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胃复安治疗胃食管反流病:使用依据及一项双盲试验结果

Metoclopramide in gastroesophageal reflux disease: rationale for its use and results of a double-blind trial.

作者信息

McCallum R W, Fink S M, Winnan G R, Avella J, Callachan C

出版信息

Am J Gastroenterol. 1984 Mar;79(3):165-72.

PMID:6367434
Abstract

We investigated the acute effect of metoclopramide on lower esophageal sphincter pressure, esophageal contraction amplitude, and gastric emptying and compared metoclopramide, 10 mg four times a day, to placebo in improving the symptoms and objective parameters of reflux esophagitis in 19 patients in a randomized, double-blind 4-wk outpatient trial. Orally administered metoclopramide, 10 mg, significantly accelerated gastric emptying of a semisolid meal in patients in whom it was delayed; lower esophageal sphincter pressure was significantly increased for up to 90 min, but there were no changes in esophageal contraction amplitude. During the treatment trial, metoclopramide resulted in an overall improvement in heartburn and regurgitation of 60%, significantly better than 32% improvement after placebo (p less than 0.05). Compared to baseline symptoms scores, metoclopramide significantly improved both daytime and nighttime heartburn and regurgitation. Compared to placebo-treated patients, the metoclopramide group had significantly fewer episodes of daytime heartburn and regurgitation (p less than 0.05), while nighttime symptoms significantly improved with both treatments. Mean antacid consumption was significantly reduced by metoclopramide, 61%, compared to placebo-treated patients, 21% (p less than 0.05), who were ingesting a mean of 1.9 oz of antacid daily. Endoscopic and histological improvement were similar in both groups, although histological healing occurred in three patients after metoclopramide compared with none in the placebo group. Our data suggest that: 1) gastric emptying and lower esophageal sphincter pressure were significantly improved by acute administration of oral metoclopramide; 2) metoclopramide therapy for 4 wk is significantly more effective than placebo (medium dose antacid therapy) in relieving the symptoms of gastroesophageal reflux without significantly altering objective parameters of esophagitis; 3) metoclopramide effectively addresses the diffuse upper gastrointestinal motor disturbances present in reflux esophagitis patients.

摘要

我们研究了甲氧氯普胺对食管下括约肌压力、食管收缩幅度和胃排空的急性作用,并在一项为期4周的随机双盲门诊试验中,将每日4次、每次10毫克的甲氧氯普胺与安慰剂进行比较,以观察其对19例反流性食管炎患者症状及客观指标的改善情况。口服10毫克甲氧氯普胺可显著加速胃排空延迟患者的半固体餐胃排空;食管下括约肌压力在长达90分钟内显著升高,但食管收缩幅度无变化。在治疗试验期间,甲氧氯普胺使烧心和反流总体改善率达60%,显著优于安慰剂组的32%改善率(P<0.05)。与基线症状评分相比,甲氧氯普胺显著改善了白天和夜间的烧心及反流症状。与安慰剂治疗的患者相比,甲氧氯普胺组白天烧心和反流发作次数显著减少(P<0.05),而两种治疗方法均使夜间症状显著改善。与平均每日摄入1.9盎司抗酸剂的安慰剂治疗患者相比,甲氧氯普胺使抗酸剂平均消耗量显著减少61%,而安慰剂组减少21%(P<0.05)。两组内镜和组织学改善情况相似,不过甲氧氯普胺治疗后有3例患者出现组织学愈合,而安慰剂组无此情况。我们的数据表明:1)口服甲氧氯普胺急性给药可显著改善胃排空和食管下括约肌压力;2)甲氧氯普胺治疗4周在缓解胃食管反流症状方面显著优于安慰剂(中等剂量抗酸剂治疗),且未显著改变食管炎的客观指标;3)甲氧氯普胺有效解决了反流性食管炎患者存在的弥漫性上消化道运动障碍。

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