心肺复苏后早期注射冰盐水的有效性和安全性临床评价

Efficacy and safety of early rapid infusion of icy normal saline in patients after cardiopulmonary resuscitation

目的：评价心搏骤停患者早期注射冰盐水实现亚低温治疗的可行性、安全性和有效性。方法采用单中心前瞻性随机对照的临床研究方法，以2011年3月到2013年10月北京市大兴区人民医院抢救的心搏骤停进行心肺复苏（CPR）后自主循环恢复（ROSC）的患者为研究对象，按随机数字表法将患者分为两组。ROSC后，冰盐水组患者立即快速静脉注射4℃生理盐水1000 mL来实现亚低温治疗，对照组给予常规头部冰袋降温治疗和腋温监测。所有患者在ROSC即刻和1 h后分别测量直肠温度；记录复苏后6 h胸片出现急性肺水肿、48 h内出现寒战、48 h再次发生心室纤颤（室颤）以及14 d内成功苏醒和死亡的患者例数。结果共有45例患者纳入本研究，其中冰盐水组23例，对照组22例。冰盐水组患者ROSC即刻直肠温度为（36.7±0.9）℃，1 h后降至（34.9±0.7）℃；对照组患者ROSC即刻直肠温度为（36.5±1.0）℃，1 h后升高至（37.9±0.9）℃，两组ROSC后1 h直肠温度比较差异有统计学意义（t＝2.228，P＝0.031）。冰盐水组14 d内成功苏醒患者例数明显多于对照组（13例比7例，χ^2＝65.710，P＝0.021），而出现急性肺水肿（4例比6例）、寒战（2例比0例）、再次发生室颤（4例比5例）和14 d内死亡（11例比12例）的患者例数与对照组比较差异均无统计学意义（均P＞0.05）。结论早期快速静脉注射4℃生理盐水来实现复苏后亚低温治疗脑复苏效果更佳理想，且是可行的、安全的、有效的。

Objective To assess the feasibility,safety,and effectiveness of early rapid icy normal saline infusion to attain mild hypothermia in cardiac arrest patients. Methods A single-center prospective randomized controlled trial was conducted. From March 2011 to October 2013,patients who had recovery of spontaneous circulation （ROSC）after cardiopulmonary resuscitation （CPR）in Beijing Daxing District People＆#39;s Hospital were randomly divided into two groups. In icy normal saline group,patients received a rapid infusion of 1 000 mL of 4 ℃ normal saline intravenously to attain a mild hypothermia. In the control group,the patients were treated with ice bag on head,and axillary temperature was monitored. For all patients,rectal temperature was measured and recorded immediately and 1 hour later . The occurrence of pulmonary edema on initial chest X-ray at 6 hours ,occurrence of tremor within 48 hours,ventricular fibrillation recurring within 48 hours,and consciousness or death within 14 days were recorded. Results A total of 45 patients were enrolled,including 23 patients in icy normal saline group and 22 in control group. The patients in icy normal saline group had a rectal temperature descended from（36.7±0.9）℃to（34.9±0.7）℃1 hour later,while the patients in control group had a rectal temperature risen from（36.5±1.0）℃to（37.9±0.9）℃1 hour later. There was significant difference in rectal temperature between two groups （t=2.228,P=0.031）. The number of patients who successfully awaken within 14 days in ice normal saline group was significantly larger than that in control group （13 cases vs. 7 cases,χ^2=65.710,P=0.021）. There was no statistical difference in the occurrence of acute pulmonary edema （4 cases vs . 6 cases）,tremor （2 cases vs . 0 case）,ventricular fibrillation recurrence （4 cases vs. 5 cases）and death within 14 days （11 cases vs. 12 cases,all P〉0.05）. Conclusions The study shows that early rapid i.v. infusion of 4℃normal saline is feasible,safe and effective for cerebral resuscitation.