The Bottom Line：來自英國的重症研究信源
2016 TBL(The Bottom Line) 推薦10大重症相關研究
由於RSS的不穩定，截至上周，本年度就沒接收過該網站的更新內容。
今日瀏覽才知道該站點一直在更新，現將其2017年至今報道的大型研究做扼要的總結如下。
問題是，在該站點報道的大約17項研究中(含1項方案設計，1項先導性研究)，隻有3項出現了陽性的結論，其中還有1項關於腫瘤重症患者感染性休克時開放性輸血策略的病死率低於限製策略——我靠!這和業內已經基本確定了的限製性輸血策略的主流又矛盾了——換句話說，再次否定了重症領域的“經典”認知!
所以我說，重症醫學現在很尷尬，什麼都證明不了!
突破點在哪裏?
1. AMACING TRIAL
造影劑水化預防高危造影劑腎病(陰性結論)
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
左西孟旦治療心外手術的左室功能障礙(陰性結論)
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可視化喉鏡的首次插管成功率(陰性結論)
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
心外術後左心孟旦對血流動力學的支持(陰性結論)
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
右美托咪定對膿毒症機械通氣患者病死率及停機日的作用(陰性結論)
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
氨甲環酸治療產後出血(試驗設計)
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
院內心跳驟停氣管插管與預後(陰性結論)
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
經驗性米卡芬淨用於治療非侵入性真菌感染的ICU獲得性膿毒症、念珠菌菌定植與多髒衰患者(陰性結論——不增加無真菌感染的生存時間)
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治療軟組織壞死性感染(陰性結論)
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
血管緊張素II 治療血管擴張性休克(陽性結論——升高血壓)
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
重症腫瘤患者的開放與限製性輸血策略(開放策略優，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個月後醫護對生存及機能預測的準確性(無)
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
重症出院患者身體鍛煉項目對機能的影響(陰性結論)
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
普瑞巴林治療慢性坐骨神經痛(陰性結論，但為什麼會被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
哀悼信對ICU死亡患者家屬悲傷症狀的效果(陰性結論)
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靜脈可壓縮性預測液體反應性 (陽性結論)
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
小劑量呋塞米對重症患者早期AKI的療效(先導性研究，陰性結論)
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.
