骶棘韧带固定术与坐骨棘筋膜固定术的疗效及其对生活质量的影响比较

Due to increasing life expectancy, pelvic organ prolapse (POP) is becoming a common disease negatively affecting parous women over 50 years of age and has a lifetime risk of 30-50%, which poses a great challenge for gynecologists. Approximately 11% of all women require operation for prolapse or urinary incontinence in her whole life, but surgeries are limited in application due to issues involving low cure rate and high recurrent rate. Adequate apical support is recognized as an essential component of a durable repair. Sacrospinous ligament fixation (SSLF) is one of the most widely used operations for apical fixation. In 2007, Peking Union Medical College Hospital invented the ischial spine fascia fixation (ISFF). Although both surgeries fix the vaginal apex to the pelvic ligaments, due to the depth of the sacrospinous ligament, SSLF often need auxiliary equipments, with a surgical success rate of about 60.5%; while the ischial spine fascia is easier to expose and suture to, which makes ISFF easier to learn and perform and with a reported surgical success rate higher than 94%. But the very few investigations on ISFF were all retrospective or prospective cohort studies to date. Therefore, we aim at further assessing the short and long-term efficacy of SSLF and ISFF in treating stage III~IV POP and their recurrence rate using Randomized Clinical Trial to produce the high level of proof for the first time. In the meantime, we include the impacts of these two operations on quality of life, in order to facilitate clinical decision making and in pursuit of an operation with better efficacy and higher satisfaction to eventually benefit more patients.

随着预期寿命增加，盆腔脏器脱垂（POP)渐成中老年妇女的常见病，其终身患病率为30-50%，严重影响妇女生活质量，临床处理棘手。约11％的妇女在一生中可能因POP或尿失禁接受手术，但现有手术方式都存在治愈率低、复发率高等问题。足够的顶端支撑是疗效持久的关键因素，其中骶棘韧带固定术（SSLF)是最常用的术式之一。2007年北京协和医院创立了坐骨棘筋膜固定术（ISFF）。虽然两者都将阴道顶端固定于骨盆韧带上，但骶棘韧带较深，致SSLF常需辅助器械，手术成功率约60.5%；而坐骨棘筋膜更易暴露和缝合，故ISFF更简单易学，手术成功率报道为94%。但目前ISFF相关研究仅有几项回顾性或前瞻性队列研究。本课题组首次采用证据级别高的随机对照试验来评估SSLF和ISFF治疗III~IV度中盆腔缺陷的近远期疗效、复发率，并首次评估其对患者生活质量的影响，以利临床决策，推广疗效更好、满意度更高的手术，造福更多患者。

随着人类预期寿命增加，盆腔脏器脱垂（POP)已成为了严重困扰中老年妇女的常见疾病。尽管手术方式繁多但普遍存在治愈率低、复发率高等问题，约11％的妇女在一生中可能因POP或尿失禁接受手术。骶棘韧带固定术（SSLF)是利用自身组织行顶端支撑最常用的术式之一。而2007年北京协和医院创立的坐骨棘筋膜固定术（ISFF）利用坐骨棘筋膜更易暴露和缝合的优势，术式更简单易学，但其效果缺乏高质量的研究佐证。本课题组首次采用高证据级别的随机对照试验来评估SSLF和ISFF治疗III~IV度中盆腔缺陷的近远期疗效、复发率，并首次评估其对患者生活质量的影响。已纳入的53例患者中有23例接受了SSLF，30例接受了ISFF，两组间除新生儿出生体重以外的其他各项术前一般情况情况及盆腔器官脱垂定量分度（POP-Q）均具有可比性。手术时间、出血量在两组间也无显著性差异。术后疼痛的发生率在ISFF和SSLF组分别为10%和34.7%，两组各有1例出现了新发的压力性尿失禁。SSLF组有1例出现术后血肿，经保守治疗后好转。两组的手术成功率、主观满意度均为100%。SSLF组的复发率为4.3%（1/23，患者暂不愿手术）。两组在术后3个月的Aa、Ba、Ap、Bp和D点均较术前明显改善（p＜0.001）；而术后3年时跟术前比较，Ap、Bp和D点仍较术前明显改善（p＜0.015）。ISFF组除PFDI-20问卷中的肠道功能分项以外，其他的各项问卷在术后3个月时均较术前明显改善（p＜0.01）；而术后3年时问卷显示的差异并不明显。进一步研究发现两组患者术前和术后的尿流率各项指标均没有明显差异。目前的研究结果显示ISFF可取得与SSLF相当的疗效，且操作更易掌握，更适宜向基层推广，以造福更多患者。