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ADIDAC试验:右布洛芬与布洛芬治疗原发性痛经患者的镇痛效果比较:一项交叉试验

ADIDAC trial: analgesia with dexibuprofen versus ibuprofen in patients suffering from primary dysmenorrhea: a crossover trial.

作者信息

Kollenz C, Phleps W, Kaehler S T

机构信息

Gebro Pharma GmbH, Fieberbrunn, Austria.

出版信息

Gynecol Obstet Invest. 2009;67(1):25-31. doi: 10.1159/000158648. Epub 2008 Sep 30.

DOI:10.1159/000158648
PMID:18824862
Abstract

BACKGROUND

Primary dysmenorrhea is estimated to affect 40-50% of menstruating young women.

METHODS

Randomized, double-blind, 3-cycle crossover, active-controlled clinical trial conducted in 102 outpatients.

RESULTS

102 patients entered the study and 77 were eligible for analyses. The mean (SD) age was 31.1 (7.0) years, and the mean cycle duration was 28.1 days (1.89) with a mean menstrual phase of 5.3 days (1.28). 40.26% of patients reported moderate pain from dysmenorrhea, and the remaining 59.74% reported severe pain. Compared to ibuprofen 400 mg, both dexibuprofen doses (200 and 300 mg) showed a trend towards superiority for sum of pain intensity difference (sum of PID), PID and total pain relief. Furthermore, dexibuprofen 200 mg had a faster onset of action compared to the double dose of ibuprofen (p = 0.035). A dose-effect relationship could be demonstrated for dexibuprofen in this visceral pain model. Tolerability was similar across all treatments.

CONCLUSIONS

In patients experiencing acute visceral pain as a result of primary dysmenorrhea, dexibuprofen was associated with a dose-dependent effective analgesia; this effect was at least equivalent to that of the double dose of ibuprofen. With its lower body-loading dose, dexibuprofen expands the alternatives available to treat this condition.

摘要

背景

据估计,原发性痛经影响40%-50%的年轻经期女性。

方法

对102名门诊患者进行随机、双盲、3周期交叉、活性药物对照的临床试验。

结果

102名患者进入研究,77名符合分析条件。平均(标准差)年龄为31.1(7.0)岁,平均周期时长为28.1天(1.89),平均经期为5.3天(1.28)。40.26%的患者报告痛经为中度疼痛,其余59.74%报告为重度疼痛。与400毫克布洛芬相比,右布洛芬的两种剂量(200毫克和300毫克)在疼痛强度差值总和(PID总和)、PID及总疼痛缓解方面均显示出优势趋势。此外,200毫克右布洛芬的起效时间比双倍剂量的布洛芬更快(p = 0.035)。在该内脏痛模型中可证明右布洛芬存在剂量效应关系。所有治疗的耐受性相似。

结论

在因原发性痛经而出现急性内脏痛的患者中,右布洛芬与剂量依赖性有效镇痛相关;这种效应至少等同于双倍剂量的布洛芬。右布洛芬的较低负荷剂量为治疗这种病症提供了更多选择。

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