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舒巴坦-度洛巴坦获批情况概述及其对推进医院获得性肺炎和呼吸机相关性肺炎治疗方案的影响:一项叙述性综述。

An overview of sulbactam-durlobactam approval and implications in advancing therapeutics for hospital-acquired and ventilator-associated pneumonia by complex: A narrative review.

作者信息

Anand Ayush, Verma Amogh, Kaur Sarabjeet, Kathayat Priyangi, Manoj Rachel M, Aakanksha Aakanksha, Turzin Justice K, Satapathy Prakasini, Khatib Mahalaqua N, Gaidhane Shilpa, Zahiruddin Quazi S, Kukreti Neelima, Rustagi Sarvesh, Surana Arihant

机构信息

B. P. Koirala Institute of Health Sciences Dharan Nepal.

MediSurg Research Darbhanga India.

出版信息

Health Sci Rep. 2024 Sep 9;7(9):e70066. doi: 10.1002/hsr2.70066. eCollection 2024 Sep.

Abstract

PURPOSE

Infections caused by , particularly those resistant to antibiotics such as carbapenem, have become a global health crisis with a significant mortality rate. Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) resulting from the (ABC) complex represent a major clinical challenge. This review aimed to understand the approval process, mechanism of action, therapeutic potential, and future implications of sulbactam-durlobactam therapy (SUL-DUR).

METHODS

PubMed, Web of Science, EMBASE, Clinical trials. gov, ICTRP, and CENTRAL were searched for studies on SUL-DUR for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia. Also, World Health Organization, U.S. Food and Drug Administration, and Centers for Disease Control and Prevention websites were searched for relevant information.

RESULTS

SUL-DUR, marketed as Xacduro, is a novel pharmaceutical combination that functions as a narrow-spectrum parenterally administered antibiotic. Sulbactam acts as a β-lactamase inhibitor, whereas durlobactam protects against degradation by enzymes. A phase 1 trial successfully established the safety and tolerability of SUL-DUR in patients with normal and mild renal impairment. A phase 2 trial demonstrated the safety and tolerability of SUL-DUR in a larger population with urinary tract infections. A phase 3 trial showed that SUL-DUR was non-inferior to colistin in terms of mortality in VAP, HAP, and bacteremia.

CONCLUSION

The combination of sulbactam and durlobactam is a promising treatment option for HAP and VAP caused by ABC complex.

摘要

目的

由[具体病原体名称未给出]引起的感染,尤其是对碳青霉烯等抗生素耐药的感染,已成为一场死亡率颇高的全球健康危机。由[ABC复合体]导致的医院获得性肺炎(HAP)和呼吸机相关性肺炎(VAP)是一项重大的临床挑战。本综述旨在了解舒巴坦-度洛巴坦疗法(SUL-DUR)的获批过程、作用机制、治疗潜力及未来影响。

方法

检索了PubMed、科学网、EMBASE、Clinical trials.gov、ICTRP和CENTRAL,以查找关于SUL-DUR治疗医院获得性肺炎和呼吸机相关性肺炎的研究。此外,还检索了世界卫生组织、美国食品药品监督管理局和疾病控制与预防中心的网站以获取相关信息。

结果

以Xacduro上市的SUL-DUR是一种新型药物组合,作为一种窄谱胃肠外给药抗生素发挥作用。舒巴坦作为一种β-内酰胺酶抑制剂,而度洛巴坦可防止被[具体酶名称未给出]酶降解。一项1期试验成功确立了SUL-DUR在肾功能正常和轻度受损患者中的安全性和耐受性。一项2期试验证明了SUL-DUR在更大规模尿路感染患者群体中的安全性和耐受性。一项3期试验表明,在VAP、HAP和菌血症的死亡率方面,SUL-DUR不劣于黏菌素。

结论

舒巴坦和度洛巴坦的组合是治疗由ABC复合体引起的HAP和VAP的一种有前景的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cca7/11386240/664bc84df8aa/HSR2-7-e70066-g002.jpg

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