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NEJM:膿毒癥急診指定治療規(guī)程中的治療啟動(dòng)時(shí)間與病死率

 王學(xué)東的圖書(shū)館 2018-05-03



Time to Treatment and Mortality during Mandated Emergency Care for Sepsis

膿毒癥急診指定治療規(guī)程中的治療啟動(dòng)時(shí)間與病死率

Christopher W. Seymour, M.D., Foster Gesten, M.D., Hallie C. Prescott, M.D., Marcus E. Friedrich, M.D., Theodore J. Iwashyna, M.D., Ph.D., Gary S. Phillips, M.A.S., Stanley Lemeshow, Ph.D., Tiffany Osborn, M.D., M.P.H., Kathleen M. Terry, Ph.D., and Mitchell M. Levy, M.D.

DOI: 10.1056/NEJMoa1703058

http://www./doi/full/10.1056/NEJMoa1703058?query=featured_home


背景

2013年開(kāi)始紐約市要求醫(yī)院遵循早期識(shí)別和治療膿毒癥的規(guī)程。 然而,更快速的膿毒癥治療是否能改善患者結(jié)局存在爭(zhēng)議。

BACKGROUND:In 2013, New York began requiring hospitals to follow protocols for the early identification and treatment of sepsis. However, there is controversy about whether more rapid treatment of sepsis improves outcomes in patients.

方法

我們研究了從2014年4月1日至2016年6月30日向紐約州衛(wèi)生署報(bào)告的膿毒癥和感染性休克患者的資料?;颊咴诘竭_(dá)急診部6小時(shí)內(nèi)開(kāi)始膿毒癥方案,并在12h內(nèi)完成膿毒癥3小時(shí)集束策略中的所有條目(即血培養(yǎng),廣譜抗生素和乳酸測(cè)量)。用多級(jí)模型評(píng)估完成3小時(shí)集束策略的時(shí)間與風(fēng)險(xiǎn)校正死亡率間的關(guān)系。同時(shí)還檢查了啟動(dòng)抗生素時(shí)間及完成初始靜脈液推注的時(shí)間。

METHODS

We studied data from patients with sepsis and septic shock that were reported to the New York State Department of Health from April 1, 2014, to June 30, 2016. Patients had a sepsis protocol initiated within 6 hours after arrival in the emergency department and had all items in a 3-hour bundle of care for patients with sepsis (i.e., blood cultures, broad-spectrum antibiotic agents, and lactate measurement) completed within 12 hours. Multilevel models were used to assess the associations between the time until completion of the 3-hour bundle and risk-adjusted mortality. We also examined the times to the administration of antibiotics and to the completion of an initial bolus of intravenous fluid.

結(jié)果

在149個(gè)醫(yī)院的49,331例患者中,40,696例(82.5%)在3小時(shí)內(nèi)完成了3小時(shí)集束治療。 3小時(shí)集束的中位時(shí)間為1.30h(四分位數(shù)范圍,0.65~2.35),抗生素使用的中位時(shí)間為0.95h(四分位數(shù)范圍,0.35~1.95),液體團(tuán)注的中位時(shí)間為2.56h(四分位數(shù)范圍,1.33~4.20)。 在12h內(nèi)完成3小時(shí)集束的患者中,較長(zhǎng)集束完成時(shí)間與風(fēng)險(xiǎn)調(diào)整后住院死亡率相關(guān)(比數(shù)比OR為1.04 /h; 95%置信區(qū)間[CI] 1.02~1.05; P <0.001),施用抗生素的時(shí)間較長(zhǎng)也是如此(or 1.04="" ;="" 95%ci,1.03~1.06;="" p=""><0.001),但沒(méi)有更長(zhǎng)時(shí)間完成靜脈液輸注則無(wú)此關(guān)聯(lián)(or,1.01 ;="" 95%ci,0.99~1.02;="" p="">

RESULTS

Among 49,331 patients at 149 hospitals, 40,696 (82.5%) had the 3-hour bundle completed within 3 hours. The median time to completion of the 3-hour bundle was 1.30 hours (interquartile range, 0.65 to 2.35), the median time to the administration of antibiotics was 0.95 hours (interquartile range, 0.35 to 1.95), and the median time to completion of the fluid bolus was 2.56 hours (interquartile range, 1.33 to 4.20). Among patients who had the 3-hour bundle completed within 12 hours, a longer time to the completion of the bundle was associated with higher risk-adjusted in-hospital mortality (odds ratio, 1.04 per hour; 95% confidence interval [CI], 1.02 to 1.05; P<0.001), as="" was="" a="" longer="" time="" to="" the="" administration="" of="" antibiotics="" (odds="" ratio,="" 1.04="" per="" hour;="" 95%="" ci,="" 1.03="" to="" 1.06;=""><0.001) but="" not="" a="" longer="" time="" to="" the="" completion="" of="" a="" bolus="" of="" intravenous="" fluids="" (odds="" ratio,="" 1.01="" per="" hour;="" 95%="" ci,="" 0.99="" to="" 1.02;="" p="">





結(jié)論

快速完成3h膿毒癥集束治療和使用抗生素可降低風(fēng)險(xiǎn)調(diào)整后的住院死亡率,但快速完成初次靜脈液輸注無(wú)此聯(lián)系。 (由國(guó)立衛(wèi)生研究院和其他機(jī)構(gòu)資助)

CONCLUSIONS

More rapid completion of a 3-hour bundle of sepsis care and rapid administration of antibiotics, but not rapid completion of an initial bolus of intravenous fluids, were associated with lower risk-adjusted in-hospital mortality. (Funded by the National Institutes of Health and others.)


短短一評(píng):

  1. 沒(méi)看全文,因此只是第一印象的評(píng)價(jià)。

  2. 毫無(wú)疑問(wèn),本研究為膿毒癥集束治療降低病死率再次提供了令人印象深刻的證據(jù)。

  3. 但本次研究最關(guān)鍵點(diǎn)之一就是:這是一個(gè)基于病例數(shù)據(jù)庫(kù)的回歸性分析,并不是一個(gè)基于假設(shè)的前瞻性研究,因此研究結(jié)論的效能還是稍欠一些——換句話(huà)說(shuō)研究的結(jié)論是否有利還需要前瞻的研究給予證實(shí)!

  4. 研究中3h完成組與未完成組的基本參數(shù)就已經(jīng)出現(xiàn)偏倚:例如性別(完成組的女性偏少)、種族(比如未完成組中黑人比較多,而這令人聯(lián)想到黑人的社會(huì)經(jīng)濟(jì)地位)、基礎(chǔ)疾?。苑尾?、終末期腎?。⒒颊邅?lái)源、感染部位等均有顯著遲疑,不過(guò)令人意想不到的是3h完成組中的血培養(yǎng)陽(yáng)性率較高,而且該組的Teaching facility(教學(xué)員工與設(shè)施)的比較遠(yuǎn)遠(yuǎn)低于未完成組(19.0% vs. 84.5%),這些矛盾都比較匪夷所思!——盡管作者聲稱(chēng)這些基礎(chǔ)參數(shù)后來(lái)都經(jīng)過(guò)校正,反正我是不相信。

  5. 本文最大的疑點(diǎn)在于對(duì)結(jié)論無(wú)法合理解釋?zhuān)罕娝苤?hBundle是由乳酸測(cè)定、抗菌藥物、補(bǔ)液及用藥前血培養(yǎng)四項(xiàng)組成,一個(gè)正常人都很清楚這四點(diǎn)中只有兩點(diǎn)屬于治療,換句話(huà)說(shuō),該Bundle如果有效,應(yīng)該是用藥和液體復(fù)蘇的共同作用之功。而本次研究卻發(fā)現(xiàn)了一個(gè)“可笑而可怕”的現(xiàn)象,就是Bundle成功與否與“液體復(fù)蘇”無(wú)關(guān)!我能說(shuō)本次研究盡管證明了Bundle的價(jià)值,同時(shí)也詆毀了Bundle嗎?

  6. 進(jìn)一步說(shuō),上述的抗菌藥物有效而復(fù)蘇無(wú)效對(duì)于這樣一個(gè)兩組中感染性休克發(fā)病率都接近50%,且平均乳酸都高于2mmol/L的病例人群是沒(méi)法解釋的。


綜上所述,本次研究的盡管仍然能提供了一個(gè)Bundle降低病死率的結(jié)論和現(xiàn)象,但深究細(xì)想,似乎存在太多疑點(diǎn)和矛盾,姑妄聽(tīng)之,慎而行之!


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