一种新型低温静脉输液装置对中枢性高热患者的降温效果及安全性研究

背景　物理降温方法是中枢性高热患者的主要降温方法,目前临床上常用的物理降温方法效果报道不一,且存在较明显的并发症。目的　探讨一种新型低温静脉输液装置（国家实用新型专利,专利号：ZL 2014 2 0070586.4）对中枢性高热患者进行物理降温治疗的效果及安全性。方法　选取2015-2019年佛山市中医院重症医学科收治的中枢性高热患者93例,采用随机数字表法将其分为对照组（n=29）、普通静脉降温组（n=32）和应用降温装置组（n=32）。对照组给予基础治疗及体表物理降温,普通静脉降温组在对照组的基础上予以静脉输注低温液体（由冰箱冷藏4 ℃）,应用降温装置组则在对照组的基础上采用新型低温静脉输液装置输注室温液体。检测三组患者治疗前、治疗24 h及治疗48 h后的凝血功能指标：纤维蛋白原（FbgC）、活化部分凝血活酶时间（APTT）、凝血酶原时间（PT）及血小板计数（PLT）;观察寒战、心律失常、皮肤受损等并发症发生率;测量治疗前及治疗2、4、8、12、24、48 h的肛温;评估治疗1周后格拉斯哥昏迷量表（GCS）评分;电话随访患者治疗28 d病死率。结果　治疗方法和时间对FbgC、APTT、PT及PLT不存在交互作用（P>0.05）;治疗方法和时间对FbgC、APTT、PT及PLT主效应均不显著（P>0.05）。应用降温装置组寒战发生率低于对照组和普通静脉降温组,皮肤受损发生率低于对照组（P<0.017）。治疗方法和时间对肛温存在交互作用（P<0.05）;治疗方法和时间对肛温主效应均显著（P<0.05）;其中应用降温装置组治疗2、4、8、12、24、48 h的肛温均低于对照组和普通静脉降温组（P<0.05）。治疗1周后应用降温装置组GCS评分高于对照组和普通静脉降温组（P<0.05）。三组患者治疗28 d病死率比较,差异无统计学意义（P>0.05）。结论　采用新型低温静脉输液装置对中枢性高热患者进行物理降温治疗具有快速且稳定的降温效果,且其并发症发生率低,可广泛应用于临床降温治疗。

Cooling Effect and Safety of a New Device for Low-temperature Intravenous Infusion in Patients with Central Hyperthermia

Background　Physical hypothermia is a major method for inducing hypothermia in patients with central hyperthermia,with different clinical effect and obvious complications reported.Objective　To explore the cooling effect and safety of a new device for low-temperature intravenous infusion（Chinese utility model patent No.ZL2014 2 0070586.4）in central hyperthermia patients.Methods　93 cases of central hyperthermia admitted to the ICU,Foshan Hospital of TCM during 2015—2019 were enrolled and randomized into control group （basic treatment and physical surface cooling,n=29）,treatment group 1 （basic treatment,physical surface cooling,and intravenous infusion of 4 ℃ fluids cooled by the refrigerator,n=32）,and treatment group 2 （basic treatment,physical surface cooling,and intravenous infusion of fluids with a room temperature maintained by the new device,n=32）.The efficacy of treatment was evaluated by comparing coagulation indicactors〔fibrinogen（FbgC）,activated partial thromboplastin time （APTT）,prothrombin time （PT） and platelet count （PLT）〕 at 24 and 48 hours after treatment to the baseline levels,and anal temperature at 2,4,8,12,24 and 48 hours after treatment to the baseline level,as well as the Glasgow Coma Scale （GCS） score at one week after treatment to the baseline level.The safety of treatment was evaluated by the incidence of complications during treatment such as chills,arrhythmia and skin damage,and 28-day mortality rate obtained by telephone-based follow-up.Results　There was no interaction between the treatment protocol and treatment duration on FbgC,APTT,PT and PLT （P>0.05）.Different treatment protocols and treatment durations had no main effects on FbgC,APTT,PT and PLT （P>0.05）.Treatment group 2 showed much lower incidence of chills and skin damage than the other groups（P<0.017）.The treatment protocol and treatment duration had an interaction on anal temperature （P<0.05）.Different treatment protocols and treatment durations produced main effects on anal temperature （P<0.05）.In particular,treatment group 2 showed much lower anal temperature at each post-treatment measurement than the other groups （P<0.05）.Treatment group 2 had a much higher average post-treatment GCS score than the other groups（P<0.05）.However,there was no significant difference on 28-day mortality among the three groups （P>0.05）.Conclusion　Endovascular cooling using the new device showed rapid and stable cooling effect in patients with central hyperthermia,with a low rate of complications,so it is worth popularizing in clinical practice.