Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease
Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease
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DOI：
10.1056/nejm199906243402502
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发表时间：
1999-06-24
影响因子：
158.5
通讯作者：
Morgan, MA
中科院分区：
文献类型：
--
作者：
Niewoehner, DE;Erbland, ML;Morgan, MA
背景和方法尽管糖皮质激素的临床疗效尚不清楚，且可能引起严重的不良反应，但全身性糖皮质激素是慢性阻塞性肺疾病（COPD）急性加重住院患者的标准治疗方法。我们进行了一项双盲、随机试验，除了其他治疗外，还使用全身性糖皮质激素（给药2周或8周）或安慰剂治疗COPD急性加重。大多数其他护理在6个月的随访期内标准化。主要终点是治疗失败，定义为任何原因导致的死亡或需要插管和机械通气，因CORD再次入院或加强药物治疗。结果在25个退伍军人事务部医疗中心的1840名潜在研究参与者中，271人有资格参与并入选; 80人接受了为期8周的糖皮质激素治疗，80人接受了为期2周的治疗，111人接受了安慰剂治疗。大约一半的潜在参与者不合格，因为他们在过去30天内接受了全身性糖皮质激素。安慰剂组的治疗失败率在30天（33%对23%，P=0.04）和90天（48%对37%，P=0.04）时显著高于两个糖皮质激素组。两组合并使用全身性糖皮质激素与较短的初始住院时间（8.5天，安慰剂组为9.7天; P=0.03）相关，并且在入组后第一天，1秒用力呼气量比安慰剂组高约0.10升。在6个月时，显著的治疗益处不再明显。八周的治疗方案并不上级两周的方案。接受糖皮质激素治疗的患者比接受安慰剂治疗的患者更有可能出现需要治疗的高血糖症（15% vs. 4%，P=0.002）。在治疗的前两周获得最大益处。严重到需要治疗的高血压是最常见的并发症。（N Engl J Med 1999;340：1941-7.）(C)1999年，马萨诸塞州医学会。
Background and Methods Although their clinical efficacy is unclear and they may cause serious adverse effects, systemic glucocorticoids are a standard treatment for patients hospitalized with exacerbations of chronic obstructive pulmonary disease (COPD). We conducted a double-blind, randomized trial of systemic glucocorticoids (given for two or eight weeks) or placebo, in addition to other therapies, for exacerbations of COPD. Most other care was standardized over the six-month period of follow-up. The primary end point was treatment failure, defined as death from any cause or the need for intubation and mechanical ventilation, readmission to the hospital for CORD, or intensification of drug therapy.Results Of 1840 potential study participants at 25 Veterans Affairs medical centers, 271 were eligible for participation and were enrolled; 80 received an eight-week course of glucocorticoid therapy, 80 received a two-week course, and 111 received placebo. About half the potential participants were ineligible because they had received systemic glucocorticoids in the previous 30 days. Rates of treatment failure were significantly higher in the placebo group than in the two glucocorticoid groups combined at 30 days (33 percent vs. 23 percent, P=0.04) and at 90 days (48 percent vs. 37 percent, P=0.04). Systemic glucocorticoids tin both groups combined) were associated with a shorter initial hospital stay (8.5 days, vs. 9.7 days for placebo; P=0.03) and with a forced expiratory volume in one second that was about 0.10 liter higher than that in the placebo group by the first day after enrollment. Significant treatment benefits were no longer evident at six months. The eight-week regimen of therapy was not superior to the two-week regimen. The patients who received glucocorticoid therapy were more likely to have hyperglycemia requiring therapy than those who received placebo (15 percent vs. 4 percent, P=0.002).Conclusions Treatment with systemic glucocorticoids results in moderate improvement in clinical outcomes among patients hospitalized for exacerbations of CORD. The maximal benefit is obtained during the first two weeks of therapy. Hyperglycemia of sufficient severity to warrant treatment is the most frequent complication. (N Engl J Med 1999;340:1941-7.) (C) 1999, Massachusetts Medical Society.