脑室内注射重组组织型纤溶酶原激活剂治疗出血后脑积水的I期研究
Phase I study of intraventricular recombinant tissue plasminogen activator for treatment of posthaemorrhagic hydrocephalus.
作者信息
Whitelaw A, Saliba E, Fellman V, Mowinckel M C, Acolet D, Marlow N
机构信息
Department of Paediatrics, Aker Hospital, University of Oslo, Norway.
出版信息
Arch Dis Child Fetal Neonatal Ed. 1996 Jul;75(1):F20-6. doi: 10.1136/fn.75.1.f20.
AIM
Phase I study to evaluate intraventricular fibrinolytic treatment with recombinant tissue plasminogen activator (tPA) as a method of clearing blood from the cerebrospinal fluid, and thus preventing permanent hydrocephalus.
METHODS
Twenty two preterm infants, aged 7 to 26 days, with progressive posthaemorrhagic ventricular dilatation (ventricular width > 4 mm over 97th centile) received one to five intraventricular bolus injections of 1.0 mg or 0.5 mg tPA at intervals of one to seven days.
RESULTS
The mean cerebrospinal fluid concentration of tPA 24 hours after 1 mg was 1860 micrograms/ml. The half life of tPA in cerebrospinal fluid was about 24 hours. Twenty one (95%) infants survived, 12 (55%) without shunt surgery. One infant had secondary intraventricular haemorrhage.
CONCLUSION
Intraventricular tPA resulted in survival without a shunt for most of the infants, but with some risk. Failure may have been due to plasminogen deficiency, an inhibitor, or late intervention.
目的
进行一项I期研究，以评估用重组组织型纤溶酶原激活剂（tPA）进行脑室内纤溶治疗作为一种从脑脊液中清除血液从而预防永久性脑积水的方法。
方法
22名年龄在7至26天的早产儿，患有进行性出血后脑室扩张（脑室宽度超过第97百分位数4毫米），每隔1至7天接受1至5次脑室内推注1.0毫克或0.5毫克tPA。
结果
1毫克tPA给药24小时后脑脊液中tPA的平均浓度为1860微克/毫升。tPA在脑脊液中的半衰期约为24小时。21名（95%）婴儿存活，12名（55%）无需分流手术。1名婴儿发生继发性脑室内出血。
结论
脑室内注射tPA使大多数婴儿存活且无需分流，但存在一定风险。治疗失败可能是由于纤溶酶原缺乏、存在抑制剂或干预过晚。
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