羟乙基淀粉用于体外循环心脏手术的临床效果观察

Effect of HES 130/0.4 as a priming solution in cardiac surgery: a randomized,prospective study

目的评估羟乙基淀粉注射液用于成人体外循环预充的风险与获益。方法采用前瞻性、随机、单盲、对照的方法进行临床试验,481例患者随机分为两组,羟乙基淀粉组体外循环预充液中主要含羟乙基淀粉130/0.4氯化钠注射液,晶体液组体外循环预充液主要含乳酸钠林格注射液。主要研究两种不同体外循环预充液组成对术后引流量的影响,分析两组患者的围手术期肝肾功能及凝血功能,评估患者手术预后情况。结果羟乙基淀粉组主动脉阻断时间、呼吸机辅助时间、超滤量、心肌灌注总量、术后血浆、呋塞米使用量、总引流量及室性心律失常次数均超过晶体液组(P<0.05),ICU时间、液体平衡量、体外循环中尿量以及血浆使用频次均低于晶体液组(P<0.05);术后第一天肌酐、尿素氮及活化部分凝血活酶时间高于晶体液组(P<0.05)。结论虽然羟乙基淀粉组主动脉阻断时间、呼吸机辅助时间、超滤量、心肌灌注总量、术后血浆、呋塞米使用量、总引流量及室性心律失常次数均超过晶体液组(P<0.05),但两组在肝、肾功能指标、凝血功能指标、术后并发症以及早期死亡率的差异均无明显统计学意义(P>0.05),故认为临床上对于术前肝、肾功能正常的成人体外循环使用羟乙基淀粉130/0.4氯化钠注射液预充方案是可以接受的。

Objective In cardiac surgery,surgeons often use a variety of methods to avoid or reduce the complications caused by cardiopulmonary bypass.The choices of prime solution in the cardiopulmonary bypass are controversial. In this study,we aimed to assess the risk and benefit of hydroxyethyl starch 130/0.4 with a commonly used balanced electrolyte solution on postoperative outcomes.Methods We used a prospective,randomized,single-blind and controlled study. Four hundred and eighty-one patients were prospectively studied and randomized into two groups. First group received a balanced electrolyte solution and the second group received hydoxyethyl starch 130/0.4 as prime solution. The postoperative outcomes of the patients were studied. Results The mean age of the patients was 46.1±12.3 in the crystalloid group,whereas 46. 1 ± 12. 1 in the HES group. There were 128 male patients in crystalloid group and 128 in HES group. Hydroxyethyl starch 130/0.4 did not have any detrimental effects on renal,liver and blood coagulation functions of patients. The aorta blocking time and breathing machine auxiliary time were longer in HES group（ P〈0.05 for each）,and the intensive care unit stay time was shorter. Hydroxyethyl starch did not increase postoperative blood loss,amount of blood and fresh frozen plasma used,but it decreased platelet concentrate requirement. Conclusion Although the aorta blocking time,breathing machine auxiliary time,postoperative blood plasma transfusion and total guide flow are more than the control group（ P〈0. 05）,the differences between the two groups in liver and kidney function,blood coagulation function indicators,early postoperative complications and mortality are no significant statistical significance（ P〉0.05）. Using hydroxyethyl starch 130/0.4 as a prime solution does not adversely affect patients＇ postoperative outcomes following cardiac surgery and is acceptable.