非侵入性通气对于肌萎缩侧索硬化患者的生存和生活质量的影响：一个随机对照实验
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Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial
DrStephen C Bourke MRCPa, , , Mark Tomlinson BAa, Tim L Williams FRCPb, Robert E Bullock FRCPc, ProfPamela J Shaw FRCPb and ProfG John Gibson FRCPa
aDepartment of Respiratory Medicine, University of Newcastle upon Tyne and the Newcastle Hospitals Trust, Newcastle upon Tyne, UK
bDepartment of Neurology, University of Newcastle upon Tyne and the Newcastle Hospitals Trust, Newcastle upon Tyne, UK
cDepartment of Anaesthesia, University of Newcastle upon Tyne and the Newcastle Hospitals Trust, Newcastle upon Tyne, UK
Available online 9 January 2006.
The Lancet Neurology, Volume 5, Issue 2, February 2006, Pages 105-106
Summary
Background
Few patients with amyotrophic lateral sclerosis currently receive non-invasive ventilation (NIV), reflecting clinical uncertainty about the role of this intervention. We aimed to assess the effect of NIV on quality of life and survival in amyotrophic lateral sclerosis in a randomised controlled trial.
Methods
92 of 102 eligible patients participated. They were assessed every 2 months and randomly assigned to NIV (n=22) or standard care (n=19) when they developed either orthopnoea with maximum inspiratory pressure less than 60% of that predicted or symptomatic hypercapnia. Primary validated quality-of-life outcome measures were the short form 36 mental component summary (MCS) and the sleep apnoea quality-of-life index symptoms domain (sym). Both time maintained above 75% of baseline (TiMCS and Tisym) and mean improvement (μMCS and μsym) were measured.
Findings
NIV improved TiMCS, Tisym, μMCS, μsym, and survival in all patients and in the subgroup with better bulbar function (n=20). This subgroup showed improvement in several measures of quality of life and a median survival benefit of 205 days (p=0·006) with maintained quality of life for most of this period. NIV improved some quality-of-life indices in those with poor bulbar function, including μsym (p=0·018), but conferred no survival benefit.
Interpretation
In patients with amyotrophic lateral sclerosis without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy. In patients with severe bulbar impairment, NIV improves sleep-related symptoms, but is unlikely to confer a large survival advantage.
非侵入性通气对于肌萎缩侧索硬化患者的生存和生活质量的影响：一个随机对照实验
摘要
背景
少数肌萎缩侧索硬化患者接受非侵入性通气（NIV），反映出对于这项干预措施的作用的临床不确定性。我们的目的是在随机对照实验中评估非侵入性通气对于肌萎缩侧索硬化患者的生存和生活质量的影响。
方法
在有适应症的102个患者中有92个患者参加这个实验，对这些患者每2个月进行一次评估，当他们进展到要么出现端坐呼吸，最大吸气压力小于预期值的60%，或出现高碳酸血症，随机分配参加NIV (n=22)或标准化护理(n=19)。初步证明有效的质量-生活结果的措施是36精神成分摘要（MCS）（？）的简略形式和睡眠呼吸暂停质量-生活重要指标定义（sym），这两者的时间（有阳性指征的时间？）均需超过基线的70%(TiMCS and Tisym)，测量平均改善程度(μMCS and μsym)。
发现
NIV可以提高TiMCS, Tisym, μMCS, μsym，所有患者的生存时间和有较好的球功能（无明显球麻痹症状）的亚组的上述指标(n=20)。这个亚组在生命质量的几项测试中都显示有改善的迹象，中期生存收益为205天(p=0.006)，这其中的大部分时间均能维持一定的生活质量，NIV可以改善那些有明显球麻痹表现（球功能很差）的患者的一些生活质量指数，包括including μsym (p=0.018)，相对比而言，生存时间方面无收益。
解释
对于没有严重的球麻痹的肌萎缩侧索硬化患者，NIV可提高有一定生存质量的生存期。这组患者由于NIV而得到的收益要远远大于目前进行的神经保护治疗所获得的收益。对于那些有明显球麻痹的患者，NIV可改善睡眠相关的临床症状，但是不可能获得生存时间方面的益处。
DrStephen C Bourke MRCPa, , , Mark Tomlinson BAa, Tim L Williams FRCPb, Robert E Bullock FRCPc, ProfPamela J Shaw FRCPb and ProfG John Gibson FRCPa
aDepartment of Respiratory Medicine, University of Newcastle upon Tyne and the Newcastle Hospitals Trust, Newcastle upon Tyne, UK
bDepartment of Neurology, University of Newcastle upon Tyne and the Newcastle Hospitals Trust, Newcastle upon Tyne, UK
cDepartment of Anaesthesia, University of Newcastle upon Tyne and the Newcastle Hospitals Trust, Newcastle upon Tyne, UK
Available online 9 January 2006.
The Lancet Neurology, Volume 5, Issue 2, February 2006, Pages 105-106
Summary
Background
Few patients with amyotrophic lateral sclerosis currently receive non-invasive ventilation (NIV), reflecting clinical uncertainty about the role of this intervention. We aimed to assess the effect of NIV on quality of life and survival in amyotrophic lateral sclerosis in a randomised controlled trial.
Methods
92 of 102 eligible patients participated. They were assessed every 2 months and randomly assigned to NIV (n=22) or standard care (n=19) when they developed either orthopnoea with maximum inspiratory pressure less than 60% of that predicted or symptomatic hypercapnia. Primary validated quality-of-life outcome measures were the short form 36 mental component summary (MCS) and the sleep apnoea quality-of-life index symptoms domain (sym). Both time maintained above 75% of baseline (TiMCS and Tisym) and mean improvement (μMCS and μsym) were measured.
Findings
NIV improved TiMCS, Tisym, μMCS, μsym, and survival in all patients and in the subgroup with better bulbar function (n=20). This subgroup showed improvement in several measures of quality of life and a median survival benefit of 205 days (p=0·006) with maintained quality of life for most of this period. NIV improved some quality-of-life indices in those with poor bulbar function, including μsym (p=0·018), but conferred no survival benefit.
Interpretation
In patients with amyotrophic lateral sclerosis without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy. In patients with severe bulbar impairment, NIV improves sleep-related symptoms, but is unlikely to confer a large survival advantage.
非侵入性通气对于肌萎缩侧索硬化患者的生存和生活质量的影响：一个随机对照实验
摘要
背景
少数肌萎缩侧索硬化患者接受非侵入性通气（NIV），反映出对于这项干预措施的作用的临床不确定性。我们的目的是在随机对照实验中评估非侵入性通气对于肌萎缩侧索硬化患者的生存和生活质量的影响。
方法
在有适应症的102个患者中有92个患者参加这个实验，对这些患者每2个月进行一次评估，当他们进展到要么出现端坐呼吸，最大吸气压力小于预期值的60%，或出现高碳酸血症，随机分配参加NIV (n=22)或标准化护理(n=19)。初步证明有效的质量-生活结果的措施是36精神成分摘要（MCS）（？）的简略形式和睡眠呼吸暂停质量-生活重要指标定义（sym），这两者的时间（有阳性指征的时间？）均需超过基线的70%(TiMCS and Tisym)，测量平均改善程度(μMCS and μsym)。
发现
NIV可以提高TiMCS, Tisym, μMCS, μsym，所有患者的生存时间和有较好的球功能（无明显球麻痹症状）的亚组的上述指标(n=20)。这个亚组在生命质量的几项测试中都显示有改善的迹象，中期生存收益为205天(p=0.006)，这其中的大部分时间均能维持一定的生活质量，NIV可以改善那些有明显球麻痹表现（球功能很差）的患者的一些生活质量指数，包括including μsym (p=0.018)，相对比而言，生存时间方面无收益。
解释
对于没有严重的球麻痹的肌萎缩侧索硬化患者，NIV可提高有一定生存质量的生存期。这组患者由于NIV而得到的收益要远远大于目前进行的神经保护治疗所获得的收益。对于那些有明显球麻痹的患者，NIV可改善睡眠相关的临床症状，但是不可能获得生存时间方面的益处。
作者: WHOEVER006 编译
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