钠钾镁钙葡萄糖注射液(乐加)用于手术中输液治疗的临床评估——前瞻性、随机、单盲、阳性药物对照、多中心临床试验

目的 以乳酸钠林格注射液为对照,验证钠钾镁钙葡萄糖注射液在手术中输注的有效性和安全性.方法 选择全身麻醉下行普外或骨科手术患者,ASA分级为Ⅰ～Ⅱ级,按随机数字表法分为试验组和对照组,试验组使用钠钾镁钙葡萄糖注射液,对照组使用乳酸钠林格注射液.以15 ml·kg-1·h-1的速度输注500 ml液体后行麻醉诱导,随后以10 ml·kg-1·h-1的速度维持前2 h,最后以8 ml·kg-1·h-1的速度维持至手术结束.术前测定受试者的血常规、肝肾功能、血生化、凝血功能指标,术中监测输液前即刻、诱导前即刻、诱导后1 h、2 h……输液结束时即刻各时间点的血流动力学指标和动脉血气、血糖;在手术结束时同样测定受试者的血液实验室指标.结果 通过循环动态维持、尿量维持、血糖控制、血清电解质维持、酸碱平衡维持5个方面做出综合评价,试验组有效率为100%,对照组有效率为99.53%,两组相比差异无统计学意义.试验组中评为安全和大致安全的受试者分别为200例和23例,所占比例分别为89.69%和10.31%.对照组中评为安全和大致安全的受试者分别为193例和18例,所占比例分别为91.47%和8.53%.两组在安全性分析方面相比差异无统计学意义.结论 在手术中输注钠钾镁钙葡萄糖注射液,与目前临床中最常用的乳酸钠林格注射液有相同的安全性和有效性.

Clinical assessment of sodium potassium magnesium calcium and glucose injection infused during surgery: a prospective, randomized, single-blind, positive drug controlled, multicentric clinical trial

Objective To compare with sodium lactate Ringer injection, this trial investigated the efficacy and safety of sodium potassium magnesium calcium and glucose injection infused during the surgery. Methods Patients with ASA grade Ⅰ -Ⅱ scheduled for elective general or orthopaedic surgery were randomly assigned to experimental group and control group. Sodium lactate Ringer injection(control group) or sodium potassium magnesium calcium and glucose injection (experimental group) was infused 500 ml with the rate 15ml·kg-1·h-1 before the induction,infused with the rate 10 ml·kg-1·h-1 for 2 h after induction,and then infused with the rate 8ml·kg-1·h-1 until the surgery was finished.Routine blood test,renal and hepatic fuction,blood biochemistry test and coagulation function were detected before and after surgery. Hemodynamics parametres, arterial blood gas analysis and blood glucose were measured before infusion, pre-induction, 1 h after induction, 2 h after induction et al until the end of infusion. Results To evaluate the changes of hemodynamics, urine volumes, blood glucose, electrolyte, acid-base balance, the effective rate in the experimental group was 100% and in the control group is 99.53% with no statistically significant difference between two groups. The patients in the experimental group assessed as safety and rough safety were 89.69%(200) and 10.31%(23) respectively and the patients in the control group as safety and rough safety were 91.47% (193) and 8.53% (18) respectively with no statistically significantly difference between two groups. Conclusion Sodium potassium magnesium calcium and glucose injection was infused as the same efficacy and safety as commonly used sodium lactate Ringer injection during the surgery.