Department of General Medicine, Chi Mei Medical Centre, Tainan, Taiwan.
Department of Internal Medicine, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan; School of Medicine for International Students, College of Medicine, I-Shou University, Kaohsiung, Taiwan.
Int J Antimicrob Agents. 2023 Aug;62(2):106844. doi: 10.1016/j.ijantimicag.2023.106844. Epub 2023 May 7.
Carbapenem-sparing antibiotics are needed urgently for patients with complicated intra-abdominal infections (cIAIs). Although several novel antibiotics - novel β-lactam/β-lactamase inhibitor combinations (e.g. ceftolozane-tazobactam and ceftazidime-avibactam) and a novel tetracycline derivative (eravacycline) - have been developed for cIAIs, it remains unclear whether these antibiotics are comparable to carbapenems for the treatment of cIAIs.
A comprehensive search of PubMed, Embase, Cochrane Library and ClinicalTrials.gov was conducted until 1 October 2022. Only randomized controlled trials (RCTs) that compared the clinical efficacy and safety of novel antibiotics against carbapenems for patients with cIAIs were included.
Among the 11 selected RCTs, no significant differences in clinical cure rate at the test-of-cure visit were observed between the study group and the control group on analysis of the clinically evaluable population [93.6% vs 93.7%, risk ratio (RR) 1.00, 95% confidence interval (CI) 0.98-1.01; P=0.84], microbiologically evaluable population (93.0% vs 94.5%, RR 0.98, 95% CI 0.96-1.00; P=0.10) and modified intention-to-treat population (85.9% vs 87.7%, RR 0.98, 95% CI 0.95-1.01; P=0.13). All findings were consistent across the subgroup analyses and sensitivity tests. Similarly, no significant difference in microbiological eradication was observed between the study group and the control group (87.8% vs 89.7%, RR 0.98, 95% CI 0.96-1.01; P=0.18). The risk of adverse events was similar in both groups.
Clinical efficacy, microbiological response and safety of the novel antibiotics, including ceftazidime-avibactam, ceftolozane-tazobactam and eravacycline, are comparable to carbapenems for the treatment of patients with cIAIs. These agents can be potential therapeutic options as carbapenem-sparing antibiotics for cIAIs.
对于复杂性腹腔内感染（cIAI）患者，迫切需要使用碳青霉烯类抗生素以外的抗生素。虽然已经开发了几种新型抗生素-新型β-内酰胺/β-内酰胺酶抑制剂组合（例如头孢他啶-阿维巴坦和头孢唑肟-他唑巴坦）和新型四环素衍生物（依拉环素）-用于 cIAI，但尚不清楚这些抗生素在治疗 cIAI 方面是否与碳青霉烯类药物相当。
对 PubMed、Embase、Cochrane Library 和 ClinicalTrials.gov 进行了全面检索，检索时间截至 2022 年 10 月 1 日。仅纳入比较新型抗生素与碳青霉烯类药物治疗 cIAI 患者的临床疗效和安全性的随机对照试验（RCT）。
在纳入的 11 项 RCT 中，在治疗结束时对临床可评估人群（93.6% vs 93.7%，RR 1.00，95%置信区间（CI）0.98-1.01；P=0.84）、微生物可评估人群（93.0% vs 94.5%，RR 0.98，95%CI 0.96-1.00；P=0.10）和改良意向治疗人群（85.9% vs 87.7%，RR 0.98，95%CI 0.95-1.01；P=0.13）进行分析，研究组与对照组的临床治愈率无显著差异。所有发现均在亚组分析和敏感性测试中一致。同样，研究组与对照组的微生物清除率也无显著差异（87.8% vs 89.7%，RR 0.98，95%CI 0.96-1.01；P=0.18）。两组的不良事件风险相似。
头孢他啶-阿维巴坦、头孢唑肟-他唑巴坦和依拉环素等新型抗生素的临床疗效、微生物反应和安全性与碳青霉烯类药物相当，可作为碳青霉烯类药物治疗 cIAI 的替代治疗药物。
