地塞米松治疗急性呼吸窘迫综合征

2020
11/20

+
分享
评论
米勒之声
A-
A+

评估地塞米松在急性呼吸窘迫综合征中的作用,地塞米松可能改善肺部和全身炎症,并缩短机械通气时间和降低死亡率。


本文由“小麻哥的日常”授权转载

今天分享一篇关于急性呼吸窘迫综合征的文献。


地塞米松治疗急性呼吸窘迫综合征:一项多中心、随机对照试验


背景: 目前还没有药物被证实是急性呼吸窘迫综合征患者的特效药物。皮质类固醇对急性呼吸窘迫综合征的疗效仍存在争议。


目的:评估地塞米松在急性呼吸窘迫综合征中的作用,地塞米松可能改善肺部和全身炎症,并缩短机械通气时间和降低死亡率。


方法: 我们在西班牙各地教学医院的17个重症监护病房(ICU),对被诊断为中度至重度急性呼吸窘迫综合征的患者进行了多中心随机对照试验,诊断标准:动脉氧分压与吸入氧浓度比值小于200mmHg,呼气末正压大于10cmH2O,吸入氧浓度大于0.5。脑死亡,晚期疾病,或接受皮质类固醇或免疫抑制药物的患者被排除在外。入组患者采用计算机化随机分配地塞米松立即治疗组或继续常规重症监护(对照组)。地塞米松组患者从第1天到第5天每天静脉注射20毫克,从第6天到第10天每天减少到10毫克。两组患者均行肺保护性机械通气。在试验期间,所有地点都保持了分配隐蔽性。主要结果是28天无呼吸机天数,定义为存活天数和从随机化当天到第28天无机械通气天数。次要结果是随机化60天后的全因死亡率。所有的分析都是按照意向治疗原则进行的。该试验在ClinicalTrials.gov上完成注册:NCT01731795。


研究结果: 在2013年3月28日至2018年12月31日期间,我们招募了277名患者,并随机将139名患者分配到地塞米松组和138名患者分配到对照组。在参加人数超过计划样本总数的88% (277/314)时由于报名率偏低,数据安全监察委员会终止了试验。地塞米松组平均无机械通气天数明显高于对照组(组间差异4.8天[95%CI 2.57~7.03] ,p < 0.0001)。60天时,地塞米松组29例(21%) ,对照组50例(36%)死亡(组间差异 -15.3% [-25.9~-4.9] ; p = 0.0047)。地塞米松组与对照组不良反应发生率无显著性差异。最常见的不良反应为 ICU 高血糖:地塞米松组105例(76%),对照组97例(70%);ICU 新发感染(如肺炎或败血症:地塞米松组33例(24%) ,对照组35例(25%) ;气压性创伤:地塞米松组14例(10%),对照组10例(7%)。


结论: 早期给予地塞米松可以缩短机械通气时间,降低中重度 ARDS患者的总体死亡率。



原文摘要

Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial


Background: There is no proven specific pharmacological treatment for patients with the acute respiratory distress syndrome (ARDS). The efficacy of corticosteroids in ARDS remains controversial. We aimed to assess the effects of dexamethasone in ARDS, which might change pulmonary and systemic inflammation and result in a decrease in duration of mechanical ventilation and mortality.


Methods: We did a multicentre, randomised controlled trial in a network of 17 intensive care units (ICUs) in teaching hospitals across Spain in patients with established moderate-to-severe ARDS (defined by a ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen of 200 mm Hg or less assessed with a positive end-expiratory pressure of 10 cm H2O or more and FiO2 of 0·5 or more at 24 h after ARDS onset). Patients with brain death, terminal-stage disease, or receiving corticosteroids or immunosuppressive drugs were excluded. Eligible patients were randomly assigned based on balanced treatment assignments with a computerised randomisation allocation sequence using blocks of 10 opaque, sealed envelopes to receive immediate treatment with dexamethasone or continued routine intensive care (control group). Patients in the dexamethasone group received an intravenous dose of 20 mg once daily from day 1 to day 5, which was reduced to 10 mg once daily from day 6 to day 10. Patients in both groups were ventilated with lung-protective mechanical ventilation. Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days at 28 days, defined as the number of days alive and free from mechanical ventilation from day of randomisation to day 28. Secondary outcome was all-cause mortality 60 days after randomisation. All analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT01731795.


Findings: Between March 28, 2013, and Dec 31, 2018, we enrolled 277 patients and randomly assigned 139 patients to the dexamethasone group and 138 to the control group. The trial was stopped by the data safety monitoring board due to low enrolment rate after enrolling more than 88% (277/314) of the planned sample size. The mean number of ventilator-free days was higher in the dexamethasone group than in the control group (between-group difference 4·8 days [95% CI 2·57 to 7·03]; p<0·0001). At 60 days, 29 (21%) patients in the dexamethasone group and 50 (36%) patients in the control group had died (between-group difference -15·3% [-25·9 to -4·9]; p=0·0047). The proportion of adverse events did not differ significantly between the dexamethasone group and control group. The most common adverse events were hyperglycaemia in the ICU (105 [76%] patients in the dexamethasone group vs 97 [70%] patients in the control group), new infections in the ICU (eg, pneumonia or sepsis; 33 [24%] vs 35 [25%]), and barotrauma (14 [10%] vs 10 [7%]).


Interpretation: Early administration of dexamethasone could reduce duration of mechanical ventilation and overall mortality in patients with established moderate-to-severe ARDS.


 


本文由作者自行上传,并且作者对本文图文涉及知识产权负全部责任。如有侵权请及时联系(邮箱:nanxingjun@hmkx.cn
关键词:
地塞米松,ARDS,ICU,治疗,患者,试验,随机

人点赞

收藏

人收藏

打赏

打赏

我有话说

0条评论

0/500

评论字数超出限制

表情
评论

为你推荐

推荐课程


社群

精彩视频

您的申请提交成功

确定 取消
剩余5
×

打赏金额

认可我就打赏我~

1元 5元 10元 20元 50元 其它

打赏

打赏作者

认可我就打赏我~

×

扫描二维码

立即打赏给Ta吧!

温馨提示:仅支持微信支付!