Infection Rates in a Large Investigational Trial of Sacral Nerve Stimulation for Fecal Incontinence
Infection Rates in a Large Investigational Trial of Sacral Nerve Stimulation for Fecal Incontinence
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DOI：
10.1007/s11605-010-1177-z
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发表时间：
2010-07-01
影响因子：
3.2
通讯作者：
Mellgren, Anders
中科院分区：
文献类型：
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作者：
Wexner, Steven D.;Hull, Tracy;Mellgren, Anders
大便失禁（FI）患者的治疗选择是有限的，手术治疗可能与高感染率和其他并发症有关。其中一种治疗方法，骶神经刺激（SNS），在欧洲被批准用于FI。在北美和澳大利亚进行了一项大型多中心试验，以评估SNS对慢性大便失禁患者的疗效。本报告的目的是分析该试验中感染并发症的发生率。有慢性大便失禁史的成年患者被纳入本研究。那些符合研究纳入/排除标准并表现出每周超过两次FI发作的患者进行了为期2周的SNS测试阶段。每周尿失禁发作和/或天数减少千分之一至50%的患者接受慢性刺激器植入。每个研究地点的研究人员将不良事件报告给主办者，然后进行编码。所有被编码为种植体部位感染的事件都包括在这个分析中。120名受试者（92%为女性，60.5 +/- 12.5岁）接受了长期植入的InterStimA (R)治疗装置（美敦力，明尼阿波利斯，MN， USA）。患者平均随访28个月（范围2.2-69.5）。120例植入者中有13例（10.8%）报告慢性系统植入后感染。1例感染自行消退，5例感染成功接受抗生素治疗。7例感染患者（5.8%）需要手术干预，6例感染患者需要全永久性装置摘除。试验刺激植入过程的持续时间在感染组（74分钟）和非感染组（74分钟）之间相似。慢性神经刺激器植入手术的平均持续时间在感染组（39分钟）和非感染组（37分钟）之间也相似。9例感染发生在慢性系统植入后一个月内，其余4例感染发生在植入后一年以上。虽然大多数（7/9）早期感染通过观察、抗生素或系统置换成功治疗，但所有4例晚期感染均导致永久性系统外植。SNS对FI的感染率相对较低。这一发现尤其重要，因为美国食品和药物管理局唯一批准的治疗终末期FI的方法是人工肠括约肌，其发病率要高得多。结合其公布的高治疗成功率，这种治疗具有积极的风险/收益概况。
Treatment options for patients with fecal incontinence (FI) are limited, and surgical treatments can be associated with high rates of infection and other complications. One treatment, sacral nerve stimulation (SNS), is approved for FI in Europe. A large multicenter trial was conducted in North America and Australia to assess the efficacy of SNS in patients with chronic fecal incontinence. The aim of this report was to analyze the infectious complication rates in that trial.Adult patients with a history of chronic fecal incontinence were enrolled into this study. Those patients who fulfilled study inclusion/exclusion criteria and demonstrated greater than two FI episodes per week underwent a 2-week test phase of SNS. Patients who showed a a parts per thousand yen50% reduction in incontinent episodes and/or days per week underwent chronic stimulator implantation. Adverse events were reported to the sponsor by investigators at each study site and then coded. All events coded as implant site infection were included in this analysis.One hundred twenty subjects (92% female, 60.5 +/- 12.5 years old) received a chronically implanted InterStimA (R) Therapy device (Medtronic, Minneapolis, MN, USA). Patients were followed for an average of 28 months (range 2.2-69.5). Thirteen of the 120 implanted subjects (10.8%) reported infection after the chronic system implant. One infection spontaneously resolved and five were successfully treated with antibiotics. Seven infections (5.8%) required surgical intervention, with infections in six patients requiring full permanent device explantation. The duration of the test stimulation implant procedure was similar between the infected group (74 min) and the non-infected group (74 min). The average duration of the chronic neurostimulator implant procedure was also similar between the infected (39 min) and non-infected group (37 min). Nine infections occurred within a month of chronic system implant and the remaining four infections occurred more than a year from implantation. While the majority (7/9) of the early infections was successfully treated with observation, antibiotics, or system replacement, all four of the late infections resulted in permanent system explantation.SNS for FI resulted in a relatively low infection rate. This finding is especially important because the only other Food and Drug Administration-approved treatment for end-stage FI, the artificial bowel sphincter, reports a much higher rate. Combined with its published high therapeutic success rate, this treatment has a positive risk/benefit profile.