Spradlin Natalie M, Wise Paul E, Herline Alan J, Muldoon Roberta L, Rosen Michael, Schwartz David A
Inflammatory Bowel Disease Center, Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA.
Am J Gastroenterol. 2008 Oct;103(10):2527-35. doi: 10.1111/j.1572-0241.2008.02063.x. Epub 2008 Aug 5.
To prospectively determine if rectal endoscopic ultrasound (EUS) can guide combination medical and surgical therapy and improve outcomes for patients with perianal fistulizing Crohn's disease.
Ten patients with perianal Crohn's disease were prospectively enrolled in a randomized prospective pilot study. The patients were randomized to either the EUS cohort or the control group. All patients underwent a rectal EUS to delineate fistula anatomy followed by an examination under anesthesia by a colorectal surgeon with seton placement and/or incision and drainage, as indicated. The surgeon was blinded to the initial EUS results of patients in the control group. Medical treatment was maximized with 6-mercaptopurine (1.0-1.5 mg/kg) or azathioprine (2.0-2.5 mg/kg), ciprofloxacin (1,000 mg a day) or metronidazole (1,500 mg a day), and infliximab (5 mg/kg at 0, 2, and 6 wk and then every 8 wk). For patients in the control group, additional interventions (seton removal and repeat surgery) were at the discretion of the surgeon (without EUS guidance). Patients in the EUS cohort had EUS performed at weeks 22 and 38, with additional surgical interventions based on EUS findings. The primary end point was complete cessation of drainage at week 54. All patients had a repeat EUS performed at week 54 to determine the fistula status on EUS (secondary end point). The need for additional surgery was defined as a treatment failure.
Ten patients were enrolled in the study. One of 5 (20%) in the control group and 4 of 5 (80%) in the EUS group had complete cessation of drainage. From the control group, 3 patients failed due to repeat surgery (2 for persistent/recurrent fistula and 1 for abscess), and 1 had a persistent drainage at week 54. In the EUS cohort, 1 patient had a recurrent abscess after his seton fell out prematurely. In the EUS cohort, the median time to cessation of drainage was 99 days, and the time to EUS evidence of fistula inactivity was 229 days.
This pilot study suggests that using EUS to guide combination medical and surgical therapy for perianal fistulizing Crohn's disease improves the outcomes.
前瞻性地确定直肠内镜超声（EUS）能否指导肛周瘘管型克罗恩病患者的药物与手术联合治疗并改善其预后。
10例肛周克罗恩病患者前瞻性纳入一项随机前瞻性试验研究。患者被随机分为EUS组或对照组。所有患者均接受直肠EUS以明确瘘管解剖结构，随后由结直肠外科医生在麻醉下进行检查，根据情况放置挂线和/或切开引流。对照组患者的外科医生对其初始EUS结果不知情。采用6-巯基嘌呤（1.0 - 1.5mg/kg）或硫唑嘌呤（2.0 - 2.5mg/kg）、环丙沙星（每日1000mg）或甲硝唑（每日1500mg）以及英夫利昔单抗（0、2和6周时剂量为5mg/kg，随后每8周一次）使药物治疗达到最大化。对于对照组患者，额外的干预措施（拆除挂线和再次手术）由外科医生自行决定（无EUS指导）。EUS组患者在第22周和第38周进行EUS检查，并根据EUS检查结果进行额外的手术干预。主要终点为第54周时引流完全停止。所有患者在第54周时再次进行EUS检查以确定EUS上的瘘管状态（次要终点）。额外手术的需求被定义为治疗失败。
10例患者纳入研究。对照组5例中有1例（20%）、EUS组5例中有4例（80%）引流完全停止。对照组中，3例患者因再次手术失败（2例因持续性/复发性瘘管，1例因脓肿），1例在第54周时仍有持续性引流。在EUS组中，1例患者在挂线过早脱落后继发脓肿。在EUS组中，引流停止的中位时间为99天，EUS显示瘘管无活动性的时间为229天。
这项试验研究表明，使用EUS指导肛周瘘管型克罗恩病的药物与手术联合治疗可改善预后。
