珂立苏治疗足月新生儿呼吸窘迫综合征临床研究

Clinical evaluation of Calsurf in treating full-term neonatal respiratory distress syndrome

目的 研究国产外源性肺表面活性物质（珂立苏）对足月新生儿呼吸窘迫综合征（respiratory distress syndrome,RDS）的疗效。方法 本研究分为两阶段：（1）第一阶段：2011年1月至2012年6月,研究珂立苏治疗足月儿RDS的疗效。根据家长意愿将RDS患儿分为珂立苏组（74例）和固尔苏组（80例）,比较在补充外源性肺表面活性物质后两组患儿血气变化、住院时间、住院费用、重要并发症发生率及重复用药率。（2）第二阶段：2012年7月至2013年3月,比较不同剂量珂立苏治疗足月儿RDS的疗效。将接受珂立苏治疗的80例足月RDS患儿,根据胸部X线改变分为轻中度组（X线胸片Ⅱ～Ⅲ级）50例和重度组（X线胸片Ⅳ级）30例,每组又分成小剂量（每次30 ～ 40 mg/kg）和大剂量（每次70 ～ 100 mg/kg）两个亚组,比较不同剂量珂立苏对RDS的疗效。结果 第1阶段：（1）两组RDS患儿在用药前及用药后0。5h和6h,动脉血pH、PaCO2和PaO2各指标差异无统计学意义（P＞0.05）。（2）两组患儿机械通气天数、总给氧天数、住院天数及重复用药率差异无统计学意义（P＞0.05）。（3）两组患儿多脏器功能衰竭、持续性肺动脉高压、急性肾功能衰竭、气胸发生率和病死率差异无统计学意义（P＞0.05）。（4）珂立苏与固尔苏组患儿平均住院费用分别为28。778千元及31.827千元,固尔苏组患儿平均减少9.6％（P＜0.05）。第2阶段：（1）对轻中度RDS,小剂量与大剂量珂立苏治疗前及治疗后0.5h和6h,pH、PaCO2和PaO2各指标差异无统计学意义（P＞0.05）。（2）对重度RDS,大剂量珂立苏改善动脉血气的效果优于小剂量珂立苏（P＜0.05）;小剂量组与大剂量组的重复用药率分别为20.0％（3/15）和33.3％ （5/15）,大剂量组患儿平均减少40％。结论 （1）对足月儿RDS,珂立苏与固尔苏均可显著改善患儿低氧血症和高碳酸血症,两组患儿机械通气时间、总吸氧时间及住院时间相似,但珂立苏组住院费用降低。（2）对轻中度RDS,小剂量与大剂量珂立苏具有相似的临床疗效;但对重度RDS,大剂量珂立苏的疗效维持较久,并可在一定程度上减少重复用药率。

Objective To evaluate the effectiveness of domestic exogenous pulmonary surfactant （EPS）-Calsurf in treating full-term neonatal respiratory distress syndrome （RDS）.Methods （1） From January 2011 to June 2012,154 full-term neonates with RDS were divided into Calsurf group （74 cases） and Curosurf group （80 cases）,comparing differences in changes of arterial blood gas,the length of hospital stay,hospitalization expenses,duration of mechanical ventilation,inspired oxygen time,the incidences of complications and repeated EPS use rates between two groups.（2） In order to compare the effectiveness of different doses of Calsurf in treating full-term neonatal RDS,from July 2012 to March 2013,80 RDS patients who received Calsurf were divided into mild-moderate group （grade Ⅱ ～ Ⅲ on chest X-ray,50 cases） and severe group （grade Ⅳ on chest X-ray,30 cases）.Furthermore,each group was divided into two subgroups,which were low-dosage（per-time 30 ～40 mg/kg） and high-dosage group （per-time 30 ～40 mg/kg）.Results （1） Before administrating Calsurf and after administrating it at 0.5 h and 6 h,the pH,PaCO2 and PaO2 of RDS patients were no significant difference in two groups （P ＞ 0.05）.（2） There were no significant difference between the duration of mechanical ventilation,inspired oxygen time,length of hospital stay in two groups （P ＞ 0.05）.But the hospitalization expenses in Calsurf and Curosurf groups were 28.778 versus 31.827 thousand yuan,respectively,with the average reduction of 9.6％ in Calsurf group （P ＜ 0.05）.（3） There were no significant difference between the morbidities and mortalities of multiple organ failure,persistent pulmonary hypertension,acute renal failure and pneumothorax in two groups （P ＞ 0.05）.（4） In mild-moderate grade RDS patients,the low-dosage or high-dosage of Calsurf had similar effectiveness in improving bloog gas （P ＞ 0.05）,the repeated Calsurf use rates of both subgroups were 16.0％ （4/25） and 20.0％ （5/25） （P ＞ 0.05）.While in severe RDS patients,high-dosage Calsurf got a better effectiveness in improving bloog gas than low-dosage Calsurf（P ＜ 0.05）.Meanwhile,the repeated Calsurf use rates of the low-dosage and high-dosage subgroups were 20.0％ （3/15） and 33.3％ （5/15）,with a 40％ reduction in high-dosage subgroup.Conclusion （1） Both Calsurf and Curosurf can significantly improve the conditions of hypoxemia and hypercapnia,moreover,the length of hospital stay and duration of mechanical ventilation of both groups are similar,with less hospitalization expense in Calsurf group.（2） Both low and high-dosage Calsurf have similar curative effect on mild-moderate RDS,but for severe RDS,high-dosage Calsurf works better,reducing the repeated EPS use rate to some extent.