Bakshi R, Frenkel G, Dietlein G, Meurer-Witt B, Schneider B, Sinterhauf U
Medical Department of Ciba-Geigy Limited, Basle, Switzerland.
J Clin Pharmacol. 1994 Mar;34(3):225-30. doi: 10.1002/j.1552-4604.1994.tb03990.x.
The analgesic efficacy of single oral doses of drinkable diclofenac dispersible 50 mg was compared with that of ibuprofen 400 mg and placebo in a randomized, double-blind, parallel-group trial in 257 adult patients (245 valid for efficacy) with severe postoperative pain after extraction of an impacted lower third molar. In this study, pain intensity (on a 100-mm visual analog scale) and pain relief from baseline (using a five-point verbal rating scale) were assessed serially during an observation period of 6 hours. Intake of rescue analgesic was permitted in case of insufficient therapeutic effect; however at least 1 hour should have elapsed after test drug consumption. On the main efficacy variable, namely, reduction in the pain intensity score, both diclofenac dispersible (n = 83) and ibuprofen (n = 80) were statistically significantly (P < .01) superior to placebo (n = 82) starting at 20 and 40 minutes, respectively, after drug intake. The active medications were also significantly (P < .01) better than placebo for the secondary efficacy parameters viz. summed pain relief scores over 6 hours (TOTPAR-6); frequency of remedication with a rescue analgesic in the three treatment groups (diclofenac, 24%; ibuprofen, 28%; placebo, 65%); mean time to remedication; and global evaluation. All the treatments were well tolerated. Thus assay sensitivity of this trial (ibuprofen significantly better than placebo) has been demonstrated; in addition, diclofenac as a dispersible formulation has been shown to be an effective analgesic for the treatment of post-surgical dental pain.
在一项针对257名拔除下颌阻生第三磨牙后出现严重术后疼痛的成年患者（245例疗效有效）的随机、双盲、平行组试验中，比较了单次口服50毫克可饮用双氯芬酸分散片与400毫克布洛芬及安慰剂的镇痛效果。在本研究中，在6小时的观察期内连续评估疼痛强度（采用100毫米视觉模拟量表）和相对于基线的疼痛缓解情况（采用五点语言评定量表）。若治疗效果不足，允许服用解救镇痛药；但在服用试验药物后至少应经过1小时。在主要疗效变量即疼痛强度评分降低方面，双氯芬酸分散片组（n = 83）和布洛芬组（n = 80）分别在服药后20分钟和40分钟开始，在统计学上显著优于安慰剂组（n = 82）（P < 0.01）。对于次要疗效参数，即6小时内的总疼痛缓解评分（TOTPAR - 6）、三个治疗组（双氯芬酸组为24%；布洛芬组为28%；安慰剂组为65%）使用解救镇痛药的补救用药频率、补救用药的平均时间以及总体评价，活性药物也显著优于安慰剂（P < 0.01）。所有治疗耐受性良好。因此，该试验的分析敏感性（布洛芬显著优于安慰剂）得到了证实；此外，双氯芬酸作为一种分散片制剂已被证明是治疗术后牙科疼痛的有效镇痛药。
