Wheeler Arthur P, Bernard Gordon R, Thompson B Taylor, Schoenfeld David, Wiedemann Herbert P, deBoisblanc Ben, Connors Alfred F, Hite R Duncan, Harabin Andrea L
Vanderbilt University, Nashville, USA.
N Engl J Med. 2006 May 25;354(21):2213-24. doi: 10.1056/NEJMoa061895. Epub 2006 May 21.
The balance between the benefits and the risks of pulmonary-artery catheters (PACs) has not been established.
We evaluated the relationship of benefits and risks of PACs in 1000 patients with established acute lung injury in a randomized trial comparing hemodynamic management guided by a PAC with hemodynamic management guided by a central venous catheter (CVC) using an explicit management protocol. Mortality during the first 60 days before discharge home was the primary outcome.
The groups had similar baseline characteristics. The rates of death during the first 60 days before discharge home were similar in the PAC and CVC groups (27.4 percent and 26.3 percent, respectively; P=0.69; absolute difference, 1.1 percent; 95 percent confidence interval, -4.4 to 6.6 percent), as were the mean (+/-SE) numbers of both ventilator-free days (13.2+/-0.5 and 13.5+/-0.5; P=0.58) and days not spent in the intensive care unit (12.0+/-0.4 and 12.5+/-0.5; P=0.40) to day 28. PAC-guided therapy did not improve these measures for patients in shock at the time of enrollment. There were no significant differences between groups in lung or kidney function, rates of hypotension, ventilator settings, or use of dialysis or vasopressors. Approximately 90 percent of protocol instructions were followed in both groups, with a 1 percent rate of crossover from CVC- to PAC-guided therapy. Fluid balance was similar in the two groups, as was the proportion of instructions given for fluid and diuretics. Dobutamine use was uncommon. The PAC group had approximately twice as many catheter-related complications (predominantly arrhythmias).
PAC-guided therapy did not improve survival or organ function but was associated with more complications than CVC-guided therapy. These results, when considered with those of previous studies, suggest that the PAC should not be routinely used for the management of acute lung injury. (ClinicalTrials.gov number, NCT00281268.).
肺动脉导管(PAC)的获益与风险之间的平衡尚未确定。
在一项随机试验中,我们使用明确的管理方案,比较了PAC指导的血流动力学管理与中心静脉导管(CVC)指导的血流动力学管理对1000例已确诊急性肺损伤患者的获益与风险关系。出院前60天内的死亡率是主要结局。
两组具有相似的基线特征。PAC组和CVC组出院前60天内的死亡率相似(分别为27.4%和26.3%;P=0.69;绝对差异为1.1%;95%置信区间为-4.4%至6.6%),至第28天无呼吸机天数的平均(±SE)值(分别为13.2±0.5和13.5±0.5;P=0.58)以及未在重症监护病房度过的天数(分别为12.0±0.4和12.5±0.5;P=0.40)也相似。PAC指导的治疗对于入组时处于休克状态的患者并未改善这些指标。两组在肺或肾功能、低血压发生率、呼吸机设置或透析或血管升压药的使用方面无显著差异。两组中约90%的方案指令得到遵循,从CVC指导治疗转为PAC指导治疗的比例为1%。两组的液体平衡相似,给予液体和利尿剂的指令比例也相似。多巴酚丁胺的使用并不常见。PAC组的导管相关并发症(主要为心律失常)约为CVC组的两倍。
PAC指导的治疗并未改善生存率或器官功能,但与CVC指导的治疗相比,并发症更多。这些结果与既往研究结果相结合表明,PAC不应常规用于急性肺损伤的管理。(ClinicalTrials.gov编号,NCT00281268。)