美託洛爾無益於預防COPD急性加重
作者：
小柯機器人發布時間：2019/10/23 17:02:29
美國阿拉巴馬大學Mark T. Dransfield領銜的科研團隊在最新研究中探討了美託洛爾是否可預防COPD急性加重。相關論文10月20日在線發表於《新英格蘭醫學雜誌》。
據悉，β受體阻滯劑可以降低中重度慢性阻塞性肺病（COPD）患者病情惡化和死亡的風險，但這些發現尚未在隨機試驗中得到證實。
在這項前瞻性隨機試驗中，研究組招募了532名40-85歲的COPD患者，平均1秒用力呼氣量（FEV1）為預測值的41.1%，將其隨機分為β受體阻滯劑（長效美託洛爾）組和安慰劑組。所有患者均伴有COPD中度氣流限制和加重的風險，如前一年的加重史或按規定補充氧氣。排除已服用β受體阻滯劑或類似藥物的患者。主要終點是治療期間COPD首次加重的時間。
美託洛爾組COPD首次加重的時間為202天，安慰劑組為222天，差異無顯著性。美託洛爾組因COPD加重而住院的風險顯著升高，風險比為1.91。兩組中可能與美託洛爾有關的副作用發生率相似，非呼吸性嚴重不良事件的總發生率也相似。在治療期間，美託洛爾組有11例患者死亡，安慰劑組有5例。
對於沒有明確的β受體阻滯劑使用指徵的中重度COPD患者，美託洛爾組和安慰劑組COPD首次加重的時間相似。且美託洛爾組中因病情惡化住院更為常見。
附：英文原文
Title:Metoprolol for the Prevention of Acute Exacerbations of COPD
Author:Mark T. Dransfield, M.D., Helen Voelker, B.A., Surya P. Bhatt, M.D., Keith Brenner, M.D., Richard Casaburi, M.D., Carolyn E. Come, M.D., J. Allen D. Cooper, M.D., Gerard J. Criner, M.D., Jeffrey L. Curtis, M.D., MeiLan K. Han, M.D., Umur Hatipo?lu, M.D., Erika S. Helgeson, Ph.D., et al., for the BLOCK COPD Trial Group*
Issue&Volume:October 20, 2019
Abstract:
BACKGROUND
Observational studies suggest that beta-blockers may reduce the risk of exacerbations and death in patients with moderate or severe chronic obstructive pulmonary disease (COPD), but these findings have not been confirmed in randomized trials.
METHODS
In this prospective, randomized trial, we assigned patients between the ages of 40 and 85 years who had COPD to receive either a beta-blocker (extended-release metoprolol) or placebo. All the patients had a clinical history of COPD, along with moderate airflow limitation and an increased risk of exacerbations, as evidenced by a history of exacerbations during the previous year or the prescribed use of supplemental oxygen. We excluded patients who were already taking a beta-blocker or who had an established indication for the use of such drugs. The primary end point was the time until the first exacerbation of COPD during the treatment period, which ranged from 336 to 350 days, depending on the adjusted dose of metoprolol.
RESULTS
A total of 532 patients underwent randomization. The mean (±SD) age of the patients was 65.0±7.8 years; the mean forced expiratory volume in 1 second (FEV1) was 41.1±16.3% of the predicted value. The trial was stopped early because of futility with respect to the primary end point and safety concerns. There was no significant between-group difference in the median time until the first exacerbation, which was 202 days in the metoprolol group and 222 days in the placebo group (hazard ratio for metoprolol vs. placebo, 1.05; 95% confidence interval [CI], 0.84 to 1.32; P=0.66). Metoprolol was associated with a higher risk of exacerbation leading to hospitalization (hazard ratio, 1.91; 95% CI, 1.29 to 2.83). The frequency of side effects that were possibly related to metoprolol was similar in the two groups, as was the overall rate of nonrespiratory serious adverse events. During the treatment period, there were 11 deaths in the metoprolol group and 5 in the placebo group.
CONCLUSIONS
Among patients with moderate or severe COPD who did not have an established indication for beta-blocker use, the time until the first COPD exacerbation was similar in the metoprolol group and the placebo group. Hospitalization for exacerbation was more common among the patients treated with metoprolol.
DOI:10.1056/NEJMoa1908142