第三磨牙围手术期预防性使用抗生素的随机 双盲安慰剂对照自身临床试验

A Randomized, Double-Blind, Placebo-Controlled, Self-Controlled Clinical Trial of Perioperative Prophylactic Antibiotic Use in Third Molar Extraction

摘要: 目的：评估第三磨牙拔除术围手术期预防性使用抗生素对术后感染、疼痛、肿胀及张口度等临床结局的影响，为临床合理用药提供循证依据。方法：选取2024年6月至2025年12月在成都市第七人民医院口腔科行第三磨牙拔除术的患者，纳入近中阻生或水平阻生患者48例患者，因双侧智齿都需要拔除，故手术为96例，其中男性24例，女性24例，年龄17~34岁。采用随机、双盲、安慰剂对照的自身对照设计。记录手术时间、术后感染发生率、术后第1、3、7天的疼痛视觉模拟量表(VAS)评分、肿胀程度及张口度。采用SPSS 23.0进行统计分析，计量资料行配对样本t检验，计数资料采用Fisher确切概率法。结果：两组手术时间比较差异无统计学意义(P > 0.05)。整体手术部位感染(SSI)发生率为6%，抗生素组感染率为2%，对照组为10%，差异无统计学意义(P = 0.204)。术后第1、3、7天，两组VAS评分及肿胀程度均随时间逐渐下降(P < 0.05)，差异无统计学意义(P > 0.05)。术后第1、3、7天，两组张口度均逐渐提高(P < 0.05)，抗生素组张口度改善显著优于对照组(P < 0.05)。结论：对于接受第三磨牙拔除术的健康人群，围手术期预防性使用抗生素未能显著降低术后感染率、疼痛或肿胀程度，但可改善术后张口度。对常规第三磨牙拔除术患者不建议无条件预防性使用抗生素，临床决策应个体化。

Abstract: Objective: To evaluate the effect of prophylactic antibiotic use during the perioperative period of third molar extraction on postoperative clinical outcomes including infection, pain, swelling, and mouth opening, and to provide evidence-based guidance for rational clinical drug use. Methods: Patients undergoing third molar extraction at the Department of Stomatology, Chengdu Seventh People’s Hospital from June 2024 to December 2025 were enrolled. A total of 48 patients (96 surgical sides) with mesioangular or horizontal impaction were included, comprising 24 males and 24 females, aged 17 - 34 years. A randomized, double-blind, placebo-controlled, self-controlled design was adopted. Operation time, incidence of postoperative infection, pain measured by Visual Analog Scale (VAS) on postoperative days 1, 3, and 7, swelling degree, and mouth opening were recorded. Statistical analysis was performed using SPSS 23.0. Paired-sample t-tests were used for continuous variables, and Fisher’s exact test was applied for categorical data. Results: No significant difference in operation time was observed between the two groups (P > 0.05). The overall incidence of surgical site infection (SSI) was 6%, with 2% in the antibiotic group and 10% in the control group; the difference was not statistically significant (P = 0.204). On postoperative days 1, 3, and 7, VAS scores and swelling degree in both groups gradually decreased over time (P < 0.05), with no significant intergroup differences (P > 0.05). On postoperative days 1, 3, and 7, mouth opening gradually improved in both groups (P < 0.05), and the improvement in mouth opening was significantly greater in the antibiotic group than in the control group (P < 0.05). Conclusion: For healthy patients undergoing third molar extraction, perioperative prophylactic antibiotic use does not significantly reduce postoperative infection rates, pain, or swelling, but it may improve postoperative mouth opening. Routine prophylactic antibiotic use is not recommended for uncomplicated third molar extractions, and clinical decisions should be individualized.