Lewis Sharon R, Pritchard Michael W, Evans David Jw, Butler Andrew R, Alderson Phil, Smith Andrew F, Roberts Ian
Lancaster Patient Safety Research Unit, Royal Lancaster Infirmary, Pointer Court 1, Ashton Road, Lancaster, UK, LA1 4RP.
Cochrane Database Syst Rev. 2018 Aug 3;8(8):CD000567. doi: 10.1002/14651858.CD000567.pub7.
Critically ill people may lose fluid because of serious conditions, infections (e.g. sepsis), trauma, or burns, and need additional fluids urgently to prevent dehydration or kidney failure. Colloid or crystalloid solutions may be used for this purpose. Crystalloids have small molecules, are cheap, easy to use, and provide immediate fluid resuscitation, but may increase oedema. Colloids have larger molecules, cost more, and may provide swifter volume expansion in the intravascular space, but may induce allergic reactions, blood clotting disorders, and kidney failure. This is an update of a Cochrane Review last published in 2013.
To assess the effect of using colloids versus crystalloids in critically ill people requiring fluid volume replacement on mortality, need for blood transfusion or renal replacement therapy (RRT), and adverse events (specifically: allergic reactions, itching, rashes).
We searched CENTRAL, MEDLINE, Embase and two other databases on 23 February 2018. We also searched clinical trials registers.
We included randomised controlled trials (RCTs) and quasi-RCTs of critically ill people who required fluid volume replacement in hospital or emergency out-of-hospital settings. Participants had trauma, burns, or medical conditions such as sepsis. We excluded neonates, elective surgery and caesarean section. We compared a colloid (suspended in any crystalloid solution) versus a crystalloid (isotonic or hypertonic).
Independently, two review authors assessed studies for inclusion, extracted data, assessed risk of bias, and synthesised findings. We assessed the certainty of evidence with GRADE.
We included 69 studies (65 RCTs, 4 quasi-RCTs) with 30,020 participants. Twenty-eight studied starch solutions, 20 dextrans, seven gelatins, and 22 albumin or fresh frozen plasma (FFP); each type of colloid was compared to crystalloids.Participants had a range of conditions typical of critical illness. Ten studies were in out-of-hospital settings. We noted risk of selection bias in some studies, and, as most studies were not prospectively registered, risk of selective outcome reporting. Fourteen studies included participants in the crystalloid group who received or may have received colloids, which might have influenced results.We compared four types of colloid (i.e. starches; dextrans; gelatins; and albumin or FFP) versus crystalloids.Starches versus crystalloidsWe found moderate-certainty evidence that there is probably little or no difference between using starches or crystalloids in mortality at: end of follow-up (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.86 to 1.09; 11,177 participants; 24 studies); within 90 days (RR 1.01, 95% CI 0.90 to 1.14; 10,415 participants; 15 studies); or within 30 days (RR 0.99, 95% CI 0.90 to 1.09; 10,135 participants; 11 studies).We found moderate-certainty evidence that starches probably slightly increase the need for blood transfusion (RR 1.19, 95% CI 1.02 to 1.39; 1917 participants; 8 studies), and RRT (RR 1.30, 95% CI 1.14 to 1.48; 8527 participants; 9 studies). Very low-certainty evidence means we are uncertain whether either fluid affected adverse events: we found little or no difference in allergic reactions (RR 2.59, 95% CI 0.27 to 24.91; 7757 participants; 3 studies), fewer incidences of itching with crystalloids (RR 1.38, 95% CI 1.05 to 1.82; 6946 participants; 2 studies), and fewer incidences of rashes with crystalloids (RR 1.61, 95% CI 0.90 to 2.89; 7007 participants; 2 studies).Dextrans versus crystalloidsWe found moderate-certainty evidence that there is probably little or no difference between using dextrans or crystalloids in mortality at: end of follow-up (RR 0.99, 95% CI 0.88 to 1.11; 4736 participants; 19 studies); or within 90 days or 30 days (RR 0.99, 95% CI 0.87 to 1.12; 3353 participants; 10 studies). We are uncertain whether dextrans or crystalloids reduce the need for blood transfusion, as we found little or no difference in blood transfusions (RR 0.92, 95% CI 0.77 to 1.10; 1272 participants, 3 studies; very low-certainty evidence). We found little or no difference in allergic reactions (RR 6.00, 95% CI 0.25 to 144.93; 739 participants; 4 studies; very low-certainty evidence). No studies measured RRT.Gelatins versus crystalloidsWe found low-certainty evidence that there may be little or no difference between gelatins or crystalloids in mortality: at end of follow-up (RR 0.89, 95% CI 0.74 to 1.08; 1698 participants; 6 studies); within 90 days (RR 0.89, 95% CI 0.73 to 1.09; 1388 participants; 1 study); or within 30 days (RR 0.92, 95% CI 0.74 to 1.16; 1388 participants; 1 study). Evidence for blood transfusion was very low certainty (3 studies), with a low event rate or data not reported by intervention. Data for RRT were not reported separately for gelatins (1 study). We found little or no difference between groups in allergic reactions (very low-certainty evidence).Albumin or FFP versus crystalloidsWe found moderate-certainty evidence that there is probably little or no difference between using albumin or FFP or using crystalloids in mortality at: end of follow-up (RR 0.98, 95% CI 0.92 to 1.06; 13,047 participants; 20 studies); within 90 days (RR 0.98, 95% CI 0.92 to 1.04; 12,492 participants; 10 studies); or within 30 days (RR 0.99, 95% CI 0.93 to 1.06; 12,506 participants; 10 studies). We are uncertain whether either fluid type reduces need for blood transfusion (RR 1.31, 95% CI 0.95 to 1.80; 290 participants; 3 studies; very low-certainty evidence). Using albumin or FFP versus crystalloids may make little or no difference to the need for RRT (RR 1.11, 95% CI 0.96 to 1.27; 3028 participants; 2 studies; very low-certainty evidence), or in allergic reactions (RR 0.75, 95% CI 0.17 to 3.33; 2097 participants, 1 study; very low-certainty evidence).
AUTHORS' CONCLUSIONS: Using starches, dextrans, albumin or FFP (moderate-certainty evidence), or gelatins (low-certainty evidence), versus crystalloids probably makes little or no difference to mortality. Starches probably slightly increase the need for blood transfusion and RRT (moderate-certainty evidence), and albumin or FFP may make little or no difference to the need for renal replacement therapy (low-certainty evidence). Evidence for blood transfusions for dextrans, and albumin or FFP, is uncertain. Similarly, evidence for adverse events is uncertain. Certainty of evidence may improve with inclusion of three ongoing studies and seven studies awaiting classification, in future updates.
危重症患者可能因严重疾病、感染(如脓毒症)、创伤或烧伤而流失体液,急需补充额外的液体以预防脱水或肾衰竭。为此可使用胶体溶液或晶体溶液。晶体溶液分子小,价格便宜,使用方便,能立即实现液体复苏,但可能会加重水肿。胶体溶液分子大,成本更高,可能能更快地使血管内空间扩容,但可能引发过敏反应、凝血障碍和肾衰竭。这是Cochrane系统评价的更新版,该评价上次发表于2013年。
评估在需要补液的危重症患者中,使用胶体溶液与晶体溶液相比,对死亡率、输血需求或肾脏替代治疗(RRT)需求以及不良事件(具体为:过敏反应、瘙痒、皮疹)的影响。
我们于2018年2月23日检索了Cochrane中心对照试验注册库(CENTRAL)、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(Embase)以及另外两个数据库。我们还检索了临床试验注册库。
我们纳入了在医院或院外急救环境中需要补液的危重症患者的随机对照试验(RCT)和半随机对照试验(quasi - RCT)。参与者患有创伤、烧伤或脓毒症等疾病。我们排除了新生儿、择期手术和剖宫产。我们比较了一种胶体溶液(悬浮于任何晶体溶液中)与一种晶体溶液(等渗或高渗)。
两名综述作者独立评估研究是否符合纳入标准、提取数据、评估偏倚风险并汇总研究结果。我们使用GRADE评估证据的确定性。
我们纳入了69项研究(65项RCT,4项quasi - RCT),共30,020名参与者。28项研究涉及淀粉溶液,20项涉及右旋糖酐,7项涉及明胶,22项涉及白蛋白或新鲜冰冻血浆(FFP);每种胶体溶液都与晶体溶液进行了比较。参与者患有一系列典型的危重症疾病。10项研究是在院外环境中进行的。我们注意到一些研究存在选择偏倚风险,并且由于大多数研究未进行前瞻性注册,存在选择性报告结果的风险。14项研究中,晶体溶液组的参与者接受了或可能接受了胶体溶液,这可能影响了结果。
我们比较了四种胶体溶液(即淀粉、右旋糖酐、明胶以及白蛋白或FFP)与晶体溶液。
我们发现中等确定性的证据表明,在随访结束时(风险比(RR)0.97,95%置信区间(CI)0.86至1.09;11,177名参与者;24项研究)、90天内(RR 1.01,95% CI 0.90至1.14;10,415名参与者;15项研究)或30天内(RR 0.99,95% CI 0.90至1.09;10,135名参与者;11项研究),使用淀粉溶液或晶体溶液在死亡率方面可能几乎没有差异。
我们发现中等确定性的证据表明,淀粉溶液可能会略微增加输血需求(RR 1.19,95% CI 1.02至1.39;1917名参与者;8项研究)和RRT需求(RR 1.30,95% CI 1.14至1.48;8527名参与者;9项研究)。极低确定性的证据意味着我们不确定两种液体对不良事件的影响:我们发现过敏反应方面几乎没有差异(RR 2.59,95% CI 0.27至24.91;7757名参与者;3项研究),晶体溶液引起的瘙痒发生率更低(RR 1.38,95% CI 1.05至1.82;6946名参与者;2项研究),晶体溶液引起的皮疹发生率更低(RR 1.61,95% CI 0.90至2.89;7007名参与者;2项研究)。
我们发现中等确定性的证据表明,在随访结束时(RR 0.99,95% CI 0.88至1.11;4736名参与者;19项研究)、90天内或30天内(RR 0.99,95% CI 0.87至1.12;3353名参与者;10项研究),使用右旋糖酐或晶体溶液在死亡率方面可能几乎没有差异。我们不确定右旋糖酐或晶体溶液是否能减少输血需求,因为我们发现输血方面几乎没有差异(RR 0.92,95% CI 0.77至1.10;1272名参与者,3项研究;极低确定性证据)。我们发现过敏反应方面几乎没有差异(RR 6.00,95% CI 0.25至144.93;739名参与者;4项研究;极低确定性证据)。没有研究测量RRT。
我们发现低确定性的证据表明,在随访结束时(RR 0.89,95% CI 0.74至1.08;1698名参与者;6项研究)、90天内(RR 0.89,95% CI 0.73至1.09;1388名参与者;1项研究)或30天内(RR 0.92,95% CI 0.74至1.16;1388名参与者;1项研究),使用明胶或晶体溶液在死亡率方面可能几乎没有差异。输血方面的证据确定性极低(3项研究),事件发生率低或未按干预措施报告数据。明胶的RRT数据未单独报告(1项研究)。我们发现两组在过敏反应方面几乎没有差异(极低确定性证据)。
白蛋白或FFP与晶体溶液:我们发现中等确定性的证据表明,在随访结束时(RR 0.98,95% CI 从0.92至1.06;13,047名参与者;20项研究)、90天内(RR 0.98,95% CI 0.92至1.04;12,492名参与者;10项研究)或30天内(RR 0.99,95% CI 0.93至1.06;12,506名参与者;10项研究),使用白蛋白或FFP与使用晶体溶液在死亡率方面可能几乎没有差异。我们不确定两种液体类型是否能减少输血需求(RR 1.31,95% CI 0.95至1.80;290名参与者;3项研究;极低确定性证据)。使用白蛋白或FFP与晶体溶液相比,对RRT需求(RR 1.11,95% CI 0.96至1.27;3028名参与者;2项研究;极低确定性证据)或过敏反应(RR 0.75,95% CI 0.17至3.33;2097名参与者,1项研究;极低确定性证据)可能几乎没有差异。
使用淀粉、右旋糖酐、白蛋白或FFP(中等确定性证据)或明胶(低确定性证据)与晶体溶液相比,对死亡率可能几乎没有差异。淀粉可能会略微增加输血和RRT需求(中等确定性证据),白蛋白或FFP对肾脏替代治疗需求可能几乎没有差异(低确定性证据)。右旋糖酐以及白蛋白或FFP在输血方面的证据不确定。同样,不良事件方面的证据也不确定。在未来更新中纳入三项正在进行的研究和七项等待分类的研究后,证据的确定性可能会提高。