针对6小时集束化治疗做出修改

以下内容来自Surviving Sepsis Campaign网站

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根据新证据对集束化治疗措施的更新

(Updated Bundles in Response to New Evidence)

自从成立以来，拯救全身性感染行动(SSC)委员会就相信，随着新证据不断出现，我们对于如何为严重全身性感染和感染性休克患者提供最佳治疗的认识也更为深入，SSC指南以及行为改进指标(1)也应当相应改变。

The leadership of the Surviving Sepsis Campaign (SSC) has believed since its inception that both the SSC Guidelines and the SSC performance improvement indicators (1) will evolve as new evidence that improves our understanding of how best to care for patients with severe sepsis and septic shock becomes available.

近期发表的三项临床试验(2,3,4)发现，对于那些已经接受及时抗生素治疗和液体复苏的感染性休克患者，或者对于所有乳酸水平> 4 mmol/L的患者，与对照组相比，使用中心静脉导管(CVC)监测中心静脉压(CVP)和中心静脉血氧饱和度(ScvO2)未能显示任何优势。因此，SSC执行委员会对集束化治疗进行了如下改动：

With publication of 3 trials (2,3,4) that do not demonstrate superiority of required use of a central venous catheter (CVC) to monitor central venous pressure (CVP) and central venous oxygen saturation (ScvO2) in all patients with septic shock who have received timely antibiotics and fluid resuscitation compared with controls or in all patients with lactate >4 mmol/L, the SSC Executive Committee has revised the improvement bundles as follows:

就诊3小时内必须完成的项目*

TO BE COMPLETED WITHIN 3 HOURS OF TIME OF PRESENTATION*:

1. 测定乳酸水平(Measure lactate level)

2. 在应用抗生素前留取血培养(Obtain blood cultures prior to administration of antibiotics)

3. 应用广谱抗生素(Administer broad spectrum antibiotics)

4. 对于低血压或乳酸水平≥ 4 mmol/L的患者输注晶体液30 ml/kg (Administer 30ml/kg crystalloid for hypotension or lactate ≥4mmol/L)

*“Time of presentation” is defined as the time of triage in the emergency department or, if presenting from another care venue, from the earliest chart annotation consistent with all elements of severe sepsis or septic shock ascertained through chart review.

*“就诊时间”定义为急诊分诊的时间，或者，如果为其他就诊途径，则病历中最早记录符合严重全身性感染或感染性休克所有表现的时间。

就诊6小时内必须完成的项目

TO BE COMPLETED WITHIN 6 HOURS OF TIME OF PRESENTATION:

5. 应用升压药物（对初始液体复苏治疗无反应的低血压）以维持平均动脉压(MAP) ≥ 65 mmHg (Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation) to maintain a mean arterial pressure (MAP) ≥65mmHg)

6. 如果初始液体复苏治疗后仍有持续低血压(MAP < 65 mmHg)或初始乳酸≥ 4 mmol/L，应重新评估容量状态及组织灌注指标，并根据表1记录相应发现(In the event of persistent hypotension after initial fluid administration (MAP < 65 mm Hg) or if initial lactate was ≥4 mmol/L, re-assess volume status and tissue perfusion and document findings according to Table 1).

7. 如果初始乳酸水平升高，应重新评估(Re-measure lactate if initial lactate elevated).

表1 (TABLE 1)

对容量状态及组织灌注进行重新评估并记录(DOCUMENT REASSESSMENT OF VOLUME STATUS AND TISSUE PERFUSION WITH):

或(EITHER)

· 由有资质的医生重复进行针对性体格检查（在初始液体复苏治疗后），包括生命体征、心肺、毛细血管再充盈时间、脉搏及皮肤(Repeat focused exam (after initial fluid resuscitation) by licensed independent practitioner including vital signs, cardiopulmonary, capillary refill, pulse, and skin findings)

或以下2项指标(OR TWO OF THE FOLLOWING):

· 测定CVP (Measure CVP)

· 测定ScvO2 (Measure ScvO2)

· 床旁心血管超声检查(Bedside cardiovascular ultrasound)

· 通过被动抬腿试验或液体负荷试验动态评估液体反应性(Dynamic assessment of fluid responsiveness with passive leg raise or fluid challenge)

值得注意的是，我们对6小时的集束化治疗措施进行了更新；但3小时SSC集束化治疗措施并未改变。

Of note, the 6-hour bundle has been updated; the 3-hour SSC bundle is not affected.

尽管任何试验均未提示使用中心静脉导管导致对患者的危害，已经发表的证据显示采用SSC集束化治疗能够显著降低病死率(5)，但是委员会仍对现有资料采取了谨慎的态度，考虑到所有研究存在的局限性，委员会认为上述集束化治疗是目前最适宜的治疗措施。

While no suggestion of harm was indicated with use of a central line in any trial, and published evidence shows significant mortality reduction using the original SSC bundles (5), the committee has taken a prudent look at all current data and, despite weaknesses as in all studies, determined the above bundles to be the appropriate approach at this time.

参考文献(References):

1. Dellinger RP, Levy MM, Rhodes A, et al. Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med 2013; 41:580–637

2. ProCESS Investigators, Yealy DM, Kellum JA, Juang DT, et al. A randomized trial of protocol-based care for early septic shock. N Engl J Med 2014; 370(18):1683-1693

3. The ARISE Investigators and the ANZICS Clinical Trials Group. Goal-directed resuscitation for patients with early septic shock. N Engl J Med 2014; 371:1496-1506

4. Mouncey PR, Osborn TM, Power GS, et al for the ProMISe trial investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med 2015: DOI: 10.1056/NEJMoa1500896

5. Levy MM, Rhodes A, Phillips GS, et al. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5 –year study. Intensive Care Med 2014; 40: 1623-1633