论文部分内容阅读
目的通过临床多中心研究观察选择性头部亚低温(SHC)治疗新生儿缺氧缺血性脑病(HIE)的安全性。方法从2002年5月至2006年2月共收集246例不同严重程度的新生儿HIE,随机分为SHC组和常温组,SHC组和常温组各失访17例和12例,有效病例共217例(SHC组117例,常温组100例)。SHC组生后6 h内开始给予SHC治疗,鼻咽部温度维持在(34±0．2)℃,直肠温度维持在34．5℃以上,持续72 h,然后自然复温。常温组直肠温度维持在36-37．5℃。两组均进行心电、血压、经皮氧饱和度、鼻咽部温度和直肠温度监测。发现心率失常者进行ECG检测。观察的主要不良反应包括:病死率、严重心律失常、静脉血栓或出血和难以纠正的低血压。SHC组72 h抽血时检测肝及肾功能、血常规、血电解质、血糖及血气分析。观察可能出现的其他不良反应。结果 SHC组和常温组的病死率分别为17．9％和25．0％(P= 0．20),死亡原因中两组均以重度脑病(SHC组和常温组分别为6．8％和7．0％,P=0．96)和呼吸衰竭(SHC组和常温组分别为6．8％和6．0％,P=0．80)为主;常温组有1例患儿出现室性心律失常和DIC;SHC组发生DIC和消化道出血患儿各1 例;两组均未出现难以纠正的严重低血压和大静脉血栓。SHC组和常温组发生严重不良反应的概率分别为1．7％和2．0％ (P=1．0)。SHC治疗期间心率降低,但仅有4例(3．4％)患儿HR<80／min;两组间血压、肝功能、肾功能、血电解质、血生化、血气分析及血常规的变化均无显著性差异。结论 SHC结合全身轻度低温72 h治疗足月新生儿HIE是可行的和安全的。
Objective To observe the safety of selective head hypothermia (SHC) in the treatment of neonatal hypoxic-ischemic encephalopathy (HIE) through a clinical multicenter study. Methods From May 2002 to February 2006 a total of 246 newborns with different severity were collected HIE were randomly divided into SHC group and room temperature group, SHC group and the room temperature group were lost in 17 cases and 12 cases, 217 cases of effective Cases (SHC group 117 cases, normobaric group 100 cases). SHC treatment was started within 6 h after birth. The nasopharyngeal temperature was maintained at (34 ± 0.2) ° C. The rectal temperature was maintained at 34.5 ° C for 72 h and then rewarmed spontaneously. Rectal temperature at room temperature group was maintained at 36-37.5 ℃. ECG, blood pressure, percutaneous oxygen saturation, nasopharyngeal temperature and rectal temperature were monitored in both groups. Heart rate disorders were detected for ECG testing. The main adverse reactions observed included mortality, severe arrhythmia, venous thrombosis or bleeding, and uncorrected hypotension. Blood samples were taken from the SHC group during 72 h of blood sampling to detect liver and renal function, blood routine, blood electrolytes, blood glucose and blood gas analysis. Observe other possible adverse reactions. Results The mortality rates of SHC group and normal temperature group were 17.9% and 25.0%, respectively (P = 0.20). Severe encephalopathy was found in both groups (6.8% in SHC group and normal temperature group 7.0%, P = 0.96) and respiratory failure (6.8% and 6.0% respectively in SHC group and normal temperature group, P = 0.80) Arrhythmia and DIC; 1 case of DIC and gastrointestinal hemorrhage occurred in SHC group; no severe and severe venous thrombosis was found in both groups. The probability of serious adverse reactions in the SHC and normothermic groups was 1.7% and 2.0%, respectively (P = 1.0). Heart rate was decreased during SHC treatment, but only 4 (3.4%) children had HR <80 / min; changes in blood pressure, liver function, renal function, blood electrolytes, blood biochemistry, blood gas analysis, No significant difference. Conclusions It is feasible and safe for SHC to treat HIE in full-term newborn with mild hypothermia for 72 h.