Aerosolized surfactant in adults with sepsis-induced acute respiratory distress syndrome
Aerosolized surfactant in adults with sepsis-induced acute respiratory distress syndrome
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DOI：
10.1056/nejm199605303342201
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发表时间：
1996-05-30
影响因子：
158.5
通讯作者：
Pattishall, EN
中科院分区：
文献类型：
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作者：
Anzueto, A;Baughman, RP;Pattishall, EN
背景急性呼吸窘迫综合征（ARDS）患者存在肺表面活性物质缺乏，肺表面活性物质替代治疗可改善患者的生理功能，初步数据表明，肺表面活性物质替代治疗可提高生存率。我们进行了一项前瞻性、多中心、双盲、随机、安慰剂对照试验，涉及725例脓毒症诱导的ARDS患者。根据基线死亡风险对患者进行分层（通过他们在急性生理学和慢性健康评估[APACHE III]指数上的评分表示），并随机分配接受连续施用的合成表面活性剂（每毫升13.5 mg二棕榈酰磷脂酰胆碱; 364例患者）或安慰剂（0.45%生理盐水; 361名患者）雾化吸入长达5天。基线时两个治疗组的人口统计学和生理学特征相似，表面活性剂组的平均（+/-SD）年龄为50+/-17岁，安慰剂组为53+/-18岁，随机分组时的平均APACHE III评分分别为70.4+/-25和70.5+/-25。两组的机械通气持续时间和在重症监护室的住院时间没有显著差异。两组患者30天的生存率均为60%。根据APACHE III评分、死亡原因、ARDS发作时间和严重程度、是否有败血症记录、基础疾病、是否有不复苏命令和医疗中心进行分析时，两组患者的生存率相似。表面活性剂组的分泌物增加明显更频繁;两组的其他并发症发生率相似。对脓毒症诱导的ARDS患者连续给予雾化合成表面活性剂对30天生存率、重症监护室住院时间、机械通气持续时间或生理功能无显著影响。(C)1996年，马萨诸塞州医学会。
Background. Patients with acute respiratory distress syndrome (ARDS) have a deficiency of surfactant, Surfactant replacement improves physiologic function in such patients, and preliminary data suggest that it may improve survival.Methods. We conducted a prospective, multicenter, double-blind, randomized, placebo-controlled trial involving 725 patients with sepsis-induced ARDS. Patients were stratified according to the risk of death at base line (indicated by their score on the Acute Physiologic and Chronic Health Evaluation [APACHE III] index) and randomly assigned to receive either continuously administered synthetic surfactant (13.5 mg of dipalmitoylphosphatidylcholine per milliliter; 364 patients) or placebo (0.45 percent saline; 361 patients) in aerosolized form for up to five days.Results. The demographic and physiologic characteristics of the two treatment groups were similar at base line, The mean (+/-SD) age was 50+/-17 years in the surfactant group and 53+/-18 years in the placebo group, and the mean APACHE III scores at randomization were 70.4+/-25 and 70.5+/-25, respectively, Hemodynamic measures, measures of oxygenation, duration of mechanical ventilation, and length of stay in the intensive care unit did not differ significantly in the two groups. Survival at 30 days was 60 percent for both groups, Survival was similar in the groups when analyzed according to APACHE III score, cause of death, time of onset and severity of ARDS, presence or absence of documented sepsis, underlying disease, whether or not there was a do-not-resuscitate order, and medical center. Increased secretions were significantly more frequent in the surfactant group; the rates of other complications were similar in the two groups.Conclusions. The continuous administration of aerosolized synthetic surfactant to patients with sepsis-induced ARDS had no significant effect on 30-day survival, length of stay in the intensive care unit, duration of mechanical ventilation, or physiologic function. (C) 1996, Massachusetts Medical Society.