Autologous skeletal-muscle-derived cell injection for anal incontinence due to obstetric trauma: a 5-year follow-up of an initial study of 10 patients
Autologous skeletal-muscle-derived cell injection for anal incontinence due to obstetric trauma: a 5-year follow-up of an initial study of 10 patients
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DOI：
10.1111/codi.12947
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发表时间：
2015-09-01
影响因子：
3.4
通讯作者：
Halligan, S.
中科院分区：
文献类型：
--
作者：
Frudinger, A.;Pfeifer, J.;Halligan, S.
目的探讨自体骨骼肌源性细胞注射治疗产科肛门失禁的疗效是否持续5年。方法对10例非手术治疗无效的产科肛门失禁患者进行观察研究。在超声引导下将自体骨骼肌源性细胞注入外括约肌缺损处。分别于植入前和植入后5年每年进行大小便失禁日记和生活质量问卷调查。分别于植入前、植入后1、2、5年进行肛门生理检查。终点包括不良事件、韦克斯纳尿失禁评分、大小便失禁发作、肛门挤压压力和5年以上的生活质量。一位独立的统计学家使用多水平线性回归来分析重复测量随时间的变化。在分析前对任何偏态分布进行对数转换。结果在5年期间，未发生与操作相关的不良事件，血液学和生化参数正常。治疗后Wexner尿失禁评分持续明显改善，排便次数和尿失禁次数减少(均P
AimOur aim was to determine whether the benefits of autologous skeletal-muscle-derived cell injection to treat obstetric anal incontinence are sustained at 5years.MethodAn observational study was performed of 10 women suffering from obstetric anal incontinence refractory to non-surgical therapy. Autologous skeletal-muscle-derived cells were injected into the external sphincter defect under ultrasound guidance. Incontinence diaries and quality of life questionnaires were obtained pre-implantation and annually after implantation for 5years. Anal physiology testing was performed before implantation and at 1, 2 and 5years after implantation. The end-points included were adverse events, Wexner incontinence scores, incontinence episodes, anal squeeze pressures and quality of life over 5years. An independent statistician used multilevel linear regression to analyse changes in repeated measures over time. Any skewed distributions were log transformed prior to analysis.ResultsNo procedure-related adverse events occurred and haematological and biochemical parameters were normal during the 5-year period. There were sustained significant improvements in the Wexner incontinence score and reduced frequency of defaecation and number of incontinence episodes (all comparisons P