Thakare R, Dasgupta A, Chopra S
Division of Microbiology, CSIR-Central Drug Research Institute, Lucknow, Uttar Pradesh, India.
Drugs Today (Barc). 2020 Apr;56(4):241-255. doi: 10.1358/dot.2020.56.4.3075796.
Imipenem/cilastatin sodium/relebactam is a combination of imipenem/cilastatin, a U.S. Food and Drug Administration (FDA)-approved antibiotic, and β-lactamase inhibitor relebactam which has been developed for the treatment of complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI) due to drug-resistant bacterial pathogens. The combination (Recarbrio) has been designated as a qualified infectious disease product (QIDP) and obtained FDA approval in 2019 for the treatment of cUTI and cIAI caused by susceptible Gram-negative microorganisms in adult patients with limited or no alternative treatment options. The product was also approved by the European Medicines Agency (EMA) in 2020 for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
亚胺培南/西司他丁钠/雷利巴坦是由亚胺培南/西司他丁(一种已获美国食品药品监督管理局(FDA)批准的抗生素)与β-内酰胺酶抑制剂雷利巴坦组成的复方制剂,该复方制剂用于治疗由耐药细菌病原体引起的复杂性尿路感染(cUTI)和复杂性腹腔内感染(cIAI)。该复方制剂(瑞卡必妥)已被指定为合格传染病产品(QIDP),并于2019年获得FDA批准,用于治疗成年患者中由易感革兰氏阴性微生物引起的cUTI和cIAI,这些成年患者的治疗选择有限或没有其他治疗选择。该产品还于2020年获得欧洲药品管理局(EMA)批准,用于治疗治疗选择有限的成年患者中由需氧革兰氏阴性菌引起的感染。