在手术伤口中具有强大的抗菌活性,D-PLEX100的局部管理100
Noam Emanuel1, Goldi A Kozloski1, Shlomo Nedvetzki1
1PolyPid Ltd. Hasivim 18, Petach Tikvah, Israel.
概括
D-PLEX是一种新型的多西环林释放糊剂,通过提供30天的局部抗微生物预防抗药性细菌,有效地预防手术部位感染 (SSI). 这种创新方法在接受结直肠手术的患者中显著降低了SSI的发生率.
科学领域:
- 传染性疾病 传染性疾病
- 手术创新 在外科创新.
- 药理学 药理学是指药理学的学科.
背景情况:
- 手术部位感染 (SSIs) 仍然是患者发病率和死亡率的重要原因.
- 目前的预防策略,主要是静脉注射的抗生素,由于药物清除速度快,存在局限性.
- 需要持续地提供局部抗微生物药物,以对抗伤口部位的耐药病原体.
研究的目的:
- 评估D-PLEX的疗效和安全性,D-PLEX是一种局部释放多克西环素的糊剂,用于预防切口性SSI.
- 评估D-PLEX对流行SSI病原体的抗菌活性,包括耐药菌株.
- 在临床前模型和临床环境中确定D-PLEX的药物释放特征和药理动力学参数.
主要方法:
- 最小杀菌度 (MBC) 对关键细菌病原体的测定.
- 在腹部和骨切口感染的子模型中的体内疗效研究.
- 在体外释放动力学和体内药理动力学分析从D-PLEX.的多克西环素.
- 在一项前性随机试验中分析SSI率和病原体耐药性,比较D-PLEX加标准护理 (SOC) 与单独的SOC在结直肠手术患者中.
主要成果:
- D-PLEX对所有测试生物体表现出显著的杀菌活性 (>3-Log10减少),包括对MRSA等耐多西环林菌株.
- 在体内研究表明,D-PLEX在腹部和胸部感染模型中显著降低了细菌负荷 (p=0.0001).
- 实验室和体内研究证实,D-PLEX从D-PLEX中释放了30天的多西环素,维持局部度 (3-5mcg/mL),系统暴露最小.
- 在结直肠外科手术患者中,D-PLEX加SOC导致SSI率显著降低 (28%与单独SOC的94%相比),在D-PLEX治疗的患者中观察到较低的抗药率.
结论:
- D-PLEX提供安全有效的30天局部抗微生物预防常见的SSI病原体,包括耐药细菌.
- D-PLEX 是SSI预防包的一个有希望的补充,它解决了系统性抗生素预防的局限性.
- 这些发现支持D-PLEX在SSI预防的第三阶段临床试验中的持续评估.
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