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中华口腔医学研究杂志(电子版) ›› 2025, Vol. 19 ›› Issue (02) : 112 -118. doi: 10.3877/cma.j.issn.1674-1366.2025.02.005

论著

硝基咪唑类抗生素在预防骨性埋伏下颌第三磨牙拔除术后感染的前瞻性随机对照研究
刘湘奇1, 陈莺1, 吴家顺1, 罗雪婷1, 杨辛1, 匡世军1,()   
  1. 1. 中山大学附属口腔医院,光华口腔医学院,广东省口腔医学重点实验室,广东省口腔疾病临床医学研究中心,广州 510055
  • 收稿日期:2025-02-08 出版日期:2025-04-01
  • 通信作者: 匡世军
  • 基金资助:
    广州市科技计划(2023A04J2167)

Evaluation of nitroimidazole antibiotics in the prevention of postoperative infection following the extraction of bone embedded mandibular third molar:A prospective randomized clinical trial

Xiangqi Liu1, Ying Chen1, Jiashun Wu1, Xueting Luo1, Xin Yang1, Shijun Kuang1,()   

  1. 1. Hospital of Stomatology,Guanghua School of Stomatology,Sun Yat-sen University,Guangdong Provincial Key Laboratory of Stomatology,Guangdong Provincial Clinical Research Center of Oral Diseases,Guangzhou 510055,China
  • Received:2025-02-08 Published:2025-04-01
  • Corresponding author: Shijun Kuang
引用本文:

刘湘奇, 陈莺, 吴家顺, 罗雪婷, 杨辛, 匡世军. 硝基咪唑类抗生素在预防骨性埋伏下颌第三磨牙拔除术后感染的前瞻性随机对照研究[J/OL]. 中华口腔医学研究杂志(电子版), 2025, 19(02): 112-118.

Xiangqi Liu, Ying Chen, Jiashun Wu, Xueting Luo, Xin Yang, Shijun Kuang. Evaluation of nitroimidazole antibiotics in the prevention of postoperative infection following the extraction of bone embedded mandibular third molar:A prospective randomized clinical trial[J/OL]. Chinese Journal of Stomatological Research(Electronic Edition), 2025, 19(02): 112-118.

目的

评估硝基咪唑类抗生素在预防骨性埋伏下颌第三磨牙(M3M)拔除术后感染的作用。

方法

选择2023年5月至2024年4月中山大学附属口腔医院口腔颌面外科门诊要求拔除骨性埋伏M3M的患者,采用前瞻性、随机对照、单盲设计,纳入439颗(390例患者)骨性埋伏M3M。其中,实验组223 颗(195 例患者)骨性埋伏M3M,拔除后给予头孢呋辛酯片(0.25 g,口服,2 次/d,疗程3 d),替硝唑(1.0 g,口服,首剂加倍,1 次/d,疗程3 d);对照组216 颗(195 例患者)骨性埋伏M3M,拔除后给予头孢呋辛酯片。对头孢呋辛酯片过敏者用盐酸克林霉素棕榈酸酯分散片(150 mg,口服,4次/d,疗程3 d)替代。每例患者每次仅拔除1颗骨性埋伏M3M,随访记录术后第7天感染的情况(伤口化脓感染、前颊部感染和咽峡前间隙感染)、术后反应(疼痛、肿胀和开口困难)及药物不良反应(中枢神经系统反应和胃肠道反应)等。采用SPSS 26.0 软件包对数据进行统计学分析。

结果

实验组术后感染发生率为4.0%(9/223),对照组为6.5%(14/216),两组间差异无统计学意义(χ2=1.322,P=0.250);术后反应两组间差异无统计学意义,包括疼痛(Z=-0.426,P=0.670)、肿胀(Z=-0.961,P=0.336)和开口困难(Z=-0.170,P=0.865)。实验组药物不良反应发生率均高于对照组,其中中枢神经系统反应发生率实验组为9.9%(22/223),对照组为3.2%(7/216),差异有统计学意义(χ2=7.805,P=0.005);胃肠道反应发生率实验组为14.3%(32/223)、对照组为6.0%(13/216),差异有统计学意义(χ2=8.278,P=0.004)。

结论

联合应用硝基咪唑类抗生素不能进一步降低骨性埋伏M3M拔除后感染的发生率,药物不良反应发生率却较高,联合应用硝基咪唑类抗生素需谨慎。

Objective

To evaluate the effect of nitroimidazole antibiotics (NIAs)on the prevention of infection after the extraction of the bone embedded mandibular impacted third molars(M3Ms).

Methods

Patients(390 patients and 439 M3Ms)who received the extraction of bone embedded M3Ms in the Department of Oral and Maxillofacial Surgery,Hospital of Stomatology,Sun Yat-sen University from May 2023 to April 2024 were enrolled and divided into two groups in a prospective,randomized controlled,single-blind design.In the experimental group,223(195 patients)bone embedded M3Ms were given cefuroxime axetil tablets(0.25 g orally,bis in die for 3 days)and tinidazole tablets(1.0 g orally,quaque die for 3 days,double the first dose)after extraction.In the control group,216(195 patients)bone embedded M3Ms were extracted and given cefuroxime axxime tablets.For those who were allergic to cefuroxime axetil tablets,the antibiotics were replaced with clindamycin palmitate hydrochloride dispersed tablets(150 mg orally,quater in die for 3 days).Only one bone embedded M3M was extracted in each patient,and the postoperative infection(wound suppurative infection,anterior buccal infection and anterior isthmic space infection),postoperative reactions(pain,swelling and trismus)and adverse drug reactions(central nervous system reaction and gastrointestinal reaction)were recorded on the 7th day after surgery.SPSS 26.0 software package was used for statistical analysis of the data.

Results

The incidence of postoperative infection was 4.0%(9/223)in the experimental group and 6.5%(14/216)in the control group,with no significant difference between the two groups(χ2=1.322,P=0.250).There were no significant difference between the two groups in postoperative reactions,including pain(Z=-0.426,P=0.670),swelling(Z=-0.961,P=0.336)and trismus(Z=-0.170,P=0.865).The incidence of adverse drug reactions in the experimental group was higher than that in the control group,including central nervous system reactions:9.9%(22/223)in the experimental group and 3.2%(7/216)in the control group(χ2=7.805,P=0.005);gastrointestinal reactions:14.3%(32/223)in the experimental group and 6.0%(13/216)in the control group(χ2=8.278,P=0.004).

Conclusions

The combination of NIAs could not further reduce the incidence of infection after the extraction of bone embedded M3Ms,but the incidence of adverse drug reactions was high,so that the combined use of NIAs should be of caution.

表1 骨性埋伏M3M拔除术后反应分级标准
表2 两组骨性埋伏下颌第三磨牙(M3M)拔除患者的年龄及性别比较
表3 两组骨性埋伏下颌第三磨牙(M3M)拔除患者的P-G分类和Winter分类的对比统计[颗(%)]
表4 两组骨性埋伏下颌第三磨牙(M3M)拔除患者的拔牙时间和拔牙后感染的对比统计[颗(%)]
表5 两组骨性埋伏下颌第三磨牙(M3M)拔除患者术后第7天出现疼痛、肿胀和开口受限的对比统计(颗)
表6 两组骨性埋伏下颌第三磨牙(M3M)拔除患者术后出现药物不良反应的对比统计[颗(%)]
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