奥马他环素在中国治疗多种感染:疗效与安全性的真实世界分析》。

IF 4.7 3区 医学 Q1 INFECTIOUS DISEASES Infectious Diseases and Therapy Pub Date : 2024-10-22 DOI:10.1007/s40121-024-01065-3
Weiwen Gao, Jian Yang, Xiangwang Zhang, Lei Tian, Dong Xu, Shuyun Xu, Dong Liu, Yan He
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引用次数: 0

摘要

简介:奥美拉唑嗪的疗效和安全性主要通过III期临床试验得到证实,但来自实际临床环境的数据却十分有限。本研究旨在探讨奥美拉唑在中国的实际使用情况,并确定其疗效的相关因素:方法:我们对 2022 年 3 月至 2024 年 3 月期间在一个中心接受奥美拉唑治疗的患者的病历进行了回顾性分析。我们分析了人口统计学特征、实验室结果、抗生素治疗方案和临床结果。我们采用逻辑回归法来确定与临床治疗失败或微生物清除失败相关的风险因素:共有 183 名患者被纳入最终分析。71.0%的患者(130/183)取得了临床成功,细菌清除率为61.9%(26/42)。20.8%(38/183)的患者出现肾功能损害,其中39.5%(15/38)的患者接受了肾毒性抗生素治疗。在治疗过程中,很少出现值得注意的药物不良反应。多变量逻辑回归分析确定了几个与治疗失败相关的独立因素:中度至重度肝损伤(OR:3.073,95% CI 1.345-7.021,p = 0.008)、入住呼吸科(OR:2.573,95% CI 1.135-5.834,p = 0.024)和奥马德西林治疗时间少于 7 天(OR:3.762,95% CI 1.626-8.706,p = 0.002):我们的研究表明,奥美拉唑霉素治疗可取得良好的临床疗效和细菌清除率,并具有积极的安全性和耐受性。然而,要验证这些初步研究结果,还需要进行高质量的随机对照试验。
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Omadacycline for Diverse Infections in China: A Real-World Analysis of Efficacy and Safety.

Introduction: The efficacy and safety of omadacycline have been primarily documented through Phase III clinical trials; however, there are limited data from real-world clinical settings. This study aims to explore the real-world use of omadacycline in China and identify the factors associated with its efficacy.

Methods: We conducted a retrospective review of medical records for patients treated with omadacycline at a single center from March 2022 to March 2024. We analyzed demographic characteristics, laboratory results, antibiotic regimens, and clinical outcomes. Logistic regression was employed to identify risk factors associated with clinical treatment failure or failure of microbial clearance.

Results: A total of 183 patients were included in the final analysis. Clinical success was achieved in 71.0% (130/183) of patients, with a bacterial clearance rate of 61.9% (26/42). Renal impairment was observed in 20.8% (38/183) of patients, with 39.5% (15/38) of these patients receiving nephrotoxic antibiotic treatments. Noteworthy adverse drug reactions were rare during the course of the treatment. Multivariate logistic regression analysis identified several independent factors associated with treatment failure: moderate to severe liver damage (OR: 3.073, 95% CI 1.345-7.021, p = 0.008), admission to the respiratory department (OR: 2.573, 95% CI 1.135-5.834, p = 0.024), and a duration of omadacycline therapy of less than 7 days (OR: 3.762, 95% CI 1.626-8.706, p = 0.002).

Conclusions: Our study demonstrates that omadacycline treatment can achieve favorable clinical success and bacterial clearance, with positive safety and tolerability outcomes. However, high-quality randomized controlled trials are needed to validate these initial findings.

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来源期刊
Infectious Diseases and Therapy
Infectious Diseases and Therapy Medicine-Microbiology (medical)
CiteScore
8.60
自引率
1.90%
发文量
136
审稿时长
6 weeks
期刊介绍: Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.
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