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Health Technol Assess:金黄色葡萄球菌菌血症:辅助利福平或然并卵!

2018-12-04 常路 环球医学

金黄色葡萄球菌菌血症是一种常见并频繁致命的感染。辅助利福平可加强早期金黄色葡萄球菌的杀灭,快速对感染病灶和血液进行消毒,从而降低传播、转移性感染和死亡风险。2018年10月,发表在《Health Technol Assess》的一项平行组、随机、盲的、安慰剂对照多中心试验调查了,辅助利福平能否降低金黄色葡萄球菌菌血症的早期死亡率。

金黄色葡萄球菌菌血症是一种常见并频繁致命的感染。辅助利福平可加强早期金黄色葡萄球菌的杀灭,快速对感染病灶和血液进行消毒,从而降低传播、转移性感染和死亡风险。2018年10月,发表在《Health Technol Assess》的一项平行组、随机、盲的、安慰剂对照多中心试验调查了,辅助利福平能否降低金黄色葡萄球菌菌血症的早期死亡率。

目的:旨在确定辅助利福平是否可以降低随机分组后12周时的细菌学(微生物学证实)失败/复发或死亡。次要目的包括评估利福平对全因死亡率、临床定义的失败/复发或死亡、毒性、耐药性的出现、菌血症病程的影响,以及评估利福平的成本效果。

设计:平行组、随机(1:1)、盲的、安慰剂对照多中心试验。

地点:英国NHS信托医院。

参与者:从一次或多次血液培养中培养出来的耐甲氧西林或易感金黄色葡萄球菌的成年(≥18岁)住院患者,这些患者接受了<96小时的抗菌药物治疗当前感染,对利福平无禁忌。

干预:标准抗菌药物治疗外,辅助利福平(600~900mg/d,口服或静脉)或安慰剂治疗14天。对研究者和患者对试验治疗设盲。随访为12周(于3、7、10、14天,直到出院前的每周进行评估,末次评估在随机分组后的12周进行)。

主要结局测量:首要结局指标为随机分组后12周期间,全因细菌学(微生物学证实)失败/复发或死亡。

结果:2012年12月~2016年10月,来自于英国29家医院的758名符合条件的参与者随机分组:利福平组370人,安慰剂组388人。中位年龄为65岁(四分位范围IQR,50~76岁)。总共485例感染(64.0%)为社区获得,132例(17.4%)为院内获得;47例(6.2%)由耐甲氧西林金黄色葡萄球菌造成。总共301人(39.7%)具有初始深部感染灶。标准抗菌药物的疗程为中位29天(IQR,18~45天),619人(81.7%)接受了氟氯西林。12周时,62/370名(16.8%)服用利福平的患者和71/388名(18.3%)服用安慰剂的参与者出现细菌性(微生物学证实)失败/复发或死亡(绝对风险差,-1.4%;95% CI,-7.0~4.3;HR,0.96;95% CI,0.68~1.35;P=0.81)。利福平组和安慰剂组分别有4(1.1%)和5(1.3%)例细菌学失败(P=0.82),分别有3(0.8%)和16(4.1%)例细菌学复发(P=0.01),分别有55(14.9%)和50(12.9%)例死亡但无细菌学失败/复发(P=0.30)。12周后,无证据显示,临床定义的失败/复发/死亡(P=0.84)、全因死亡(P=0.60)、严重(P=0.17)或3/4级(P=0.36)不良事件(AE)存在差异。然而,利福平组和安慰剂组分别有63人(17.0%)和39人(10.1%)出现抗菌药物或试验药物相关的AEs(P=0.004),分别有24人(6.5%)和6人(1.5%)出现药物相互作用(P=0.0005)。成本和健康相关生活质量影响的评估显示,金黄色葡萄球菌菌血症发病12周要平均花费£12197。利福平估计可节省10%的发病成本(P=0.14)。调整后,利福平对总质量调整生命年(QALYs)的影响为阳性(0.004 QALYs),但无统计学显着性(标准误差0.004 QALYs)。

结论:在金黄色葡萄球菌菌血症成年患者中,辅助利福平未比标准抗菌药物治疗提供总体获益。

将来的工作:鉴于大量的死亡率,应该调查其他抗菌药物组合或改善资源管理

原始出处:

Thwaites GE, et al. Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemia: the ARREST RCT. Health Technol Assess. 2018 Oct;22(59):1-148. doi: 10.3310/hta22590.

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    2019-03-02 rgjl
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    2019-05-11 shock_melon
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createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Thu Dec 06 06:39:00 CST 2018, time=2018-12-06, status=1, ipAttribution=)]
    2019-09-05 shizhenshan
  4. 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createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Thu Dec 06 06:39:00 CST 2018, time=2018-12-06, status=1, ipAttribution=)]
  5. 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createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Thu Dec 06 06:39:00 CST 2018, time=2018-12-06, status=1, ipAttribution=)]
  6. 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createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Thu Dec 06 06:39:00 CST 2018, time=2018-12-06, status=1, ipAttribution=)]
  7. 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createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Thu Dec 06 06:39:00 CST 2018, time=2018-12-06, status=1, ipAttribution=)]
    2018-12-06 dongjia2015
  8. 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