Perotin Jeanne Marie, Leroy Sylvie, Marquette Charles Hugo, Mal Hervé, Dutau Hervé, Bourdin Arnaud, Vergnon Jean Michel, Pison Christophe, Barbe Coralie, Deslee Gaëtan
Service de Pneumologie, INSERM U1250, Hôpital Universitaire, Reims, France,
Service de Pneumologie, CHU de Nice, FHU OncoAge, Université Côte d'Azur, Nice, France.
Int J Chron Obstruct Pulmon Dis. 2018 Nov 5;13:3645-3649. doi: 10.2147/COPD.S176366. eCollection 2018.
Endobronchial coil treatment (ECT) is a minimally invasive procedure developed for palliative care of patients with severe emphysema. ECT has demonstrated a decrease in hyperinflation, an improvement in quality of life, and an acceptable safety profile in randomized controlled trials (RCTs). Because alpha-1 antitrypsin deficiency (AATD) is a classical exclusion criterion in RCTs, there is no available data for ECT in AATD. In this post hoc analysis of the REVOLENS study (Réduction volumique endobronchique par spirales; ClinicalTrials.gov Identifier: NCT01822795), a multicenter 1:1 RCT which compared bilateral ECT with usual care in severe emphysema, we analyzed the efficacy and safety results at 1 year in six patients with AATD (five males, one female; mean age: 52±9 years) who underwent ECT. A significant decrease in hyperinflation (0.35 L decrease in residual volume [RV]) was observed in four out of six patients at 6 months and three out of six patients at 12 months, and an improvement in quality of life (improvement of 4 points in the St George's Respiratory Questionnaire [SGRQ]) was observed in four out of six patients at both 6 and 12 months. Efficacy results at 6 and 12 months from the six AATD patients were compared with 84 non-AATD patients who underwent ECT, and no statistically significant differences were found for FEV, RV, 6MWT score and SGRQ score. Respiratory-related serious adverse event was limited to pneumonia in one AATD patient at 1 year post-ECT. This post hoc study suggests that AATD patients may have similar efficacy and safety outcomes at 1 year as non-AATD patients. Because of the paucity of available data, appropriately powered studies are needed to determine the effects of ECT in AATD.
支气管内线圈治疗（ECT）是一种为重度肺气肿患者的姑息治疗而开发的微创手术。在随机对照试验（RCT）中，ECT已显示出肺过度充气减少、生活质量改善以及可接受的安全性。由于α-1抗胰蛋白酶缺乏症（AATD）是RCT中的经典排除标准，因此尚无关于AATD患者接受ECT的数据。在REVOLENS研究（螺旋支气管容积减少；ClinicalTrials.gov标识符：NCT01822795）的这项事后分析中，这是一项多中心1:1 RCT，比较了双侧ECT与重度肺气肿常规治疗的效果，我们分析了6例接受ECT的AATD患者（5例男性，1例女性；平均年龄：52±9岁）在1年时的疗效和安全性结果。6个月时，6例患者中有4例肺过度充气显著降低（残气量[RV]减少0.35 L），12个月时6例患者中有3例；6个月和12个月时，6例患者中有4例生活质量改善（圣乔治呼吸问卷[SGRQ]提高4分）。将6例AATD患者在6个月和12个月时的疗效结果与84例接受ECT的非AATD患者进行比较，发现第一秒用力呼气容积（FEV）、残气量（RV）、6分钟步行试验（6MWT）评分和SGRQ评分无统计学显著差异。呼吸相关严重不良事件仅限于1例AATD患者在ECT后1年发生肺炎。这项事后研究表明，AATD患者在1年时的疗效和安全性结果可能与非AATD患者相似。由于可用数据匮乏，需要开展有足够样本量的研究来确定ECT对AATD患者的影响。
