Vakil B J, Armitage P, Clifford R E, Laurence D R
Trans R Soc Trop Med Hyg. 1979;73(5):579-83. doi: 10.1016/0035-9203(79)90058-0.
A trial has been conducted of the efficacy of human tetanus immunoglobulin (250 I U) administered intrathecally (intracisternally) in addition to standard treatment (equine antitoxin intravenously, penicillin, anticonvulsants). The trial was analysed sequentially and was stopped for 120 patients when there was no longer any chance of achieving a statistically significant difference in favour of intrathecal administration. The sequential plan was modified during the trial. A prognostic correlation was found between onset of the first symptom and admission to hospital.
除标准治疗(静脉注射马抗毒素、青霉素、抗惊厥药)外,还进行了一项关于鞘内(脑池内)注射人破伤风免疫球蛋白(250 IU)疗效的试验。该试验采用序贯分析,当鞘内给药不再有任何机会产生统计学显著差异时,对120例患者停止试验。试验过程中对序贯计划进行了修改。发现首发症状出现与入院之间存在预后相关性。