口服头孢氨苄-克拉维酸、头孢呋辛和阿莫西林-克拉维酸治疗牙齿感染的有效性：一项基于印度真实世界、回顾性电子病历的研究

Effectiveness of Oral Cephalexin-Clavulanic Acid, Cefuroxime, and Amoxicillin-Clavulanic Acid in the Management of Dental Infections: A Real-World, Retrospective, Electronic Medical Record-Based Study in India.

作者信息

Banerjee Kalyan, Kakkar Ajay, Shamsi Kashif Ahmed, Bansal Deepak, Mathur Priyesh, Potode Nitin Madan, Pagariya Pankaj, Azher Sha Perveez, Chaudhari Apurva, Mandal Ritu, Karadkhele Archana S, Markandeywar Neeraj, Dharmadhikari Shruti, Khandhedia Chintan, Mane Amey, Mehta Suyog, Joglekar Sadhna

机构信息

Asansol Dental and Maxillofacial Clinic, Kolkata, West Bengal, India.

Le Visage Dental Clinic, Mumbai, Maharashtra, India.

出版信息

Drugs Real World Outcomes. 2024 Mar;11(1):53-68. doi: 10.1007/s40801-023-00406-x. Epub 2023 Dec 18.

DOI:10.1007/s40801-023-00406-x

PMID:38109028

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10928032/

Abstract

BACKGROUND

Despite multiple antibiotics being available to manage dental infections (DI), there is lack of data comparing commonly prescribed antibiotics in India.

OBJECTIVES

The aim of this study was to evaluate the real-world effectiveness and tolerability of cephalexin-clavulanic acid fixed-dose combination (cephalexin CV FDC) in contrast with amoxicillin-clavulanic acid (co-amoxiclav FDC) and cefuroxime among patients with dental infections (odontogenic) in India.

METHODS

This retrospective, multi-centric, observational, real-world electronic medical record (EMR)-based study was conducted between January 2022 and December 2022. The EMRs of 355 adults with DI receiving oral cephalexin CV, co-amoxiclav, or cefuroxime were categorized into two distinct groups: Group I (Test Group) with patients prescribed cephalexin extended release 375/750 mg along with clavulanic acid 125 mg; and Group II (Comparator Group) with patients prescribed co-amoxiclav 625 mg (500 mg amoxicillin + 125 mg clavulanic acid) or cefuroxime (250 mg/500 mg).

RESULTS

Toothache was the most common complaint, reported by 95.5% of patients, followed by swelling (46.8%), tooth sensitivity (35.5%), pus discharge (33.0%), redness and halitosis (30.4% each). Dental caries was observed in 81.1% of patients. Clinical improvement, defined as improvement/partial resolution of infection-related clinical signs and symptoms (composite measure of pain, swelling, fever, requirement of additional antimicrobial therapy) as per dentists' judgment, was recorded in 98.3% of patients with cephalexin CV, 96.8% of patients with co-amoxiclav, and 98.9% of patients treated with cefuroxime within 10 days. Time (days) to clinical improvement was numerically lesser among patients receiving cephalexin CV (4.6 ± 2.0) compared with cefuroxime (4.9 ± 2.1) and co-amoxiclav (5.0 ± 2.6). All treatments were well tolerated.

CONCLUSION

Cephalexin CV was as effective as co-amoxiclav and cefuroxime, with faster clinical improvement and better resolution of certain symptoms.

摘要

背景

尽管有多种抗生素可用于治疗牙齿感染（DI），但在印度缺乏比较常用抗生素的数据。

目的

本研究的目的是评估头孢氨苄 - 克拉维酸固定剂量组合（头孢氨苄CV固定剂量复方制剂）与阿莫西林 - 克拉维酸（阿莫西林克拉维酸钾固定剂量复方制剂）和头孢呋辛在印度牙齿感染（牙源性）患者中的实际有效性和耐受性。

方法

这项回顾性、多中心、观察性、基于真实世界电子病历（EMR）的研究于2022年1月至2022年12月进行。355名接受口服头孢氨苄CV、阿莫西林克拉维酸钾或头孢呋辛治疗的DI成年患者的电子病历被分为两个不同的组：第一组（试验组），患者服用缓释头孢氨苄375/750毫克以及克拉维酸125毫克；第二组（对照组），患者服用阿莫西林克拉维酸钾625毫克（500毫克阿莫西林 + 125毫克克拉维酸）或头孢呋辛（250毫克/500毫克）。

结果

牙痛是最常见的主诉，95.5%的患者报告有牙痛，其次是肿胀（46.8%）、牙齿敏感（35.5%）、排脓（33.0%）、发红和口臭（各30.4%）。81.1%的患者观察到有龋齿。根据牙医的判断，临床改善定义为感染相关临床体征和症状的改善/部分缓解（疼痛、肿胀、发热、额外抗菌治疗需求的综合指标），在接受头孢氨苄CV治疗的患者中有98.3%实现，接受阿莫西林克拉维酸钾治疗的患者中有96.8%实现，接受头孢呋辛治疗的患者中有98.9%在10天内实现。与头孢呋辛（4.9±2.1）和阿莫西林克拉维酸钾（5.0±2.6）相比，接受头孢氨苄CV治疗的患者达到临床改善的时间（天数）在数值上更少（4.6±2.0）。所有治疗耐受性良好。