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口服西沙必利和胃复安治疗糖尿病性自主神经病变的评估:一项为期八周的双盲交叉研究。

Evaluation of oral cisapride and metoclopramide in diabetic autonomic neuropathy: an eight-week double-blind crossover study.

作者信息

de Caestecker J S, Ewing D J, Tothill P, Clarke B F, Heading R C

机构信息

University Department of Medicine, Royal Infirmary, Edinburgh, UK.

出版信息

Aliment Pharmacol Ther. 1989 Feb;3(1):69-81. doi: 10.1111/j.1365-2036.1989.tb00192.x.

Abstract

Nineteen diabetic patients with autonomic neuropathy were enrolled in a double-blind crossover study of cisapride, metoclopramide and placebo. Symptoms were evaluated from diary cards and from assessments undertaken at the end of each eight week treatment period. Measurements of oesophageal transit, gastric emptying and whole gut transit were made before treatment began and at the end of each treatment period. Three patients dropped out early in the study, and the results from 16 patients were analysed. The severity of autonomic neuropathy, judged from cardiovascular reflex tests, correlated with delayed oesophageal transit and prolonged gastric emptying, but abnormal oesophageal transit and gastric emptying were often unrelated to the presence of upper gastrointestinal symptoms. Neither cisapride nor metoclopramide had a statistically significant effect on oesophageal transit, gastric emptying or whole-gut transit, nor was any significant effect on symptoms identified, although a trend towards reduced nausea and vomiting with metoclopramide and reduced epigastric fullness and diarrhoea with cisapride was suggested. Upper gastrointestinal symptoms correlate poorly with objective abnormalities of gastrointestinal motor function in diabetes. In consequence, the symptomatic benefit to be expected from correction of these motor abnormalities remains uncertain.

摘要

19名患有自主神经病变的糖尿病患者参与了一项关于西沙必利、甲氧氯普胺和安慰剂的双盲交叉研究。症状通过日记卡以及在每个为期8周的治疗期结束时进行的评估来评价。在治疗开始前以及每个治疗期结束时测量食管通过时间、胃排空和全肠道通过时间。3名患者在研究早期退出,对16名患者的结果进行了分析。根据心血管反射试验判断的自主神经病变严重程度与食管通过延迟和胃排空延长相关,但食管通过异常和胃排空异常通常与上消化道症状的存在无关。西沙必利和甲氧氯普胺对食管通过时间、胃排空或全肠道通过时间均无统计学显著影响,对所确定的症状也无任何显著影响,尽管提示甲氧氯普胺有减轻恶心和呕吐的趋势,西沙必利有减轻上腹部饱胀和腹泻的趋势。糖尿病患者的上消化道症状与胃肠运动功能的客观异常相关性较差。因此,纠正这些运动异常所预期的症状改善效果仍不确定。

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