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一项双盲、多剂量、安慰剂对照、交叉研究,旨在比较给予多西环素缓释剂(Doryx R)和强力霉素(Vibramycin R)的健康受试者胃肠道不适的发生率。

A double-blind, multiple-dose, placebo-controlled, cross-over study to compare the incidence of gastrointestinal complaints in healthy subjects given Doryx R and Vibramycin R.

作者信息

Berger R S

机构信息

Department of Medicine, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick.

出版信息

J Clin Pharmacol. 1988 Apr;28(4):367-70. doi: 10.1002/j.1552-4604.1988.tb03160.x.

Abstract

Ninety-eight healthy subjects completed a double-blind, placebo-controlled, multiple-dose cross-over study to compare the incidence of gastrointestinal side effects of Doryx (Parke-Davis, Morris Plains, NJ) capsules (enteric-coated doxycycline hyclate pellets) and Vibramycin (Pfizer, New York, NY) capsules (doxycycline hyclate powder). Doryx produced statistically significantly fewer episodes of nausea, vomiting, stomach of abdominal discomfort, and decreased appetite than did Vibramycin. For every symptom, Vibramycin produced statistically significantly more symptom reports than did placebo. Although Doryx produced significantly more reports of nausea than did placebo, there was no significant difference for the other symptoms. Based on these results, Doryx is superior to Vibramycin when considering the incidence of gastrointestinal side effects.

摘要

98名健康受试者完成了一项双盲、安慰剂对照、多剂量交叉研究,以比较多力新(辉瑞公司,新泽西州莫里斯平)胶囊(肠溶衣盐酸多西环素微丸)和强力霉素(辉瑞公司,纽约)胶囊(盐酸多西环素粉)胃肠道副作用的发生率。与强力霉素相比,多力新产生的恶心、呕吐、胃部或腹部不适以及食欲减退发作在统计学上显著更少。对于每种症状,强力霉素产生的症状报告在统计学上显著多于安慰剂。尽管多力新产生的恶心报告显著多于安慰剂,但其他症状并无显著差异。基于这些结果,在考虑胃肠道副作用发生率时,多力新优于强力霉素。

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