Geddes D, Davies M, Koyama H, Hansell D, Pastorino U, Pepper J, Agent P, Cullinan P, MacNeill S J, Goldstraw P
Department of Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom.
N Engl J Med. 2000 Jul 27;343(4):239-45. doi: 10.1056/NEJM200007273430402.
Although many patients with severe emphysema have undergone lung-volume-reduction surgery, the benefits are uncertain. We conducted a randomized, controlled trial of the surgery in patients with emphysema. Patients with isolated bullae were excluded because such patients are known to improve after bullectomy.
Potentially eligible patients were given intensive medical treatment and completed a smoking-cessation program and a six-week outpatient rehabilitation program before random assignment to surgery or continued medical treatment. After 15 patients had been randomized, the entry criteria were modified to exclude patients with a carbon monoxide gas-transfer value less than 30 percent of the predicted value or a shuttle-walking distance of less than 150 m, because of the deaths of 5 such patients (3 treated surgically and 2 treated medically).
Of the 174 subjects who were initially assessed, 24 were randomly assigned to continued medical treatment and 24 to surgery. At base line in both groups, the median forced expiratory volume in one second (FEV1) was 0.75 liter, and the median shuttle-walking distance was 215 m. Five patients in the surgical group (21 percent) and three patients in the medical group (12 percent) died (P=0.43). After six months, the median FEV1 had increased by 70 ml in the surgical group and decreased by 80 ml in the medical group (P=0.02). The median shuttle-walking distance increased by 50 m in the surgical group and decreased by 20 m in the medical group (P=0.02). There were similar changes on a quality-of-life scale and similar changes at 12 months of follow-up. Five of the 19 surviving patients in the surgical group had no benefit from the treatment.
In selected patients with severe emphysema, lung-volume-reduction surgery can improve FEV1, walking distance, and quality of life. Whether it reduces mortality is uncertain.
尽管许多重度肺气肿患者接受了肺减容手术,但其益处尚不确定。我们对肺气肿患者进行了该手术的随机对照试验。孤立性肺大疱患者被排除,因为已知此类患者在肺大疱切除术后病情会改善。
潜在符合条件的患者在随机分配接受手术或继续药物治疗之前,先接受强化药物治疗,并完成戒烟计划和为期六周的门诊康复计划。15名患者随机分组后,由于5名一氧化碳气体转运值低于预测值的30%或往返步行距离小于150米的患者死亡(3名接受手术治疗,2名接受药物治疗),入组标准被修改以排除此类患者。
在最初评估的174名受试者中,24名被随机分配接受继续药物治疗,24名接受手术治疗。两组的基线一秒用力呼气量(FEV1)中位数均为0.75升,往返步行距离中位数均为215米。手术组5名患者(21%)和药物治疗组3名患者(12%)死亡(P = 0.43)。六个月后,手术组FEV1中位数增加了70毫升,药物治疗组减少了80毫升(P = 0.02)。手术组往返步行距离中位数增加了50米,药物治疗组减少了20米(P = 0.02)。生活质量量表上有类似变化,随访12个月时也有类似变化。手术组19名存活患者中有5名未从治疗中获益。
在选定的重度肺气肿患者中,肺减容手术可改善FEV1、步行距离和生活质量。其是否降低死亡率尚不确定。