Planas M E, Gay-Escoda C, Bagán J V, Santamaría J, Peñarrocha M, Donado M, Puerta J L, García-Magaz I, Ruíz J, Ortiz P
Faculty of Odontology, University of Barcelona, Spain.
Eur J Clin Pharmacol. 1998 Feb;53(6):405-9. doi: 10.1007/s002280050400.
To assess the efficacy of metamizol 1 g and 2 g in the relief of pain after surgical extraction of the lower third molar, and to compare the therapeutic effect with that of ibuprofen 600 mg or placebo.
A total of 253 patients aged between 18 years and 60 years who had undergone extraction of the lower third molar (types II-IV) under local anaesthesia, up to a maximum of 108 mg of mepivacaine, were randomly assigned to a single oral dose of a new galenic form (drinkable vials) of metamizol 1 g (n = 75), metamizol 2 g (n = 72), ibuprofen 600 mg (n = 74) or placebo (n = 32). Pain intensity was evaluated by a 100-mm visual analogue scale. To enter the study, a pain level of 50 mm or more was required. The duration of the trial was 1 h. Assessments were carried out at 15, 30 and 60 min after treatment.
The analgesic efficacy of metamizol 2 g was significantly better than ibuprofen and placebo with regard to all evaluated parameters. The values of the pain intensity difference at 15 min, the percentage of patients with a decrease of 50% or more on the visual analogue scale at 60 min and the sum of pain intensity differences at 60 min showed metamizol 2 g to be significantly more effective than metamizol 1 g. In general, metamizol 1 g was as effective as ibuprofen 600 mg. The analgesic efficacy of placebo was significantly lower than that of all active treatments. A lower number of patients treated with metamizol 1 g (n = 1) or metamizol 2 g (n = 1) needed rescue medication than those given ibuprofen (n = 7) or placebo (n = 5). No serious adverse effects developed and none of the patients had to leave the study for this reason.
The model of the lower third molar, for which the analgesic outcome referred to the first hour after drug administration, demonstrated that the analgesic efficacy of oral metamizol 2 g was significantly higher than that of ibuprofen 600 mg or placebo. Metamizol 1 g and ibuprofen 600 mg showed a similar therapeutic effect. All regimens were as well tolerated as placebo.
评估1克和2克安乃近缓解下颌第三磨牙拔除术后疼痛的疗效，并将其治疗效果与600毫克布洛芬或安慰剂进行比较。
总共253例年龄在18岁至60岁之间、在局部麻醉（最多108毫克甲哌卡因）下接受下颌第三磨牙（II-IV型）拔除术的患者，被随机分配单次口服一剂新剂型（可饮用小瓶）的1克安乃近（n = 75）、2克安乃近（n = 72）、600毫克布洛芬（n = 74）或安慰剂（n = 32）。通过100毫米视觉模拟量表评估疼痛强度。要进入研究，疼痛水平需达到50毫米或更高。试验持续时间为1小时。在治疗后15、30和60分钟进行评估。
就所有评估参数而言，2克安乃近的镇痛效果明显优于布洛芬和安慰剂。15分钟时的疼痛强度差值、60分钟时视觉模拟量表上疼痛降低50%或更多的患者百分比以及60分钟时的疼痛强度差值总和显示，2克安乃近比1克安乃近明显更有效。总体而言，1克安乃近与600毫克布洛芬效果相当。安慰剂的镇痛效果明显低于所有活性治疗药物。接受1克安乃近（n = 1）或2克安乃近（n = 1）治疗的患者需要急救药物的人数少于接受布洛芬（n = 7）或安慰剂（n = 5）治疗的患者。未出现严重不良反应，也没有患者因此而退出研究。
以药物给药后第一小时的镇痛结果为参考的下颌第三磨牙模型表明，口服2克安乃近的镇痛效果明显高于600毫克布洛芬或安慰剂。1克安乃近和600毫克布洛芬显示出相似的治疗效果。所有治疗方案的耐受性与安慰剂相同。
