Pediatr Infect Dis J:头孢西丁胺-阿维菌素治疗≥3个月至18岁儿童并发尿路感染的安全性和有效性

2020-05-31 MedSci原创 MedSci原创

头孢噻啶胺-阿维菌素对成人复杂尿路感染(cUTI)有效且耐受性良好,但尚未对儿童cUTI患者进行评估。

头孢噻啶胺-阿维菌素对成人复杂尿路感染(cUTI)有效且耐受性良好,但尚未对儿童cUTI患者进行评估。

 

这项单盲、多中心、主动对照的2期研究(NCT02497781)将≥3个月至<18岁的cUTI患儿随机入组(3:1),接受静脉注射(IV)头孢西迪胺-阿维菌素或头孢吡肟≥72小时,随后可选择口服转换。总治疗时间为7-14天。主要目标是评估安全性。次要目标包括描述性疗效和药代动力学。一名双盲观察者确定不良事件(AE)的因果关系和临床结局,直至后期随访(最后一次静脉/口服治疗后20-36天)。

 

结果,共有95名儿童接受了≥1剂量的静脉注射研究药物(头孢噻肟-阿维菌素,n = 67;头孢吡肟,n = 28)。最主要的基线革兰氏阴性尿路病原体是大肠杆菌(92.2%)。53.7%和53.6%的患者分别发生在头孢噻肟-阿维菌素组和头孢吡肟组的AEs。严重AE发生在11.9%(头孢他啶-阿维菌素组)和7.1%(头孢吡肟组)患者中。1例严重AE(头孢噻肟-阿维菌素组)被认为与药物相关。在微生物学意图-治疗分析组中,两组在IV期结束时均观察到有利的临床反应率>95%,在治愈试验时仍为88.9%(头孢噻啶胺-阿维菌素组)和82.6%(头孢哌酮组)。在治愈期试验时,患者的微生物学反应率分别为79.6%(头孢西丁胺-阿维菌素)和60.9%(头孢吡肟)。

 

综上所述,该研究结果表明,头孢西丁胺-阿维菌素在儿童感染性尿毒症患者中的耐受性良好,其安全性与成人感染性尿毒症患者和单独使用头孢西丁胺的安全性一致,并且对革兰氏阴性病原体感染性尿毒症的儿童患者似乎有效。

 

原始出处:

 

John S Bradley, Emmanuel Roilides, et al., Safety and Efficacy of Ceftazidime-Avibactam in the Treatment of Children ≥3 Months to <18 Years With Complicated Urinary Tract Infection: Results From a Phase 2 Randomized, Controlled Trial. Pediatr Infect Dis J. 2019 Sep;38(9):920-928. doi: 10.1097/INF.0000000000002395.

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    2020-08-28 feather89
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    2020-07-08 丁鹏鹏
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    2020-06-02 jj000003

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