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一项比较肺减容手术与药物治疗重度肺气肿的随机试验。

A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema.

作者信息

Fishman Alfred, Martinez Fernando, Naunheim Keith, Piantadosi Steven, Wise Robert, Ries Andrew, Weinmann Gail, Wood Douglas E

机构信息

University of Pennsylvania, Philadelphia, USA.

出版信息

N Engl J Med. 2003 May 22;348(21):2059-73. doi: 10.1056/NEJMoa030287. Epub 2003 May 20.

Abstract

BACKGROUND

Lung-volume-reduction surgery has been proposed as a palliative treatment for severe emphysema. Effects on mortality, the magnitude and durability of benefits, and criteria for the selection of patients have not been established.

METHODS

A total of 1218 patients with severe emphysema underwent pulmonary rehabilitation and were randomly assigned to undergo lung-volume-reduction surgery or to receive continued medical treatment.

RESULTS

Overall mortality was 0.11 death per person-year in both treatment groups (risk ratio for death in the surgery group, 1.01; P=0.90). After 24 months, exercise capacity had improved by more than 10 W in 15 percent of the patients in the surgery group, as compared with 3 percent of patients in the medical-therapy group (P<0.001). With the exclusion of a subgroup of 140 patients at high risk for death from surgery according to an interim analysis, overall mortality in the surgery group was 0.09 death per person-year, as compared with 0.10 death per person-year in the medical-therapy group (risk ratio, 0.89; P=0.31); exercise capacity after 24 months had improved by more than 10 W in 16 percent of patients in the surgery group, as compared with 3 percent of patients in the medical-therapy group (P<0.001). Among patients with predominantly upper-lobe emphysema and low exercise capacity, mortality was lower in the surgery group than in the medical-therapy group (risk ratio for death, 0.47; P=0.005). Among patients with non-upper-lobe emphysema and high exercise capacity, mortality was higher in the surgery group than in the medical-therapy group (risk ratio, 2.06; P=0.02).

CONCLUSIONS

Overall, lung-volume-reduction surgery increases the chance of improved exercise capacity but does not confer a survival advantage over medical therapy. It does yield a survival advantage for patients with both predominantly upper-lobe emphysema and low base-line exercise capacity. Patients previously reported to be at high risk and those with non-upper-lobe emphysema and high base-line exercise capacity are poor candidates for lung-volume-reduction surgery, because of increased mortality and negligible functional gain.

摘要

背景

肺减容手术已被提议作为严重肺气肿的一种姑息治疗方法。其对死亡率、获益程度和持续时间以及患者选择标准尚未明确。

方法

共有1218例严重肺气肿患者接受了肺康复治疗,并被随机分配接受肺减容手术或继续接受药物治疗。

结果

两个治疗组的总死亡率均为每人年0.11例死亡(手术组的死亡风险比为1.01;P = 0.90)。24个月后,手术组15%的患者运动能力提高超过10瓦,而药物治疗组为3%(P < 0.001)。根据中期分析排除140例手术死亡高风险亚组患者后,手术组的总死亡率为每人年0.09例死亡,而药物治疗组为每人年0.10例死亡(风险比为0.89;P = 0.31);24个月后,手术组16%的患者运动能力提高超过10瓦,而药物治疗组为3%(P < 0.001)。在上叶为主型肺气肿且运动能力低的患者中,手术组的死亡率低于药物治疗组(死亡风险比为0.47;P = 0.005)。在非上叶肺气肿且运动能力高的患者中,手术组的死亡率高于药物治疗组(风险比为2.06;P = 0.02)。

结论

总体而言,肺减容手术增加了运动能力改善的机会,但与药物治疗相比并未带来生存优势。对于上叶为主型肺气肿且基线运动能力低的患者确实产生了生存优势。先前报道的高风险患者以及非上叶肺气肿且基线运动能力高的患者不是肺减容手术的合适人选,因为死亡率增加且功能获益可忽略不计。

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