少量出血患者使用术中回收式自体输血临床意义的随机对照研究
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摘要
目的：随着我国医学技术的不断发展,手术量及用血量不断攀升。鉴于同种异体输血的并发症问题和血源紧张现状,我国提倡使用自体输血。术中回收式自体输血多采用Cell Saver设备(CS),已在多种手术中有着广泛的应用。但是,国内外指南在何种程度的出血量建议使用CS存在差异,临床实际应用与指南建议也不一致。本研究拟在少量出血手术(出血量<20%按公斤体重计算的血容量)的患者中比较回输CS自体血和不回输CS自体血对患者造成的影响,评估回输CS自体血在此类患者中能否改善组织灌注,是否对体内炎症水平产生影响,以及能否改善患者术后恢复情况,探讨在少量出血手术应用CS是否合理。
方法：选择北京协和医院因严重腰椎间盘突出、腰椎管狭窄或腰椎滑脱拟行腰椎后路手术的患者。入选标准：年龄18-75岁,ASA Ⅰ-Ⅱ级,预计手术出血量<20%血容量。排除标准：术前贫血、严重心脑血管疾病、免疫系统疾病、感染性疾病、3个月内有手术史或输血史。按随机数字表将患者随机分为两组,回输组在手术结束前输注CS自体血；对照组不予回输CS自体血,以等量胶体液代替。采血点为手术诱导前、术中主要步骤结束时、术后半小时、术后1天和术后3天。检测项目有全血细胞分析、静脉血气、脑氧饱和度及炎症因子(白细胞介素6、白细胞介素10及中性粒细胞弹性蛋白酶)。随访两组患者术后体温、引流量、VAS评分、不适主诉(头晕/乏力/心悸)、切口愈合、开始下地时间及术后住院时间。
结果：共有41例患者参与本研究,1例因术中失血过多(>1000m1),1例因术中测Hb<90g/L,1例因缺失采血点过多剔除。余下38例患者被随机分为回输组(n=19)及对照组(n=19),两组在人口特征、基线资料及术中出血量无统计学差异。回输组的术后半小时血红蛋白为116.5±10.7g/L,术后1天为115.4±12.3g/L,均高于术中的106.6±12.6g/L(P<0.05),但术后3天的血红蛋白与术中无统计学差异。对照组术后半小时乳酸为2.5±1.0mmol/L,高于术前的1.3±0.6mmol/L(P<0.05).术后1天对照组的IL-6较术前升高(151.2±73.7ng/L和141.0±94.6ng/L,P<0.05),而回输组无此变化。术后3天回输组的IL-10较术前升高(338.5±137.3ng/L和326.2±134.1ng/L,P<0.05),而对照组无此变化。术后血红蛋白、血乳酸、脑氧饱和度、白细胞及炎症因子在两组间无统计学差异。回输组异体输血率为5.3%,对照组异体输血率为0。两组在术后发热、术后疼痛、不适主诉、切口愈合、开始下地时间及术后住院时间方面无统计学差异。
结论：健康成人患者少量出血手术应用CS对血红蛋白及组织灌注的改善有限,对炎症及异体输血率无显著影响,亦不能改善患者预后,且增加患者医疗费用,建议谨慎使用。
Objectives:The volume of blood used for transfusion in China continues to soar as a result of the increasing amount of surgery. Because of the shortage of blood products and the complications of allogeneic transfusion, autologous transfusion has been advocated in China. Cell Salvage devices for intraoperative autotransfusion, such as Cell Saver (CS), is commonly used in a wide variety of surgical procedures. However, the CS indications suggested in domestic and international guidelines are inconsistent in the extent of surgery bleeding, and doctors tend to prepare CS when less blood loss is anticipated. To investigate the effect of cell saver blood in patients undergoing mild-bleeding surgery (defined as blood loss less than20%estimated blood volume based on body weight) compared with non-CS transfusion patients. Tissue perfusion, in vivo inflammatory level and postoperative recovery were studied to determine whether the CS transfusion is reasonable in this setting.
Methods:Our study comprised patients scheduled for posterior lumbar surgery at Peking Union Medical College Hospital. Inclusion criteria were defined as follows:age of18-75years, ASA I or II, estimated blood loss less than20%blood volume. Exclusion criteria included preoperative anemia, severe cardiovascular or cerebrovascular disease, immune disorder, infectious disease, and a history of surgery or transfusion within3months. Patients were randomized into two groups according to computer-generated random table numbers. The transfusion group was given the Cell Saver blood intraoperatively, while the control group received equal volume of colloid solution instead. Blood samples were obtained at:before induction of anesthesia, the end of the main steps in the surgery, half an hour,1day and3days after surgery. The parameters including complete blood count, venous blood gas, cerebral oxygenation, and inflammatory factors (lnterleukin-6, lnterleukin-10and neutrophil elastase) were compared between the two groups, together with the postoperative recovery such as post-op body temperature, drainage, VAS pain scores, chief complaint (dizziness, fatigue or palpitation), wound healing, post-op ambulation time, complication and length of stay.
Results:41patients scheduled for elective lumbar surgery were enrolled with all their informed consent.3cases were excluded for intraoperative massive bleeding (>1000ml), intraoperative Hb<90g/L and multiple missing data. The remaining38cases were randomized into the transfusion group (n=19) and the control group (n=19). The two groups were comparable in demographic data, baseline conditions and intraoperative blood loss. In the transfusion group, Hemoglobin was116.5±10.7g/L at post-op1/2hr and115.4±12.3g/L on post-op day1, both elevated compared with intra-op (106.6±12.6g/L, P<0.05). On post-op day3, the statistical differences of hemoglobin no longer existed. Lactate was elevated at post-op1/2hour (2.5±1.0mmol/L) versus pre-op values (1.3±0.6mmol/L)(P<0.05) in the control group, while the trend was absent in the transfusion group. IL-6on post-op day1was elevated than pre-op only in the control group (151.2±73.7ng/L vs.141.0±94.6ng/L, P<0.05).11-10on post-op day3was elevated than pre-op only in the transfusion group (338.5±137.3ng/L vs.326.2±134.1ng/L, P<0.05). There were no significant differences in postoperative hemoglobin, lactate, cerebral oxygenation, white blood cells and inflammatory factors between the two groups. The allogeneic transfusion rates of the control group and the transfusion group were0and5.3%respectively. No statistically differences were observed in fever, pain, chief complaint, wound healing, post-op ambulation time or length of stay between the two groups.
Conclusions:The use of CS in healthy adult patients undergoing mild-bleeding surgery only temporarily improved hemoglobin and tissue oxygenation, with little influence on inflammation and allogeneic transfusion rate, as well as prognosis amelioration. CS may be not cost-effective under this circumstance. The application of CS should be considered with caution when mild blood loss is anticipated in our research setting.
方法：选择北京协和医院因严重腰椎间盘突出、腰椎管狭窄或腰椎滑脱拟行腰椎后路手术的患者。入选标准：年龄18-75岁,ASA Ⅰ-Ⅱ级,预计手术出血量<20%血容量。排除标准：术前贫血、严重心脑血管疾病、免疫系统疾病、感染性疾病、3个月内有手术史或输血史。按随机数字表将患者随机分为两组,回输组在手术结束前输注CS自体血；对照组不予回输CS自体血,以等量胶体液代替。采血点为手术诱导前、术中主要步骤结束时、术后半小时、术后1天和术后3天。检测项目有全血细胞分析、静脉血气、脑氧饱和度及炎症因子(白细胞介素6、白细胞介素10及中性粒细胞弹性蛋白酶)。随访两组患者术后体温、引流量、VAS评分、不适主诉(头晕/乏力/心悸)、切口愈合、开始下地时间及术后住院时间。
结果：共有41例患者参与本研究,1例因术中失血过多(>1000m1),1例因术中测Hb<90g/L,1例因缺失采血点过多剔除。余下38例患者被随机分为回输组(n=19)及对照组(n=19),两组在人口特征、基线资料及术中出血量无统计学差异。回输组的术后半小时血红蛋白为116.5±10.7g/L,术后1天为115.4±12.3g/L,均高于术中的106.6±12.6g/L(P<0.05),但术后3天的血红蛋白与术中无统计学差异。对照组术后半小时乳酸为2.5±1.0mmol/L,高于术前的1.3±0.6mmol/L(P<0.05).术后1天对照组的IL-6较术前升高(151.2±73.7ng/L和141.0±94.6ng/L,P<0.05),而回输组无此变化。术后3天回输组的IL-10较术前升高(338.5±137.3ng/L和326.2±134.1ng/L,P<0.05),而对照组无此变化。术后血红蛋白、血乳酸、脑氧饱和度、白细胞及炎症因子在两组间无统计学差异。回输组异体输血率为5.3%,对照组异体输血率为0。两组在术后发热、术后疼痛、不适主诉、切口愈合、开始下地时间及术后住院时间方面无统计学差异。
结论：健康成人患者少量出血手术应用CS对血红蛋白及组织灌注的改善有限,对炎症及异体输血率无显著影响,亦不能改善患者预后,且增加患者医疗费用,建议谨慎使用。
Objectives:The volume of blood used for transfusion in China continues to soar as a result of the increasing amount of surgery. Because of the shortage of blood products and the complications of allogeneic transfusion, autologous transfusion has been advocated in China. Cell Salvage devices for intraoperative autotransfusion, such as Cell Saver (CS), is commonly used in a wide variety of surgical procedures. However, the CS indications suggested in domestic and international guidelines are inconsistent in the extent of surgery bleeding, and doctors tend to prepare CS when less blood loss is anticipated. To investigate the effect of cell saver blood in patients undergoing mild-bleeding surgery (defined as blood loss less than20%estimated blood volume based on body weight) compared with non-CS transfusion patients. Tissue perfusion, in vivo inflammatory level and postoperative recovery were studied to determine whether the CS transfusion is reasonable in this setting.
Methods:Our study comprised patients scheduled for posterior lumbar surgery at Peking Union Medical College Hospital. Inclusion criteria were defined as follows:age of18-75years, ASA I or II, estimated blood loss less than20%blood volume. Exclusion criteria included preoperative anemia, severe cardiovascular or cerebrovascular disease, immune disorder, infectious disease, and a history of surgery or transfusion within3months. Patients were randomized into two groups according to computer-generated random table numbers. The transfusion group was given the Cell Saver blood intraoperatively, while the control group received equal volume of colloid solution instead. Blood samples were obtained at:before induction of anesthesia, the end of the main steps in the surgery, half an hour,1day and3days after surgery. The parameters including complete blood count, venous blood gas, cerebral oxygenation, and inflammatory factors (lnterleukin-6, lnterleukin-10and neutrophil elastase) were compared between the two groups, together with the postoperative recovery such as post-op body temperature, drainage, VAS pain scores, chief complaint (dizziness, fatigue or palpitation), wound healing, post-op ambulation time, complication and length of stay.
Results:41patients scheduled for elective lumbar surgery were enrolled with all their informed consent.3cases were excluded for intraoperative massive bleeding (>1000ml), intraoperative Hb<90g/L and multiple missing data. The remaining38cases were randomized into the transfusion group (n=19) and the control group (n=19). The two groups were comparable in demographic data, baseline conditions and intraoperative blood loss. In the transfusion group, Hemoglobin was116.5±10.7g/L at post-op1/2hr and115.4±12.3g/L on post-op day1, both elevated compared with intra-op (106.6±12.6g/L, P<0.05). On post-op day3, the statistical differences of hemoglobin no longer existed. Lactate was elevated at post-op1/2hour (2.5±1.0mmol/L) versus pre-op values (1.3±0.6mmol/L)(P<0.05) in the control group, while the trend was absent in the transfusion group. IL-6on post-op day1was elevated than pre-op only in the control group (151.2±73.7ng/L vs.141.0±94.6ng/L, P<0.05).11-10on post-op day3was elevated than pre-op only in the transfusion group (338.5±137.3ng/L vs.326.2±134.1ng/L, P<0.05). There were no significant differences in postoperative hemoglobin, lactate, cerebral oxygenation, white blood cells and inflammatory factors between the two groups. The allogeneic transfusion rates of the control group and the transfusion group were0and5.3%respectively. No statistically differences were observed in fever, pain, chief complaint, wound healing, post-op ambulation time or length of stay between the two groups.
Conclusions:The use of CS in healthy adult patients undergoing mild-bleeding surgery only temporarily improved hemoglobin and tissue oxygenation, with little influence on inflammation and allogeneic transfusion rate, as well as prognosis amelioration. CS may be not cost-effective under this circumstance. The application of CS should be considered with caution when mild blood loss is anticipated in our research setting.
引文
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