关键词: 低温静脉输液装置, 中枢性高热, 降温效果, 专利

Abstract: 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.

Key words: Low-temperature intravenous infusion device, Central hyperthermia, Cooling effect, Patents