Meng Rui, Guan Xin, Sun Lei, Fei Zhengyang, Li Yuxin, Luo Mengjie, Ma Aixia, Li Hongchao
School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.
Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing, China.
Front Med (Lausanne). 2022 Sep 16;9:935343. doi: 10.3389/fmed.2022.935343. eCollection 2022.
Eravacycline is a novel, fully synthetic fluorocycline antibiotic for the treatment of adults with complicated intra-abdominal infections (cIAIs). However, the efficacy and safety of eravacycline compared with current clinically common antibiotics remain unknown.
This study aims to compare the efficacy and safety of eravacycline and other clinically common antibiotics in China, including tigecycline, meropenem, ertapenem, ceftazidime/avibactam+metronidazole, piperacillin/tazobactam, imipenem/cilastatin, and ceftriaxone+metronidazole, for the treatment of adults with cIAIs and to provide a reference for clinical choice.
The PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were electronically searched to collect clinical randomized controlled studies (RCTs) comparing different antibiotics in the treatment of patients with cIAIs from inception to June 1, 2021. Two reviewers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies.
A total of 4050 articles were initially retrieved, and 25 RCTs were included after screening, involving eight treatment therapies and 9372 patients. The results of network meta-analysis showed that in the intention-to-treat (ITT) population, the clinically evaluable (CE) population, and the microbiologically evaluable (ME) population, the clinical response rate of eravacycline was not significantly different from that of the other 7 therapies ( > 0.05). In terms of microbiological response rate, eravacycline was significantly better than tigecycline [tigecycline vs. eravacycline: RR = 0.82, 95%CI (0.65,0.99)], and there was no significant difference between the other 6 regimens and eravacycline ( > 0.05). In terms of safety, the incidence of serious adverse events, discontinuation rate, and all-cause mortality of eravacycline were not significantly different from those of the other 7 treatment therapies ( > 0.05).
Based on the evidence generated by the current noninferiority clinical trial design, the efficacy and safety of eravacycline for the treatment of adults with cIAIs are not significantly different from those of the other 7 commonly used clinical antibiotics in China. In terms of microbiological response rate, eravacycline was significantly better than tigecycline. In view of the severe multidrug-resistant situation in China, existing drugs have difficulty meeting the needs of clinical treatment, and the new antibacterial drug eravacycline may be one of the preferred options for the treatment of cIAIs in adults.
依拉环素是一种新型的、全合成的氟环素类抗生素,用于治疗成人复杂性腹腔内感染(cIAIs)。然而,与目前临床常用抗生素相比,依拉环素的疗效和安全性尚不清楚。
本研究旨在比较依拉环素与其他临床常用抗生素(包括替加环素、美罗培南、厄他培南、头孢他啶/阿维巴坦+甲硝唑、哌拉西林/他唑巴坦、亚胺培南/西司他丁和头孢曲松+甲硝唑)在中国治疗成人cIAIs的疗效和安全性,为临床选择提供参考。
通过电子检索PubMed、Embase、Cochrane图书馆和ClinicalTrials.gov数据库,收集从建库至2021年6月1日比较不同抗生素治疗cIAIs患者的临床随机对照试验(RCT)。两名研究者独立筛选文献、提取数据并评估纳入研究的偏倚风险。
初步检索到4050篇文章,筛选后纳入25项RCT,涉及8种治疗方案和9372例患者。网状Meta分析结果显示,在意向性分析(ITT)人群、临床可评价(CE)人群和微生物学可评价(ME)人群中,依拉环素的临床有效率与其他7种治疗方案相比差异无统计学意义(>0.05)。在微生物学有效率方面,依拉环素显著优于替加环素[替加环素与依拉环素:RR = 0.82,95%CI(0.65,0.99)],其他6种方案与依拉环素相比差异无统计学意义(>0.05)。在安全性方面,依拉环素的严重不良事件发生率、停药率和全因死亡率与其他7种治疗方案相比差异无统计学意义(>0.05)。
基于当前非劣效性临床试验设计得出的证据,依拉环素治疗成人cIAIs的疗效和安全性与中国其他7种常用临床抗生素相比差异无统计学意义。在微生物学有效率方面,依拉环素显著优于替加环素。鉴于中国严峻的多重耐药形势,现有药物难以满足临床治疗需求,新型抗菌药物依拉环素可能是治疗成人cIAIs的首选药物之一。