A pilot study of intrastricture steroid versus placebo injection after balloon dilatation of Crohn's strictures
A pilot study of intrastricture steroid versus placebo injection after balloon dilatation of Crohn's strictures
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DOI：
10.1016/j.cgh.2007.04.013
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发表时间：
2007-09-01
影响因子：
12.6
通讯作者：
Saunders, Brian P.
中科院分区：
文献类型：
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作者：
East, James E.;Brooker, Jim C.;Saunders, Brian P.
背景与目的：因克罗恩病而行回结肠切除术后发生肠梗阻是很常见的。结肠镜球囊扩张是有效的，但经常需要反复扩张。在回顾性研究中，有报道称球囊扩张后结构内注射类固醇可减少重复扩张的需要，但没有随机数据。方法：我们进行了一项初步研究，比较内镜下克罗恩回结肠吻合口狭窄球囊扩张后局部注射曲安奈德（总剂量40 mg）与生理盐水安慰剂。主要终点为再扩张或手术时间。随访52周。结果：13例患者随机分组，7例使用类固醇，6例使用安慰剂。各组基线和扩张特征匹配良好。意向治疗分析中，安慰剂组6例患者中有1例需要再扩张，类固醇组7例患者中有5例需要再扩张（log rank检验P= 0.06； Cox回归P= 0.10；风险比6.1；95%可信区间0.7-53.0）。在按方案分析中，差异更为显著（对数秩检验P= 0.03； Cox回归P= 0.07；风险比为7.7；95%可信区间为0.9-67.9）。结论：对克罗恩氏回结肠吻合口狭窄行球囊扩张后，单纯使用曲安奈德注射液治疗并不能缩短再扩张时间，且有恶化的趋势。在获得更多的数据之前，应仔细考虑在临床实践中使用该技术。
Background & Aims: Restricturing after ileocolonic resection for Crohn's disease is common. Colonoscopic balloon dilatation is effective but repeated dilatations often are required. Intrastricture steroid injection after balloon dilatation has been reported to reduce the need for repeat dilatation in retrospective series, but no randomized data are available. Methods: We performed a pilot study comparing local quadrantic injection of triamcinolone (40 mg total dose) after endoscopic balloon dilatation of Crohn's ileocolonic anastomotic strictures vs saline placebo. The primary end point was time to redilatation or surgery. Patients were followed up for 52 weeks. Results: Thirteen patients were randomized, 7 to steroid and 6 to placebo. Groups were well matched for baseline and dilatation characteristics. In the intention-to-treat analysis, 1 of 6 patients in the placebo group and 5 of 7 patients in the steroid group needed redilatation (log rank test P=.06; Cox regression P=.10; hazard ratio, 6.1; 95% confidence interval, 0.7-53.0). In the per-protocol analysis the differences were more significant (log rank test P=.03; Cox regression P=.07; hazard ratio, 7.7; 95% confidence interval, 0.9-67.9). Conclusions: A single treatment of intrastricture triamcinolone injection did not reduce the time to redilatation after balloon dilatation of Crohn's ileocolonic anastomotic strictures and there was a trend toward a worse outcome. The use of this technique in clinical practice should be considered carefully until more data are available.