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双盲、随机、安慰剂对照研究,旨在评估替加色罗对健康志愿者胃运动、感觉及肌电功能的影响。

Double-blind, randomized, placebo-controlled study to evaluate the effects of tegaserod on gastric motor, sensory and myoelectric function in healthy volunteers.

作者信息

Talley N J, Camilleri M, Burton D, Thomforde G, Koch K, Rucker M J, Peterson J, Zinsmeister A R, Earnest D L

机构信息

Translational & Epidemiological Research Program, Mayo Clinic Division of Gastroenterology and Hepatology, and Clinical Enteric Neuroscience, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.

出版信息

Aliment Pharmacol Ther. 2006 Sep 1;24(5):859-67. doi: 10.1111/j.1365-2036.2006.03049.x.


DOI:10.1111/j.1365-2036.2006.03049.x
PMID:16918891
Abstract

BACKGROUND: The effects of tegaserod on gastric accommodation and postprandial satiety remain unclear. AIM: To compare the effects of tegaserod 6 mg twice daily vs. placebo on gastric volumes, postprandial symptoms, gastric emptying, small bowel transit and the surface electrogastrogram in female and male healthy volunteers. METHODS: Randomized, double-blind, placebo-controlled study evaluated gastric function before and after 7 days of tegaserod 6 mg twice daily (n = 21) vs. placebo (n = 20) in healthy volunteers. Validated methods were used to study gastric emptying, myoelectrical activity, volumes and satiation postnutrient challenge. RESULTS: There were no significant effects of tegaserod on the primary endpoints assessing gastric function: emptying of solids or liquids, total gastric volumes or myoelectrical activity. Maximum tolerated volume and aggregate symptom score with nutrient challenge on placebo were 1,035 mL (+/-44) and 130 (+/-15) vs. 989 mL (+/-43) and 117 (+/-15) during tegaserod, respectively (all P = N.S.). Postprandial change in proximal gastric volume by single photon emission-computed tomography was decreased in females on tegaserod (246 +/- 30) vs. placebo (358 +/- 32) (P = 0.015). Proximal fasting volumes in females were increased on tegaserod (126 +/- 12) vs. placebo (92 +/- 13) (P = 0.066). CONCLUSIONS: While tegaserod decreased proximal gastric volume change after a meal, it does not appear to have significant effects on gastric motor and sensory function in healthy individuals. Further studies are required in patients with disturbances of gastric motor and sensory function.

摘要

背景:替加色罗对胃容纳功能和餐后饱腹感的影响尚不清楚。 目的:比较每日两次服用6毫克替加色罗与安慰剂对健康男女志愿者胃容量、餐后症状、胃排空、小肠转运及体表胃电图的影响。 方法:一项随机、双盲、安慰剂对照研究,评估了健康志愿者每日两次服用6毫克替加色罗(n = 21)与安慰剂(n = 20)7天前后的胃功能。采用经过验证的方法研究胃排空、肌电活动、容量及营养刺激后的饱腹感。 结果:替加色罗对评估胃功能的主要终点指标无显著影响:固体或液体排空、总胃容量或肌电活动。安慰剂组营养刺激后的最大耐受容量和总症状评分分别为1035毫升(±44)和130(±15),替加色罗组分别为989毫升(±43)和117(±15)(均P =无统计学意义)。单光子发射计算机断层扫描显示,替加色罗组女性餐后近端胃容量变化较安慰剂组降低(246±30 vs. 358±32)(P = 0.015)。替加色罗组女性空腹近端胃容量较安慰剂组增加(126±12 vs. 92±13)(P = 0.066)。 结论:虽然替加色罗可减少餐后近端胃容量变化,但对健康个体的胃运动和感觉功能似乎无显著影响。胃运动和感觉功能障碍患者需要进一步研究。

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DA-9701: A New Multi-Acting Drug for the Treatment of Functional Dyspepsia.

Biomol Ther (Seoul). 2013-5-30

[2]
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