Efficacy and tolerability of the specific cyclooxygenase-2 inhibitor DFP compared with naproxen sodium in patients with postoperative dental pain
Efficacy and tolerability of the specific cyclooxygenase-2 inhibitor DFP compared with naproxen sodium in patients with postoperative dental pain
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DOI：
10.1016/s0149-2918(99)80031-9
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发表时间：
1999-08-01
影响因子：
3.2
通讯作者：
Mills, S
中科院分区：
文献类型：
--
作者：
Gottesdiener, K;Mehlisch, DR;Mills, S
DFP[3-(2-propyloxy)-(4-methyl-sulfonyl-phenyl)-(5(5-二甲基)-呋喃酮]是一种高度特异的环氧合酶-2抑制剂(在转基因中国仓鼠卵巢细胞实验中具有2500倍的选择性)，已被证明在疼痛和炎症的临床前模型中有效。本研究采用单剂量、随机、双掩蔽、双模拟、安慰剂对照的平行分组研究，比较196名患者(平均年龄25.8岁；男性187例，95.4%)在拔除大于或等于2/3磨牙后经历中到重度疼痛的DFP 5、25和50 mg与萘普生钠550 mg和安慰剂的比较。在给药后24小时内评估总体止痛效果、起效时间、起效时间、最大止痛效果和耐受性。DFP 25毫克和50毫克，以及活性比较剂，萘普生钠550毫克，都比安慰剂有效得多。DFP 25毫克组、DFP 50毫克组和萘普生钠550毫克组的止痛效果无显著差异。DFP在50毫克以下的单次剂量耐受性一般很好。DFP 50 mg对术后牙痛有效，与活性对照药萘普生钠550 mg无明显差异。
DFP [3-(2-propyloxy)-(4-methyl-sulfonyl-phenyl)-(5 5-dimethyl)-furanone] is a highly specific cyclooxygenase-2 inhibitor (>2500-fold selective in transfected Chinese hamster ovary cell assays) that has demonstrated efficacy in preclinical models of pain and inflammation. The present single-dose, randomized, double-masked, double-dummy, placebo-controlled, parallel-group study was undertaken to compare DFP 5, 25, and 50 mg with naproxen sodium 550 mg and with placebo in 196 patients (mean age, 25.8 years; 187 [95.4%] males) who experienced moderate-to-severe pain after surgical removal of greater than or equal to 2 third molars. Overall analgesic effect, duration of effect, time to onset of analgesic effect, peak analgesic effect, and tolerability were assessed over a 24-hour postdose period. Both DFP 25 and 50 mg, as well as the active comparator, naproxen sodium 550 mg, were significantly more effective than placebo. The onset of analgesic effect in the DFP 25-mg, DFP 50-mg, and naproxen sodium 550-mg groups did not differ significantly. DFP was generally well tolerated in single doses up to 50 mg. DFP 50 mg was efficacious in the treatment of postoperative dental pain and was indistinguishable from the active comparator, naproxen sodium 550 mg.