He Rong, Lin Fei, Yu Bin, Qiu Jingyue, Zheng Lingli
Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
Department of Pharmacy, The First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
Front Pharmacol. 2022 Sep 28;13:975578. doi: 10.3389/fphar.2022.975578. eCollection 2022.
This study aims to assess the clinical efficacy and adverse events of delafloxacin for the treatment of acute bacterial infections in adult patients through meta-analysis. The PubMed, Embase, Cochrane library, Web of Science, and Clinical trails databases were searched up to 26 March 2022. Only randomized controlled trials (RCTs) that evaluated delafloxacin and comparator antibiotics for treating acute bacterial infections in adult patients were included. The clinical cure rate and microbiological eradication rate at the posttreatment evaluation, while the secondary outcomes included the risk of adverse events (AEs). In total, six randomized controlled trials (RCTs) involving 3,019 patients with acute bacterial infection were included. There were no significant differences in the clinical cure rate between delafloxacin and comparators (OR = 1.06%, 95% CI = 0.89-1.26, I = 0%). Overall, the results showed that delafloxacin had a microbiological eradication rate (documented and presumed) similar to the comparators (OR = 1.33%, 95% CI = 0.94-1.88, I = 0%) in the pooled analysis of the six studies. Any treatment-emergent adverse events (TEAEs) did not show significant differences between delafloxacin and the comparators (OR = 0.93%, 95% CI = 0.80-1.08, I = 75%). Serious adverse events (SAEs) did not differ between the delafloxacin and comparators (OR = 0.94%, 95% CI = 0.67-1.32, I = 0%). The results of gastrointestinal disorders were (OR = 1.26%, 95% CI = 1.01-1.56, I = 89%), and nausea, vomiting, and diarrhea were (OR = 0.77%, 95% CI = 0.45-1.34, I = 79%), (OR = 1.00%, 95% CI = 0.74-1.36, I = 72%), and (OR = 2.10%, 95% CI = 1.70-2.96, I = 0%), respectively. The results showed that there was no significant difference in the incidence of nausea and vomiting between delafloxacin and the comparator, but the incidence of diarrhea was higher. The analysis of neurological disorders indicated that the incidence of nervous system disorders was lower in the delafloxacin group (OR = 0.71%, 95% CI = 0.50-1.01, I = 52%). The clinical efficacy, microbiological eradication rate and the incidence of AEs of delafloxacin in the treatment of acute bacterial infections were similar to those of the comparators, as an alternative therapeutic agent.
本研究旨在通过荟萃分析评估德拉氟沙星治疗成年患者急性细菌感染的临床疗效和不良事件。检索了截至2022年3月26日的PubMed、Embase、Cochrane图书馆、Web of Science和临床试验数据库。仅纳入评估德拉氟沙星和对照抗生素治疗成年患者急性细菌感染的随机对照试验（RCT）。治疗后评估的临床治愈率和微生物清除率为主要结局，而次要结局包括不良事件（AE）风险。总共纳入了6项涉及3019例急性细菌感染患者的随机对照试验。德拉氟沙星与对照药物的临床治愈率无显著差异（OR = 1.06%，95%CI = 0.89 - 1.26，I² = 0%）。总体而言，结果显示在六项研究的汇总分析中，德拉氟沙星的微生物清除率（记录和推测）与对照药物相似（OR = 1.33%，95%CI = 0.94 - 1.88，I² = 0%）。德拉氟沙星与对照药物之间的任何治疗中出现的不良事件（TEAE）均无显著差异（OR = 0.93%，95%CI = 0.80 - 1.08，I² = 75%）。德拉氟沙星与对照药物之间的严重不良事件（SAE）无差异（OR = 0.94%，95%CI = 0.67 - 1.32，I² = 0%）。胃肠道疾病的结果为（OR = 1.26%，95%CI = 1.01 - 1.56，I² = 89%），恶心、呕吐和腹泻分别为（OR = 0.77%，95%CI = 0.45 - 1.34，I² = 79%）、（OR = 1.00%，95%CI = 0.74 - 1.36，I² = 72%）和（OR = 2.10%，95%CI = 1.70 - 2.96，I² = 0%）。结果显示，德拉氟沙星与对照药物之间恶心和呕吐的发生率无显著差异，但腹泻的发生率较高。神经系统疾病分析表明，德拉氟沙星组神经系统疾病的发生率较低（OR = 0.71%，95%CI = 0.50 - 1.01，I² = 52%）。作为一种替代治疗药物，德拉氟沙星治疗急性细菌感染的临床疗效、微生物清除率和不良事件发生率与对照药物相似。
