重症医学

The Bottom Line 2017年至今报道的大型研究总结

作者:Newsccm 来源:重症危通社 日期:2017-08-17
导读

         在该站点报道的大约17项研究中(含1项方案设计,1项先导性研究),只有3项出现了阳性的结论,其中还有1项关于肿瘤重症患者感染性休克时开放性输血策略的病死率低于限制策略——我靠!这和业内已经基本确定了的限制性输血策略的主流又矛盾了——换句话说,再次否定了重症领域的“经典”认知!

        还记得本公众号介绍的著名的The Bottom Line吗?

        The Bottom Line:来自英国的重症研究信源

        2016 TBL(The Bottom Line) 推荐10大重症相关研究

        由于RSS的不稳定,截至上周,本年度就没接收过该网站的更新内容。

        今日浏览才知道该站点一直在更新,现将其2017年至今报道的大型研究做扼要的总结如下。

        问题是,在该站点报道的大约17项研究中(含1项方案设计,1项先导性研究),只有3项出现了阳性的结论,其中还有1项关于肿瘤重症患者感染性休克时开放性输血策略的病死率低于限制策略——我靠!这和业内已经基本确定了的限制性输血策略的主流又矛盾了——换句话说,再次否定了重症领域的“经典”认知!

        所以我说,重症医学现在很尴尬,什么都证明不了!

        突破点在哪里?

        1. AMACING TRIAL

        造影剂水化预防高危造影剂肾病(阴性结论)

        Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial.

        Lancet. 2017 Apr 1;389(10076):1312-1322.

        doi: 10.1016/S0140-6736(17)30057-0.

        PMID: 28233565

        INTERPRETATION:We found no prophylaxis to be non-inferior and cost-saving in preventing contrast-induced nephropathy compared with intravenous hydration according to current clinical practice guidelines.

        2. LEVO-CTS TRIAL

        左西孟旦治疗心外手术的左室功能障碍(阴性结论)

        Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.

        N Engl J Med. 2017 May 25;376(21):2032-2042.

        doi: 10.1056/NEJMoa1616218.

        PMID: 28316276

        CONCLUSIONS:Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass.

        3. MACMAN TRAIL

        ICU可视化喉镜的首次插管成功率(阴性结论)

        Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial.

        JAMA. 2017 Feb 7;317(5):483-493.

        doi: 10.1001/jama.2016.20603.

        PMID: 28118659

        CONCLUSIONS AND RELEVANCE:Among patients in the ICU requiring intubation, video laryngoscopy compared with direct laryngoscopy did not improve first-pass orotracheal intubation rates and was associated with higher rates of severe life-threatening complications. Further studies are needed to assess the comparative effectiveness of these 2 strategies in different clinical settings and among operators with diverse skill levels.

        4. CHEETAH TRIAL

        心外术后左心孟旦对血流动力学的支持(阴性结论)

        Levosimendan for Hemodynamic Support after Cardiac Surgery.

        N Engl J Med. 2017 May 25;376(21):2021-2031.

        doi: 10.1056/NEJMoa1616325.

        PMID: 28320259

        CONCLUSIONS:In patients who required perioperative hemodynamic support after cardiac surgery, low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo.

        5. DESIRE TRIAL

        右美托咪定对脓毒症机械通气患者病死率及停机日的作用(阴性结论)

        Effect of Dexmedetomidine on Mortality and Ventilator-Free Days in Patients Requiring Mechanical Ventilation With Sepsis: A Randomized Clinical Trial.

        JAMA. 2017 Apr 4;317(13):1321-1328.

        doi: 10.1001/jama.2017.2088.

        PMID: 28322414

        CONCLUSIONS AND RELEVANCE:Among patients requiring mechanical ventilation, the use of dexmedetomidine compared with no dexmedetomidine did not result in statistically significant improvement in mortality or ventilator-free days. However, the study may have been underpowered for mortality, and additional research may be needed to evaluate this further.

        6. WOMAN TRIAL

        氨甲环酸治疗产后出血(试验设计)

        The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial.

        Trials. 2010 Apr 16;11:40.

        doi: 10.1186/1745-6215-11-40.

        PMID: 20398351

        .....The main analyses will be on an 'intention to treat' basis, irrespective of whether the allocated treatment was received or not. Subgroup analyses for the primary outcome will be based on type of delivery; administration or not of prophylactic uterotonics; and on whether the clinical decision to consider trial entry was based primarily on estimated blood loss alone or on haemodynamic instability. A study with 15,000 women will have over 90% power to detect a 25% reduction from 4% to 3% in the primary endpoint of mortality or hysterectomy.

        7. American Heart Association’s Get With The Guidelines Resuscitation Investigators

        院内心跳骤停气管插管与预后(阴性结论)

        Association Between Tracheal Intubation During Adult In-Hospital Cardiac Arrest and Survival.

        JAMA. 2017 Feb 7;317(5):494-506.

        doi: 10.1001/jama.2016.20165.

        PMID: 28118660

        CONCLUSIONS AND RELEVANCE:Among adult patients with in-hospital cardiac arrest, initiation of tracheal intubation within any given minute during the first 15 minutes of resuscitation, compared with no intubation during that minute, was associated with decreased survival to hospital discharge. lthough the study design does not eliminate the potential for confounding by indication, these findings do not support early tracheal intubation for adult in-hospital cardiac arrest.

        8. EMPIRICUS TRIAL

        经验性米卡芬净用于治疗非侵入性真菌感染的ICU获得性脓毒症、念珠菌菌定植与多脏衰患者(阴性结论——不增加无真菌感染的生存时间)

        Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure: The EMPIRICUS Randomized Clinical Trial.

        JAMA. 2016 Oct 18;316(15):1555-1564.

        doi: 10.1001/jama.2016.14655.

        PMID: 27706483

        CONCLUSIONS AND RELEVANCE:Among nonneutropenic critically ill patients with ICU-acquired sepsis, Candida species colonization at multiple sites, and multiple organ failure, empirical treatment with micafungin, compared with placebo, did not increase fungal infection-free survival at day 28.

        9. INSTINCT TRIAL

        免疫球蛋白G治疗软组织坏死性感染(阴性结论)

        Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial.

        Intensive Care Med. 2017 Apr 18.

        doi: 10.1007/s00134-017-4786-0.

        PMID: 27706483

        CONCLUSIONS:In ICU patients with NSTI, we observed no apparent effects of adjuvant IVIG on self-reported physical functioning at 6 months.

        10. ATHOS-3 TRAIL

        血管紧张素II 治疗血管扩张性休克(阳性结论——升高血压)

        Angiotensin II for the Treatment of Vasodilatory Shock

        N Engl J Med. 2017 Aug 3;377(5):419-430.

        doi: 10.1056/NEJMoa1704154.

        PMID: 28528561

        CONCLUSIONS:Angiotensin II effectively increased blood pressure in patients with vasodilatory shock that did not respond to high doses of conventional vasopressors. (Funded by La Jolla Pharmaceutical Company; ATHOS-3 ClinicalTrials.gov number, NCT02338843 .).

        11. TRICOP TRAIL

        重症肿瘤患者的开放与限制性输血策略(开放策略优,矛盾了!)

        Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncological Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial

        Critical Care Medicine 2017;45(5)766-776.

        doi:10.1097/CCM.0000000000002283

        PMID: 28240687

        CONCLUSIONS:We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.

        12. Detsky Trial

        ICU入院6个月后医护对生存及机能预测的准确性(无)

        Discriminative Accuracy of Physician and Nurse Predictions for Survival and Functional Outcomes 6 Months After an ICU Admission

        JAMA. 2017 Jun 6;317(21):2187-2195.

        doi: 10.1001/jama.2017.4078.

        PMID: 28528347

        CONCLUSIONS AND RELEVANCE:ICU physicians' and nurses' discriminative accuracy in predicting 6-month outcomes of critically ill patients varied depending on the outcome being predicted and confidence of the predictors. Further research is needed to better understand how clinicians derive prognostic estimates of long-term outcomes.

        13. REVIVE TRAIL

        重症出院患者身体锻炼项目对机能的影响(阴性结论)

        Effectiveness of an exercise programme on physical function in patients discharged from hospital following critical illness

        Thorax 2017; 72:600-609.

        doi:10.1136/thoraxjnl-2016-209576

        PMID: 27852953

        CONCLUSIONS:There was no statistically significant difference in the primary outcome measure of self-reported physical function following this 6-week exercise programme. Secondary outcome results will help inform future studies.

        14. PRECISE TRIAL

        普瑞巴林治疗慢性坐骨神经痛(阴性结论,但为什么会被Bottom Line收入?)

        Trial of Pregabalin for Acute and Chronic Sciatica

        NEMJ 2017; 376:1111-1121.

        doi:10.1056/NEJMoa1614292

        PMID: 28328324

        CONCLUSIONS:Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group.

        15. Kentish-Barnes. Trial

        哀悼信对ICU死亡患者家属悲伤症状的效果(阴性结论)

        Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial

        Intensive Care Medicine 2017;

        DOI 10.1007/s00134-016-4669-9

        PMID: 28197680

        CONCLUSIONS:In relatives of patients who died in the ICU, a condolence letter failed to alleviate grief symptoms and may have worsened depression and PTSD-related symptoms.

        16. Corl KA. Trial

        自主呼吸的重症患者下腔静脉可压缩性预测液体反应性 (阳性结论)

        Inferior Vena Cava collapsibility detects fluid responsiveness among spontaneously breathing critically ill patients

        Journal of Critical care 2017; 41: 130-137.

        DOI: 10.1016/j.jcrc.2017.05.008

        PMID: 28525778

        CONCLUSION:IVC collapsibility, as measured by POCUS, performs well in distinguishing fluid responders from non-responders, and may be used to guide IVF resuscitation among spontaneously breathing critically-ill patients.

        17. SPARK TRAIL

        小剂量呋塞米对重症患者早期AKI的疗效(先导性研究,阴性结论)

        The effect of low-dose furosemide in critically ill patients with early acute kidney injury

        J Crit Care. 2017 Jul 12;42:138-146.

        doi: 10.1016/j.jcrc.2017.07.030.

        PMID: 28732314

        CONCLUSIONS:In this pilot trial, furosemide did not reduce the rate of worsening AKI, improve recovery or reduce RRT; however, was associated with greater electrolyte abnormalities.

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