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术前使用抗生素对种植成功率的影响:中国头孢克肟和奥硝唑的一项回顾性队列研究

Effect of preoperative antibiotic use on the implant success rate: a retrospective cohort study of cefixime and ornidazole in China.

作者信息

Lou An, Zhu Xuan, Pei Hongtai, Zhou Jing, Li Ming

机构信息

School of Stomatology, Hunan University of Chinese Medicine, Changsha, Hunan, People's Republic of China.

Changsha Stomatological Hospital, Changsha, Hunan, People's Republic of China.

出版信息

BMC Oral Health. 2025 Sep 26;25(1):1466. doi: 10.1186/s12903-025-06853-y.

Abstract

BACKGROUND

This study aims to enhance the current clinical understanding of prophylactic antibiotic treatment in China before implant surgeries, and improve the experience and adherence of patients who undergo implant procedures.  METHODS : Patients eligible for inclusion in the past six years were divided into two groups of 500 patients each. Patients in the medication group received one 500 mg cefixime tablet and one 500 mg ornidazole tablet 0.5 hours before implantation. Patients in the non-medicated group did not receive any medicine. Patients were evaluated at two follow-ups: 7-14 days and 3-6 months after implant surgeries. The primary outcome was implant failure, which was characterized as implant detachment or complete loss during follow-ups, implant mobility (clinical mobility >1 mm) detected by surgeons when manually tightening abutments at the second follow-up (3-6 months after surgeries), or complications requiring clinical intervention occurred, including peri-implant bone resorption exceeding acceptable levels. Secondary outcomes were postoperative infection and adverse events. We statistically analyzed study outcomes using the Pearson Chi-square test, Fisher's exact test, and a multiple logistic regression model to evaluate differences between the two groups. P values less than 0.05 or 95% confidence intervals of relative risk or odds ratio values excluding one were considered statistically significant.

RESULTS

We noted implant failures (medication group: four patients, 0.8% and non-medicated group: three patients, 0.6%) and postoperative infections (medication group: 23 patients, 4.6% and non-medicated group: 25 patients, 5.0%) were no statistically significant difference between the two groups. However, adverse events showed a statistically significant increase in the medication group (medication group: 111 patients, 22.2% and non-medicated group: 21 patients, 4.2%), including nausea, vomiting, hypersomnia, dizziness, and diarrhea. There was a statistically non-significant increase in fever in the non-medicated group. No statistically significant evidence existed in preventing postoperative infection between the two groups across smoking status, age, implant system, number of implants (1, 2-3, and ≥4), sinus elevation surgery, implant placement, and guided bone regeneration surgery.

CONCLUSIONS

Antibiotic prophylaxis using ornidazole in conjunction with cefixime in implant surgery may not have clinical benefits but significantly increases adverse events. Therefore, the necessity of prophylactic antibiotic use in healthy patients before implant surgeries needs to be reconsidered.

摘要

背景

本研究旨在加强目前中国对种植牙手术前预防性抗生素治疗的临床认识,并改善接受种植牙手术患者的体验和依从性。方法:将过去六年符合纳入标准的患者分为两组,每组500例。用药组患者在植入前0.5小时服用一片500毫克头孢克肟片和一片500毫克奥硝唑片。未用药组患者未接受任何药物治疗。在种植牙手术后7至14天和3至6个月这两个随访时间点对患者进行评估。主要结局为种植失败,其定义为随访期间种植体脱落或完全丢失、在第二次随访(手术后3至6个月)外科医生手动拧紧基台时检测到的种植体松动(临床松动度>1毫米),或发生需要临床干预的并发症,包括种植体周围骨吸收超过可接受水平。次要结局为术后感染和不良事件。我们使用Pearson卡方检验、Fisher精确检验和多元逻辑回归模型对研究结局进行统计学分析,以评估两组之间的差异。P值小于0.05或相对风险或比值比的95%置信区间不包括1被认为具有统计学意义。结果:我们注意到种植失败(用药组:4例患者,0.8%;未用药组:3例患者,0.6%)和术后感染(用药组:23例患者,4.6%;未用药组:25例患者,5.0%)在两组之间无统计学显著差异。然而,不良事件在用药组有统计学显著增加(用药组:111例患者,22.2%;未用药组:21例患者,4.2%),包括恶心、呕吐、嗜睡、头晕和腹泻。未用药组发热有统计学上不显著的增加。在吸烟状况、年龄、种植系统、种植体数量(1颗、2至3颗和≥4颗)、上颌窦提升手术、种植体植入和引导骨再生手术方面,两组在预防术后感染方面均无统计学显著证据。结论:种植牙手术中使用奥硝唑联合头孢克肟进行抗生素预防可能没有临床益处,但会显著增加不良事件。因此,需要重新考虑在健康患者种植牙手术前使用预防性抗生素的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/558a/12465351/4571fd381fae/12903_2025_6853_Fig1_HTML.jpg

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