全麻非心脏手术患者羟乙基淀粉130／0．4电解质注射液与羟乙基淀粉130／0．4氯化钠溶液容量治疗效果的比较：多中心、前瞻、随机、双盲、对照研究

Plasma volume expanding effect of hydroxyethyl starch 13010.4 and electrolyte solution versus hydroxyethyl starch 13010.4 and normal saline in patients undergoing noncardiac surgery under general anesthesia： a multicenter prospective, randomized, double-blind, controlled clinical trial

目的比较全麻非心脏手术患者羟乙基淀粉（HES）130／0．4电解质注射液与HES130／0．4氯化钠溶液容量治疗的效果。方法择期全麻非心脏外科手术（神经外科手术除外）患者242例，年龄18～64岁，体重指数18～29kg／m2，性别不限，ASA分级Ⅰ或Ⅱ级，采用随机数字表法，将患者随机分为试验组和对照组：麻醉诱导后经1h静脉输注6％HES130／0．4电解质注射液或6％HES130／0．4氯化钠溶液15ml／kg。于HES输注前和输注结束后15min时取动脉血样，行血气分析，记录pH值、BE、HCO3、电解质（K＋、Na＋、Cl＋、Mg2＋）；测定Hct、Hb、血液生化指标（ALT、AST、Cr、BUN和血糖）、凝血功能指标，记录电解质和血液生化指标异常有临床意义的发生情况、血管活性药物的使用情况，与研究药物有关不良事件（凝血酶原时间延长、活化部分凝血活酶时间延长和高氯血症）的发生情况和术中液体出人量。结果试验组和对照组最终完成91例和95例。两组液体用量和尿量比较差异均无统计学意义（P〉0．05）。与对照组比较，试验组输注结束后15min时pH值、BE、HCO3-、K＋、Mg2＋升高，Na＋、Cl-降低（P〈0．05），Hb和Hct差异无统计学意义（P〉0．05）；与输注前比较，输注结束后15rain时对照组BE、HCO3-、Mg2＋、Hb和Hct降低，Cl-升高，试验组Na＋、Mg2＋、Hb和Hct降低，Cl-升高（P〈0．05）。试验组血钾、血氯异常有临床意义的发生率明显低于对照组（P〈O．05）。两组血管活性药物使用率、与研究药物有关的不良事件发生率、生化指标异常有临床意义的发生率比较差异无统计学意义（P〉0．05）。结论与6％HES130／0．4氯化钠溶液比较，6％HES130／0．4电解质注射漓扩容效能无尊异．侣能更好地维持机体电解质和酸碱平衡。

Objective To compare the plasma volume expanding effect of hydroxyethyl starch （HES） 130/0.4 and electrolyte solution （E-HES） and HES 130/0.4 and normal saline （NS-HES） in patients undergoing noncardiac surgery under general anesthesia. Methods A multicenter, prospective, randomized, double-blind, controlled clinical trial was conducted. Two hundred and forty-two ASA Ⅰ or Ⅱpatients aged 18-64 yr with body mass index 18-29 kg/m2 undergoing noncardiac surgery were randomly divided into 2 groups： group E-HES and group NS-HES. E-HES and NS-HES 15 ml/kg was infused iv over 1 h immediately after induction of anesthesia in groups E-HES and NS-HES respectively. Arterial blood samples were taken before （baseline） and at 15 min after the end of HES infusion for blood gas analysis （pH value, BE, HCO3- , K＋ , Na＋ , Cl- , Mg2＋ ） and measurement of Hb, Hct, blood chemistry （ALT, AST, Cr, BUN, Glu） and coagulation function. The electrolyte abnormality, requirement for vasopressor, treatment-related adverse effects （prolonged protbrombin time, activated partial thromboplastin time and hyperchloremia） and fluid balance were recorded. Results Of the 242 patients, 122 received E-HES and 120 received NS-HES. Ninety-one patients in group E-HES and 95 in group NS-HES completed the trial. The pH value, BE, HCO3 - , K＋ , and Mg2＋ were significantly higher and Na＋ and Cl- lower at 15 min after HES infusion was finished in group E-HES than in group NS-HES. BE, HCO3- , Na＋ , Mg2＋ , Hb and Hct were significantly decreased while Cl- was significantly increased in group NS-HES while Na2＋ , Mg2＋ , Hb and Hct were significantly decreased and Cl- was increased in group E-HES at 15 min after HES infusion as compared with the baseline values before infusion. The incidence of clinical significant abnormality in plasma K＋ and Cl- was significantly lower in group E-HES than in group NS-HES. There were no significant differences in Hb, Hct, urine output, amount of HES infused, vasopressor requirement, the incidence of clinically significant abnormality in blood chemistry and treatment-related adverse effects between the 2 groups. Conclusion E-HES and NS-HES have the same plasma volume expanding effect, but E-HES maintains better electrolyte and acid-base balance than NS-HES.