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骶神经调节疗法会一直存在吗?一种治疗大便失禁的新疗法的临床效果。

Is sacral neuromodulation here to stay? Clinical outcomes of a new treatment for fecal incontinence.

作者信息

Johnson Bobby L, Abodeely Adam, Ferguson Martha A, Davis Bradley R, Rafferty Janice F, Paquette Ian M

机构信息

Department of Surgery, Division of Colorectal Surgery, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.

出版信息

J Gastrointest Surg. 2015 Jan;19(1):15-9; discussion 19-20. doi: 10.1007/s11605-014-2611-4. Epub 2014 Aug 13.

Abstract

INTRODUCTION

Sacral neuromodulation (SNM) was approved by the FDA for the treatment of fecal incontinence (FI) in 2011, and previous industry-sponsored trials have shown excellent clinical outcomes. The purpose of this study is to examine clinical outcomes of patients treated during our initial experience with SNM.

METHODS

A prospective database of patients treated with SNM for FI by one of three colorectal surgeons at two separate institutions was maintained starting in 2011. Patients showing ≥50% improvement of weekly incontinent episodes during test stimulation were offered permanent implantation of the SNM device. Disease severity was tracked using the Wexner score.

RESULTS

A total of 145 patients received a full system implantation (of 152 who received test stimulation). The median preoperative Wexner score of 14 decreased to 3, 3 months after implantation and persisted to 12 months. At 12 months, 95.2% of patients achieved >50% improvement in Wexner Score and 67.6% achieved >75% improvement. The most common adverse event was infection (3.4%). Three patients (2.1%) required lead revision.

CONCLUSIONS

SNM is a safe and effective therapy for the treatment of FI. Postoperative patient surveillance is important, as many patients require programming changes, and some will require a lead revision over time.

摘要

引言

骶神经调节(SNM)于2011年获美国食品药品监督管理局(FDA)批准用于治疗大便失禁(FI),此前由行业资助的试验已显示出出色的临床效果。本研究的目的是检验在我们最初使用SNM的经验中接受治疗的患者的临床效果。

方法

从2011年开始,维护一个由两家独立机构的三位结直肠外科医生之一为治疗FI而接受SNM治疗的患者的前瞻性数据库。在测试刺激期间每周失禁发作改善≥50%的患者被提供SNM设备的永久植入。使用韦克斯纳评分跟踪疾病严重程度。

结果

共有145名患者接受了完整系统植入(152名接受测试刺激的患者中)。术前韦克斯纳评分中位数为14,植入后3个月降至3,并持续至12个月。在12个月时,95.2%的患者韦克斯纳评分改善>50%,67.6%的患者改善>75%。最常见的不良事件是感染(3.4%)。三名患者(2.1%)需要导线翻修。

结论

SNM是治疗FI的一种安全有效的疗法。术后患者监测很重要,因为许多患者需要调整程控,而且随着时间的推移,一些患者将需要导线翻修。

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