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·401·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6·标准与指南·中国严重脓毒症/脓毒性休克治疗指南(2014)中华医学会重症医学分会DOI:10.
3760/cma.
j.
issn.
2095-4352.
2015.
06.
001通讯作者:严静,Email:zjicu@163.
com脓毒症(sepsis)是由感染引起的全身炎症反应综合征(SIRS),可发展为严重脓毒症(severesepsis)和脓毒性休克(septicshock).
严重脓毒症和脓毒性休克是重症医学面临的重要临床问题,随着人口的老龄化、肿瘤发病率上升以及侵入性医疗手段的增加,脓毒症的发病率在不断上升,每年全球新增数百万脓毒症患者,其中超过1/4的患者死亡[1-6].
中华医学会重症医学分会2007年组织编写了《成人严重脓毒症与脓毒性休克血流动力学监测与支持指南》,为脓毒症的诊治提供了规范和指导,但是随着近年来国内外该领域研究的不断深入,为了更好地指导我国重症医学工作者对严重脓毒症和脓毒性休克的治疗,中华医学会重症医学分会组织专家应用循证医学的方法制定了本指南.
1定义脓毒症是指明确或可疑的感染引起的SIRS.
严重脓毒症是指脓毒症伴由其导致的器官功能障碍和/或组织灌注不足.
脓毒性休克是指脓毒症伴由其所致的低血压,虽经液体治疗后仍无法逆转.
2诊断标准脓毒症、严重脓毒症、脓毒性休克诊断标准见表1~2.
表1脓毒症诊断标准明确或可疑的感染,具备以下临床特点:一般临床特征:(1)发热(体温>38.
3℃);(2)低体温(体温90次/min,或大于不同年龄正常值的2个标准差;(4)气促;(5)精神状态的改变;(6)明显水肿或液体正平衡(24h超过20mL/kg);(7)高血糖症〔血糖>7.
7mmol/L(>140mg/dL)〕且无糖尿病史.
炎症反应指标:(1)白细胞增多〔WBC计数>12*109/L(>12000/μL)〕;(2)白细胞减少〔WBC计数44.
2μmol/L(>0.
5mg/dL);(4)凝血功能异常(INR>1.
5或APTT>60s);(5)肠梗阻(肠鸣音消失);(6)血小板减少〔血小板计数70μmol/L(>4mg/dL)〕.
组织灌注指标:(1)高乳酸血症(>1mmol/L);(2)毛细血管再灌注能力降低或瘀斑形成.
注:WBC为白细胞,SBP为收缩压,MAP为平均动脉压,PaO2/FiO2为氧合指数,INR为国际标准化比值,APTT为活化部分凝血活酶时间表2严重脓毒症和脓毒性休克诊断标准严重脓毒症是脓毒症伴由其导致的器官功能障碍和/或组织灌注不足(以下任意一项)脓毒症所致低血压;乳酸水平超过实验室检测正常水平上限;即使给予足够的液体复苏,尿量仍176.
8μmol/L(2.
0mg/dL);胆红素>34.
2μmol/L(2mg/dL);血小板计数1.
5)脓毒性休克是指脓毒症伴由其所致的低血压,虽经液体治疗后仍无法逆转3检索方法本指南针对相关重要临床问题进行文献检索.
文献检索时间为1993年1月到2014年12月.
文献检索首先确定包括脓毒症、严重脓毒症、脓毒性休克及特定问题的合适关键词,在MEDLINE、EMBASE和CochraneLibrary(Cochrane系统评价数据库,CDSR)、万方数据库、中国知网等综合数据库中进行检索,文献质量要求为Jadad评分大于等于3分,Jadad评分标准见表3.
指南手机版电子书·402·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6GRADE系统将推荐强度分为强(1级)或弱(2级).
决定推荐强度的影响因素见表5.
将推荐等级分配为强或弱的临床意义比证据质量分级更大.
我们评估推荐项目的有利效果是否优于其不良效果,推荐强度反映该评估可信度及专家的意见:推荐的有利效果(有益健康、更低的医护人员和患者负担、节省的费用)将明显优于不良效果(有害健康、更高的医护人员和患者负担、更高的费用).
在低质量证据下进行强烈推荐时,其潜在不利之处亦需进行斟酌.
弱推荐等级表明推荐的有利效果很可能将超过不良效果,不过专家对这些推荐的权衡把握不足——这是因为某些证据质量较低(因此优势和风险仍存在不确定性)或其优点和缺点接近平衡.
强推荐等级用"推荐"表示,而弱推荐等级用"建议"表示.
对于不宜按照GRADE分级进行推荐的意见,本指南给予了单独列举的说明并且显示"未分级"(UG).
表4证据质量的确定基本方法A级(高级):RCT;B级(中级):降级的RCT或升级的观察研究;C级(低级):进展顺利的观察研究与对照RCT;D级(极低级):降级的对照研究或基于其他证据的专家意见削弱证据强度的因素1.
低质量的计划与实施的随机对照试验,意味着存在偏倚的可能性较大2.
结果的不一致性,包括子群分析的相关问题3.
证据的间接性(不同群体、干预性、对照、结果、比较)4.
结果的不精确性5.
报告偏倚的高可能性可能会增加证据强度的主要因素1.
大的作用的重要性(直接证据、相关风险>2无可信的混杂因素)2.
非常大的作用的重要性(相关风险>5且不会影响有效性)(通过两个水平)3.
剂量-反应梯度注:RCT为随机对照试验表3Jadad评分标准随机分组序列的产生方法2分:通过计算机产生的随机序列或随机数表产生的序列;1分:试验提到随机分配,但产生随机序列的方法未予交待;0分:半随机或准随机试验,指采用交替分配病例的方法,如入院顺序、出生日期单双数.
随机化隐藏2分:恰当:中心或药房控制分配方案、或用序列编号一致的容器、现场计算机控制、密封不透光的信封或其他使临床医生和受试者无法预知分配序列的方法;1分:不清楚:只表明使用随机数字表或其他随机分配方案;0分:不恰当:交替分配、病例号、星期日数、开放式随机号码表、系列编码信封以及任何不能防止分组的可预测性的措施.
双盲法2分:描述了实施双盲的具体方法并且被认为是恰当的,如采用完全一致的安慰剂等;1分:试验仅提及采用双盲法;0分:试验提及采用双盲,但方法不恰当,如比较片剂与注射剂而未提及使用双伪法.
退出与失访1分:对退出与失访的病例数和退出理由进行了详细的描述;0分:没有提到退出与失访.
表5确定强推荐和弱推荐的因素考虑因素推荐的过程高质量或中等质量证据(是否存在高质量或中等质量的证据)证据的质量越高,越可能采用强推荐获益与伤害和负担之间平衡的确定(是否存在确定性)理想后果与不良后果之间的差异确定性越大,越可能采用强推荐.
净效益越小和该效益确定性越低,越可能采用弱推荐价值的确定性或相似性(是否存在确定性或相似性)价值和偏好的确定性或相似性越大,越可能采用强推荐来源的含义与备选或其他相关决定的成本相比,干预成本越低(即是消耗的资源越少),越可能采用强推荐4推荐等级我们按照推荐等级的评估、制定与评价系统(GradesofRecommendationsAssessment,DevelopmentandEvaluation,GRADE)的原则,指导证据质量评估〔从高(A级)到极低(D级)〕,确定推荐等级(表4~5)[7-9].
GRADE系统的建立首先需对证据质量进行连续评估,然后评估疗效与风险之间的平衡、负担以及费用,根据这些评估情况确定治疗推荐等级.
证据质量和推荐强度的明确分级是GRADE系统评价方法的关键及典型特点.
本系统将证据质量分为高(A级)、中(B级)、低(C级)、极低(D级).
随机试验最初为高质量证据,但可能因试验实施过程的限制、结果的不一致或不精确、证据为间接证据以及可能的报告偏倚而造成证据质量下降(表4).
间接证据包括研究人群、干预措施、结果的评定以及这些因素与相关问题之间的关联情况.
·403·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6意见不一致时,采用下述投票程序:(1)对持续存在分歧的部分,推荐或反对某一干预措施(和特定的替代措施相比较)至少需要50%的参与者认可,少于20%选择替代措施(选择认为是平等的).
未满足此项标准将不产生推荐意见.
(2)一个推荐意见被列为强推荐而非弱推荐,则需要得到至少70%的参与者认可[10].
初始复苏推荐意见1:推荐对脓毒症导致组织低灌注(经过最初的液体冲击后持续低血压或血乳酸≥4mmol/L)的患者采取早期目标导向的液体复苏.
在进行初始复苏的最初6h内,下述复苏目标可以作为规范化治疗的一部分:(1)中心静脉压8~12mmHg;(2)平均动脉压(MAP)≥65mmHg;(3)尿量≥0.
5mL·kg-1·h-1;(4)上腔静脉血氧饱和度或混合静脉血氧饱和度≥0.
70或0.
65.
(1B)Rivers等[11]研究发现,早期定量液体复苏可提高急诊科脓毒性休克患者的存活率.
最初6h达到以上推荐中的生理标准,可使患者28d病死率降低15.
9%,此治疗策略称为早期目标导向治疗(earlygoal-directedtherapy,EGDT).
我国8家重症加强治疗病房(ICU)314例脓毒症患者的多中心随机对照试验显示,EGDT组28d病死率(75.
2%)较对照组(57.
5%)降低17.
7%[12].
然而,ARISE研究将51个临床研究中心的1600例脓毒性休克患者随机分为EGDT组和常规治疗组,并未发现两组间28d病死率、ICU病死率、院内病死率存在统计学差异[13].
我们对6项RCT[11-16]研究进行Meta分析显示,EGDT可降低脓毒症患者的短期(院内、ICU或28d)病死率.
然而,两项大规模多中心随机对照研究(ProCESS研究和ARISE研究)显示,EGDT组严重脓毒症和脓毒性休克的远期(60d或90d)病死率并无明显改善.
ProCESS研究将美国31个急诊中心的1341例脓毒症患者随机分为程序化EGDT组、程序化标准治疗组(不置入中心静脉导管,但可应用升压药物和/或输血)和常规治疗组,结果显示,3组间60d病死率无显著差异〔21.
0%、18.
2%、18.
9%;程序化标准治疗组比常规治疗组:相对危险度(RR)=1.
04,95%可信区间(95%CI)=0.
82~1.
31,P=0.
83;程序化EGDT组比程序化标准治疗组:RR=1.
15,95%CI=0.
88~1.
51,P=0.
31〕,3组间90d病死率、1年病死率和呼吸支持治疗率也无显著差异[17].
ARISE研究发现,EGDT组(18.
6%)和常规治疗组(18.
8%)90d病死率差异无统计学意义(RR=0.
98,95%CI=0.
80~1.
21,P=0.
09)[13,18].
而Rivers等[11]的研究发现,EGDT组60d病死率(56.
9%)较标准治疗组(44.
3%)降低12.
6%(RR=0.
67,95%CI=0.
46~0.
96,P=0.
03),差异有统计学意义.
我们对以上3项RCT研究[11,13,17]进行Meta分析显示,EGDT组和对照组对脓毒症患者远期(60d或90d)病死率无差异.
另外,由于ProCESS研究和ARISE研究涉及到常规治疗(UsualCare)的概念,即由实施治疗的临床医生自主决定复苏目标及监测方法.
我们对目前为止设立EGDT组和常规治疗组的3项RCT研究[14-15,17]进行Meta分析发现,两组间患者的病死率无差异.
然而,由于多年来EGDT的广泛推广,常规治疗组的临床医生可能已经接受了较好的脓毒性休克的治疗训练,掌握了治疗技术并且明确了有效的复苏目标[18].
综上所述,现有的循证医学证据支持EGDT可降低脓毒症患者的短期病死率(院内病死率、ICU病死率或28d病死率),尚无证据显示EGDT增加脓毒症患者的远期(60d或90d)病死率.
因此推荐,对脓毒症诱发组织低灌注的患者可采用EGDT进行液体复苏.
推荐意见2:推荐在严重脓毒症和脓毒性休克患者液体复苏过程中,乳酸和乳酸清除率可作为判断预后的指标.
(1D)研究表明,血清乳酸水平与患者的病情严重程度和预后密切相关,是组织低灌注的标志之一[11,19-20].
而脓毒症诱发持续低血压但无高乳酸血症的患者病死率并不高[21].
研究表明,血清乳酸水平>1.
5mmol/L的脓毒症患者病死率有所增加[22],是独立于临床体征和器官功能障碍之外的脓毒症预后因素[23].
血清乳酸水平的降低标志着全身组织缺氧情况的改善,与病死率降低相关[24],是较准确的预后指标之一[25].
Jansen等[26]研究发现,对入住ICU的高乳酸血症(>3.
0mmol/L)患者进行以乳酸为导向的治疗(lactate-guidedtherapy,在初始8h内使血清乳酸水平每2h下降≥20%),其院内病死率较对照组(无乳酸测量值)明显降低〔风险比(HR)=-0.
61,95%CI=0.
43~0.
87,P=-0.
006〕,并建议在初始8h内每2h监测血清乳酸水平,之后每8~12h监测血清乳酸水平.
然而,由于患者不同的机体基础状态(如肝脏、肾脏基础,及既往药物使用史),单纯监测某一时刻的血清乳酸水平不能准确反映组织氧供、氧耗·404·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6的动态变化.
因此,临床为了准确评估机体组织细胞的灌注和氧代谢情况,以及患者对治疗的反应,动态监测血清乳酸水平的变化,将乳酸清除率作为评估预后的一个重要指标.
美国急诊医学休克研究网络协作组(EmergencyMedicineShockResearchNetwork,EMSHOCKNET)对166例脓毒症患者进行液体复苏的观察性研究发现,复苏6h内乳酸清除率>10%的患者院内病死率为19%,6h内乳酸清除率0.
70者的院内病死率为23%(95%CI=0.
17~0.
30),6h内乳酸清除率>10%者的院内病死率为17%(95%CI=0.
11~0.
24).
因此,复苏6h内乳酸清除率≥10%可能预示脓毒症患者的较低病死率[24,27-29].
但仍缺乏关于乳酸清除率的前瞻性多中心随机对照研究.
综上所述,血清乳酸水平是严重脓毒症和脓毒性休克患者预后的独立影响因素之一,复苏6h内乳酸清除率≥10%可能预示脓毒症患者的较低病死率.
因此推荐,在严重脓毒症和脓毒性休克患者液体复苏过程中,乳酸和乳酸清除率可作为判断预后的指标.
液体与液体反应性推荐意见3:推荐晶体液作为严重脓毒症和脓毒性休克的首选复苏液体.
(1B)严重脓毒症和脓毒性休克初始液体复苏时首选晶体液与胶体液,对患者的病死率无影响.
Bansal等[30]对7项多中心随机对照试验[31-37]进行Meta分析显示,初始液体复苏选用晶体液(生理盐水、乳酸林格液)与胶体液(白蛋白、6%或10%羟乙基淀粉或其他胶体液)对脓毒症患者28~30d病死率无影响.
CRISTAL研究的亚组分析显示,脓毒症患者进行液体复苏时应用晶体液(226/779例死亡)与胶体液(215/774例死亡),28d病死率无显著差异(HR=0.
95,95%CI=0.
78~1.
10).
我们对4项RCT研究[33,36-39]进行的Meta分析显示,分别以晶体液(生理盐水、乳酸林格液)与胶体液(6%或10%羟乙基淀粉或其他胶体液)作为初始复苏液体,两组脓毒症患者的90d病死率无显著差异.
由于胶体液相对晶体液对病死率改善无明显受益,且价格较贵,因此推荐,对严重脓毒症和脓毒性休克的液体复苏首选晶体液.
推荐意见4:不建议使用羟乙基淀粉进行严重脓毒症和脓毒性休克的液体复苏.
(2B)Bansal等[30]对Veneman、VISEP、CRYSTMAS、FINESS、6S、CHEST6项RCT研究[33-37,39]进行的Meta分析显示,羟乙基淀粉与生理盐水、醋酸林格液比,对严重脓毒症或脓毒性休克28~30d病死率(OR=1.
21,95%CI=0.
98~1.
48)、90d病死率(OR=1.
29,95%CI=0.
90~1.
82)无改善.
CRISTAL研究显示,羟乙基淀粉组与生理盐水组比,两组间28d病死率(28.
00%比28.
19%;HR=0.
97,95%CI=0.
76~1.
25)、90d病死率(32.
00%比35.
37%;HR=0.
89,95%CI=0.
71~1.
11)无显著差异[38].
我们对以上RCT研究[33-39]进行Meta分析显示,羟乙基淀粉较其他复苏液体对脓毒症和脓毒性休克的病死率无改善.
Perner等[40]进行了一项平行对照、双盲随机、多中心研究,纳入804例严重脓毒症患者,在液体复苏时分别选用6%羟乙基淀粉130/0.
42和醋酸林格液,两组间6个月病死率(53.
3%比47.
5%;RR=1.
12,95%CI=0.
98~1.
29,P=0.
10)、1年病死率(56.
0%比51.
5%;RR=1.
09,95%CI=0.
96~1.
24,P=0.
20)无差异.
因此,脓毒症患者在液体复苏时选用羟乙基淀粉不能改善近期和远期生存率.
CHEST研究对近7000例ICU危重病患者进行研究发现,分别选用6%羟乙基淀粉130/0.
42和生理盐水进行复苏,羟乙基淀粉组患者对肾脏替代治疗(RRT)的需求较高(7.
0%比5.
8%;RR=1.
21,95%CI=1.
00~1.
45,P=0.
04),且肾损伤发生率更高(38.
0%比34.
6%,P=0.
005)[39].
Schortgen等[41]的一项多中心随机研究发现,严重脓毒症或脓毒性休克患者应用6%的羟乙基淀粉200/0.
60~0.
66较3%明胶液有较高的急性肾损伤(AKI)发生率(42%比23%,P=0.
028).
我们对6项RCT研究[33-36,39,41]进行Meta分析显示,羟乙基淀粉与晶体液相比,前者可增加脓毒症患者的AKI发生率及RRT的需求.
因此不建议使用羟乙基淀粉作为严重脓毒症或脓毒性休克的复苏液体.
推荐意见5:严重脓毒症和脓毒性休克患者液体复苏时可考虑应用白蛋白.
(2B)SAFE研究显示,严重脓毒症和脓毒性休克患者液体复苏时输注4%白蛋白很安全且效果与0.
9%生理盐水无显著差异(合并脑外伤患者除外,脑外伤亚组病死率:白蛋白组比晶体组为24.
5%比15.
1%;·405·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6RR=1.
62,95%CI=1.
12~2.
34,P=0.
009)[42].
Delaney等[43]对17项相关研究进行Meta分析显示,白蛋白可能降低脓毒症患者28d病死率(OR=0.
82,95%CI=0.
67~1.
00,P=0.
047).
一项纳入1818例严重脓毒症患者的多中心随机对照的ALBIOS研究显示,应用20%白蛋白联合晶体液进行液体复苏,患者28d病死率与仅用晶体液组比无显著差异(31.
8%比32.
0%;RR=1.
00,95%CI=0.
87~1.
14,P=0.
94),90d病死率、新器官衰竭发生率也差异无统计学意义,然而白蛋白联合晶体液组7d内的液体正平衡量明显低于仅用晶体液组,平均心率低于仅用晶体液组,MAP高于仅用晶体液组[44].
我们对CRISTAL研究(4%或20%白蛋白)、ALBIOS研究(20%白蛋白)、SAFE研究等5项RCT研究[30,37-38,42,44]进行Meta分析显示,应用白蛋白进行液体复苏并不会增加严重脓毒症和脓毒性休克患者28d病死率.
因此,严重脓毒症和脓毒性休克患者进行胶体复苏时可考虑应用白蛋白.
然而目前的结论显示,液体复苏时使用白蛋白并不能降低患者病死率,且由于其价格较为昂贵,建议医师在治疗时认真考虑患者病情、药品价格及供应情况等社会因素.
推荐意见6:液体复苏时可考虑使用限氯晶体液复苏.
(UG)研究发现,大量使用生理盐水或以其为溶媒的液体进行液体复苏将导致稀释性高氯性酸中毒的发生[45-46].
一项前瞻性、非盲、序贯试验对773例干预期(限氯液体治疗组,脓毒症患者55例)和760例对照期(不限氯液体治疗组,脓毒症患者75例;P=0.
08)的危重患者的研究发现,限氯液体治疗组患者平均肌酐(14.
8μmol/L)升高水平低于不限氯液体治疗组(22.
6μmol/L,P=0.
03),其肾脏损伤或衰竭的发生率明显低于不限氯液体治疗组(8.
4%比14%,P95次/min的脓毒性休克患者,采用去甲肾上腺素维持MAP≥65mmHg,其中77例受试者接受持续短效β受体阻滞剂(艾司洛尔),将患者在ICU期间的心率维持在80~94次/min;另77例受试者接受标准治疗;结果显示,艾司洛尔组所有患者均达到目标心率,治疗期间心率显著低于标准治疗组(P72h的粒细胞缺乏患者,抗菌药物的疗程需延长至>4周或至病灶愈合、症状消失[209].
推荐意见34:对流感病毒引起的严重脓毒症/脓毒性休克尽早开始抗病毒治疗.
(UG)一些观察性研究发现,对疑似或确诊流感、严重流感引起的脓毒症,早期应用抗病毒治疗有可能降低病死率[211-215].
常用抗病毒药物为神经氨酸酶抑制剂(奥司他韦或扎那米韦).
研究发现,双倍剂量的奥司他韦抗病毒治疗流感病毒引起的脓毒症未显示出优越性,建议应用常规剂量治疗[216].
但尚无相关的RCT研究.
推荐意见35:建议对可能有特定感染源(如坏死性软组织感染、腹腔感染、导管相关性血流感染)的脓毒症患者,应尽快明确其感染源,并尽快采取恰当的感染源控制措施.
(2C)研究结果提示,脓毒症感染源控制原则包括感染源的早期诊断和及时处理(特别是脓肿引流、感染坏死组织清创、处理可能感染的装置等)[217].
对可以通过手术或引流等方法清除的感染灶,包括:腹腔内脓肿、胃肠道穿孔、胆管炎、肾盂肾炎、肠缺血、坏死性软组织感染和其他深部间隙感染(如脓胸或严重的关节内感染),均应在复苏成功后尽快清除[218].
如考虑感染源为血管通路,应及时清除[219-220].
以上研究均为观察性研究,无相关的RCT研究.
机械通气推荐意见36:推荐对脓毒症诱发急性呼吸窘迫综合征(ARDS)患者进行机械通气时设定小VT(6mL/kg).
(1B)对ARDS患者应进行肺保护通气策略,设置较小的VT.
4项RCT的Meta分析显示,ARDS患者机械通气时设定较小的VT(6mL/kg比12mL/kg左右),可改善ICU病死率[221-224].
6项RCT的Meta分析显示,ARDS患者机械通气时设定较小的VT(6mL/kg比12mL/kg),可改善住院病死率[221-225].
更小的VT(如3mL/kg)可能减少呼吸机相关肺损伤,但对生存率的影响还有待进一步证实[226].
推荐意见37:建议测量ARDS患者的机械通气平台压,平台压的初始上限设定为30cmH2O以达到肺保护的目的.
(2B)一项Meta分析提示,对确诊ARDS患者采取限制气道压和VT的方法可以降低病死率[227].
一项回顾性研究显示,即使平台压≤30cmH2O也应降低VT[228],因为小VT会降低住院病死率[229].
推荐意见38:对脓毒症诱发ARDS的患者应使用PEEP防止肺泡塌陷.
(1C)·411·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6对ARDS患者提高PEEP可以保持肺单位处于开放状态,防止肺泡塌陷,有利于血气交换.
6项RCT的Meta分析显示,ARDS患者使用较高PEEP与较低PEEP比,不改善住院病死率,但可以改善ICU病死率[223,230-234].
对其中3项研究进行亚组Meta分析显示,中度或重度ARDS(PaO2/FiO2≤200mmHg)患者使用较高PEEP后,住院病死率也有所下降[223,233-234].
避免呼气末肺泡塌陷有助于在使用相对较高平台压时最大程度地降低呼吸机引起的肺损伤.
推荐意见39:建议对脓毒症诱发的中重度ARDS患者使用俯卧位通气,尤其适用于PaO2/FiO217h)的实施才可能获益.
同时,需注意避免致命的并发症,如气管插管和胸管意外脱出的发生.
推荐意见40:建议对脓毒症诱发的轻度ARDS试用无创通气(non-invasivventilation,NIV).
(2C)NIV避免了气管插管,可降低感染发生率,减少镇静用药.
4项RCT的Meta分析显示,与氧疗相比,NIV可降低ARDS患者30d住院病死率[244-247].
亚组的Meta分析显示,NIV可以改善轻度ARDS(200mmHg10mmol/L(>180mg/dL)〕的严重脓毒症患者,应控制血糖≤10mmol/L(≤180mg/dL),并建议采用规范化(程序化)血糖管理方案.
(1A)严重脓毒症患者连续两次血糖>10mmol/L(180mg/dL),应考虑高血糖.
既往多项研究提出,强化胰岛素治疗能减少感染发生率,降低病死率,尤其是外科ICU患者获益较多[321-322].
多项随机对照试验[323-327]及几项关于血糖控制范围的Meta分析[328-332]显示,强化胰岛素治疗〔3.
89~6.
11mmol/L(70~110mg/dL)〕与传统血糖控制〔10~11.
1mmol/L(180~200mg/dL)〕相比,并未降低外科、内科或综合ICU患者的病死率,反而增加了严重低血糖事件〔≤2.
2mmol/L(40mg/dL)〕的发生.
几项针对脓毒症和脓毒性休克的研究也同样得出上述结论[325-326,333-334].
近期对不同类型ICU患者的血糖控制目标进行Meta分析[310,321-323,325-327,335-341]显示,重症患者住院病死率及ICU病死率差异不大,而强化胰岛素组低血糖的发生率却明显增高,因此不推荐对重症患者采用强化胰岛素治疗.
鉴于目前尚无证据显示,将血糖控制在6.
11~7.
78mmol/L(110~140mg/dL)比7.
78~10mmol/L(140~180mg/dL)对预后有显著改善作用[342-344],建议血糖上限目标应≤10mmol/L(≤180mg/dL),各医疗单位应采用合适的规范化(程序化)血糖管理方案进行血糖管理.
推荐意见52:建议脓毒症/脓毒性休克患者每1~2h监测一次血糖,直至血糖和胰岛素用量稳定后可每4h监测一次.
(UG)2010年Holzinger等[344]对持续动态血糖监测(CGMS)的回顾性研究发现,CGMS的低血糖发生率仅是对照组(2h监测血糖)的1/7,但两组血糖低于6.
11mmol/L(110mg/dL)、8.
33mmol/L(150mg/dL)的发生率、平均血糖值、ICU住院时间及病死率等并无差异.
CGMS有助于降低低血糖事件发生,但不同皮下组织间液血糖浓度的差异、不同血糖测定仪、病理性肥胖等因素,均可能使测定的准确性下降,此外CGMS设备常使医疗花费增加.
多项关于强化胰岛素治疗的研究[322,324-326,335]阐述了初期血糖监测间隔多为每30min~1h或每1~2h,血糖相对平稳后每2~4h、每4~6h监测,但对此尚无较强的证据支持,尽管均是脓毒症患者,但其糖代谢状态并非相·414·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6同,具体监测间隔也应以具体病情为基础,在血流动力学不稳定和应用儿茶酚胺等情况下需注意低血糖的发生,多数患者1~2h的监测间隔应能满足血糖调整,又能避免低血糖的发生;血糖较稳定可延长监测时间,持续血糖监测应更有助于血糖的安全有效管理[344-349].
需注意可能影响床边末梢血糖快速检测准确性和可重复性的因素,包括仪器类型和型号、操作者间差异,以及患者的因素,如红细胞比容(贫血时假性升高)、动脉血氧分压(PaO2)和药物,尤其是高血压和使用儿茶酚胺的患者[350-351],必要时测血浆血糖水平.
连续性肾脏替代治疗(CRRT)推荐意见53:建议脓毒症合并肾衰竭的患者,如需RRT,应采用CRRT.
(2D)CRRT治疗适应证主要是两大类:一是重症患者并发肾损害,二是非肾脏疾病或肾损害的重症状态.
包括:急性肾衰竭、全身感染、SIRS(重症急性胰腺炎、创伤)、心脏手术后、重度血钠异常、顽固性心力衰竭、横纹肌溶解、中毒等.
CRRT与间歇性肾脏替代治疗(IRRT):近年有9项研究未发现何种RRT模式更为有利.
一项回顾性队列研究认为,CRRT相对间歇性血液透析而言,前者进展为慢性透析的可能性较小[352].
一项前瞻性随机对照试验纳入了104例ICU患者,比较了间歇性血液透析(3~4h一次,每日1次)与CRRT(18~35mL·kg-1·h-1)对远期预后的影响,结果显示,两者28d生存率及总生存率未见明显差异.
该研究认为,两种方法互补:间歇性血液透析适合于快速电解质和废物清除,CRRT适合于高热量需求和血流动力学不稳定者[353].
美国一项多中心前瞻性RCT研究认为,CRRT与IRRT对ICU内AKI患者的结局无明显影响[354].
法国21个医疗中心、跨学科的ICU内多器官功能障碍综合征(MODS)患者(包含63%脓毒症患者)的前瞻性随机试验发现,间歇性血液透析组与连续性静脉-静脉血液透析滤过组28、60、90d生存率及RRT时间、ICU住院时间、总住院时间均无明显差异[355].
两项关于CRRT与延长的IRRT的研究认为,延长的IRRT与CRRT同样安全、有效,并未增加病死率[356-357].
一项研究比较了CRRT和IRRT结果显示,两种方法的住院病死率及总住院病死率、肾功能恢复、住院时间均无明显差异,但CRRT对血流动力学稳定有较好的耐受性[358-359].
另外两项包括部分脓毒症患者的研究未发现何种RRT模式更有利[360-361].
CRRT的时机:法国12个ICU的80例患者的前瞻性随机、多中心研究认为,严重脓毒症/脓毒性休克患者早期使用CRRT是有害的[362].
美国一项多中心观察性研究(PICARD)认为,尿素氮〔>4.
22mmol/L(>76mg/dL)〕较高时再行RRT生存率将降低[363].
来自23个ICU的观察性队列研究(RENAL)发现,早期〔达到RIFLE-I(急性肾损伤的诊断和分级标准1期)到CRRT的时间间隔〕应用CRRT并未提高28d及90d生存率[364].
有研究认为,早期使用2L/h的持续性静脉-静脉血液滤过(CVVH)并不能减少脓毒症相关的炎性介质,如白细胞介素(IL-6、IL-8、IL-10)、肿瘤坏死因子-α(TNF-α),也不能改善脓毒症引起的器官功能障碍.
对无严重急性肾衰竭的MODS患者不建议行CVVH治疗[365].
推荐意见54:不建议使用高容量血液滤过治疗脓毒症合并AKI.
(2B)有关RRT的剂量,我们对5项针对脓毒症或脓毒症为亚组的RCT进行Meta分析显示,标准容量血液滤过组(≤35mL·kg-1·h-1)与高容量血液滤过组(>35mL·kg-1·h-1)相比,两组病死率无明显差异,死亡相对风险为0.
73(95%CI=0.
46~1.
16)[366-370].
2013年发表的研究显示[371],无充分证据推荐对脓毒症/脓毒性休克患者进行高容量血液滤过治疗,需要进行更大的多中心及相关结局资料的研究.
2014年发表的高容量血液滤过对脓毒症引起AKI治疗效果的Meta分析显示[372],无充分证据支持对脓毒症引起的AKI患者进行常规高容量血液滤过治疗有益处.
关于标准容量血液滤过(≤35mL·kg-1·h-1),有2项RCT研究比较了相对高剂量血液滤过组(35mL·kg-1·h-1)和相对低剂量血液滤过组(20mL·kg-1·h-1),结果显示,两组重症患者病死率无差异.
其中一项大规模多中心随机对照试验(含63%脓毒症患者)比较了强化RRT组(35mL·kg-1·h-1,每周6次)和低强化RRT组(20mL·kg-1·h-1,每周2次),结果显示,两组重症患者60d病死率无差异(RR=1.
19,95%CI=0.
88~1.
62)[373].
另一项包含了54%脓毒症患者的随机对照研究结果显示,标准容量血液滤过组(20mL·kg-1·h-1)与高容量血液滤过组(35mL·kg-1·h-1)的连续性静脉-静脉血液透析滤过治疗对ICU住院时间和30d生存率无明显差异[374].
·415·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6对高容量血液滤过(>35mL·kg-1·h-1),有3项研究认为更高剂量的血液滤过对脓毒症预后无益处.
一项前瞻性随机多中心IVOIRE研究,包含18个ICU的140例严重脓毒症合并AKI的患者,比较了35mL·kg-1·h-1血液滤过与70mL·kg-1·h-1血液滤过的结果显示,两者28、60、90d病死率均无明显差异[375].
一项针对280例脓毒症合并AKI患者的单中心随机临床试验,比较了特大容量血液滤过(85mL·kg-1·h-1)与大容量血液滤过(50mL·kg-1·h-1)的结果显示,两者对28d、90d病死率无明显差异[376].
一项小规模(33例)随机对照试验显示,高容量血液滤过(100mL·kg-1·h-1)与相对低容量血液滤过(35mL·kg-1·h-1)治疗脓毒症患者6h,两者60d生存率无差异,但发现早期高容量血液滤过有利于清除血浆中某些炎性介质,如IL-6等,20d时炎性介质则无明显差异[377].
有2项研究显示,高容量血液滤过可减少血管活性药物的使用;其中一项单中心随机对照研究(43例)比较了高容量血液滤过(65mL·kg-1·h-1)与高容量血液滤过(35mL·kg-1·h-1)的结果显示,前者可增加尿量,减少血管活性药物,但两者病死率无差异,由于该方案不是盲法,尚需大规模试验证实[366].
另一项单中心随机交叉试验(11例),比较了高容量血液滤过(6L/h)与标准容量血液滤过(1L/h)治疗脓毒性休克患者8h的结果显示,高容量血液滤过能明显减少去甲肾上腺素用量(10.
5μg/min降至1.
0μg/min),但该研究未比较病死率的情况[378].
糖皮质激素推荐意见55:不推荐常规使用糖皮质激素治疗脓毒性休克.
(1B)糖皮质激素应用于治疗肾上腺皮质功能不全,但低剂量糖皮质激素是否预防重症患者严重感染和脓毒性休克的发生目前尚无定论.
对低剂量糖皮质激素治疗脓毒性休克,我们对15项RCT进行Meta分析发现,糖皮质激素组(1058例,死亡353例)和安慰剂组(1032例,死亡359例)病死率无显著差异,糖皮质激素不能降低病死率(RR=0.
96,95%CI=0.
86~1.
07,P=0.
44)[379-393].
其中一项RCT为欧洲一项大规模多中心试验(CORTICUS),选取了无持续休克、死亡风险较低的严重脓毒症患者,且不考虑血压对血管活性药物是否敏感,结果显示,糖皮质激素未降低病死率[389].
有研究认为,糖皮质激素会引起休克复发、消化道出血的可能性[379].
两项回顾性研究[394-395]及两项小规模RCT[388,396]证实了使用低剂量糖皮质激素可缩短使用血管活性药物的时间.
英国一项大规模随机双盲对照试验提示,糖皮质激素可缩短住院时间,但不会影响病死率[393].
德国的双盲随机对照交叉试验选择了有血管活性药物依赖的脓毒性休克患者,结果显示,氢化可的松可使血流动力学恢复稳定,并减少肾上腺素用量[397].
德国的前瞻性随机双盲对照试验显示,应激剂量的氢化可的松可降低脓毒性休克患者创伤后应激障碍的发生率,但未减少去甲肾上腺素的用量,格拉斯哥昏迷评分(GCS)无改善[398].
应激性溃疡推荐意见56:建议使用H2受体拮抗剂(H2RA)或质子泵抑制剂(PPI)预防有出血危险因素的严重脓毒症患者发生应激性溃疡.
(2B)在包括20%~25%的脓毒症的ICU住院患者中开展的多项研究证实了,应激性溃疡的预防可减少上消化道出血的发生率[399-402].
这种获益同样适用于严重脓毒症和脓毒性休克患者.
3项Meta分析显示,应激性溃疡的预防虽然未被证实可降低病死率,但可减少上消化道出血的风险[403-405],我们对21项RCT进行Meta分析显示,预防性应用PPI/H2RA能减少上消化道出血[406-426].
一项包含13项比较预防性使用PPI/H2RA的医院获得性肺炎风险RCT的Meta分析显示,预防性使用PPI/H2RA可增加院内获得性肺炎的发生[407-428],对病死率却未见明显改善[407-415,419-422].
推荐意见57:应激性溃疡的预防,建议优先使用PPI.
(2C)Meta分析证据表明,PPI较H2RA能更有效地预防上消化道出血[405,428-430],而对住院时间及院内获得性肺炎的发生率、病死率无明显差异.
预防上消化道出血的同时,需警惕因胃内pH值升高而致感染风险增加的可能.
加拿大的一项系统性评价表明,抑酸剂与肠源性感染的增加有关,尚需进一步研究其是否有因果关系[427].
美国一项系统性回顾研究亦表明,应用PPI可增加肠源性细菌感染的易感性[431].
美国一项Meta分析和德国一项回顾性观察研究发现,ICU患者PPI与难辨艰难梭菌感染(CDI)的发生可能有关联,PPI是难辨梭菌相关性疾病的独立危险因素,这一危险因素在抗菌药物与PPI联合用药时危险性增加[432-433].
·416·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
6中医中药治疗脓毒症属于祖国医学"外感热病""脱证""血证""暴喘""神昏""脏竭症"等范畴.
其发生主要由于素体正气不足,外邪入侵,入里化热,耗气伤阴;正气虚弱,毒邪内陷,络脉气血运行不畅,导致毒热、瘀血、痰浊内阻,瘀阻脉络,进而令各脏器受邪而损伤,引发本病.
脓毒症治疗的要旨是在脓毒症初期阶段即截断其病势,防止向严重脓毒症方向发展,这与《黄帝内经》提出的"治未病"理论不谋而合.
目前临床多分为"四证四法":毒热证与清热解毒法、腑气不通证与通里攻下法、血瘀证与活血化瘀法、急性虚证与扶正固本法.
其中热证又分热邪之轻重、病位之浅深、病势之缓急,并结合具体脏腑进行分型治疗;瘀证分病情轻重、虚证分阴虚阳虚分别予以不同治疗.
1辨证施治1.
1清热解毒法:症见高热持续不退,烦躁,神昏,恶心呕吐,舌质红绛,脉数等.
临床常用清热解毒中药及热毒清、热毒平、清瘟败毒饮、清气凉营汤、黄连解毒汤、凉膈散等清热解毒的方药治疗.
中成药有清开灵、醒脑静注射液等[434].
1.
2通腑泻下法:症见腹胀,呕吐,无排便排气,肠鸣音减弱或消失,舌苔黄腻,脉弦等.
代表方大承气汤能显著降低MODS患者病死率,用于脓毒症的治疗可减少炎性介质的产生、抑制炎症反应、调节免疫功能,同时还具有抗菌作用[435].
1.
3活血化瘀法:症见高热,或神昏,或疼痛状如针刺刀割,痛处固定不移,常于夜间加重,肿块,出血,舌质紫暗或有瘀斑,脉沉迟或沉弦等.
常予以红花、赤芍、川芎、当归、丹参等活血化瘀中药及血府逐瘀汤等方药治疗.
中成药以复方丹参注射液和血必净注射液为代表,而血必净治疗脓毒症显示出一定的疗效特点,但缺乏严格的循证医学证据证实其疗效、安全性和作用机制,应开展进一步深入研究[436-437].
1.
4扶正固脱法:阴脱症见意识恍惚或烦躁不安,面色潮红,两眶内陷,皮肤皱褶,身热心烦,口渴欲饮,少尿或无尿,舌红干燥,脉细数等,临床常用生脉注射液[438]或参麦注射液以益气养阴固脱;阳脱症见冷汗淋漓,四肢逆冷,忽尔昏愦,面赤唇紫,口开目闭,手撒遗尿,舌淡或紫,脉微欲绝或散大无根等,临床常用参附注射液以益气温阳固脱.
阴阳俱脱而症见急病重病,突然大汗不止或汗出如油,精神疲惫不支,声短息微,遗尿失禁,舌卷少津,脉微细欲绝或脉大无力等,可联用生脉注射液、参麦注射液及参附注射液.
2单味药2.
1大黄:单味生大黄可治疗严重脓毒症,具有促进胃肠蠕动、保护肠道黏膜、促进内毒素排出、减少细菌及毒素移位及抗炎抑菌作用[439-440],对MODS有显著的预防治疗作用,能提高累及4个以上脏器MODS的存活率[441].
2.
2丹参:丹参的水溶性成分具有良好的抗血栓形成和改善循环作用,从而减轻脏器功能的损害.
体外实验发现丹参有肯定拮抗脂多糖(LPS)作用,其对肺的保护作用可能是通过抑制或减少TNF-α等细胞因子在血及肺组织中的表达,减轻了由此介导的肺部急性炎症反应.
2.
3人参:诸多实验研究证实[442],人参多种有效成分对内毒素结构的直接破坏作用不明显,但对其引起的发热、白细胞骤降及休克、死亡均有较强的拮抗和防护效果.
近年来动物实验显示,一些单味中药及提取物如黄芪、丹参、银杏叶制剂、雷公藤提取物、三七总皂苷、黄芩提取物等,可减轻组织或器官的炎性损伤.
3针灸电针足三里穴具有抗炎和减轻脏器损伤的作用,可降低脓毒症胃肠功能障碍患者的腹腔压力,改善胃液潴留,促进胃肠蠕动.
中医药治疗脓毒症尚存在一些问题与不足,主要是现有文献报道多限于简单的疗效观察,缺乏前瞻性、大样本、多中心RCT资料的支持.
研究结果虽然有疗效,但对其产生疗效的机制认识的并不太清楚,结果可信度不高,尚需进一步研究.
中华医学会重症医学分会指南制定专家组成员(按姓氏笔划排序):于凯江(哈尔滨医科大学附属肿瘤医院);马晓春(中国医科大学附属第一医院);王春亭(山东省立医院);艾宇航(中南大学湘雅医院);刘大为(北京协和医院);安友仲(北京大学人民医院);许媛(首都医科大学附属北京同仁医院);严静(浙江医院);李建国(武汉大学中南医院);李维勤(南京军区南京总医院);邱海波(东南大学附属中大医院);何振扬(海南省人民医院);宋青(解放军总医院);陈德昌(上海长征医院);周发春(重庆医科大学附属第一医院);胡振杰(河北医科大学第四医院);秦英智(天津市第三中心医院);钱传云(昆明医学院第一附属医院);徐磊(天津市第三中心医院);席修明(首都医科大学附属复兴医院);黄青青(昆明医学院第二附属医院);曹相原(宁夏医科大学总医院);康焰(四川大学华西医院);管向东(中山大学附属第一医院);黎毅敏(广州医学院第一附属医院)中华医学会重症医学分会指南制定工作组成员:蔡国龙(浙江医院重症医学科);陈进(浙江医院重症医学科);虞意华(浙江医院重症医学科);胡才宝(浙江医院重症医学科);蔡洪流(浙江大学医学院附属第一医院重症医学科);李立斌(浙江大学医学院附属第二医院重症医学科);蔡华波(浙江大学附属邵逸夫医院重症医学科);李茜(浙江省人民医院重症医学科);王灵聪(浙江省中医药大学附属第一医院重症医学科);童洪杰(浙江省中医药大学);郝雪景(浙江省中医药大学);沈毅(浙江大学公共卫生学院)·417·中华危重病急救医学2015年6月第27卷第6期ChinCritCareMed,June2015,Vol.
27,No.
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(收稿日期:2015-04-07)(本文编辑:李银平)