Division of Pediatric Neurosurgery, Neuroscience Institute, Johns Hopkins All Children's Hospital, Saint Petersburg, Tampa, Florida; Division of Pediatric Neurosurgery, Department of Neurosurgery and Brain Repair, University of South Florida, Tampa, Florida; Department of Pediatrics, Johns Hopkins Medicine, Baltimore, Maryland.
Department of Urology, University of South Florida, Tampa, Florida.
J Urol. 2016 Dec;196(6):1735-1740. doi: 10.1016/j.juro.2016.05.111. Epub 2016 Jun 8.
Although previous studies have revealed high success rates (70% to 85%) after an intradural somatic-to-autonomic nerve transfer procedure in children with spinal dysraphism, no study has had a control group or blinded observers. We report a rigorously designed study to investigate the effectiveness of the Xiao procedure.
Children with neurogenic bladder dysfunction related to myelomeningocele or lipomyelomeningocele who required spinal cord detethering were randomized to 2 groups at surgery, with half undergoing only spinal cord detethering and half undergoing the Xiao procedure in addition to detethering. Double-blind evaluations were performed at regular intervals during the 3-year followup.
A total of 10 patients underwent spinal cord detethering only and 10 underwent detethering plus the Xiao procedure. The Xiao procedure did not result in voluntary voiding or continence in any patient, but patients undergoing spinal cord detethering plus the Xiao procedure were more likely to have greater improvements in total bladder capacity, bladder overactivity and overall quality of life than those who underwent detethering only. By the end of the study no participant or evaluator was able to accurately predict to which group the patients had been assigned.
The results of this randomized controlled trial are in agreement with recently published similarly poor results of the Xiao procedure in patients with spinal cord injury. Improvements in bladder parameters observed in this study may be related to sacral nerve root section, a necessary portion of the Xiao procedure, instead of reinnervation. Confirmatory animal studies are recommended before further clinical trials of the Xiao procedure are performed in humans.
尽管先前的研究显示，在脊髓脊膜膨出症儿童中进行硬脊膜内体感觉神经至自主神经转移手术后成功率较高（70%至 85%），但没有研究设立对照组或盲法观察者。我们报告一项严格设计的研究，以调查肖氏手术的有效性。
有神经源性膀胱功能障碍的儿童，这些儿童与脊髓脊膜膨出或脂肪脊膜膨出相关，需要进行脊髓松解术，在手术时将这些儿童随机分为两组，一组仅进行脊髓松解术，另一组除了进行脊髓松解术外，还进行肖氏手术。在 3 年的随访期间定期进行双盲评估。
共有 10 名患者仅进行脊髓松解术，10 名患者进行脊髓松解术加肖氏手术。肖氏手术没有导致任何患者出现自主排尿或控尿，但接受脊髓松解术加肖氏手术的患者比仅接受脊髓松解术的患者在总膀胱容量、膀胱过度活动和整体生活质量方面更有可能出现更大的改善。到研究结束时，没有参与者或评估者能够准确预测患者被分配到哪个组。
这项随机对照试验的结果与最近发表的脊髓损伤患者肖氏手术同样较差的结果一致。本研究中观察到的膀胱参数的改善可能与肖氏手术中必需的一部分——骶神经根切断有关，而不是再神经支配。建议在对人类进一步进行肖氏手术的临床试验之前，进行确认性动物研究。
