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肺减容手术与支气管内瓣膜:一项随机对照试验
European Respiratory Journal
(
IF
24.3
)
Pub Date : 2023-04-27
, DOI:
10.1183/13993003.02063-2022
Sara C Buttery
1,
2
,
Winston Banya
1
,
Rocco Bilancia
3
,
Elizabeth Boyd
3
,
Julie Buckley
3
,
Neil J Greening
4,
5
,
Kay Housley
6
,
Simon Jordan
2
,
Samuel V Kemp
1
,
Alan J B Kirk
3
,
Lorna Latimer
4,
5
,
Kelvin Lau
7
,
Rod Lawson
6
,
Adam Lewis
8
,
John Moxham
9
,
Sridhar Rathinam
5
,
Michael C Steiner
4,
5
,
Sara Tenconi
6
,
David Waller
7
,
Pallav L Shah
1,
2
,
Nicholas S Hopkinson
2,
10
,
Affiliation
- National Heart and Lung Institute, Imperial College London, London, UK.
- Royal Brompton and Harefield Hospitals, London, UK.
- Department of Thoracic Surgery, West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK.
- Department of Respiratory Sciences, University of Leicester, Leicester, UK.
- Institute for Lung Health, National Institute for Health Research Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital, Leicester, UK.
- Northern General Hospital, Sheffield, UK.
- St Bartholomew's Hospital, London, UK.
- Department of Health Sciences, Brunel University London, Uxbridge, UK.
- King's College, London, UK.
- National Heart and Lung Institute, Imperial College London, London, UK
背景
Lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves can improve outcomes in appropriately selected patients with emphysema. 然而,没有直接的比较数据可以为适合这两种手术的人做出临床决策提供信息。我们的目的是调查 LVRS 与 12 个月时的 BLVR 相比是否产生更好的健康结果。
方法
这项多中心、单盲、平行组试验将来自五家英国医院的适合进行靶向肺减容手术的患者随机分配至 LVRS 或 BLVR,并使用 i-BODE 评分比较 1 年时的结果。这种综合疾病严重程度测量包括体重指数、气流阻塞、呼吸困难和运动能力(增量穿梭步行试验)。负责收集结果的研究人员对治疗分配一无所知。所有结局均在意向治疗人群中进行评估。
结果
88 名参与者(48% 为女性,平均值±标准差年龄 64.6±7.7 岁,1 秒用力呼气量百分比预测为 31.0±7.9%)在英国的五个专科中心招募并随机分配至 LVRS(n=41)或 BLVR(n=47)。在 12 个月的随访中,49 名参与者(21 名 LVRS/28 名 BLVR)获得了完整的 i-BODE。i-BODE 评分的改善(LVRS –1.10±1.44对比BLVR –0.82±1.61;p=0.54)及其各个组成部分在组间均无差异。两种处理在气体捕集方面产生了相似的改进(预测的残留体积百分比:LVRS –36.1% (95% CI –54.6– –10%)对比BLVR –30.1% (95% CI –53.7– –9%);p=0.81) . 每个治疗组均有 1 例死亡。
结论
我们的研究结果不支持这样的假设,即 LVRS 在适合两种治疗的个体中明显优于 BLVR。
"点击查看英文标题和摘要"
Lung volume reduction surgery versus endobronchial valves: a randomised controlled trial
Background
Lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves can improve outcomes in appropriately selected patients with emphysema. However, no direct comparison data exist to inform clinical decision making in people who appear suitable for both procedures. Our aim was to investigate whether LVRS produces superior health outcomes when compared with BLVR at 12 months.
Methods
This multicentre, single-blind, parallel-group trial randomised patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR and compared outcomes at 1 year using the i-BODE score. This composite disease severity measure includes body mass index, airflow obstruction, dyspnoea and exercise capacity (incremental shuttle walk test). The researchers responsible for collecting outcomes were masked to treatment allocation. All outcomes were assessed in the intention-to-treat population.
Results
88 participants (48% female, mean±sd age 64.6±7.7 years, forced expiratory volume in 1 s percent predicted 31.0±7.9%) were recruited at five specialist centres across the UK and randomised to either LVRS (n=41) or BLVR (n=47). At 12 months follow-up, the complete i-BODE was available in 49 participants (21 LVRS/28 BLVR). Neither improvement in the i-BODE score (LVRS –1.10±1.44 versus BLVR –0.82±1.61; p=0.54) nor in its individual components differed between groups. Both treatments produced similar improvements in gas trapping (residual volume percent predicted: LVRS –36.1% (95% CI –54.6– –10%) versus BLVR –30.1% (95% CI –53.7– –9%); p=0.81). There was one death in each treatment arm.
Conclusion
Our findings do not support the hypothesis that LVRS is a substantially superior treatment to BLVR in individuals who are suitable for both treatments.
更新日期:2023-04-27