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【NEJM】支气管内的瓣膜降低肺部充气过度

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这个帖子发布于10年零119天前，其中的信息可能已发生改变或有所发展。
Chronic obstructive pulmonary disease (COPD) is characterized by progressive limitation of airflow that results in air trapping and hyperinflation. Some patients with this disease also have irreversible pulmonary emphysema due to the destruction of alveolar septa in the lung.1 These abnormalities are manifested as breathlessness, limited activity, and impaired quality of life.1 Hyperinflation itself makes the respiratory muscles inefficient both at rest and during exertion. The diaphragm and intercostal muscles in these patients have important structural muscle-fiber abnormalities, as well as alterations in signaling pathways and increased expression of inflammatory cytokines.2,3 On the basis of these observations, reducing pulmonary hyperinflation would seem to make therapeutic sense.

This idea is not new. Since Bonet's description of “voluminous lungs” in 1679, clinicians have been searching for therapies that can decrease lung volumes and thereby improve outcomes in patients with emphysema. Some of the benefit from medical treatment involving inhaled long-acting bronchodilators, with or without corticosteroids, is achieved by means of reducing lung volumes both at rest and during exertion.4,5 The lower lung volumes correlate with improvements in the forced expiratory volume in 1 second (FEV1) and fewer COPD-related complications. However, more relief is desirable.

Over the past 15 years, the surgical intervention known as lung-volume–reduction surgery has been used to reduce hyperinflation; as a result of lower lung volumes, it also improves respiratory-muscle function.6 The National Emphysema Treatment Trial indicated that in a subgroup of patients with COPD — specifically, those with an upper-lobe distribution of emphysema and low exercise capacity — lung-volume–reduction surgery led to reduced mortality, improved exercise capacity, and decreased exacerbations.7 Currently, lung-volume–reduction surgery is not widely used, in part because of the lack of long-term data showing extended benefits of this intervention, as well as the risk of complications associated with the procedure. Thus, alternative interventions are needed to reduce hyperinflation.

In 2003, Snell and colleagues8 reported that endobronchial valves can be placed safely and reliably with the use of a bronchoscope. Several uncontrolled clinical studies followed, involving various endobronchial-valve devices that showed reductions in lung hyperinflation along with improvement in the patient's lung function and exercise capacity. Are endobronchial valves the answer to the quest for a safe and effective way to reduce hyperinflation?

In this issue of the Journal, Sciurba and colleagues describe their randomized trial comparing EBV placement and standard medical therapy in patients with heterogeneous emphysema (ClinicalTrials.gov number, NCT00129584).9 The investigators placed endobronchial valves that prevented air entry into selected subsegmental bronchi of hyperinflated lung lobes while allowing air to escape from the bronchi into which they were placed. Patients who received endobronchial valves had modest improvements in lung function and exercise performance. At 6 months, the FEV1 increased by 1.0 percentage point of the predicted value in the group with endobronchial valves and decreased by 0.9 percentage point of the predicted value in the control group (P=0.005). This improvement in FEV1 came at a cost of a significant increase in COPD exacerbations and episodes of hemoptysis; pneumonia was also a complication in the endobronchial-valve group.

Before we embrace the use of endobronchial valves for treating emphysema, we need to evaluate several limitations of this study. First, there was a lack of standardization of concomitant medical therapy in both study groups, although the investigators stated that patients “underwent 6 to 8 weeks of pulmonary rehabilitation and optimized medical management at the discretion of the treating physician within the context of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.” In my opinion, the patients with severe or very severe COPD (i.e., those for whom the GOLD III or IV guidelines were applicable) enrolled in this study received suboptimal medical therapy. For example, only 57% of patients received recommended bronchodilators at baseline, and we do not know what happened to those patients during the course of the study. Thus, it is possible that more aggressive medical therapy could have had a positive effect on lung function, quality of life, and exercise performance.1

Second, there is no rationale for the investigators' use of prophylactic antibiotics after the placement of endobronchial valves. Antibiotics did not prevent the subsequent development of pneumonia that occurred several weeks after the intervention. Did the investigators have preliminary microbiologic data to guide antibiotic therapy? I believe that exhaustive microbiologic assessments should have been made in these patients with severe lung disease, because they are at high risk for lung infection by resistant pathogens.

Finally, the lung volumes, as measured by means of body plethysmography, did not change significantly during the study, in either group. Thus, changes in lung function seen in patients with endobronchial valves may not be due to decreased hyperinflation but to other unknown mechanisms.

Because of the fragile condition of these patients, rigorous testing of medical and surgical interventions for COPD is needed. It is especially important to standardize and optimize medical therapy before any other interventions are implemented, otherwise it is impossible to fully understand the benefits and potential complications of new treatments. In my opinion, it is premature to recommend the routine use of endobronchial valves in patients with COPD.
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本人认领该文翻译，24小时完成，如未完成，请其它战友自由认领。
2010-09-25 10:20
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  • • 疫情之下——考博版
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Chronic obstructive pulmonary disease (COPD) is characterized by progressive limitation of airflow that results in air trapping and hyperinflation. Some patients with this disease also have irreversible pulmonary emphysema due to the destruction of alveolar septa in the lung.1 These abnormalities are manifested as breathlessness, limited activity, and impaired quality of life.1 Hyperinflation itself makes the respiratory muscles inefficient both at rest and during exertion. The diaphragm and intercostal muscles in these patients have important structural muscle-fiber abnormalities, as well as alterations in signaling pathways and increased expression of inflammatory cytokines.2,3 On the basis of these observations, reducing pulmonary hyperinflation would seem to make therapeutic sense.
慢性阻塞性肺病的特点是进行性的通气受限，可导致气体滞留和肺充气过度。患有此病的一些患者由于肺泡间隔的破坏，可能产生肺气肿。这些病理变化可表现为呼吸急促，活动受限和生活质量的下降。肺过度膨胀使呼吸肌在静息和用力时的效率都降低。这些患者的膈肌和肋间肌的肌纤维出现了重要的结构和信号通路异常，以及炎症因子的过度表达。基于这些观察结果，减轻肺过度充气可能具有治疗意义

This idea is not new. Since Bonet's description of “voluminous lungs” in 1679, clinicians have been searching for therapies that can decrease lung volumes and thereby improve outcomes in patients with emphysema. Some of the benefit from medical treatment involving inhaled long-acting bronchodilators, with or without corticosteroids, is achieved by means of reducing lung volumes both at rest and during exertion.4,5 The lower lung volumes correlate with improvements in the forced expiratory volume in 1 second (FEV1) and fewer COPD-related complications. However, more relief is desirable.
这一理念并不新奇。自1679年Bonet对“voluminous lungs”进行描述以来，医务工作者一直在寻求减少肺体积和改善肺气肿患者症状的治疗手段。包括吸入长效支气管扩张剂（含有或不含激素）令某些人受益，其机制是同时减少静息和运动时的肺容积。肺容积的降低与FEV1改善呈正相关关系，与COPD相关并发症呈负相关关系。但人们期待更显著的症状改善。

Over the past 15 years, the surgical intervention known as lung-volume–reduction surgery has been used to reduce hyperinflation; as a result of lower lung volumes, it also improves respiratory-muscle function.6 The National Emphysema Treatment Trial indicated that in a subgroup of patients with COPD — specifically, those with an upper-lobe distribution of emphysema and low exercise capacity — lung-volume–reduction surgery led to reduced mortality, improved exercise capacity, and decreased exacerbations.7 Currently, lung-volume–reduction surgery is not widely used, in part because of the lack of long-term data showing extended benefits of this intervention, as well as the risk of complications associated with the procedure. Thus, alternative interventions are needed to reduce hyperinflation.
在过去15年中，有一项名为肺减容术的外科介入手段用于减轻肺过度充气，减小肺容积还可改善呼吸肌功能。全国肺气肿治疗实验显示对于COPD患者，尤其是上叶的肺气肿和运动能力低下的患者，肺减容术可降低死亡率，改善运动能力，减缓病情恶化。但目前，肺减容术应用并不广泛，部分由于缺少长期数据对这种外科介入远期疗效的支持。因此，需要其他治疗手段来减轻肺过度充气。

In 2003, Snell and colleagues8 reported that endobronchial valves can be placed safely and reliably with the use of a bronchoscope. Several uncontrolled clinical studies followed, involving various endobronchial-valve devices that showed reductions in lung hyperinflation along with improvement in the patient's lung function and exercise capacity. Are endobronchial valves the answer to the quest for a safe and effective way to reduce hyperinflation?
2003年，Snell和同事们报道可在纤支镜引导下在气管内安全可靠的植入瓣膜，之后涌现出一系列无对照临床试验，包括各种气管内瓣膜装置，这些装置可减轻肺充气过度，并可改善患者肺功能及活动能力。那么，是否气管内瓣膜就是安全有效减轻肺充气过度的答案呢？

In this issue of the Journal, Sciurba and colleagues describe their randomized trial comparing EBV placement and standard medical therapy in patients with heterogeneous emphysema (ClinicalTrials.gov number, NCT00129584).
在这一期杂志中，Sciurba和同事们叙述了他们的随机实验，实验中将植入EBV的肺气肿患者与接受标准治疗的患者进行对比

The investigators placed endobronchial valves that prevented air entry into selected subsegmental bronchi of hyperinflated lung lobes while allowing air to escape from the bronchi into which they were placed.
研究人员向气管内放置瓣膜，选择性阻止气体进入过度充气的肺段，并令气体进入瓣膜所在的肺段。

Patients who received endobronchial valves had modest improvements in lung function and exercise performance.
接受气管内瓣膜植入患者的肺功能和运动能力得到了轻度改善
At 6 months, the FEV1 increased by 1.0 percentage point of the predicted value in the group with endobronchial valves and decreased by 0.9 percentage point of the predicted value in the control group (P=0.005). This improvement in FEV1 came at a cost of a significant increase in COPD exacerbations and episodes of hemoptysis; pneumonia was also a complication in the endobronchial-valve group.
第六个月，支气管内瓣膜植入组的FEV1增加了预测值的1%，对照组FEV1下降了0.9%，两组差异P=0.005,FEV1的改善伴随着COPD的症状加剧和咳血的发生；瓣膜植入组还出现了肺炎等并发症

Before we embrace the use of endobronchial valves for treating emphysema, we need to evaluate several limitations of this study.
在我们接受采用支气管内瓣膜治疗肺气肿之前，需要对这项研究的一些局限之处做出评价。

First, there was a lack of standardization of concomitant medical therapy in both study groups, although the investigators stated that patients “underwent 6 to 8 weeks of pulmonary rehabilitation and optimized medical management at the discretion of the treating physician within the context of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.”
首先，研究组和对照组都缺少伴随内科治疗的标准化，尽管研究者声称患者接受了6-8周的肺功能康复和医师的酌情优化处置
In my opinion, the patients with severe or very severe COPD (i.e., those for whom the GOLD III or IV guidelines were applicable) enrolled in this study received suboptimal medical therapy. For example, only 57% of patients received recommended bronchodilators at baseline, and we do not know what happened to those patients during the course of the study. Thus, it is possible that more aggressive medical therapy could have had a positive effect on lung function, quality of life, and exercise performance.1
在我看来，重度或极重度的COPD患者（适用于GOLD III或IV的患者）接受的内科治疗并非最理想。例如，只有57%的患者在基线水平接受了支气管扩张剂治疗，我不也不清楚在治疗过程中这些患者又发生了什么。因此，有可能更积极的内科治疗可能对患者的肺功能、生活质量和运动表现产生更为积极的作用。

Second, there is no rationale for the investigators' use of prophylactic antibiotics after the placement of endobronchial valves. Antibiotics did not prevent the subsequent development of pneumonia that occurred several weeks after the intervention. Did the investigators have preliminary microbiologic data to guide antibiotic therapy? I believe that exhaustive microbiologic assessments should have been made in these patients with severe lung disease, because they are at high risk for lung infection by resistant pathogens.
其次，研究者在放置支架后预防性使用抗生素缺乏理由。抗生素并不能预防放置支架数周后肺炎的发生。是否这些研究人员拥有指导抗生素使用的初步微生物学证据？我认为应当对有严重肺病的患者进行详尽的微生物学评估，因为他们是耐药菌所致肺炎的高危患者

Finally, the lung volumes, as measured by means of body plethysmography, did not change significantly during the study, in either group. Thus, changes in lung function seen in patients with endobronchial valves may not be due to decreased hyperinflation but to other unknown mechanisms.
最后，采用体积描记法测量的肺容积，在两组患者中均未发生显著变化。因此，植入瓣膜组肺功能的改变可能不是由于肺充气过度减轻所致，而是其他未知的机制。

Because of the fragile condition of these patients, rigorous testing of medical and surgical interventions for COPD is needed. It is especially important to standardize and optimize medical therapy before any other interventions are implemented, otherwise it is impossible to fully understand the benefits and potential complications of new treatments. In my opinion, it is premature to recommend the routine use of endobronchial valves in patients with COPD
鉴于肺气肿患者虚弱的身体状况，需要对COPD的内外科治疗手段进行严格把关。尤其是在进行任何介入治疗前，要对内科治疗进行标准化和优化，否则不可能充分了解一种新治疗手段的优点和潜在并发症。在我看来，目前将支气管瓣膜植入作为COPD患者的常规治疗还为时过早
2010-09-26 22:09
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ginnyran 编辑于 2010-09-27 16:10
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慢性阻塞性肺病以进行性的通气受限为特点，可导致气体滞留和肺充气过度。一些该患者由于肺泡间隔的破坏，可能发生不可逆的肺气肿。这些异常状况可表现为呼吸急促，活动受限和生活质量的下降。仅肺过度膨胀就可以令呼吸肌在静息和用力时效率都降低，这些患者的膈肌和肋间肌不仅发生重要的的肌纤维结构异常，还会发生信号通路的改变及炎症因子的过度表达。基于这些结论，减轻肺过度充气可能具有治疗意义

这一理念并不新奇。自1679年Bonet对“宽大肺”进行描述以来，医务工作者一直在寻求减少肺容积和改善肺气肿患者病情的方法。吸入长效支气管扩张剂（含有或不含激素）可令某些患者受益，其机制是同时减少静息和运动时的肺容积。肺容积减少得越多，FEV1改善越明显，但COPD相关并发症发生率越高。尽管如此，人们仍期待更显著的症状改善。

过去15年中，有一项名为肺减容术的外科介入手段用于减轻肺过度充气，这种手术在减小肺容积的同时还可改善呼吸肌功能。全国肺气肿治疗实验显示对于COPD患者，尤其是上叶的肺气肿和运动能力低下的患者，肺减容术可降低死亡率，改善运动能力，减缓病情恶化。但目前，肺减容术应用并不广泛，部分因为缺少长期数据对这种外科介入远期疗效的支持。因此，需要其他治疗手段来减轻肺过度充气。

2003年，Snell和同事们报道可在纤支镜引导下在气管内安全可靠的植入瓣膜，之后涌现出一系列无对照临床试验，包括各种气管内瓣膜装置，这些装置可减轻肺充气过度，并可改善患者肺功能及活动能力。那么，是否气管内瓣膜就是安全有效减轻肺充气过度的答案呢？

在这一期杂志中，Sciurba和同事们讲述了他们的随机实验，实验中将植入EBV的肺气肿患者与接受标准内科治疗的患者进行了对照。 他们在支气管内放置瓣膜，选择性阻止气体进入过度充气的肺段，使气体进入瓣膜所在的肺段。接受支气管内瓣膜植入患者的肺功能和运动能力得到了轻度改善。第六个月，支气管内瓣膜植入组的FEV1增加了预测值的1%，而对照组FEV1下降了0.9%，两组差异P=0.005,FEV1的改善伴随着COPD的症状加剧和发生咳血；此外瓣膜植入组还出现了肺炎。

我认为在接受采用支气管内瓣膜治疗肺气肿之前，需要对这项研究的一些局限之处做出评价。

首先，研究组和对照组都缺少伴随内科治疗的标准化，尽管研究者声称患者接受了6-8周的肺功能康复和医师的酌情优化处置。在我看来，重度或极重度的COPD患者（适用于GOLD III或IV的患者）接受的内科治疗并非最理想。例如，只有57%的患者在基线水平接受了支气管扩张剂治疗，我不也不清楚在治疗过程中这些患者又发生了什么。因此，有可能更积极的内科治疗可能对患者的肺功能、生活质量和运动表现产生更为积极的作用。

其次，研究者在放置支架后预防性使用抗生素缺乏理由。抗生素并不能预防放置支架数周后肺炎的发生。是否这些研究人员拥有指导抗生素使用的初步微生物学证据？我认为应当对有严重肺病的患者进行详尽的微生物学评估，因为他们是耐药菌所致肺炎的高危患者

最后，采用体积描记法测量的肺容积，在两组患者中均未发生显著变化。因此，植入瓣膜组肺功能的改变可能不是由于肺充气过度减轻所致，而是其他未知的机制。

鉴于肺气肿患者虚弱的身体状况，需要对COPD的内外科治疗手段进行严格把关。尤其是在进行任何介入治疗前，要对内科治疗进行标准化和优化，否则不可能充分了解一种新治疗手段的优点和潜在并发症。在我看来，目前将支气管瓣膜植入作为COPD患者的常规治疗还为时过早
2010-09-27 15:34
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yingtiao 编辑于 2010-09-27 15:55
  • • 【2021版】讨论：以消化道症状为主而非消化科疾病的诊治案例

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