一项针对胃轻瘫的临时内镜下黏膜胃电刺激的双盲、随机、安慰剂对照试验。
A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis.
机构信息
Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.
出版信息
Gastrointest Endosc. 2011 Sep;74(3):496-503.e3. doi: 10.1016/j.gie.2011.05.022.
BACKGROUND
Endoscopically placed, temporary gastric electrical stimulation (tGES) may relieve symptoms of gastroparesis (Gp) and predict permanent gastric electrical stimulation (GES) outcomes.
OBJECTIVE
To measure effects of 72 hours of temporary GES on Gp symptoms.
DESIGN, SETTING, AND PATIENTS: From 2005 to 2006, we conducted a hospital-based, randomized, placebo-controlled, crossover trial of two consecutive, 4-day sessions (session 1 and session 2), enrolling 58 patients (11 males, 47 females; mean age 46 years) with GP symptom histories of three etiologies (idiopathic, 38; diabetes mellitus, 13; postsurgical, 7).
INTERVENTION
72 continuous hours temporary GES was provided for group A during session 1, and for group B during session 2.
MAIN OUTCOME MEASUREMENTS
Symptoms measured daily; gastric emptying, electrogastrography, and quality of life measured at baseline and session close.
RESULTS
In session 1, vomiting decreased in both groups, but was greater with stimulation, resulting in a day 3 difference of -1.02 (95% CI, -1.62 to -0.42; P < .001). Scores did not return to baseline during washout; on day 4, the difference persisted at -1.08 (95% CI, -1.81 to -0.35; P = .005). In session 2, vomiting slightly decreased with stimulation and slightly increased without it; at day 8, the nonactivated group had nonsignificantly greater vomiting, 0.12 (-0.68 to 0.92; P = .762). An overall treatment effect of a slight, nonsignificant daily decrease in average vomiting scores, -0.12 (-0.26 to 0.03; P = .116), was observed by pooling stimulation effects across sessions.
LIMITATIONS
Missing data; potential physiological imbalances between groups.
CONCLUSIONS
Although overall treatment effects were not significant, differences in favor of stimulation were suggested. Barriers to observing treatment effects included a decrease in vomiting for both groups during session 1, insufficient washout, and the absence of baseline vomiting for some patients. Future studies should better define inclusion criteria, use longer washout periods, randomize by etiology and baseline physiological findings, and pursue alternative designs. (
CLINICAL TRIAL REGISTRATION NUMBER
00432835.).
背景
经内镜放置的临时胃电刺激（tGES）可能缓解胃轻瘫（Gp）症状，并预测永久性胃电刺激（GES）的结果。
目的
测量 72 小时临时 GES 对 Gp 症状的影响。
设计、地点和患者：我们于 2005 年至 2006 年进行了一项基于医院的、随机、安慰剂对照、交叉试验，包括连续两个为期 4 天的疗程（疗程 1 和疗程 2），共纳入 58 名患者（男性 11 名，女性 47 名；平均年龄 46 岁），病因有三种（特发性 38 例；糖尿病 13 例；手术后 7 例）。
干预
在疗程 1 中，A 组接受 72 小时连续 tGES，B 组在疗程 2 中接受 tGES。
主要观察指标
每日测量症状；在基线和疗程结束时测量胃排空、胃电图和生活质量。
结果
在疗程 1 中，两组的呕吐均有所减轻，但刺激组的呕吐减轻更为明显，导致第 3 天的差异为-1.02（95%可信区间，-1.62 至-0.42；P<0.001）。洗脱期内评分未恢复至基线；第 4 天，差异仍为-1.08（95%可信区间，-1.81 至-0.35；P=0.005）。在疗程 2 中，刺激时呕吐略有减少，不刺激时略有增加；第 8 天，非激活组呕吐明显增加，为 0.12（-0.68 至 0.92；P=0.762）。通过跨疗程汇总刺激效果，观察到平均呕吐评分每日略有、无统计学意义的减少，为-0.12（-0.26 至 0.03；P=0.116），这表明存在总体治疗效果。
局限性
数据缺失；组间可能存在潜在的生理失衡。
结论
尽管总体治疗效果不显著，但刺激组的疗效更为显著。观察治疗效果的障碍包括疗程 1 中两组的呕吐均有所减轻、洗脱期不足以及部分患者缺乏基线呕吐。未来的研究应更好地定义纳入标准，使用更长的洗脱期，根据病因和基线生理发现进行随机分组，并探索替代设计。（临床试验注册号：00432835。）
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