国际麻醉学与复苏杂志   2013, Issue (1): 1-1
    
钠钾镁钙葡萄糖注射液应用于烧伤休克液体复苏的临床疗效评估
张可汗1()
1.江苏恒瑞医药股份有限公司市场部
Clinical evaluation of sodium potassium magnesium calcium and glucose injection during fluid resuscitation of burn shock: a prospective, randomized, single-blinded, positive drug controlled, multicentre clinical trial
 全文:
摘要:

目的 以乳酸钠林格注射液为对照,验证乐加®(钠钾镁钙葡萄糖注射液)用于烧伤休克液体复苏方面的有效性和安全性。方法 199例符合入组标准的烧伤患者,伤后6h内开始实施液体复苏治疗,随机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。用法用量遵循1970年全国烧伤会议公式。液体复苏前测定受试者的血常规、肝肾功能、血生化、凝血功能指标,输液过程中监测血流动力学指标和动脉血气、血糖;在复苏开始后第一个24 h、第二个24 h输液结束时同样测定受试者的血液实验室指标。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清电解质、动脉血乳酸含量、血气指标、血糖变化情况,安全性评价指标为临床试验期间观察到的不良反应的发生率和发生的具体情况。结果 通过血清电解质维持、血乳酸含量检测、血糖检测、酸碱平衡维持几个方面做出综合评价,两组相比差异无统计学意义。试验组中评为安全为99例,所占比例为100%。对照组中评为安全和大致安全的受试者为99例,所占比例为100%。两组在安全性分析方面相比差异无统计学意义。结论 在烧伤复苏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。

关键词: 钠钾镁钙葡萄糖注射液;乳酸钠林格注射液;烧伤复苏;输液
Abstract:

Objectives: To evaluate the efficacy and safety of sodium potassium magnesium calcium and glucose injection (Le Jia®) comparing sodium lactated ringer’s solution for burn resuscitation. Methods: 199 burned patients, who met the criterion and were performed fluid resuscitation during the first 6 hours after injury, were enrolled in this study and assigned randomly either to the sodium potassium magnesium calcium and glucose injection group (test group) or to the sodium lactated ringer’s group (control group). Before the fluid resuscitation according to 1970 National Conference of Burn Injuries formula, the clinical index such as routine blood count, liver and kidney functions, blood biochemistry and coagulation function were detected. The hemodynamic index, arterial blood gas and serum glucose levels were monitored during fluid infusion, and all blood lab index were detected at the end of the first and second 24h after resuscitation beginning, respectively. The efficacy index were the changes of serum electrolyte, arterial blood lactate, blood gas and serum glucose levels after resuscitation of two different electrolyte solution, and the safety index were the incidence and specific situation of adverse drug reaction. Results: Comprehensive analysis was performed from the aspects of maintaining of serum electrolyte and acid-base equilibrium and changes of blood lactate and glucose levels. No statistically significant difference was found between the two groups. In safety evaluation, safe cases in test group were 99 (100%) as well as in control group. No statistically significant difference was found in safety evaluation. Conclusions: Sodium potassium magnesium calcium and glucose injection (Le Jia®) has the comparative efficacy and safety to sodium lactated ringer’s solution, the most commonly used in clinic for burn resuscitation.

Key words: Sodium potassium magnesium calcium and glucose injection; Sodium lactated ringer’s injection; Resuscitation of burn; Infusion