Gastric electrical stimulation is safe and effective: A long-term study in patients with drug-refractory gastroparesis in three regional centers
Gastric electrical stimulation is safe and effective: A long-term study in patients with drug-refractory gastroparesis in three regional centers
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DOI：
10.1159/000102961
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发表时间：
2007-01-01
期刊：
影响因子：
3.2
通讯作者：
Abell, Thomas L.
中科院分区：
文献类型：
--
作者：
Anand, Curuchi;Al-Juburi, Amar;Abell, Thomas L.
背景：药物难治性胃轻瘫以前没有可接受的替代疗法。虽然胃电刺激已经使用了十多年，但没有长期的多中心数据。研究方法：我们连续研究了214例药物难治性胃轻瘫患者（146例特发性，45例糖尿病，23例手术后），他们同意从1992年1月至2005年1月在三个中心参加各种临床研究和临床方案，导致156名患者植入胃电刺激装置，另外58名患者作为对照。将患者分为三组：（1）同意但从未永久植入;（2）植入永久性器械，以及（3）在等待永久性器械时同意。随时间随访患者的胃肠道症状、固体胃排空、健康相关生活质量、生存率、器械保留和并发症。使用人口统计学、描述性统计量和t检验比较基线和末次随访。结果如下：在最近一次随访时，中位随访时间为4年，共5，568患者月，大多数植入患者（156例中的135例）存活，器械完好，胃肠道症状显著减轻，健康相关生活质量改善，胃排空改善，90%的患者在3种主要症状中至少有1种症状缓解。大多数患者通常因囊袋感染而接受手术，后来成功地重新植入。没有与器械直接相关的死亡。结论：基于在三个中心植入胃电刺激装置并随访长达十年的患者样本，胃电刺激治疗药物难治性胃轻瘫既安全又有效。
Background: Drug-refractory gastroparesis has previously been without acceptable alternative therapies. Although gastric electrical stimulation has been used for over a decade, no long-term multicenter data exist. Methods: We studied 214 consecutive drug-refractory patients with the symptoms of gastroparesis (146 idiopathic, 45 diabetic, 23 after surgery) who consented to participate in a variety of clinical research and clinical protocols at three centers from January 1992 through January 2005, resulting in 156 patients implanted with a gastric electrical stimulation device and the other 58 patients serving as controls. The patients were stratified into three groups: (1) consented but never permanently implanted; (2) implanted with permanent device, and (3) consented while awaiting a permanent device. The patients were followed over time for gastrointestinal symptoms, solid gastric emptying, health-related quality of life, survival, device retention, and complications. Demographics, descriptive statistics, and t tests were used for comparison between baseline and latest follow-up. Results: At latest follow-up, median 4 years for 5,568 patient months, most patients implanted (135 of 156) were alive with intact devices, significantly reduced gastrointestinal symptoms, and improved health-related quality of life, with evidence of improved gastric emptying, and 90% of the patients had a response in at least 1 of 3 main symptoms. Most patients explanted, usually for pocket infections, were later reimplanted successfully. There were no deaths directly related to the device. Conclusion: Based on this sample of patients, implanted with gastric electrical stimulation devices at three centers and followed for up toward a decade, gastric electrical stimulation for drug- refractory gastroparesis is both safe and effective.