Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：复杂的腹腔内感染（cIAIs）患者急需保留碳青霉烯类抗生素。即使几种新型抗生素-新型β-内酰胺-β-内酰胺酶抑制剂组合-头孢特洛赞-他唑巴坦和头孢他啶-阿维巴坦，并开发了用于cIAIs的新型四环素衍生物-eravacycline，对于cIAIs,这些抗生素是否与碳青霉烯类相当尚不清楚.
方法：在PubMed上进行了全面搜索，Embase,科克伦图书馆,和ClinicalTrials.gov，直到2022年10月1日。仅包括比较新型抗生素对碳青霉烯类患者的临床疗效和安全性的RCT。
结果：在11个选定的RCT中，在临床可评估人群的分析中，研究组与对照组之间的临床治愈率在治愈测试中没有显着差异（93.6％vs93.7％，风险比[RR]，1.00；95%CI，0.98-1.01；p=0.84），微生物学可评价人群(93.0%vs94.5%；RR，0.98；95%CI，0.96-1.00；p=0.10），和改良的意向治疗人群(85.9%vs87.7%；RR，0.98；95%CI，0.95-1.01；p=0.13）。所有这些发现在亚组分析和敏感性测试中保持一致。同样，在微生物根除方面，研究组和对照组之间没有显着差异（87.8％vs89.7％；RR，0.98；95%CI，0.96-1.01；p=0.18）。两组之间的不良事件风险相似。
结论：临床疗效，微生物反应，以及新型抗生素的安全性，包括头孢他啶-阿维巴坦,头孢洛赞-他唑巴坦,在cIAI患者的治疗中，埃拉环素与碳青霉烯相当。这些药物可以作为cIAIs的碳青霉烯类抗生素的潜在治疗选择。
方法：在PubMed上进行了全面搜索，Embase,科克伦图书馆,和ClinicalTrials.gov，直到2022年10月1日。仅包括比较新型抗生素对碳青霉烯类患者的临床疗效和安全性的RCT。
结果：在11个选定的RCT中，在临床可评估人群的分析中，研究组与对照组之间的临床治愈率在治愈测试中没有显着差异（93.6％vs93.7％，风险比[RR]，1.00；95%CI，0.98-1.01；p=0.84），微生物学可评价人群(93.0%vs94.5%；RR，0.98；95%CI，0.96-1.00；p=0.10），和改良的意向治疗人群(85.9%vs87.7%；RR，0.98；95%CI，0.95-1.01；p=0.13）。所有这些发现在亚组分析和敏感性测试中保持一致。同样，在微生物根除方面，研究组和对照组之间没有显着差异（87.8％vs89.7％；RR，0.98；95%CI，0.96-1.01；p=0.18）。两组之间的不良事件风险相似。
结论：临床疗效，微生物反应，以及新型抗生素的安全性，包括头孢他啶-阿维巴坦,头孢洛赞-他唑巴坦,在cIAI患者的治疗中，埃拉环素与碳青霉烯相当。这些药物可以作为cIAIs的碳青霉烯类抗生素的潜在治疗选择。
