诺氟沙星对肝硬化存活无效，但对腹水有益

StephenW

Norfloxacin ineffective for cirrhosis survival, but beneficial in ascites

Moreau R, et al. Gastroenterol. 2018;doi:10.1053/j.gastro.2018.08.026.
September 6, 2018

Results of a randomized control trial of patients with advanced cirrhosis without recent fluoroquinolone therapy showed that norfloxacin did not reduce 6-month mortality but did appear to increase survival among patients with low ascites fluid protein concentration.

“Of note, the beneficial effect of norfloxacin on the risk of any infection and Gram-negative bacterial infections, was maintained, and even extended to Gram-positive bacterial infections, during the double-blind post-treatment period,” Richard Moreau, MD, from the Assistance Publique – Hôpitaux de Paris, and colleagues wrote. “Since 77% of the enrolled patients had alcoholic cirrhosis, our results mainly apply to patients with alcoholic cirrhosis.”

Moreau and colleagues randomly assigned 144 patients to receive norfloxacin and 147 to receive placebo.

At 6 months, the mortality rate was similar between the norfloxacin group (n = 19; 95% CI, 9.3-21.6) and the control group (n = 27; 95% CI, 13.5-26.8), which confirmed a nonsignificant reduction in mortality between the two groups (HR = 0.69; 95% CI, 0.38-1.23).

Baseline ascitic fluid protein levels were available in 66.8% of patients with ascites from the combined cohorts. Among the 102 patients with levels less than 15 g per liter, 6-month cumulative mortality was significantly lower in the norfloxacin group than controls (HR = 0.35; 95% CI, 0.13-0.93).

In contrast, 6-month cumulative mortality among the 53 patients with ascitic fluid protein levels of 15 g per liter or higher did not differ between the treatment and placebo groups.

The researchers report no serious adverse events correlated with study treatment.

Regarding secondary outcomes, the cumulative incidence of any infection was significantly lower in the norfloxacin group than controls, including the Gram-negative bacterial infections. Rates of spontaneous bacterial peritonitis and infections caused by multidrug resistant bacteria were similar between the groups.

“Although these results should be interpreted with caution, in particular because of missing data regarding ascitic fluid protein levels in some patients, they strongly suggest, along with previous findings obtained in an independent study, that patients with advanced cirrhosis and low ascitic fluid protein levels are good candidates for prolonged norfloxacin administration to decrease mortality,” the researchers concluded. – by Talitha Bennett

Disclosure: Moreau reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.

StephenW

诺氟沙星对肝硬化存活无效，但对腹水有益

Moreau R，et al。 Gastroenterol。 2018; DOI：10.1053 / j.gastro.2018.08.026。
2018年9月6日

对没有近期氟喹诺酮治疗的晚期肝硬化患者进行的一项随机对照试验结果显示，诺氟沙星并未降低6个月的死亡率，但确实可以提高腹水液蛋白浓度低的患者的生存率。

“值得注意的是，在双盲治疗期间，诺氟沙星对任何感染风险和革兰氏阴性细菌感染的有益作用得以维持，甚至延伸至革兰氏阳性细菌感染，”Richard Moreau，MD来自巴黎的援助公社 - HôpitauxdeParis及其同事写道。 “由于77％的登记患者患有酒精性肝硬化，我们的结果主要适用于酒精性肝硬化患者。”

Moreau及其同事随机分配了144名接受诺氟沙星治疗的患者和147名接受安慰剂治疗的患者。

在6个月时，诺氟沙星组（n = 19; 95％CI，9.3-21.6）与对照组（n = 27; 95％CI，13.5-26.8）的死亡率相似，证实了无显着性降低。两组间死亡率（HR = 0.69; 95％CI，0.38-1.23）。

66.8％的合并队列腹水患者可获得基线腹水蛋白水平。在102名每升水平低于15克的患者中，诺氟沙星组的6个月累积死亡率显着低于对照组（HR = 0.35; 95％CI，0.13-0.93）。

相比之下，治疗组和安慰剂组之间53名腹水蛋白水平为15克/升或更高的患者的6个月累积死亡率没有差异。

研究人员报告没有与研究治疗相关的严重不良事件。

关于次要结果，诺氟沙星组的任何感染累积发生率显着低于对照组，包括革兰氏阴性细菌感染。各组之间自发性细菌性腹膜炎和多药耐药细菌引起的感染率相似。

“虽然这些结果应该谨慎解释，特别是由于缺乏一些患者腹水蛋白水平的数据，他们强烈建议，以及在一项独立研究中获得的先前发现，患有晚期肝硬化和低腹水蛋白水平的患者研究人员总结道，这是长期服用诺氟沙星以降低死亡率的良好候选药物。 - Talitha Bennett

披露：Moreau报告没有相关的财务披露。有关其他作者的相关财务披露，请参阅完整的研究。

情缘好好

也就是说沙星类的药可以治疗自发性腹膜炎？