HIGH-DOSE CORTICOSTEROIDS IN PATIENTS WITH THE ADULT RESPIRATORY-DISTRESS SYNDROME
HIGH-DOSE CORTICOSTEROIDS IN PATIENTS WITH THE ADULT RESPIRATORY-DISTRESS SYNDROME
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DOI：
10.1056/nejm198712173172504
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发表时间：
1987-12-17
影响因子：
158.5
通讯作者：
BRIGHAM, KL
中科院分区：
文献类型：
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作者：
BERNARD, GR;LUCE, JM;BRIGHAM, KL
糖皮质激素被广泛用于成人呼吸窘迫综合征（ARDS）的治疗，但尚无有效证据。我们对99名患有难治性低氧血症、胸部X线片显示弥漫性双侧浸润且经肺动脉插管证实无充血性心力衰竭的患者进行了一项甲基强的松龙治疗的前瞻性、随机、双盲、安慰剂对照试验。ARDS的原因包括败血症（27%）、吸入性肺炎（18%）、胰腺炎（4%）、休克（2%）、脂肪栓塞（1%）和其他原因或一种以上的原因（42%）。50名患者接受甲基强的松龙（每公斤体重30毫克，每6小时一次，持续24小时），49名患者按照相同的时间表接受安慰剂。连续测量肺分流率、动脉氧分压与肺泡氧分压的比值、胸片严重程度评分、总胸廓顺应性和肺动脉压。我们观察到，在进入后或进入后5天内，这些特征在组间无统计学差异。入组后45天，甲基强的松龙组和安慰剂组的死亡率没有差异（分别为50人中的30人[60%; 95%置信区间，46至74]和49人中的31人[63%; 95%置信区间，49至77]; P = 0.74）或ARDS逆转（50例中的18例[36%] vs. 49例中的19例[39%]; P = 0.77）。然而，死亡率数据的置信区间相对较宽，无法排除治疗的小影响。甲泼尼龙组（50例中有8例[16%]）和安慰剂组（49例中有5例[10%]; P = 0.60）的感染并发症相似。我们的数据表明，在因败血症、吸入性或混合原因导致的ARDS患者中，大剂量甲基强的松龙不会影响预后。
Corticosteroids are widely used as therapy for the adult respiratory distress syndrome (ARDS) without proof of efficacy. We conducted a prospective, randomized, double-blind, placebo-controlled trial of methylprednisolone therapy in 99 patients with refractory hypoxemia, diffuse bilateral infiltrates on chest radiography and absence of congestive heart failure documented by pulmonary-artery catheterization. The causes of ARDS included sepsis (27 percent), aspiration pneumonia (18 percent), pancreatitis (4 percent), shock (2 percent), fat emboli (1 percent), and miscellaneous causes or more than one cause (42 percent). Fifty patients received methylprednisolone (30 mg per kilogram of body weight every six hours for 24 hours), and 49 received placebo according to the same schedule. Serial measurements were made of pulmonary shunting, the ratio of partial pressure of arterial oxygen to partial pressure of alveolar oxygen, the chest radiograph severity score, total thoracic compliance, and pulmonary-artery pressure. We observed no statistical differences between groups in these characteristics upon entry or during the five days after entry. Forty-five days after entry there were no differences between the methylprednisolone and placebo groups in mortality (respectively, 30 of 50 [60 percent; 95 percent confidence interval, 46 to 74] and 31 of 49 [63 percent; 95 percent confidence interval, 49 to 77]; P = 0.74) or in the reversal of ARDS (18 of 50 [36 percent] vs. 19 of 49 [39 percent]; P = 0.77). However, the relatively wide confidence intervals in the mortality data make it impossible to exclude a small effect of treatment. Infectious complications were similar in the methylprednisolone group (8 of 50 [16 percent]) and the placebo group (5 of 49 [10 percent]; P = 0.60). Our data suggest that in patients with established ARDS due to sepsis, aspiration, or a mixed cause, high-dose methylprednisolone does not affect outcome.