Maxwell Nicola C, Nuttall Diane, Kotecha Sailesh
Department of Child Health, Cardiff University, Cardiff, United Kingdom.
Early Hum Dev. 2009 May;85(5):291-6. doi: 10.1016/j.earlhumdev.2008.12.002. Epub 2009 Jan 13.
Ureaplasma has long been implicated in the pathogenesis of both preterm labour and neonatal morbidity, particularly chronic lung disease of prematurity (CLD), but despite numerous studies, reviews and meta-analyses, its exact role remains unclear. Many papers call for a definitive randomised control trial to determine if eradication of pulmonary Ureaplasma decreases the rates of CLD but few address in detail the obstacles to an adequately powered clinical trial. We review the evidence for Ureaplasma as a causative agent in CLD, asking why a randomised control trial has not been performed. We surveyed the opinions of senior neonatologists in the UK on whether they felt that there was sufficient evidence for Ureaplasma either causing or not causing CLD and whether a definitive trial was needed, as well as their views on the design of such a trial. Additionally, we ascertained current practice with respect to Ureaplasma detection in preterm neonates in the UK. There is clear support for an adequately powered randomised controlled clinical trial by senior neonatologists in the UK. There are no reasons why a definitive trial cannot be conducted especially as the appropriate samples, and methods to culture or identify the organism by PCR are already available.
脲原体长期以来一直被认为与早产和新生儿发病机制有关，尤其是早产儿慢性肺病（CLD），但尽管有大量研究、综述和荟萃分析，其确切作用仍不清楚。许多论文呼吁进行一项确定性随机对照试验，以确定根除肺部脲原体是否能降低CLD的发生率，但很少有论文详细讨论开展一项有足够效力的临床试验所面临的障碍。我们回顾了脲原体作为CLD致病因子的证据，探讨为何尚未进行随机对照试验。我们调查了英国资深新生儿科医生对于他们是否认为有足够证据证明脲原体导致或不导致CLD以及是否需要进行确定性试验的看法，以及他们对该试验设计的意见。此外，我们确定了英国目前对早产新生儿进行脲原体检测的做法。英国资深新生儿科医生明确支持开展一项有足够效力的随机对照临床试验。没有理由不能进行确定性试验，特别是因为合适的样本以及通过PCR培养或鉴定该病原体的方法已经具备。
