Bovine surfactant therapy for patients with acute respiratory distress syndrome
Bovine surfactant therapy for patients with acute respiratory distress syndrome
复制标题
DOI：
10.1164/ajrccm.155.4.9105072
复制
发表时间：
1997-04-01
影响因子：
24.7
通讯作者：
Gold, AJ
中科院分区：
文献类型：
--
作者：
Gregory, TJ;Steinberg, KP;Gold, AJ
急性呼吸窘迫综合征患者肺表面活性物质缺乏。我们对ARDS患者使用牛表面活性物质进行了一项随机、前瞻性、对照、开放标签的临床研究，以获得有关其安全性和有效性的初步信息。患者在标准治疗的基础上，通过气管内滴注肺表面活性物质或仅接受标准治疗。研究人员对三组接受表面活性物质的患者进行了研究：接受最多8剂50毫克磷脂/公斤的患者，接受最多8剂100毫克/公斤磷脂的患者，以及接受最多4剂100毫克/公斤磷脂的患者。结果测量包括呼吸支持参数、动脉血气、器官系统衰竭、支气管肺泡灌洗(BAL)分析、免疫学分析、存活率和28天研究期间的不良事件。59名研究患者可进行评估；43名在表面活性物质组，16名在对照组。治疗开始后120h的FiO2仅在接受4剂磷脂/kg表面活性物质治疗的患者与对照组患者相比显著降低(p=0.011)。同一组患者的死亡率为18.8%，而对照组为43.8%(p=0.075)。表面活性物质滴注总体上耐受性良好，没有发现安全问题。这项先导性研究提供了表面活性物质可能对ARDS患者有治疗益处的初步证据，并为该制剂的进一步临床研究提供了理论基础。
Lung surfactant is deficient in patients with acute respiratory distress syndrome (ARDS). We performed a randomized, prospective, controlled, open-label clinical study of administration of a bovine surfactant to patients with ARDS to obtain preliminary information about its safety and efficacy. Patients received either surfactant by endotracheal instillation in addition to standard therapy or standard therapy only. Three different groups of patients receiving surfactant were studied: patients receiving up to eight doses of 50 mg phospholipids/kg, those receiving up to eight doses of 100 mg phospholipids/kg, and those receiving up to four doses of 100 mg phospholipids/kg. Outcome measures included ventilatory support parameters, arterial blood gases, organ system failures, bronchoalveolar lavage (BAL) analyses, immunologic analyses, survival, and adverse events during the 28-d study period. Fifty-nine study patients were evaluable; 43 in the surfactant group and 16 in the control group. The FIO2 at 120 h after treatment began was significantly decreased only for patients who received up to four doses of 100 mg phospholipids/kg surfactant as compared with control patients (p = 0.011). Mortality in the same group of patients was 18.8%, as compared with 43.8% in the control group (p = 0.075). The surfactant instillation was generally well tolerated, and no safety concerns were identified. This pilot study presents preliminary evidence that surfactant might have therapeutic benefit for patients with ARDS, and provides rationale for further clinical study of this agent.