Yu Jiaxin, Zhang Baoshuang, Yang Yang, Dou Wei, Li Yuliu, Yang Anji, Ruan Xiao, Zuo Wei, Zhang Bo
Department of pharmacy & State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China.
Infection. 2024 Dec;52(6):2445-2454. doi: 10.1007/s15010-024-02307-9. Epub 2024 Jul 23.
Sulbactam (SBT) is one of the most significant treatments for patients with extensively drug-resistant Acinetobacter baumannii (XDR-AB). However, the efficacy and safety of SBT and its high dose regimen has not been well documented. This retrospective study aimed to assess the efficacy and safety of SBT-based treatment, particularly at high-dose (≥ 6 g/day), for XDR-AB infection.
A total of 52 XDR-AB infected patients treated with intravenous SBT at Peking Union Medical College Hospital were included. The primary outcome was 28-day all-cause mortality, while the secondary outcome was 14-day clinical response and the time of response. The formulation of SBT in our study is 0.5 g per vial.
Among the patients, the 28-day all-cause mortality rate was 36.5% (19/52), and the favorable 14-day clinical response rate was 59.6% (31/52). The 28-day mortality was independently associated coinfection with gram-positive bacteria (GPB) and a shorter duration of therapy. Patients with intracranial infection might have a longer survival time. A favorable 14-day clinical response was associated with the dose of SBT, and a longer treatment duration. However, the higher creatinine clearance (CrCl) associated with a worse clincal response. In addition, a higher SBT dosage was significantly correlated with a shorter time to clinical response. No adverse effects related were reported.
The single-agent formulation of SBT emerges as a promising alternative for the treatment of XDR-AB infection, such as intracranial infection, particularly at high doses (≥ 6 g/day). Besides, longer duration of treatment correlates with higher survival rate and better favorable clinical response. Higher CrCl negatively correlates with favorable clinical response.
舒巴坦（SBT）是治疗广泛耐药鲍曼不动杆菌（XDR-AB）患者的最重要治疗方法之一。然而，SBT及其高剂量方案的疗效和安全性尚未得到充分记录。这项回顾性研究旨在评估以SBT为基础的治疗，特别是高剂量（≥6克/天）治疗XDR-AB感染的疗效和安全性。
纳入北京协和医院52例接受静脉注射SBT治疗的XDR-AB感染患者。主要结局是28天全因死亡率，次要结局是14天临床反应及反应时间。本研究中SBT的制剂为每瓶0.5克。
患者中，28天全因死亡率为36.5%（19/52），14天良好临床反应率为59.6%（31/52）。28天死亡率与革兰氏阳性菌（GPB）合并感染及治疗时间较短独立相关。颅内感染患者可能有更长的生存时间。14天良好临床反应与SBT剂量及更长的治疗时间相关。然而，肌酐清除率（CrCl）越高，临床反应越差。此外，较高的SBT剂量与较短的临床反应时间显著相关。未报告相关不良反应。
SBT单药制剂成为治疗XDR-AB感染（如颅内感染）的一种有前景的替代方法，特别是高剂量（≥6克/天）时。此外，较长的治疗时间与较高的生存率和更好的临床反应相关。较高的CrCl与良好的临床反应呈负相关。
