钠钾葡萄糖注射液用于小儿术后输液治疗的临床评估

摘要

目的 以5%葡萄糖氯化钠注射液(可添加氯化钾注射液)为对照,验证钠钾葡萄糖注射液在小儿手术后输注的安全性和有效性.方法 选择小儿普通外科腹部中小手术术后患者,按随机数字表分为试验组及对照组,试验组使用钠钾葡萄糖注射液,对照组使用5%葡萄糖氯化钠注射液.有效性评价指标为受试者在输注上述两种含电解质液体前后的血糖、血清电解质及pH值变化情况.安全性评价指标为临床试验期间观察到的不良反应、不良事件的发生率和发生的具体情况.结果 两组相比,在治疗前后血糖、血清电解质和pH值的变化,以及无异常率均无统计学差异.两组中均无严重不良事件发生,试验组与对照组均为100%安全病例.结论 在小儿手术后输注钠钾葡萄糖注射液,与目前临床常用的5%葡萄糖氯化钠注射液(可添加氯化钾注射液)有相同的安全性和有效性.%Objective To evaluate the efficacy and safety of sodium potassium and glucose injection in pediatric post-operation patients, as compared with 5% sodium chloride glucose injection which can be added in potassium chloride solution. Methods Pediatric post-operation patients who had minor or medium abdominal general operations were randomly assigned to experimental group and control group according to random digits table. Sodium potassium and glucose injection ( experimental group ) or 5% sodium chloride glucose injection ( control group ) were infused. The efficacy was assessed by the measurements of blood glucose, serum electrolytes and pH values before and after infusion. The safety was assessed by the incidences of adverse reaction or adverse events. Results Between two groups, the measurements of blood glucose, serum electrolytes, pH values and their changes were no statistically different before and after infusion. There were also no differences in incidences of blood glucose, serum electrolytes and pH values outside the normal range. No severe adverse event was observed in both groups. Both of experimental and control groups were 100% safe. Conclusions Sodium potassium and glucose injection has the same efficacy and safety as commonly used 5% sodium chloride glucose injection, when infused in pediatric patients after surgery.