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莫西沙星与克林霉素治疗牙源性脓肿和炎症浸润的疗效和安全性比较:一项 II 期、双盲、随机试验。

Comparative efficacy and safety of moxifloxacin and clindamycin in the treatment of odontogenic abscesses and inflammatory infiltrates: a phase II, double-blind, randomized trial.

机构信息

Department of Restorative and Preventive Dentistry, Center for Dental and Oral Medicine, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.

出版信息

Antimicrob Agents Chemother. 2011 Mar;55(3):1142-7. doi: 10.1128/AAC.01267-10. Epub 2010 Dec 20.

DOI:10.1128/AAC.01267-10
PMID:21173173
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3067083/
Abstract

Moxifloxacin penetrates well into oromaxillary tissue and covers the causative pathogens that show an increasing resistance to standard antibiotics. Clinical reports suggest that moxifloxacin may be effective for the treatment of odontogenic infections that can lead to serious complications. The objective of this prospective, randomized, double-blind, multicenter study was to compare the efficacies and safeties of moxifloxacin and clindamycin for the medical treatment of patients with gingival inflammatory infiltrates and as an adjuvant therapy for patients with odontogenic abscesses requiring surgical treatment. Patients received either 400 mg moxifloxacin per os once daily or 300 mg clindamycin per os four times daily for 5 days consecutively. The primary efficacy endpoint was the percent reduction in patients' perceived pain on a visual analogue scale at days 2 to 3 from baseline. Primary analysis included 21 moxifloxacin- and 19 clindamycin-treated patients with infiltrates and 15 moxifloxacin- and 16 clindamycin-treated patients with abscesses. The mean pain reductions were 61.0% (standard deviation [SD], 46.9%) with moxifloxacin versus 23.4% (SD, 32.1%) with clindamycin (P = 0.006) for patients with infiltrates and 55.8% (SD, 24.8%) with moxifloxacin versus 42.7% (SD, 48.5%) with clindamycin (P = 0.358) for patients with abscesses. A global efficacy assessment at days 2 to 3 and 5 to 7 showed faster clinical responses with moxifloxacin in both abscess and infiltrate patients. Rates of adverse events were lower in moxifloxacin- than in clindamycin-treated patients. In patients with inflammatory infiltrates, moxifloxacin was significantly more effective in reducing pain at days 2 to 3 of therapy than clindamycin. No significant differences between groups were found for patients with odontogenic abscesses.

摘要

莫西沙星能很好地渗透到口腔颌面部组织中,并覆盖对抗生素标准治疗呈耐药性不断增加的病原体。临床报告表明,莫西沙星可能对导致严重并发症的牙源性感染的治疗有效。本前瞻性、随机、双盲、多中心研究的目的是比较莫西沙星和克林霉素治疗牙龈炎性浸润患者的疗效和安全性,并作为需要手术治疗的牙源性脓肿患者的辅助治疗。患者连续 5 天每天口服 400 mg 莫西沙星或 300 mg 克林霉素,每天 4 次。主要疗效终点是自基线起第 2-3 天患者视觉模拟评分(VAS)感知疼痛的百分比降低。主要分析包括 21 例莫西沙星治疗和 19 例克林霉素治疗的炎性浸润患者,以及 15 例莫西沙星治疗和 16 例克林霉素治疗的脓肿患者。莫西沙星组疼痛缓解率为 61.0%(标准差[SD],46.9%),克林霉素组为 23.4%(SD,32.1%)(P=0.006),炎性浸润患者;莫西沙星组疼痛缓解率为 55.8%(SD,24.8%),克林霉素组为 42.7%(SD,48.5%)(P=0.358),脓肿患者。在第 2-3 天和第 5-7 天的总体疗效评估中,莫西沙星治疗的脓肿和炎性浸润患者的临床反应更快。莫西沙星组不良反应发生率低于克林霉素组。在炎性浸润患者中,莫西沙星在治疗的第 2-3 天降低疼痛的效果明显优于克林霉素。牙源性脓肿患者组间无显著差异。

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