米索前列醇和雷尼替丁对双氯芬酸药代动力学及胃肠道症状的不同影响。
Differential effects of misoprostol and ranitidine on the pharmacokinetics of diclofenac and gastrointestinal symptoms.
作者信息
Dammann H G, Simon-Schultz J, Steinhoff I, Damaschke A, Schmoldt A, Sallowsky E
机构信息
Krankenhaus Bethanien, Hamburg, Germany.
出版信息
Br J Clin Pharmacol. 1993 Oct;36(4):345-9. doi: 10.1111/j.1365-2125.1993.tb00374.x.
Abstract
- The effects of oral misoprostol (800 microg day(-1)) and ranitidine (300 mg day(-1)) on the pharmacokinetics of diclofenac (100 mg) were assessed in a three-way randomized crossover study in 18 healthy male subjects. 2. Subjects were studied over three 8 day periods, during which they received twice-daily placebo, misoprostol, or ranitidine. A single dose of diclofenac was given orally on days 1 and 8, and plasma diclofenac concentrations were measured by h.p.l.c. over 24 h. 3. Misoprostol caused a non-significant 19% increase in the mean Cmax value of diclofenac on both days 1 and 8. After 8 days of dosing with misoprostol there was a significant (P = 0.04) 20% decrease in the AUC of diclofenac. 4. Ranitidine had no statistically significant effects on the pharmacokinetics of diclofenac. 5. Co-administration of misoprostol and diclofenac was associated with a higher frequency and severity of gastrointestinal symptoms and frequency of bowel opening, and a decrease in faecal consistency when compared with either placebo or ranitidine plus diclofenac (P < 0.01).
摘要
- 在一项针对18名健康男性受试者的三向随机交叉研究中，评估了口服米索前列醇（800微克/天）和雷尼替丁（300毫克/天）对双氯芬酸（100毫克）药代动力学的影响。2. 受试者在三个为期8天的时间段内接受研究，在此期间，他们每天两次接受安慰剂、米索前列醇或雷尼替丁。在第1天和第8天口服单剂量双氯芬酸，并通过高效液相色谱法在24小时内测量血浆双氯芬酸浓度。3. 米索前列醇在第1天和第8天均使双氯芬酸的平均Cmax值无显著升高19%。在用米索前列醇给药8天后，双氯芬酸的AUC显著降低（P = 0.04）20%。4. 雷尼替丁对双氯芬酸的药代动力学无统计学显著影响。5. 与安慰剂或雷尼替丁加双氯芬酸相比，米索前列醇与双氯芬酸联合给药时胃肠道症状的频率和严重程度以及排便频率更高，粪便稠度降低（P < 0.01）。
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