Hirschl Ronald B, Croce Martin, Gore Dennis, Wiedemann Herbert, Davis Ken, Zwischenberger Joseph, Bartlett Robert H
Department of Surgery, University of Michigan Medical Center, Ann Arbor, Michigan 48109-0245, USA.
Am J Respir Crit Care Med. 2002 Mar 15;165(6):781-7. doi: 10.1164/ajrccm.165.6.2003052.
We evaluated the safety and efficacy of partial liquid ventilation (PLV) with perflubron in adult patients with acute lung injury and the acute respiratory distress syndrome (ARDS) in a multicenter, prospective, controlled, randomized exploratory clinical trial. Ninety adult patients with PaO2/FIO2 ratios > 60 and < 300 with ARDS for no more than 24 hours were randomized to receive PLV (n = 65) with administration of perflubron through an endotracheal tube sideport or conventional mechanical ventilation (CMV, n = 25) for a maximum of five days. Although a significant reduction in progression to ARDS was noted among patients with PLV, no significant differences in the number of days free from the ventilator at 28 days (CMV = 6.7 +/- 1.8, PLV = 6.3 +/- 1.0 days, p = 0.85), the incidence of mortality (CMV = 36%, PLV = 42%, p = 0.63), or any pulmonary-related parameter were observed. During a post hoc subgroup analysis, significantly more rapid discontinuation of mechanical ventilation (p = 0.045) and a trend toward an increase in the number of days free from the ventilator at 28 days (CMV = 3.2 +/- 1.9, PLV = 8.0 +/- 2.2 days, p = 0.06) were observed during PLV among those patients under 55 years of age with acute lung injury or ARDS. Episodes of hypoxia, respiratory acidosis, and bradycardia occurred more frequently in the PLV group, but these were transient and self-limited. Further evaluation of PLV is warranted to further define beneficial effects in well-defined groups of patients and also to gain additional information regarding safety.
在一项多中心、前瞻性、对照、随机探索性临床试验中，我们评估了全氟溴烷部分液体通气（PLV）用于成人急性肺损伤和急性呼吸窘迫综合征（ARDS）患者的安全性和有效性。90例ARDS病程不超过24小时、动脉血氧分压/吸入氧浓度（PaO2/FIO2）比值＞60且＜300的成年患者被随机分组，其中65例接受经气管插管侧孔给予全氟溴烷的PLV治疗，25例接受传统机械通气（CMV）治疗，最长治疗5天。尽管接受PLV治疗的患者进展为ARDS的情况显著减少，但在脱机天数（28天时，CMV组为6.7±1.8天，PLV组为6.3±1.0天，p = 0.85）、死亡率（CMV组为36%，PLV组为42%，p = 0.63）或任何肺部相关参数方面均未观察到显著差异。在事后亚组分析中，年龄＜55岁的急性肺损伤或ARDS患者接受PLV治疗期间，观察到机械通气撤机明显更快（p = 0.045），且28天时脱机天数有增加趋势（CMV组为3.2±1.9天，PLV组为8.0±2.2天，p = 0.06）。PLV组缺氧、呼吸性酸中毒和心动过缓发作更频繁，但均为短暂且自限性。有必要对PLV进行进一步评估，以进一步明确其在特定患者群体中的有益效果，并获取更多关于安全性的信息。
