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: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: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
目的观察羟乙基淀粉130/0.4电解质注射液与羟乙基淀粉130/0.4氯化钠溶液对休克患者血清降钙素原、C反应蛋白(CRP)及S100β蛋白水平影响。方法将74例休克患者随机分为对照组37例与试验组37例,2组均给予常规治疗及对症治疗。对照组患者术...目的观察羟乙基淀粉130/0.4电解质注射液与羟乙基淀粉130/0.4氯化钠溶液对休克患者血清降钙素原、C反应蛋白(CRP)及S100β蛋白水平影响。方法将74例休克患者随机分为对照组37例与试验组37例,2组均给予常规治疗及对症治疗。对照组患者术后给予羟乙基淀粉130/0.4氯化钠溶液初始剂量为10~20 m L,之后每日保持为500~1000 m L,静脉滴注;试验组给予羟乙基淀粉130/0.4电解质注射液,用法用量与对照组相同。2组患者均治疗7 d。比较2组患者的血气分析及电解质指标、血清降钙素原、CRP、S100β蛋白水平及药物不良反应发生情况。结果治疗后,对照组与试验组的降钙素原分别为(9.57±1.36),(5.47±0.58)μg·L^(-1),CRP分别为(45.47±5.03),(12.94±1.73)mg·L^(-1),S100β分别为(0.16±0.05),(0.05±0.01)μg·L^(-1),差异均有统计学意义(P<0.05)。治疗后,对照组与试验组的收缩压分别为(86.22±10.73),(103.53±14.61)mm Hg;舒张压分别为(61.44±6.51),(66.94±6.62)mm Hg;心率分别为(101.52±9.73),(95.51±10.42)次/分;平均动脉压分别为(70.91±9.94),(78.52±8.43)mm Hg;休克指数分别为1.50±0.22,1.22±0.21;差异均有统计学意义(P<0.05)。试验组的药物不良反应有血钾异常、皮疹,药物不良反应发生率为5.41%(2/37例);对照组的药物不良反应有血钾异常、高氯血症、皮疹,药物不良反应发生率为10.81%(4/37例),2组差异无统计学意义(P>0.05)。结论与羟乙基淀粉130/0.4氯化钠溶液比较,羟乙基淀粉130/0.4电解质注射液能够下调血清降钙素原、CRP、S100β蛋白水平,维持机体电解质和酸碱平衡,安全性较高。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6%羟乙基淀粉(HES)130/0.4对骨折创伤兔子血清白蛋白、微血管白蛋白渗漏、炎性因子的影响。方法:将20只健康雌性大白兔随机分为模型组和HES组,各10只,均采用钝器敲打后肢造成后肢骨折,行骨折切开内固定术。术后,模型组注射10 m L/kg生理盐水,HES组注射10 m L/kg 6%HES 130/0.4,连续3 d。比较两组血清白蛋白水平、微血管白蛋白渗漏情况以及白细胞介素-6(IL-6)、C反应蛋白(CRP)、降钙素原(PCT)水平。结果:术后72 h,两组血清白蛋白水平低于术前,但HES组高于模型组,差异有统计学意义(P<0.05);HES组肠系膜微血管白蛋白渗漏率低于模型组,差异有统计学意义(P<0.05);两组血清IL-6、CRP以及PCT水平高于术前,但HES组低于模型组,差异有统计学意义(P<0.05)。结论:骨折创伤兔子术后存在血清白蛋白水平下降、炎性因子水平升高情况,给予6%HES 130/0.4治疗可以减小血清白蛋白降低幅度,下调IL-6、CRP以及PCT水平,改善白蛋白渗漏情况。
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: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。
文摘目的观察羟乙基淀粉130/0.4电解质注射液与羟乙基淀粉130/0.4氯化钠溶液对休克患者血清降钙素原、C反应蛋白(CRP)及S100β蛋白水平影响。方法将74例休克患者随机分为对照组37例与试验组37例,2组均给予常规治疗及对症治疗。对照组患者术后给予羟乙基淀粉130/0.4氯化钠溶液初始剂量为10~20 m L,之后每日保持为500~1000 m L,静脉滴注;试验组给予羟乙基淀粉130/0.4电解质注射液,用法用量与对照组相同。2组患者均治疗7 d。比较2组患者的血气分析及电解质指标、血清降钙素原、CRP、S100β蛋白水平及药物不良反应发生情况。结果治疗后,对照组与试验组的降钙素原分别为(9.57±1.36),(5.47±0.58)μg·L^(-1),CRP分别为(45.47±5.03),(12.94±1.73)mg·L^(-1),S100β分别为(0.16±0.05),(0.05±0.01)μg·L^(-1),差异均有统计学意义(P<0.05)。治疗后,对照组与试验组的收缩压分别为(86.22±10.73),(103.53±14.61)mm Hg;舒张压分别为(61.44±6.51),(66.94±6.62)mm Hg;心率分别为(101.52±9.73),(95.51±10.42)次/分;平均动脉压分别为(70.91±9.94),(78.52±8.43)mm Hg;休克指数分别为1.50±0.22,1.22±0.21;差异均有统计学意义(P<0.05)。试验组的药物不良反应有血钾异常、皮疹,药物不良反应发生率为5.41%(2/37例);对照组的药物不良反应有血钾异常、高氯血症、皮疹,药物不良反应发生率为10.81%(4/37例),2组差异无统计学意义(P>0.05)。结论与羟乙基淀粉130/0.4氯化钠溶液比较,羟乙基淀粉130/0.4电解质注射液能够下调血清降钙素原、CRP、S100β蛋白水平,维持机体电解质和酸碱平衡,安全性较高。
