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Abstract：
Background Antimicrobial resistance by bacteria poses a substantial threat to morbidity and mortality worldwide, and treatment of resistant infections is a challenge for the treating clinician. Levonadifloxacin is a novel broad-spectrum agent belonging to the benzoquinolizine subclass of quinolone, which can be used by both oral and intravenous administration for the treatment of infections caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methods This prescription event monitoring study captured data from 1266 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of various bacterial infections. The duration of the study was 18 months. Study outcomes were clinical success and microbial success at the end of therapy. Global assessments were done for safety and efficacy at the end of therapy using a 5-point Likert scale (excellent, very good, good, satisfactory, and poor). Results The mean (median) duration of therapy was 7.2 (7.0) days, with a median time to clinical improvement of four days. Oral therapy was administered to 224 patients; 940 received IV, and 102 received IV followed by oral therapy. Patients were prescribed levonadifloxacin for gram-positive infections, skin and soft tissue infections, diabetic foot infections, septicemia, catheter-related blood-stream infections, bone and joint infections, febrile neutropenia, and respiratory infections, including COVID-19 pneumonia. The clinical cure on the eighth day was 95.7%, whereas the microbial success on the eighth day was 93.3% (n=60). For different types of infections, the clinical success rates ranged from 85.2% to 100%. There were only 30 treatment-emergent adverse events reported in 29 patients. Overall, about 95.6% of patients rated the efficacy as good to excellent, whereas only 3.8% of patients rated it satisfactory; for safety, 95.7% of patients rated it as good to excellent, with only 3.9% of patients rated it as satisfactory. Conclusions The excellent safety and efficacy profile of levonadifloxacin, when administered as an oral or intravenous therapy, makes it a desirable treatment modality for the management of various bacterial infections, including those caused by resistant pathogens such as MRSA and quinolone-resistant Staphylococcus aureus (QRSA). Features of levonadifloxacin, such as availability in both IV and oral form, minimal drug-drug interactions, lack of the need to adjust dosages in renal and hepatically impaired patients along with a broad spectrum of coverage, make it a suitable agent that meets several unmet clinical needs of physicians.
摘要：
背景：细菌的抗菌素耐药性对全世界的发病率和死亡率构成重大威胁。和耐药感染的治疗是治疗临床医生的一个挑战。左旋阿霉素是一种新型的广谱药物，属于喹诺酮类药物的苯并喹诺嗪亚类，它可以通过口服和静脉给药用于治疗由革兰氏阳性菌引起的感染，包括耐甲氧西林金黄色葡萄球菌（MRSA）。患者和方法该处方事件监测研究捕获了来自在现实世界环境中接受左旋萘沙星(口服和/或IV)的1266名患者的数据,以评估治疗各种细菌感染的安全性和有效性。研究的持续时间为18个月。研究结果是治疗结束时的临床成功和微生物成功。使用5点Likert量表（优秀，非常好,不错,令人满意,和穷人）。结果治疗的平均（中位数）持续时间为7.2（7.0）天，临床改善的中位时间为4天。对224例患者进行了口服治疗；940例接受了静脉注射，102例接受静脉内注射，然后口服治疗。患者因革兰氏阳性感染而被处方为左旋地氟沙星，皮肤和软组织感染，糖尿病足感染,败血症,导管相关性血流感染,骨和关节感染，发热性中性粒细胞减少症,和呼吸道感染，包括COVID-19肺炎。第八天临床治愈率为95.7%,而第八天的微生物成功率为93.3％（n=60）。对于不同类型的感染，临床成功率为85.2%~100%.29例患者仅报告了30例治疗引起的不良事件。总的来说,约95.6%的患者评价疗效为好到优,而只有3.8%的患者认为令人满意；为了安全起见，95.7％的患者将其评为良好到优秀，只有3.9%的患者认为令人满意。结论左旋阿昔沙星具有良好的安全性和有效性,当作为口服或静脉内治疗给药时，使其成为管理各种细菌感染的理想治疗方式，包括由耐药病原体引起的，如MRSA和耐喹诺酮金黄色葡萄球菌（QRSA）。左旋阿霉素的特点，例如IV和口服形式的可用性，最小的药物-药物相互作用，不需要调整肾脏和肝脏受损患者的剂量以及广泛的覆盖范围，使其成为一种合适的药物，满足医生的一些未满足的临床需求。
