肺减容手术:随机临床试验的荟萃分析。

Robert L Berger, Kathryn A Wood, Howard J Cabral, Sheila Goodnight-White, Edward P Ingenito, Anthony Gray, John Miller, Steven C Springmeyer
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引用次数: 12

摘要

背景:观察性研究表明,对于选定的晚期肺气肿患者亚群,肺减容手术(LVRS)优于最佳药物治疗。除了国家肺气肿治疗试验(NETT)外,随机临床试验(rct)未能纳入足够数量的患者,无法为临床医生和患者提供关于LVRS有用性的令人信服的结果数据。据推测,对这些随机对照试验(随访3-12个月)的荟萃分析可能会提供关于LVRS在肺气肿患者中的价值的更有说服力的信息。方法:全面检索MEDLINE数据库1994年1月至2004年1月关于LVRS的随机对照试验。结果:在记录在案的8项随机对照试验中,6项研究(306例患者)随访3至12个月,被认为适合进行meta分析。这些RCT人群的主要基线特征包括异质性肺气肿,可比较的纳入/排除标准,回顾起来,通过6分钟步行距离(6MWD)测量的低步行能力。这种情况与NETT的“主要是上肺叶-低运动耐受性肺气肿”队列非常相似。荟萃分析人群的LVRS组在肺功能(FEV(1) p < 0.0001, FVC p < 0.0001,残气量p < 0.0001,总肺活量p = 0.004)、气体交换(动脉血氧分压p < 0.0001)和运动能力(6MWD p = 0.0002)方面的结果优于医学队列。虽然关于生活质量测量的信息不够统一,不足以进行荟萃分析,但对现有数据的调查显示,每项随机对照试验中,手术组的结果优于医学组。两组随机分配治疗后6-12个月的死亡率相似,这表明LVRS的手术死亡率在几个月内被医疗组的死亡所抵消。结论:该荟萃分析显示,选择性晚期异质性肺气肿和低运动耐量(6MWD)患者的LVRS效果优于药物治疗。
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Lung volume reduction surgery: a meta-analysis of randomized clinical trials.

Background: Observational studies have suggested that lung volume reduction surgery (LVRS) is superior to optimal medical therapy for selected subsets of patients with advanced emphysema. Randomized clinical trials (RCTs) with the exception of the National Emphysema Treatment Trial (NETT), failed to enroll a sufficient number of patients to provide clinicians and patients with convincing outcome data on the usefulness of LVRS. It was postulated that a meta-analysis of these RCTs (3-12 months' follow up) may provide more compelling information on the value of LVRS in patients with emphysema.

Methods: A comprehensive search of the MEDLINE database between January 1994 and January 2004 for RCTs on LVRS was performed.

Results: From a total of eight RCTs on record, six studies (306 patients) with 3- to 12-month follow up were deemed suitable for meta-analysis. Key baseline features of these RCT populations included heterogeneous emphysema, comparable inclusion/exclusion criteria and, in retrospect, low walking capacity as measured by the 6-minute walk distance (6MWD). This profile closely resembles NETT's 'predominantly upper lobe--low exercise tolerance emphysema' cohort. The LVRS arm of the meta-analysis population showed better results than the medical cohort in terms of pulmonary function (FEV(1) p < 0.0001, FVC p < 0.0001, residual volume p < 0.0001, total lung capacity p = 0.004), gas exchange (arterial partial pressure of oxygen p < 0.0001) and exercise capacity (6MWD p = 0.0002). Although information on quality-of-life measures was not sufficiently uniform to qualify for meta-analysis, a survey of available data revealed better results in the surgical than in the medical arms of each RCT. Mortality 6-12 months after random assignment to treatment was similar in the two study arms, suggesting that the operative mortality from LVRS was offset, within months, by deaths in the medical arm.

Conclusions: This meta-analysis showed that a selected subset of patients with advanced, heterogeneous emphysema and low exercise tolerance (6MWD) experienced better outcomes from LVRS than from medical therapy.

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