苯巴比妥预防早产儿脑室内出血的多中心调查报告  

Multicenter investigative report for the effect of prophylactic phenobarbital on intraventricular hemorrhage in premature infants in China

作　　者：陈惠金[1] 魏克伦[2] 姚裕家[3] 杨于嘉[4] 周丛乐[5] 范秀芳[6] 高喜容[7] 江莲[8] 刘晓红[9] 钱继红[1] 王莉[10] 吴本清 吴高强 张青梅[13] 张小兰[14] 周晓玉[15] 

机构地区：[1]上海交通大学医学院附属新华医院上海市儿科医学研究所,上海200092 [2]中国医科大学附属二院,辽宁沈阳110004 [3]四川大学附属华西第二医院,四川成都610041 [4]中南大学附属湘雅医院,湖南长沙410011 [5]北京大学附属第一医院,北京100034 [6]山东省济南市妇幼保健院,山东济南250012 [7]湖南省儿童医院,湖南长沙410007 [8]河北医科大学第四医院,河北石家庄050011 [9]广东省深圳市儿童医院,广东深圳518026 [10]新疆医科大学一附院,乌鲁木齐830054 [11]暨南大学第二附属医院广东省深圳市人民医院,广东深圳518020 [12]新疆乌鲁木齐市妇幼保健院,新疆乌鲁木齐830000 [13]辽宁省沈阳市妇婴医院,辽宁沈阳110014 [14]广东省深圳市妇幼保健院,广东深圳518028 [15]南京大学附属南京儿童医院,江苏南京210008

出　　处：《临床儿科杂志》2008年第11期986-993,共8页Journal of Clinical Pediatrics

基　　金：中华医学会儿科分会新生儿学组立项课题

摘　　要：目的作为早产儿脑室内出血(IVH)的预防药物,苯巴比妥一直以来颇存争议,褒贬参半,近年来已不再被推荐在早产儿中预防应用。为了客观评估苯巴比妥对早产儿IVH的预防效果,在中华医学会儿科分会新生儿学组的发起下,国内十余家大型医院于2005年1月始进行了为期近两年的早产儿脑损伤多中心协作研究。方法2005年1月至2006年8月期间,3家单位对所有胎龄≤34周的早产儿和2家单位对所有胎龄<37周早产儿在生后6h内给予苯巴比妥负荷量20mg/kg,24h后再予维持量5mg/(kg·d)共5d。对所有早产儿在生后7d内常规进行初次床边头颅B超检查,以后每隔3～7d复查一次,直至出院。结果5家单位接受苯巴比妥预防的早产儿共1574例作为预防组,5家单位中主要因疏忽而漏予苯巴比妥的早产儿以及另4家单位未接受苯巴比妥预防的所有早产儿共1433例为对照组。两组在胎龄、出生体重、性别、Apgar评分以及分娩方式之间的差异均无统计学意义。预防组IVH和重度IVH发生率分别为9.8%(154/1574例)和2.0%(32/1574例);对照组IVH和重度IVH发生率分别为14.1%(202/1433例)和3.6%(52/1433例)。两组在IVH和重度IVH发生率之间的差异均有统计学意义(χ2=13.364,P=0.000;χ2=7.034,P=0.008)。预防组由重度IVH向轻度IVH的转变率明显高于对照组(62.5%vs1.9%,连续性校正χ2=21.201,P=0.000)。对两组高危因素分析显示,应用苯巴比妥可明显改善因机械呼吸而容易导致的IVH加重现象。结论调查数据基本可反映我国主要大城市中苯巴比妥预防早产儿IVH的实际疗效。结果显示,苯巴比妥对早产儿IVH具有良好的预防作用,尤其可以肯定其在稳定病情、减轻IVH严重程度的效果,可为新生儿学组制定我国相应的早产儿脑损伤防治方案提供参考。根据这项多中心调查结果,可以推荐对早产儿在生后早期常规应用苯巴比妥预防IVH。Objectives Prophylactic phenobarbital therapy is much controversial all the time with either positive or negative appraisal for the prevention of intraventricular hemorrhage （IVH） in premature infants. It is recently no longer routinely used clinically. In order to assess objectively the effect of phenobarbital on IVH, sponsored by the Subspecialty Group of Neonatology of Pediatric Society, China Medical Association, more than ten large-scale hospitals joined the near two-year multicenter investigation named Brain Injuries in Premature Infants in China. The present study presents the investigative result for the effect of prophylactic phenobarbital on IVH in premature infants in 5 big hospitals that all belong to the Third Class and A Level licensed. Methods All premature infants with gestation less than 34 weeks in three hospitals and less than 37 weeks in other two hospitals received phenobarbital intravenously on loading, doses of 20 mg/kg as early than 6 hours of age as possible. Twenty-four hours after loading, a maintenance .dose of 5 mg/kg daily was followed for 5 days. All premature infants were routinely examined by cranial ultrasound within seven days after birth, and then repeated every another 3 - 7 days till the discharge from the hospital during Jan. 2005 to Aug. 2006. Results A total of 3007 premature infants were admitted to 9 hospitals during the investigation. Among them, 1 754 cases in five hospitals received phenobarbital early after birth as the prophylactic group, other 1 433 cases in four hospitals did not receive phenobarbital as control group including 37 cases in 5 hospitals without the use of phenobatbital due to neglect. No significant differences in gestational age, birth weight, sex, Apgar scores and delivery mode were found between two groups. The incidences of IVH and severe IVH were 9.8% （154/1574） and 2.0% （32/1574） in the prophylactic group, and 14.1% （202/1433） and 3.6% （52/1433） in control group, respectively. There were very significant differences in the

关 键 词：早产儿 脑室内出血 苯巴比妥 多中心研究 中国 

分 类 号：R722.6[医药卫生—儿科]