摘要
既往的一项随机化临床试验，对持续性胸腔外负压（CNEP）和标准疗法对于呼吸窘迫综合征新生儿的疗效进行了比较研究，其研究结果引发了公众对于新生儿死亡率和致残率的关注。作者以该项试验所纳入的儿童作为对象，调查其在儿童期晚期的临床结局，研究上述两种人工通气模式是否会引发远期后遗症。方法：由一名儿科医师和一名心理医师，根据标准测验方法，对门诊患儿进行神经学临床结局、认知功能和残疾状况评估。从原先接受临床试验项目的205例存活患儿中，挑选133例，当其9-15岁时进行相关评估。原先的试验将患儿对随机化分为两组，分别接受两种不同的人工通气模式治疗；其中65对患儿的资料完整，被纳入本次研究。以死亡或残疾作为主要临床结局的评估指标。结果：两组患儿的主要临床结局基本一致（CNEP组 OR1．0，95％CI0．14-2．41）。经分析，两组间治疗方式无显著性差异（OR1．05，0．54-2．06）。总体IQ不存在显著的组间差异，但是，CNEP组的平均作业IQ比传统治疗组高6．8分（95％CI1．5-12．1）。神经心理学测试结果与上述检验结果相一致，但是，CNEP组患儿的语言表达和视觉空间技能评分明显较高。结论：尽管一些不良的新生儿临床结局存在着细微的组间差异，但是，无论配对比较还是非配对分析，均不能确证新生儿CNEP将导致更加严重的长期后遗症的发生。通过本次研究，作者认为：将来对新生儿医疗干预措施进行研究时，如果这些措施可能对患儿迟发性残疾状况造成影响，那么，进行试验设计时，就应当对其长期临床结局加以关注。
A previous randomlsect trtat negative extrathoracic pressure （CNEP） versus standard treatment tor newborn infants with respiratory distress syndrome raised public concerns about mortality and neonatal morbidity. We studied the outcome in late childhood of children entered into the trial to establish whether there were long-term sequelae attributable to either mode of ventilation. Methods： Outpatient assessment of neurological outcome, cognitive function, and disability was done by a paediatrician and a psychologist using standardised tests.133 of 205 survivors from the original trial were assessed at 9 - 15 years of age. Of the original pairs randomly assigned to each ventilation mode, the results from 65 complete pairs were available. The primary outcome was death or severe disability. Findings： Primary outcome was equally distributed between groups （odds ratio for the CNEP group 1.0; 95%CI 0.41 -2.41） In unpaired analysis there was no significant difference between treatment modalities （1.05,0. 54 -2.06） . Full IQ did not differ significantly between the groups, but mean performance IQ was 6.8 points higher in the CNEP group than in the conventional-treatment group （95%CI 1.5 - 12. 1） -. Results of neuropsychological testing were consistent with this finding, with scores on language production and visuospatial skills being significantly higher in the CNEP group. Interpretation： We saw no evidence of poorer longterm outcome after neonatal CNEP whether analysis was by original pairing or by unpaired comparisons, despite small differences in adverse neonatal outcomes. The experience of our study indicates that future studies of neonatal interventions with the potential to influence later morbidity should be designed with longer-term outcomes in mind.
