CAJ | 학술논문

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(R))用于烧伤休克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.
목적 이유산납림격주사액위대조,험증납갑미개포도당주사액(악가(R))용우소상휴극액체복소방면적유효성화안전성.방법 198례부합입조표준적소상환자,상후6h내개시실시액체복소치료,수궤수자표법분위시험조화대조조,시험조사용납갑미개포도당주사액,대조조사용유산납림격주사액.용법용량준순1970년전국소상회의공식.액체복소전측정수시자적혈상규、간신공능、혈생화、응혈공능지표,수액과정중감측혈류동역학지표화동맥혈기、혈당；재복소개시후제1개24h、제2개24 h수액결속시동양측정수시자적혈액실험실지표.유효성평개지표위수시자재수주상술량충함전해질액체전후적혈청전해질、동맥혈유산함량、혈기지표、혈당변화정황,안전성평개지표위림상시험기간관찰도적부작용적발생솔화발생적구체정황.결과 통과혈청전해질유지、혈유산함량검측、혈당검측、산감평형유지궤개방면주출종합평개,량조비교차이무통계학의의.시험조중평위안전적수시자위99례,소점비례위100％.대조조중평위안전화대치안전적수시자위99례,소점비례위100％.량조재안전성분석방면비교차이무통계학의의.결론 재소상복소중수주납갑미개포도당주사액,여목전림상중최상용적유산납림격주사액유상동적안전성화유효성.
Objective To evaluate the efficacy and safety of sodium potassium magnesium calcium and glucose injection(Le Jia (R)) 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 (R)) has the comparative efficacy and safety to sodium lactated ringer's solution,the most commonly used in clinic for burn resuscitation.