Zuniga John R, Malmström Hans, Noveck Robert J, Campbell John H, Christensen Steven, Glickman Robert S, Tomasetti Boyd J, Boesing Stephen E
University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
J Oral Maxillofac Surg. 2010 Nov;68(11):2735-42. doi: 10.1016/j.joms.2010.05.075.
The purpose of the present study was to assess the safety and efficacy of oral diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) that uses ProSorb dispersion technology (Xanodyne Pharmaceuticals, Inc, licensed from AAIPharma, Wilmington, NC), to treat adult patients with acute pain after third molar extraction.
In the present multicenter, randomized, double-blind, placebo-controlled trial, patients experiencing a baseline level of pain (≥ 50 mm on a 100-mm visual analog scale within 4 hours after surgery) were randomized to receive a single dose of DPSGC at 25, 50, or 100 mg or placebo. Pain intensity and relief were assessed for 6 hours after dosing. The efficacy endpoints included the summed pain intensity difference, total pain relief, and the median time to the onset of perceptible and meaningful pain relief (using the 2-stopwatch method).
A total of 249 randomized patients had a significant increase in the summed pain intensity difference and total pain relief values at 3 and 6 hours across all DPSGC-treated groups compared with the placebo group (P < .0001). The onset of perceptible and meaningful pain relief was significantly faster in all DPSGC groups than in the placebo group, including the DPSGC 25-mg group (25 minutes [P = .0002] and 52 minutes [P < .0001] for perceptible and meaningful pain relief, respectively). Significantly fewer patients in the DPSGC groups required rescue medication compared with those in the placebo group (P < .0001). The global evaluation scores were significantly greater for the patients who received DPSGC than for those who received placebo (P < .0001), and more than 65% of DPSGC-treated patients rated the medication as good, very good, or excellent compared with 18% of the placebo-treated patients. DPSGC was generally well tolerated, and no serious adverse events were reported.
The results from the present single-dose study of postoperative dental pain suggest that DPSGC offers significant pain relief compared with placebo and that the study medication provided was well tolerated by patients who required pain relief after third molar extraction.
本研究旨在评估采用ProSorb分散技术（由北卡罗来纳州威尔明顿的AAIPharma授权，Xanodyne制药公司生产）的口服双氯芬酸钾液状软明胶胶囊（DPSGC）治疗成年患者第三磨牙拔除术后急性疼痛的安全性和有效性。
在本多中心、随机、双盲、安慰剂对照试验中，基线疼痛水平（术后4小时内视觉模拟量表100mm上≥50mm）的患者被随机分配接受25mg、50mg或100mg单剂量DPSGC或安慰剂。给药后6小时评估疼痛强度和缓解情况。疗效终点包括疼痛强度差值总和、总疼痛缓解情况以及可感知且有意义的疼痛缓解开始的中位时间（采用双秒表法）。
与安慰剂组相比，所有接受DPSGC治疗的组中，共有249例随机分组患者在3小时和6小时时疼痛强度差值总和及总疼痛缓解值显著增加（P <.0001）。所有DPSGC组可感知且有意义的疼痛缓解开始时间均显著快于安慰剂组，包括DPSGC 25mg组（可感知和有意义的疼痛缓解分别为25分钟[P =.0002]和52分钟[P <.0001]）。与安慰剂组相比，DPSGC组需要急救药物的患者明显更少（P <.0001）。接受DPSGC治疗的患者的总体评估得分显著高于接受安慰剂治疗的患者（P <.0001），超过65%接受DPSGC治疗的患者将药物评为良好、非常好或优秀，而接受安慰剂治疗的患者这一比例为18%。DPSGC总体耐受性良好，未报告严重不良事件。
本次关于术后牙痛的单剂量研究结果表明，与安慰剂相比，DPSGC能显著缓解疼痛，且所提供的研究药物在第三磨牙拔除术后需要止痛的患者中耐受性良好。
