Comparison of CryoMaze With Cut-and-Sew Maze Concomitant With Mitral Valve Surgery: A Randomized Noninferiority Trial

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Impact of Interface Type on Noninvasive Ventilation Efficacy in Patients With Neuromuscular Disease: A Randomized Cross-Over Trial

Background and objectiveAround 25% of patients with neuro-muscular diseases (NMD) are treated by home noninvasive ventilation (NIV) through an oronasal mask. However, there is growing evidence that nasal masks require lower NIV pressures and result in fewer residual obstructive events. We hypothesized that nasal masks would improve efficacy and reduce side effects compared to oronasal masks in this population.Methodsopen label, cross-over, randomized, study in 2 tertiary care hospitals. Patients with NMD treated by home NIV were randomized for one-week periods to nasal and oronasal interfaces respectively (cross-over). At the end of each period, nocturnal polygraphy (monitoring mouth opening) under NIV, synchronized with transcutaneous partial pressure in CO₂ (tcCO₂) was performed. Data were collected from the NIV built-in software and NIV side-effects were collected. Intention-to-treat and per protocol analyses were performed. The primary outcome was mean nocturnal SpO₂. The secondary outcomes were: percentage of sleep with SpO₂ < 90%, oxygen desaturation index (ODI), mean tcCO₂, mean duration of mouth opening during sleep, level of non-intentional leaks and side-effects.ResultsThirty patients with NMD were included. There were no between-group differences for either the primary or secondary outcomes. Post hoc comparisons showed that changing between interfaces reduced NIV efficacy: mean nocturnal SpO₂ (p = 0.04), ODI (p = 0.01), mean tcCO2 (p = 0.048), side-effects (p = 0.008).ConclusionNasal masks did not improve NIV efficacy or reduce side effects compared to oronasal masks in patients with NMD treated by home NIV. The efficacy of NIV is reduced during the transition to another interface, requiring close monitoring.Registration number: NCT03458507.     

电视胸腔镜与小切口开胸治疗临床早期非小细胞肺癌患者术后生活质量的前瞻性随机对照研究

目的比较电视胸腔镜手术(video-assisted thoracoscopic surgery,VATS)与小切口开胸手术(minimalincision thoracotomy,MIT)治疗临床早期非小细胞肺癌(non-small cell lung cancer,NSCLC)及其两种手术方式术后患者生活质量的变化特点。方法我们的研究为前瞻性随机对照临床研究生活质量的阶段分析。共纳入2008年1月1日至2011年12月10日中山大学肿瘤防治中心收治的106例NSCLC患者(男57例、女49例,平均年龄57.60岁),采用单中心、双盲试验的随机分组方法分为VATS组(n=57)和MIT组(n=49)。利用肺癌症状量表(LungCancer Symptom Scale,LCSS)评估两组患者术前、术后第1、3、6、9和12个月的生活质量。结果两组患者在年龄、性别、肿瘤所在肺叶、肿瘤病理分期、病理类型、术后并发症、肿瘤直径、手术时间、术中出血量和胸腔引流管置留时间等方面差异无统计学意义(P>0.05)。术后6个月中,VATS组内各指标评分与术前评分的差异无统计学意义(P>0.05);MIT组内术后1个月食欲[(1.04±0.71)vs.(2.00±0.83),F=6.357,P=0.021]、疲劳[(4.55±1.17)vs.(10.19±2.10),F=4.721,P=0.043]、气促[(2.18±0.86)vs.(10.26±2.05),F=10.020,P=0.005]及疾病对正常生活的影响[(5.16±1.70)vs.(17.60±3.17),F=12.319,P=0.002]评分与术前比较,差异有统计学意义。结论VATS行早期肺癌根治术后患者生活质量与术前无明显差异,术后恢复平稳。