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肌肉内依托芬那酯与双氯芬酸治疗肾绞痛的缓解效果比较:一项随机、单盲、对照研究。

Intramuscular Etofenamate versus Diclofenac in the Relief of Renal Colic : A Randomised, Single-Blind, Comparative Study.

机构信息

Hospital D. Pedro V, Porto, Portugal.

出版信息

Clin Drug Investig. 2003;23(11):701-6. doi: 10.2165/00044011-200323110-00002.

Abstract

OBJECTIVE

To compare the efficacy and adverse effects of intramuscular etofenamate and intramuscular diclofenac in the relief of acute renal colic.

PATIENTS AND METHODS

A multicentre, randomised, single-blind study was performed in 119 patients admitted to the emergency room for renal colic. Patients were assigned to treatment with either etofenamate 1000mg or diclofenac 75mg, both administered intramuscularly. Pain was self-assessed using a 4-point verbal rating scale (VRS) and a visual analogue scale (VAS) just before drug administration and 30, 60, 120 and 240 min later.

RESULTS

The two groups were similar with regard to baseline characteristics. The percentages of patients who reported an improvement in the VRS at 60 min post-administration (primary variable) were 84.5% with etofenamate and 83.3% with diclofenac (p = 0.73). At the other timepoints (30, 120 and 240 min), the proportions of patients improved were, respectively, 69.5%, 82.6% and 79.3% in the etofenamate group, and 75.0%, 81.7% and 80.0% in the diclofenac group. The VAS score showed a statistically significant improvement in both groups, but no differences between groups were found.Analgesic rescue medication was required by 11 (18.6%) patients in the etofenamate group and by 12 (20.0%) patients in the diclofenac group. Mild to moderate adverse events were reported by 3.4% of patients receiving etofenamate and by 5.0% of patients receiving diclofenac.

CONCLUSION

Etofenamate and diclofenac were similarly effective and tolerated in the relief of acute renal colic.

摘要

目的

比较肌内注射依托芬那酯和双氯芬酸治疗急性肾绞痛的疗效和不良反应。

患者和方法

对 119 例因肾绞痛到急诊室就诊的患者进行了一项多中心、随机、单盲研究。患者被分配接受依托芬那酯 1000mg 或双氯芬酸 75mg 肌内注射治疗。疼痛使用 4 分口述评分量表(VRS)和视觉模拟评分量表(VAS)在给药前及给药后 30、60、120 和 240 分钟时进行自我评估。

结果

两组患者的基线特征相似。给药后 60 分钟报告 VRS 改善的患者比例(主要变量)分别为依托芬那酯组 84.5%和双氯芬酸组 83.3%(p=0.73)。在其他时间点(30、120 和 240 分钟),依托芬那酯组分别有 69.5%、82.6%和 79.3%的患者改善,双氯芬酸组分别有 75.0%、81.7%和 80.0%的患者改善。两组 VAS 评分均有统计学显著改善,但组间无差异。依托芬那酯组 11 例(18.6%)和双氯芬酸组 12 例(20.0%)患者需要使用镇痛解救药物。接受依托芬那酯治疗的患者中有 3.4%报告有轻度至中度不良反应,接受双氯芬酸治疗的患者中有 5.0%报告有轻度至中度不良反应。

结论

依托芬那酯和双氯芬酸在缓解急性肾绞痛方面同样有效且耐受良好。

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