Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need ...Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven®) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4;for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.展开更多
目的探讨术中输入乳酸林格氏液体和羟乙基淀粉130/0.4氯化钠注射液对腹腔镜下胃肠癌根治术患者术后结局的影响。方法本研究为随机、双盲前瞻性研究。选择2011年7月—2013年3月择期胃肠外科肿瘤大手术患者88例,美国麻醉医生分级（ASA）Ⅰ...目的探讨术中输入乳酸林格氏液体和羟乙基淀粉130/0.4氯化钠注射液对腹腔镜下胃肠癌根治术患者术后结局的影响。方法本研究为随机、双盲前瞻性研究。选择2011年7月—2013年3月择期胃肠外科肿瘤大手术患者88例,美国麻醉医生分级（ASA）Ⅰ~Ⅱ,随机分成4组：Ⅰ组（乳酸林格氏液负荷和维持）,Ⅱ组（羟乙基淀粉130/0.4氯化钠注射液负荷,乳酸林格氏液维持）,Ⅲ组（羟乙基淀粉130/0.4氯化钠注射液负荷和维持）,Ⅳ组（预注乳酸林格氏液体,羟乙基淀粉130/0.4氯化钠注射液负荷,乳酸林格氏液体维持）;负荷治疗以9 m L·L^-1羟乙基淀粉130/0.4氯化钠注射液或者乳酸林格氏液,再以12 m L·L^-1羟乙基淀粉130/0.4氯化钠注射液或者乳酸林格氏液体输注1 h,之后液体治疗根据麻醉医师判断,将心搏出量变异（SVV）值维持在13%左右。术后观察包括术后胃肠功能恢复时间、并发症以及术后住院时间。结果输液顺序不影响术后结局。术中输入乳酸林格氏液体≥2 L以及并发症影响术后肠蠕动恢复时间和进食恢复时间（双因素ANOVA,P=0.020）,但是只有术后并发症延长术后住院时间（P=0.001）。术中输入乳酸林格氏液和并发症作为独立因素均延长进食恢复时间达2 d。术中输入〉1 L的羟乙基淀粉130/0.4氯化钠注射液对术后胃肠功能恢复无影响,而且维持术中尿液分泌优于乳酸林格氏液。结论术中输入乳酸林格氏液延长腹腔镜下胃肠癌术后的胃肠功能恢复时间,而羟乙基淀粉130/0.4氯化钠注射液不影响术后胃肠功能恢复;只有并发症延长住院时间。展开更多
目的:应用羟乙基淀粉130/0.4(商品名称万汶)溶液对实验犬行急性高容量血液稀释(AHHD)后观察血液流变特性和凝血指标的变化,为围术期AHHD方案的制定提供实验依据。方法:实验犬随机分为万汶组(A组)和林格氏液组(B组),各10只。麻醉后以60 m...目的:应用羟乙基淀粉130/0.4(商品名称万汶)溶液对实验犬行急性高容量血液稀释(AHHD)后观察血液流变特性和凝血指标的变化,为围术期AHHD方案的制定提供实验依据。方法:实验犬随机分为万汶组(A组)和林格氏液组(B组),各10只。麻醉后以60 m l/kg,15 m l/m in分别输注,达到高容量血液稀释状态,并维持血循环指标在正常范围。检测稀释前(T1)、稀释后30 m in(T2)及稀释后60 m in(T3)血液流变学指标和凝血指标等。结果:①AHHD后两组全血黏度、Hct均降低,A组的全血黏度明显低于B组(P<0.05),A组的红细胞变形指数升高,红细胞聚集指数降低,而B组的红细胞聚集指数增高,且两组之间差异显著(P<0.05);②A组在AHHD后PT、APTT与T1相比有延长,但无显著性差异(P>0.05),纤维蛋白原定量降低显著,并与B组差异明显(P<0.05)。结论:使用万汶行一定程度AHHD对实验犬可以保持血液循环功能稳定,优化血液流变学状态,有利于微循环灌注,对凝血功能影响小。展开更多
文摘Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven®) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4;for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.
文摘目的探讨术中输入乳酸林格氏液体和羟乙基淀粉130/0.4氯化钠注射液对腹腔镜下胃肠癌根治术患者术后结局的影响。方法本研究为随机、双盲前瞻性研究。选择2011年7月—2013年3月择期胃肠外科肿瘤大手术患者88例,美国麻醉医生分级（ASA）Ⅰ~Ⅱ,随机分成4组：Ⅰ组（乳酸林格氏液负荷和维持）,Ⅱ组（羟乙基淀粉130/0.4氯化钠注射液负荷,乳酸林格氏液维持）,Ⅲ组（羟乙基淀粉130/0.4氯化钠注射液负荷和维持）,Ⅳ组（预注乳酸林格氏液体,羟乙基淀粉130/0.4氯化钠注射液负荷,乳酸林格氏液体维持）;负荷治疗以9 m L·L^-1羟乙基淀粉130/0.4氯化钠注射液或者乳酸林格氏液,再以12 m L·L^-1羟乙基淀粉130/0.4氯化钠注射液或者乳酸林格氏液体输注1 h,之后液体治疗根据麻醉医师判断,将心搏出量变异（SVV）值维持在13%左右。术后观察包括术后胃肠功能恢复时间、并发症以及术后住院时间。结果输液顺序不影响术后结局。术中输入乳酸林格氏液体≥2 L以及并发症影响术后肠蠕动恢复时间和进食恢复时间（双因素ANOVA,P=0.020）,但是只有术后并发症延长术后住院时间（P=0.001）。术中输入乳酸林格氏液和并发症作为独立因素均延长进食恢复时间达2 d。术中输入〉1 L的羟乙基淀粉130/0.4氯化钠注射液对术后胃肠功能恢复无影响,而且维持术中尿液分泌优于乳酸林格氏液。结论术中输入乳酸林格氏液延长腹腔镜下胃肠癌术后的胃肠功能恢复时间,而羟乙基淀粉130/0.4氯化钠注射液不影响术后胃肠功能恢复;只有并发症延长住院时间。
文摘目的:应用羟乙基淀粉130/0.4(商品名称万汶)溶液对实验犬行急性高容量血液稀释(AHHD)后观察血液流变特性和凝血指标的变化,为围术期AHHD方案的制定提供实验依据。方法:实验犬随机分为万汶组(A组)和林格氏液组(B组),各10只。麻醉后以60 m l/kg,15 m l/m in分别输注,达到高容量血液稀释状态,并维持血循环指标在正常范围。检测稀释前(T1)、稀释后30 m in(T2)及稀释后60 m in(T3)血液流变学指标和凝血指标等。结果:①AHHD后两组全血黏度、Hct均降低,A组的全血黏度明显低于B组(P<0.05),A组的红细胞变形指数升高,红细胞聚集指数降低,而B组的红细胞聚集指数增高,且两组之间差异显著(P<0.05);②A组在AHHD后PT、APTT与T1相比有延长,但无显著性差异(P>0.05),纤维蛋白原定量降低显著,并与B组差异明显(P<0.05)。结论:使用万汶行一定程度AHHD对实验犬可以保持血液循环功能稳定,优化血液流变学状态,有利于微循环灌注,对凝血功能影响小。
