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: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
目的:观察使用羟乙基淀粉(130/0.4)对重度子痫前期患者围术期对肾功能的影响。方法:选取40例腰硬联合麻醉下行剖宫产术、重度子痫前期患者为研究对象,随机分为羟乙基淀粉组和乳酸林格氏液组,每组20例。比较两组患者术中液体输注总量及...目的:观察使用羟乙基淀粉(130/0.4)对重度子痫前期患者围术期对肾功能的影响。方法:选取40例腰硬联合麻醉下行剖宫产术、重度子痫前期患者为研究对象,随机分为羟乙基淀粉组和乳酸林格氏液组,每组20例。比较两组患者术中液体输注总量及血压、心率和呼吸的变化。比较两组新生儿1 min和5 min Apgar评分。比较T0、T1、T2的Scr和β2-MG浓度,NAG、Uosm,以及24 h出血量和尿量。结果:羟乙基淀粉组的液体输注总量明显少于乳酸林格氏液组,差异有统计学意义(P<0.05)。两组新生儿1 min和5 min Apgar评分比较,差异无统计学意义(P>0.05)。羟乙基淀粉组手术前后患者血压、心率和呼吸的变化明显小于乳酸林格氏液组,差异均有统计学意义(P<0.05)。两组T0、T1和T2的Scr及β2-MG浓度、NAG比较,差异均无统计学意义(P>0.05)。两组24 h出血量和尿量比较,差异无统计学意义(P>0.05)。结论:羟乙基淀粉(130/0.4)和乳酸林格氏液均可用于重度子痫前期患者,羟乙基淀粉(130/0.4)在纠正低血容量、稳定血流动力方面更好;羟乙基淀粉(130/0.4)和乳酸林格氏液对重度子痫前期患者肾功能可能均无影响。展开更多
目的探讨羟乙基淀粉130/0.4氯化钠注射液在剖宫产术中的临床应用价值。方法将2013年1月—2014年6月210例行择期剖宫产产妇随机分为观察组及对照组各105例,观察组输注羟乙基淀粉130/0.4氯化钠注射液500 m L,对照组输注乳酸钠林格液500 m...目的探讨羟乙基淀粉130/0.4氯化钠注射液在剖宫产术中的临床应用价值。方法将2013年1月—2014年6月210例行择期剖宫产产妇随机分为观察组及对照组各105例,观察组输注羟乙基淀粉130/0.4氯化钠注射液500 m L,对照组输注乳酸钠林格液500 m L,然后实施腰-麻联合麻醉。结果 2组产妇的均顺利完成手术,无呼吸抑制,脉搏血氧饱和度在98%-100%,术前平均动脉压、心率比较无显著性差异（P〉0.05）;观察组术中平均动脉压高于对照组;心率、低血压发生率,麻黄碱总用量低于对照组（P〈0.05）。结论腰-硬联合麻醉行剖宫产手术前输注羟乙基淀粉130/0.4氯化钠注射液,能有效减少术中低血压的发生,是安全可靠的措施。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: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。
文摘目的:观察使用羟乙基淀粉(130/0.4)对重度子痫前期患者围术期对肾功能的影响。方法:选取40例腰硬联合麻醉下行剖宫产术、重度子痫前期患者为研究对象,随机分为羟乙基淀粉组和乳酸林格氏液组,每组20例。比较两组患者术中液体输注总量及血压、心率和呼吸的变化。比较两组新生儿1 min和5 min Apgar评分。比较T0、T1、T2的Scr和β2-MG浓度,NAG、Uosm,以及24 h出血量和尿量。结果:羟乙基淀粉组的液体输注总量明显少于乳酸林格氏液组,差异有统计学意义(P<0.05)。两组新生儿1 min和5 min Apgar评分比较,差异无统计学意义(P>0.05)。羟乙基淀粉组手术前后患者血压、心率和呼吸的变化明显小于乳酸林格氏液组,差异均有统计学意义(P<0.05)。两组T0、T1和T2的Scr及β2-MG浓度、NAG比较,差异均无统计学意义(P>0.05)。两组24 h出血量和尿量比较,差异无统计学意义(P>0.05)。结论:羟乙基淀粉(130/0.4)和乳酸林格氏液均可用于重度子痫前期患者,羟乙基淀粉(130/0.4)在纠正低血容量、稳定血流动力方面更好;羟乙基淀粉(130/0.4)和乳酸林格氏液对重度子痫前期患者肾功能可能均无影响。
文摘目的探讨羟乙基淀粉130/0.4氯化钠注射液在剖宫产术中的临床应用价值。方法将2013年1月—2014年6月210例行择期剖宫产产妇随机分为观察组及对照组各105例,观察组输注羟乙基淀粉130/0.4氯化钠注射液500 m L,对照组输注乳酸钠林格液500 m L,然后实施腰-麻联合麻醉。结果 2组产妇的均顺利完成手术,无呼吸抑制,脉搏血氧饱和度在98%-100%,术前平均动脉压、心率比较无显著性差异（P〉0.05）;观察组术中平均动脉压高于对照组;心率、低血压发生率,麻黄碱总用量低于对照组（P〈0.05）。结论腰-硬联合麻醉行剖宫产手术前输注羟乙基淀粉130/0.4氯化钠注射液,能有效减少术中低血压的发生,是安全可靠的措施。
