选择性头部亚低温治疗新生儿缺氧缺血性脑病临床研究

目的 研究选择性头部亚低温(SHC)治疗新生儿缺氧缺血性脑病(HIE)的安全性及临床疗效.方法 收集新生儿重度HIE共54例,至入院96h有效病例41例,随机分为SHC组(n=21)和对照组(n=20).SHC组患儿生后6 h内开始给予SHC治疗,鼻咽部温度维持在(34.0±0.2)℃,直肠温度维持>34.5℃,持续72 h,然后自然复温;对照组患儿直肠温度维持36.0～37.5℃.两组均进行心电图、血压、经皮氧饱和度、鼻咽部温度和直肠温度监测.观察主要不良反应包括:严重心律失常、静脉血栓或出血、难以纠正的低血压.疗效观察指标包括:18个月时严重伤残发生率和病死率,智能测验运动发育指数及认知发育指数.结果 两组均未出现严重心律失常、低血压和肾功能衰竭.至生后18个月随访,共失访6例(14.6%),其中SHC组和对照组的失访率分别为14.3%(3/21)和15.0%(3/20),差异无显著性(P>0.05),实际有效病例SHC组为18例,对照组为17例.SHC组和对照组的死亡和严重伤残联合发生率分别为22.2%(4/18)、52.9%(9/17),差异有显著性(P<0.05).结论 SHC持续72 h治疗新生儿HIE是可行和安全的,可降低神经系统后遗症发生率及严重伤残率.

Clinical study of selective head cooling with mild systemic hypothermia in neonates with hypoxic-ischemic encephalopathy

Objective To study the safety and efficacy of selective head cooling (SHC) with mild systemic hypotherrnia in neonates with HIE. Methods Fifty-four term infants with severe neonatal HIE were randomly assigned to the head cooling group (n=27) and control group (n=27). Forty-one infants in 96 h after admission were eligible for the study(SHC group n=21, control group n=20). In SHC group, the naso-pharyngeal temperature was maintained at (34.0±0.2) ℃ and rectal temperature maintained at 34～35 ℃ for 72 h, then rewarmed spontaneously. In control group, normal rectal temperature was maintained. During the period of the study, the infants of two groups were monitored on nasopharyngeal temperature, heart rate, respiratory rate,transcutaneous arterial oxygen saturation and blood pressure. Primary adverse effects inclu-ding severe arrhythmia, venous thrombosis or hemorrhage and severe hypotension were observed. The efficacy indicators including rate of death and severe disability, exercise and cognition development index were as-sessed. Results Severe arrhythmia, hypotension and renal failure were not found in both groups. Follow-up was conducted until postnatal 18 months and was not available in 6 babies (3 in SHC group and 3 in control group respectively). Death and severe disability occurred in 4 of 18 infants (22.2%)in SHC group and in 9 of 17 infants(52.9% ) in the control group respectively (P<0.05). Conclusion SHC for 72 h with mild systemic hypothermia in neonates with HIE is safe and effective. The therapy could reduce the risk of disabili-ty and handicap significantly.