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临时內镜下粘膜胃电刺激治疗胃轻瘫的一项双盲随机安慰剂对照试验

发布日期:2014-1-29 12:40:20 文章来源:GIE 作者次数:1312

     

    背景
    內镜下放置临时胃电刺激(tGES)可以减缓胃轻瘫(Gp)症状,也可以预测永久性电刺激(GES)结果。
    目的
    测量72小时临时胃电刺激(GES)对胃轻瘫(Gp)症状的影响。
    设计、环境和患者
    从2005年到2006年,我们进行了一项以医院为基础的随机安慰剂对照交叉试验,这个试验分为两个连续阶段(阶段1和2),每个阶段为期4天,且有58例(其中男性11例,女性47例,平均年龄46岁)患胃轻瘫(Gp)症状史患者参加,这些胃轻瘫症状主要来源于三大病因,即原发性38例,糖尿病13例,术后7例,
    干预
    72小时不间断地临时胃电刺激(GES)分别在阶段1期间提供给A组,2期间提供给B组。
    主要结果测量
    每日测量症状;胃排空情况、胃电图描记、试验开始时和结束时生命特征。
    结果
    第一阶段两组中呕吐都有所减少,但是在用电刺激组减少的更多,这样在第三天产生了-1.02的差异(95%置信区间CI为−1.62至−0.42且P<0.001)。清洗胃期间其分值也未返回到基线;第四天两组差异仍为-1.08 (95%置信区间CI为−1.81至−0.35且P=0.005)。第2阶段电刺激组呕吐略有下降,而未用电刺激组呕吐反而有轻微增加;第八天,未刺激组呕吐又有所增加,不过增加值没有统计学意义,两组的差异达到0.12(置信区间为−0.68至0.92且P =0.762)。因此我们通过联系两阶段的刺激效应,发现这样的总体治疗效果,即平均呕吐分值日下降轻微且无统计学意义,差异为-0.12(-0.26-0.03,P=0.116)。
    局限性
    数据遗失;两组间潜存的生理失衡。
    结论
    虽然两组整体治疗效果差异不明显,但我们还是建议用电刺激。阻碍观察治疗效果的因素包括第一阶段中两组呕吐次数下降,冲洗不彻底,以及一些患者刚入组时就存在呕吐症状。将来的研究应更好地界定纳入标准,应延长冲洗时间,应根据病因和入组时的生理情况将患者随机化。(临床试验注册号:00432835。)
    缩写词EGG为胃电图,Gp为胃轻瘫,GES为胃电刺激,GET为胃排空时间,tGES为临时胃电刺激
     
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    A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis
    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.)
     
     
     
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