Herting E, Gefeller O, Speer C P, Harms K, Halliday H L, Curstedt T, Robertson B
Research Unit for Experimental Perinatal Pathology, Karolinska Hospital, Stockholm, Sweden.
Eur J Pediatr. 1994 Nov;153(11):842-9. doi: 10.1007/BF01972895.
Within a randomized European multicentre trial the time of onset, severity and progression of intracerebral haemorrhages (ICH) were investigated prospectively by serial cranial ultrasonography in 343 ventilated infants with severe respiratory distress syndrome (RDS) following instillation of single or multiple doses of a natural porcine surfactant (Curosurf). In 148/343 infants (43%) ICH was diagnosed (grade I or II: 22%, grade III or IV: 21%). In 26 cases (8%) ICH was present on the ultrasound scan prior to surfactant instillation at a median age of 6 h. Incidence and severity of ICH was similar after single- or multiple-dose surfactant treatment. Using a logistic regression model the following risk factors predictive of ICH were defined: low birth weight, allocation to certain hospitals, vaginal delivery, Apgar score < or = 6, rectal temperature on admission < or = 36 degrees C, primary anaemia, acidosis prior to treatment, RDS grade IV in pre-treatment chest films and poor response to surfactant treatment.
Our study provides supportive evidence that multiple doses of Curosurf do not increase the risk for ICH as compared to single-dose administration.
在一项欧洲多中心随机试验中,对343例患有严重呼吸窘迫综合征(RDS)的通气婴儿在滴注单剂量或多剂量天然猪肺表面活性物质(固尔苏)后,通过系列头颅超声前瞻性地研究了脑出血(ICH)的发病时间、严重程度及进展情况。在343例婴儿中有148例(43%)诊断为ICH(Ⅰ级或Ⅱ级:22%,Ⅲ级或Ⅳ级:21%)。26例(8%)在滴注表面活性物质前超声检查发现有ICH,中位年龄为6小时。单剂量或多剂量表面活性物质治疗后ICH的发生率和严重程度相似。使用逻辑回归模型确定了以下预测ICH的危险因素:低出生体重、分配到某些医院、阴道分娩、阿氏评分≤6、入院时直肠温度≤36℃、原发性贫血、治疗前酸中毒、治疗前胸部X线片显示RDS为Ⅳ级以及对表面活性物质治疗反应不佳。
我们的研究提供了支持性证据,表明与单剂量给药相比,多剂量固尔苏不会增加ICH的风险。