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SGS2013:网片与自体组织治疗阴道脱垂无差异

2013-5-15 作者:佚名   来源:EGMN 我要评论0
Tags: 阴道脱垂  

  美国南卡罗来纳州查尔斯顿——在美国妇外科医师协会(SGS)2013年会上(与美国外科医师协会联合主办),MedStar华盛顿医院中心/乔治城大学妇产与泌尿科的Robert E. Gutman博士报告称,一项前瞻性随机试验表明,无论阴道脱垂修复术使用的是阴道网片还是自身组织,术后3年随访时的治愈率和患者满意度都很高。

  在这项试验纳入的65例2~4期阴道脱垂妇女(之后受试者招募工作因15.6%的网片暴露率而终止)中,51例(网片组25例,非网片组26例)有生活质量数据可以用于3年最终分析,41例有2年或3年盆腔器官脱垂量化(POP-Q)检测数据。基线时,受试者被随机分配至网片组和非网片组。该试验的3个月数据和1年数据之前已经报告过。

  结果显示,术后3年两组患者的POP-Q分期或单项POP-Q评分均无明显差异,网片组和非网片组大部分患者的POP-Q分期较之基线都有所改善(分别占90%和86%)。此外,在症状改善程度方面,从盆底障碍量表(PFDI)、盆底影响问卷(PFIQ)、盆腔器官脱垂/尿失禁性功能量表(PISQ)评分及其亚量表评分来看,亦未发现组间差异。而且,根据各种治愈定义来判断的治愈率也没有组间差异。

  例如,如果把治愈定义为POP-Q分期≤1期,那么网片组和非网片组的治愈率分别为45%和43%。如果把治愈定义为无到达处女膜的脱垂,那么两组的治愈率分别为85%和71%。如果把治愈定义为没有膨出症状(PFDI第3条答案为“无”),两组治愈率分别为92%和81%。无论是采用上述定义还是其他定义,包括患者病情改善整体印象问卷(PGI-I)评分为非常好或很好,无脱垂再手术、综合采用各种定义的复合结局指标,都没有发现两组之间存在任何显著的统计学差异。

  Gutman博士在会上说,值得注意的是,在之前报告的1年分析结果(3例患者在术后1年内即需要接受手术切除)和3年分析结果之间没有出现新的网片暴露。只出现了1例1年后脱垂再手术病例,而这名患者其实也是在1年分析之前接受的二次手术。此外,阴道前壁脱垂患者的解剖学治愈率最低,并且无明显的组间差异。

  虽然该试验由于提前终止受试者招募工作而导致了检验效能不足,而且失访的患者人数也较多,但在其他方面仍然很有说服力,包括随访期长、多中心设计以及完善的治愈定义。

  Gutman博士总结道,鉴于网片组和非网片组的治愈率相似、两组的生活质量改善情况都很好、网片暴露率达到了15.6%、1年和3年随访之间只出现了1例新的网片暴露事件,提示“开展阴道网片修复术确实需要仔细权衡,包括充分的患者知情同意程序”。上述研究结果对阴道网片修复术的长期价值提出了质疑,因为使用了网片的患者相对于使用自身组织的患者并没有获得任何优势,反而出现了更多的并发症。

阴道相关的拓展阅读:

Mesh, native tissue for prolapse repair yield similar 3-year outcomes
CHARLESTON, S.C. – Cure rates and patient satisfaction following vaginal prolapse repair were high at 3-year follow-up regardless of whether vaginal mesh or native tissue was used for the repair, according to findings from a prospective randomized trial.
The findings raise questions about the long-term value of vaginal mesh repairs because subjects treated with mesh had more complications without experiencing benefit beyond that observed in the native tissue repair patients, Dr. Robert E. Gutman reported at the annual meeting of the Society of Gynecologic Surgeons.
Of 65 women who were enrolled in the trial before enrollment was halted because of a 15.6% mesh exposure rate, 51 – including 25 in the mesh group and 26 in the no mesh group – had quality of life data available for the planned 3-year final analysis, and 41 had 2- or 3-year pelvic organ prolapse quantification (POP-Q) examination information available.
No differences were noted between the groups with respect to POP-Q stage or individual POP-Q points at 3 years, and the majority in both the mesh and no mesh groups (90% and 86%, respectively) improved in stage from baseline, said Dr. Gutman of MedStar Washington Hospital Center and of the department of obstetrics and gynecology and urology at Georgetown University, both in Washington.
Furthermore, no differences were seen between the groups with respect to symptomatic improvement as assessed by the Pelvic Floor Distress Inventory (PFDI), the Pelvic Floor Impact Questionnaire (PFIQ), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ), including subscale scores. Also, cure rates – using a variety of definitions for cure – did not differ between the groups.
For example, based on a POP-Q stage of 1 or less as a definition of cure, 45% and 43% of those in the mesh and no mesh groups, respectively, were cured. When no prolapse beyond the hymen was used as a definition, 85% and 71% were cured When absence of bulge symptoms (a "no" answer to item 3 on the PFDI) was used as a definition, 92% and 81% were cured. The differences between the groups for these and other definitions – including a rating of very much better or much better on the Patient Global Impression of Improvement Index (PGI-I), having no prolapse reoperation, and composite outcomes using various combinations of these definitions – were not statistically significant, Dr. Gutman said.
Of note, no new mesh exposures occurred between the previously reported 1-year analysis (three cases required surgical excision before 1 year) and the 3-year analysis. The only prolapse reoperation after 1 year was in a woman who also had a reoperation prior to the 1-year analysis, he said at the meeting, which was jointly sponsored by the American College of Surgeons.
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