Department of Pharmacy Practice, Henry Ford Hospital, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, MI, USA.
Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, MI, USA.
Ann Pharmacother. 2024 Jul;58(7):735-741. doi: 10.1177/10600280231204566. Epub 2023 Oct 10.
To review the pharmacology, efficacy, and safety of intravenous sulbactam-durlobactam (SUL-DUR) in the treatment of carbapenem-resistant (CRAB) infections.
PubMed databases and ClinicalTrials.gov were searched using the following terms:
Articles published in English between January 1985 and September 13, 2023, related to pharmacology, safety, efficacy, and clinical trials were reviewed.
A phase II trial compared SUL-DUR with placebo with imipenem and cilastatin in both groups. Overall treatment success in the microbiological intention-to-treat analysis was reported in 76.6% of patients in the SUL-DUR group compared with 81% patients in the placebo group. A phase III trial compared SUL-DUR with colistin in adults with confirmed CRAB infections. Patients received either SUL-DUR or colistin and background therapy with imipenem-cilastatin. SUL-DUR was noninferior to colistin for 28-day all-cause mortality (19% vs 32.3%, treatment difference -13.2%; 95% CI [-30.0 to 3.5]).
Clinicians have limited options to treat CRAB infections. SUL-DUR has demonstrated efficacy against CRAB in patients with pneumonia and may be considered a viable treatment option. Nonetheless, potential impact of concomitant imipenem-cilastatin as background therapy on clinical trial findings is unclear. Further studies are needed to elucidate the role of SUL-DUR alone or in combination with other active antimicrobials for the treatment of CRAB infections.
SUL-DUR has shown to be predominantly noninferior to alternative antibiotics in the treatment of pneumonias caused by CRAB, making it a viable treatment option. Further postmarketing data is needed to ascertain its role in other infections.
综述静脉注射舒巴坦-他唑巴坦（SUL-DUR）治疗耐碳青霉烯类鲍曼不动杆菌（CRAB）感染的药理学、疗效和安全性。
使用以下术语在 PubMed 数据库和 ClinicalTrials.gov 进行检索：
检索了 1985 年 1 月至 2023 年 9 月 13 日期间发表的与药理学、安全性、疗效和临床试验相关的英文文章。
一项 II 期试验比较了 SUL-DUR 与安慰剂联合使用美罗培南和西司他丁与安慰剂联合使用的疗效。在微生物学意向治疗分析中，SUL-DUR 组的总体治疗成功率为 76.6%，而安慰剂组为 81%。一项 III 期试验比较了 SUL-DUR 与黏菌素在确诊为 CRAB 感染的成人中的疗效。患者接受 SUL-DUR 或黏菌素联合美罗培南-西司他丁背景治疗。SUL-DUR 在 28 天全因死亡率方面非劣效于黏菌素（19%比 32.3%，治疗差异-13.2%；95%CI[-30.0 至 3.5]）。
与现有药物相比，对患者护理和临床实践的相关性：临床医生治疗 CRAB 感染的选择有限。SUL-DUR 已证明对肺炎患者的 CRAB 有效，可能是一种可行的治疗选择。然而，背景治疗中同时使用美罗培南-西司他丁对临床试验结果的潜在影响尚不清楚。需要进一步的研究来阐明 SUL-DUR 单独或与其他活性抗菌药物联合治疗 CRAB 感染的作用。
SUL-DUR 在治疗 CRAB 引起的肺炎方面主要表现为非劣效于其他抗生素，是一种可行的治疗选择。需要进一步的上市后数据来确定其在其他感染中的作用。
