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The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

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Open Journal of Anesthesiology 2013年第7期3卷 326-337页

作者： Nobutada Morioka Makoto Ozaki Michiaki Yamakage Hiroshi Morimatsu Yasuyuki Suzuki Frank Bepperling Hideki Miyao Akiyoshi Namiki Kiyoshi Morita Department of Anesthesia and Intensive Care Medicine National Center for Child Health and Development Tokyo Japan Department of Anesthesiology Okayama University Okayama Japan Department of Anesthesiology Saitama Medical Center Saitama Medical University Kawagoe Japan Department of Anesthesiology Sapporo Medical University School of Medicine Sapporo Japan Department of Anesthesiology Tokyo Women’s Medical University Tokyo Japan Fresenius Kabi Deutschland GmbH Bad Homburg Germany Otaru City Hospitals Otaru-shi Japan.

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 bo

关键词： High Dose Volume Effect Safety 6% Hydroxyethyl Starch 130/0.4 Elective Surgery Multi-Center Study

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预输注6%羟乙基淀粉预防腰麻联合硬膜外麻醉后低血压的临床体会

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医学理论与实践 2014年第21期27卷 2874-2875页

作者：黄波江苏省海安县曲塘中心卫生院麻醉科 226661

目的:观察麻醉前输注6%羟乙基淀粉在下腹手术应用腰麻联合硬膜外麻醉后预防低血压等不良反应的结果。方法:将60例下腹部及下肢手术患者,随机分为预输注6%羟乙基淀粉组(A组)和预输注乳酸钠林格氏液组(B组),观察两组患者麻醉后各时点收缩... 详细信息

目的:观察麻醉前输注6%羟乙基淀粉在下腹手术应用腰麻联合硬膜外麻醉后预防低血压等不良反应的结果。方法:将60例下腹部及下肢手术患者,随机分为预输注6%羟乙基淀粉组(A组)和预输注乳酸钠林格氏液组(B组),观察两组患者麻醉后各时点收缩压(SBP)、心率(HR)的变化、低血压发生率。结果:B组在麻醉后SBP下降明显高于A组(P6%羟乙基淀粉能有效地预防低血压等不良反应的发生。

关键词： 6% 羟乙基淀粉腰麻联合硬膜外麻醉低血压

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