查看更多>>摘要：目的 评价布洛芬超前镇痛对国人下颌阻生第三磨牙拔除术后疼痛的影响，以期为其临床应用提供参考。 方法 采用多中心、随机、双盲、安慰剂平行对照的试验设计。纳入2022年4月至2023年10月于首都医科大学口腔医学院（40例）、首都医科大学附属北京天坛医院（22例）及首都医科大学附属北京朝阳医院（20例）就诊的82例下颌阻生第三磨牙患者，布洛芬组与对照组各41例，分别于术前15 min口服300 mg布洛芬缓释胶囊和安慰剂。两组患者于术后3 d内均按计划服用布洛芬缓释胶囊。通过数字评定量表统计患者在拔牙术后30 min、4 h、6 h、8 h、24 h、48 h、72 h的疼痛评分，并记录术后4~6 d额外镇痛药使用量。 结果 82例患者均符合试验方案。试验过程中两组患者均未发生恶心、呕吐、过敏等不良事件。布洛芬组患者术后4、6、8 h的疼痛评分［2.0（1.0，4.0）、2.0（1.0，4.0）、2.0（1.0，4.0）分］均显著低于对照组［分别为4.0（3.0，5.0）、5.0（2.5，6.0）、5.00（2.0，6.0）分］（Z=-3.73，P<0.001；Z=-3.38，P<0.001；Z=-2.11，P=0.035）。两组患者术后30 min、24 h、48 h和72 h的疼痛评分差异均无统计学意义（P>0.05）。布洛芬组与对照组分别有26.8%（11/41）和56.1%（23/41）的患者于术后4~6 d额外服用镇痛药，布洛芬组患者术后额外用药量［0.0（0.0，1.0）粒］显著低于对照组［1.0（0.0，3.0）粒］（Z=-2.81，P=0.005）。 结论 术前15 min口服300 mg布洛芬缓释胶囊，并在术后连续用药3 d的疼痛管理方案可有效降低患者术后疼痛程度及镇痛药物使用总量。综合考量其有效性、安全性和经济性，推荐布洛芬作为围手术期疼痛管理的一线药物，提升患者诊疗的舒适性是切实可行的。 Objective To evaluate the impact of preemptive analgesia with ibuprofen on postoperative pain following the extraction of impacted mandibular third molars in a Chinese population, aiming to provide a clinical reference for its application. Methods This multicenter, randomized, double-blind, placebo-controlled parallel-group trial was conducted from April 2022 to October 2023 at the Capital Medical University School of Stomatology (40 cases), Beijing TianTan Hospital, Capital Medical University (22 cases), and Beijing Chao-Yang Hospital, Capital Medical University (20 cases). It included 82 patients with impacted mandibular third molars, with 41 in the ibuprofen group and 41 in the control group. Participants in the ibuprofen group received 300 mg of sustained-release ibuprofen capsules orally 15 min before surgery, while the control group received a placebo. Both groups were instructed to take sustained-release ibuprofen capsules as planned for 3 days post-surgery. Pain intensity was measured using the numerical rating scale at 30 min, 4 h, 6 h, 8 h, 24 h, 48 h, and 72 h after surgery, and the use of additional analgesic medication was recorded during days 4 to 6 postoperatively. Results All 82 patients completed the study according to the protocol. No adverse events such as nausea, vomiting, or allergies were reported in either group during the trial. The ibuprofen group exhibited significantly lower pain scores at 4 h [2.0 (1.0, 4.0) vs. 4.0 (3.0, 5.0)] (Z=-3.73, P<0.001), 6 h [2.0 (1.0, 4.0)vs. 5.0(2.5, 6.0)] (Z=-3.38, P<0.001), and 8 h [2.0 (1.0, 4.0)vs. 5.0 (2.0, 6.0)] (Z=-2.11, P=0.035) postoperatively compared to the control group. There were no statistically significant differences in pain scores between the groups at 30 min, 24 h, 48 h, and 72 h postoperatively (P>0.05). Additionally, 11 out of 41 patients (26.8%) in the ibuprofen group and 23 out of 41 patients (56.1%) in the control group required extra analgesic medication between days 4 and 6 post-surgery, with the ibuprofen group taking significantly fewer additional pills [0.0 (0.0, 1.0)vs. 1.0 (0.0, 3.0)] (Z=-2.81, P=0.005). Conclusions A pain management regimen involving 300 mg of oral sustained-release ibuprofen capsules administered 15 minutes before surgery and continued for 3 d postoperatively effectively reduces pain levels and the total amount of analgesic medication used after the extraction of impacted mandibular third molars. Considering its efficacy, safety, and cost-effectiveness, ibuprofen is recommended as a first-line drug for perioperative pain management, enhancing patient comfort during diagnosis and treatment in a feasible manner.
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