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重症领域哪些干预是有害的?

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vancom 发表于 2015-8-3 11:19:55 |阅读模式 |复制链接
        意大利人2013年组织专家对2013年7月以前发表的重症领域多中心临床干预试验(mRCT)进行了系统分析。

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纳入与排除标准

纳入:研究发表在同行评阅杂志的文章;mRCT设计;运用在成人患者上的非外科干预;死亡率增加或降低在统计学上有意义。

排除:半随机或非随机设计;外科干预;儿童人群;仅涉及围术期;院外;死亡率差异的统计学意义仅限于亚组分析或校正后;认可度低于问卷调查者的50%。


结果

共计24项mRCT研究探寻15项临床干预。


七项治疗降低危重患者的死亡率。

伴有急性呼吸衰竭的特殊人群(如COPD急性加重,呼吸性酸中毒,低氧性呼吸衰竭,有创机械通气撤机)进行无创通气(共计8项mRCT);心脏骤停后给予亚低温治疗;ARDS患者给予俯卧位和低潮气量通气;存在或有创伤失血性休克风险人群给予氨甲环酸治疗(盲);机械通气患者实施每日唤醒计划;肝硬化伴原发性细菌性腹膜炎患者给予白蛋白治疗(盲)。这其中仅有两项研究为盲法。


八项治疗增加危重患者的死亡率。

创伤失血性休克给予琥珀酰水杨酸交联血红蛋白(非盲);脓毒性休克给予羟乙基淀粉;高频振荡通气(非盲);ARDS给予沙丁胺醇(iv);超正常范围给予全身性氧输送;强化胰岛素治疗(非盲,血糖控制在81-108mg/dL)。这其中有五项研究为盲法。


这些研究结果认同度如何?为了探索这个问题,意大利人随后开展了一项问卷调查,结果并不乐观。61个国家的555位临床医师参与了问卷调查,大多数为美国、澳大利亚及意大利人,80%的为ICU工作者。总的来说,这些人对上述研究的认可度达到81%,但只有71%的参与者将研究结果运用在临床。其中,保护性通气有85%的受访者进行了临床应用,氨甲环酸只有56%,俯卧位只有55%。应用及认可度不高主要受制于部分研究的样本量、研究质量、中心数量不多的原因。


附1:24项mRCT

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3. Brochard L, Mancebo J, Wysocki M, et al: Noninvasive ventilation for acuteexacerbations of chronic obstructive pulmonary disease. N Engl J Med 1995; 333:817–822
4. Guérin C, Reignier J, Richard JC, et al; PROSEVA Study Group: Pronepositioning in severe acute respiratory distress syndrome.
N Engl J Med 2013;368:2159–2168
5. Amato MB, Barbas CS, Medeiros DM, et al: Effect of a protectiveventilationstrategy on mortality in the acute respiratory distress syndrome. N Engl J Med 1998; 338:347–354
6. The Acute Respiratory Distress Syndrome Network: Ventilation with lowertidal volumes as compared with traditional tidal volumes for acute lung injuryand the acute respiratory distress syndrome. NEngl J Med 2000;342:1301–1308
7. Hayes MA, Timmins AC, Yau EH, et al: Elevation of systemic oxygen deliveryin the treatment of critically ill patients. NEngl J Med 1994; 330:1717–1722
8. Takala J, Ruokonen E, Webster NR, et al: Increased mortality associated withgrowth hormone treatment in critically ill adults. NEngl J Med 1999; 341:785–792
9. Finfer S, Chittock DR, Su SY, et al; NICE-SUGAR Study Investigators: Intensiveversus conventional glucose control in critically ill patients. N Engl J Med 2009; 360:1283–1297

10. Perner A, Haase N, Guttormsen AB, et al; 6S Trial Group;Scandinavian Critical Care Trials Group: Hydroxyethyl starch 130/0.42 versus Ringer’sacetate in severe sepsis. N Engl J Med 2012; 367:124–134
11. Ferguson ND, Cook DJ, Guyatt GH, et al; OSCILLATE Trial Investigators;Canadian Critical Care Trials Group: High-frequency oscillation in early acuterespiratory distress syndrome. N Engl J Med2013; 368:795–805
12. Heyland D, Muscedere J, Wischmeyer PE, et al; Canadian Critical Care TrialsGroup: A randomized trial of glutamine and antioxidants in critically illpatients. N Engl J Med 2013;368:1489–1497
13. Sloan EP, Koenigsberg M, Gens D, et al: Diaspirin cross-linked hemoglobin(DCLHb) in the treatment of severe traumatic hemorrhagic shock: A randomizedcontrolled efficacy trial. JAMA1999; 282:1857–1864
14. Gao Smith F, Perkins GD, Gates S, et al; BALTI-2 study investigators: Effectof intravenous β-2 agonist treatment onclinical outcomes in acute respiratory distress syndrome (BALTI-2): Amulticentre, randomised controlled trial. Lancet2012; 379:229–235
15. Girard TD, Kress JP, Fuchs BD, et al: Efficacy and safety of a paired sedationand ventilator weaning protocol for mechanically ventilated patients inintensive care (Awakening and Breathing Controlled trial): A randomisedcontrolled trial. Lancet 2008; 371:126–134
16. Nava S, Ambrosino N, Clini E, et al: Noninvasive mechanical ventilation inthe weaning of patients with respiratory failure due to chronic obstructivepulmonary disease. A randomized, controlled trial. Ann Intern Med 1998;128:721–728
17. Plant PK, Owen JL, Elliott MW: Early use of non-invasive ventilation foracute exacerbations of chronic obstructive pulmonary disease on generalrespiratory wards: A multicentre randomised controlled trial. Lancet 2000;355:1931–1935
18. Ferrer M, Esquinas A, Leon M, et al: Noninvasive ventilation in severe hypoxemicrespiratory failure: A randomized clinical trial. AmJ Respir Crit Care Med 2003;168:1438–1444
19. Ferrer M, Valencia M, Nicolas JM, et al: Early noninvasive ventilation avertsextubation failure in patients at risk: A randomized trial. Am J Respir Crit CareMed 2006; 173:164–170
20. Collaborating Research Group for Noninvasive Mechanical Ventilation ofChinese Respiratory Society: Pulmonary infection control window in treatment ofsevere respiratory failure of chronic obstructive pulmonary diseases: Aprospective, randomized controlled, multi-centred study. Chin Med J (Engl) 2005;118:1589–1594
21. Ferrer M, Sellarés J, Valencia M, et al: Non-invasive ventilation after extubationin hypercapnic patients with chronic respiratory disorders: Randomisedcontrolled trial. Lancet 2009; 374:1082–1088

22. Nava S, Grassi M, Fanfulla F, et al: Non-invasiveventilation in elderly patients with acute hypercapnic respiratory failure: A randomizedcontrolled trial. Age Ageing 2011; 40:444–450
23. Villar J, Kacmarek RM, Pérez-Méndez L, et al: A high positive endexpiratorypressure, low tidal volume ventilatory strategy improves outcome in persistentacute respiratory distress syndrome: A randomized, controlled trial. Crit Care Med 2006; 34:1311–1318
24. Shakur H, Roberts I, Bautista R, et al; CRASH-2 trial collaborators: Effectsof tranexamic acid on death, vascular occlusive events, and blood transfusionin trauma patients with significant haemorrhage (CRASH-2): A randomised,placebo-controlled trial. Lancet 2010; 376:23–32


附2:24项mRCT的基本数据


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原文:Landoni et al. Mortality in Multicenter Critical Care Trials: AnAnalysis of Interventions With a Significant Effect. Crit Care Med. 2015 Aug;43(8):1559-68. doi:10.1097/CCM.0000000000000974.


附3:24项mRCT的样本量等数据

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附4:8项增加死亡率的mRCT相关数据

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