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——前瞻性、随机、单盲、阳性药物对照、多中心临床试验

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

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（乐加⑧）用于烧伤休：充液体复苏方面的有效性和安全性。方法198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。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1个24h、第2个24h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副作用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，两组比较差异无统计学意义。试验组中评为安全的受试者为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比较差异无统计学意义。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。

Objective To evaluate the efficacy and safety of sodium potassium magnesium calcium and glucose injection（Le Jia ） comparing with sodium lactated ringer＇s solution for burn resuscitation. Methods 198 burned patients who met the criterion were performed fluid resuscitation during the first 6 h after injury. All patients who were enrolled in this study had been assigned assigned either the sodium potassium magnesium calcium and glucose injection group （test group） or the sodium lactated ringer＇s group （control group） according to random number table. 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 indexes were detected at the end of the first and second 24 h after resuscitation beginning. The efficacy index is 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 is the incidence and specific situation of adverse drug reaction. Results Comprehensive analysis was performed from the aspects of maintaining of serum electrolyte, acid-base equilibrium, 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.