布洛芬超前镇痛对下颌阻生第三磨牙拔除术后疼痛影响的随机对照试验  

Effect of preemptive analgesia with ibuprofen on postoperative pain after mandibular third molar extraction:a randomized controlled trial

作　　者：魏雪竺 郜康 张婧 赵彬[4] 刘之光 吴瑞卿 欧明明 张琪[6] 李威[7] 程茜[7] 谢亦林[7] 张天翼 李雅杰 王昊[6] 王左敏[7] 张伟[8] 周建 Wei Xuezhu;Gao Kang;Zhang Jing;Zhao Bin;Liu Zhiguang;Wu Ruiqing;Ou Mingming;Zhang Qi;Li Wei;Cheng Qian;Xie Yilin;Zhang Tianyi;Li Yajie;Wang Hao;Wang Zuomin;Zhang Wei;Zhou Jian(Department of Emergency and General Dentistry,Capital Medical University School of Stomatology,Beijing 100050,China;Department of VIP Dental Service,Capital Medical University School of Stomatology,Beijing 100050,China;Department of Oral Maxillofacial Surgery,Capital Medical University School of Stomatology,Beijing 100050,China;Department of Pharmacy,Peking Union Medical College Hospital,Peking Union Medical College,Chinese Academy of Medical Sciences,Beijing 100730,China;Statistics Department,Pharmacology Base,Beijing Anzhen Hospital,Capital Medical University,Beijing 100011,China;Department of Stomatology,Beijing TianTan Hospital,Capital Medical University,Beijing 100070,China;Department of Stomatology,Beijing Chao-Yang Hospital,Capital Medical University,Beijing 100020,China;Department of Oral and Maxillofacial Surgery,Peking University School and Hospital of Stomatology&National Center for Stomatology&National Clinical Research Center for Oral Diseases&National Engineering Research Center of Oral Biomaterials and Digital Medical Devices&Beijing Key Laboratory of Digital Stomatology,Beijing 100081,China)

机构地区：[1]首都医科大学口腔医学院急诊综合诊疗中心,北京100050 [2]首都医科大学口腔医学院特诊特需科,北京100050 [3]首都医科大学口腔医学院口腔颌面外科,北京100050 [4]中国医学科学院北京协和医学院北京协和医院药剂科,北京100730 [5]首都医科大学附属北京安贞医院药理基地统计部,北京100011 [6]首都医科大学附属北京天坛医院口腔科,北京100070 [7]首都医科大学附属北京朝阳医院口腔科,北京100020 [8]北京大学口腔医学院·口腔医院口腔颌面外科、国家口腔医学中心、国家口腔疾病临床医学研究中心、口腔生物材料和数字诊疗装备国家工程研究中心、口腔数字医学北京市重点实验室,北京100081

出　　处：《中华口腔医学杂志》2024年第3期230-236,共7页Chinese Journal of Stomatology

基　　金：北京市属医院科研培育计划(PX2021056);中国医学科学院中央级公益性科研院所基本科研业务费专项资金(2023-JKCS-19)。

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。ObjectiveTo 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.MethodsThis 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.ResultsAll 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).C

关 键 词：镇痛 疼痛 超前镇痛 疼痛管理 布洛芬 磨牙 第三 拔牙 

分 类 号：R782.11[医药卫生—口腔医学]