Clin Infect Dis:福斯霉素(ZTI-01) VS 哌拉西林-他唑巴坦治疗复杂尿路感染的疗效

2020-10-04 MedSci原创 MedSci原创

ZTI-01(注射用福斯霉素)是一种环氧化物抗生素,其分化作用机制(MOA)可抑制细菌细胞壁合成的早期步骤。ZTI-01在体外具有广泛的活性谱,包括耐多药的革兰氏阴性病原体,在美国,ZTI-01正在开

ZTI-01(注射用福斯霉素)是一种环氧化物抗生素,其分化作用机制(MOA)可抑制细菌细胞壁合成的早期步骤。ZTI-01在体外具有广泛的活性谱,包括耐多药的革兰氏阴性病原体,在美国,ZTI-01正在开发用于治疗复杂性尿路感染(cUTI)和急性肾盂肾炎(AP)。

将疑似或经微生物学证实的cUTI/AP住院成人按1:1随机分配到6g ZTI-01 q8h或4.5g静脉注射(IV)哌拉西林-他唑巴坦(PIP-TAZ)q8h,固定7天疗程(不口服转换);伴有菌血症的患者可接受长达14天的治疗。

 

结果,465例随机患者中,分别有233例和231例接受ZTI-01和PIP-TAZ治疗。在微生物学改良意向治疗(m-MITT)人群中,与PIP-TAZ相比,ZTI-01达到了非劣效性的主要目标,总成功率分别为64.7%(119/184名患者)vs 54.5%(97/178名患者);治疗差异为10.2%(95%置信区间[CI]:-0.4,20.8)。评估治愈(TOC,第19-21天)时,各组的临床治愈率很高,且相似(分别为90.8%[167/184]vs 91.6%[163/178])。在使用脉冲场凝胶电泳分型的独特病原体的事后分析中,m-MITT的TOC总成功率:ZTI-01为69.0%(127/184),而PIP-TAZ为57.3%(102/178)(差异11.7% 95% CI:1.3,22.1)。ZTI-01的耐受性良好。大多数治疗中出现的不良事件,包括低钾血症和血清转氨酶升高,都是轻微和短暂的。

综上所述,该研究结果表明,ZTI-01对包括AP在内的cUTI治疗有效,为严重革兰氏阴性感染患者提供了具有差异化MOA的一种新的静脉治疗选择。

 

原始出处:

 

Keith S KayeLouis B Rice, et al., Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial. Clin Infect Dis. 2019 Nov 27;69(12):2045-2056. doi: 10.1093/cid/ciz181.

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    2020-10-04 内科新手

    谢谢梅斯提供这么好的信息,学到很多

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