国产与进口6%羟乙基淀粉130/0.4注射液容量治疗疗效和安全性的对比研究

Comparison the effect and the safety of the Voluven and Tianqingning used in the operation

目的与进口6%羟乙基淀粉130/0.4注射液进行对比性研究,评价国产6%羟乙基淀粉130/0.4注射液的有效性及安全性。方法患者随机分为研究组123例,对照组117例,术中输注研究药物或对照药物10ml.kg-1.h-1,输注时间2h,期间观察患者生命体征,记录液体出入量与合并用药,比较术前和输注后血常规、血电解质、凝血功能、肝肾功能、尿常规指标变化;并记录术中不良事件发生与处理。结果两组患者用药期间BP、HR、SpO2均能维持正常,BP和HR的变化率两组间差异无统计学意义。两组患者术中出入量、应用血管活性药物及应用血液制品人数与用量组间差异无统计学意义。输注后两组Hct、Hb下降幅度一致,血K+、Na+略低于应用前,血Cl-高于应用前,血糖有升高,PT、APTT时间延长,TT时间略缩短。肝功能ALT、AST超过正常值1.5倍的两组各有4例。肾功能BUN、Cr研究组有11例,对照组7例高于正常。结论国产6%羟乙基淀粉130/0.4注射液用于全麻下非心脏外科手术患者术中容量治疗扩容效果安全可靠,与进口6%羟乙基淀粉130/0.4注射液作用相似。

Objective To evaluate the efficacy and safety of domestic hydroxyethyl starch130/0.4 （Tianqingning） for volume replacement in surgical patients. Methods Two hundred and fourty ASA Ⅰ- Ⅱ patients, aged 18 to 65 years old, weighted 40 to 80 kg, scheduled for selective surgery under general anesthesia were divided randomly into two groups. The patients in group A were infused Tianqingning 10 ml·kg^-1·h^-1 for 2 h after induction of anesthesia. Those in group B were infused Voluven （hydroxyethyl starch130/0.4 ） instead of Tianqingning as in group A. The total fluid input and output during operation, vital signs and hemodynamics were recorded. The changes of blood electrolytes,coagulation, liver and renal function were measured as well. Results BP, HR and SpO2 were kept in normal range during operation in both groups. There were no significant differences between the two groups in the changes of total fluid input and output during operation, vital signs, hemodynamics,blood electrolytes, coagulation, liver and renal functions. Conclusion Application of Tianqingning for volume therapy in surgical patients is as effective and safe as Voluven.