0.04）。对于伴有完全性深静脉反流的浅静脉反流患者，三年时加压治疗组的复发率为46%，加压治疗加手术组为32%（P = 0.33）。与加压治疗组患者相比，加压治疗加手术组患者在三年后无溃疡时间的比例更高（78%对71%；P = 0.007，曼-惠特尼U检验）。
结论
除加压包扎外，手术纠正浅静脉反流虽不能改善溃疡愈合，但可降低四年时溃疡的复发率，并使无溃疡时间的比例更高。
试验注册
当前受控试验ISRCTN07549334 [controlled-trials.com] 。
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