Randomized double-blind placebo-controlled trial of 40 mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial).
Randomized double-blind placebo-controlled trial of 40 mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial).
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DOI：
10.1186/cc11895
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发表时间：
2012-12-11
期刊：
影响因子：
--
通讯作者：
Gao F
中科院分区：
文献类型：
--
作者：
Patel JM;Snaith C;Thickett DR;Linhartova L;Melody T;Hawkey P;Barnett AH;Jones A;Hong T;Cooke MW;Perkins GD;Gao F
一些观察性研究表明，他汀类药物调节脓毒症的病理生理学，并可能阻止其进展。这项研究的目的是确定急性应用阿托伐他汀是否能减少他汀类药物初治的脓毒症住院患者的脓毒症进展。一项单中心II期随机、双盲、安慰剂对照试验。脓毒症患者随机接受阿托伐他汀40 mg/d或安慰剂治疗，住院时间最长为28天。主要终点是在住院期间脓毒症进展为严重脓毒症的比率。100名患者被随机分配，49名患者接受阿托伐他汀治疗，51名患者接受安慰剂治疗。与安慰剂相比，阿托伐他汀组患者转为严重败血症的转换率显著降低(4%比24%p=0.007)，需要治疗的人数为5人。在住院时间、重症监护病房入院时间、28天和12个月的再入院或死亡率方面没有显著差异。阿托伐他汀组在第4天时血浆胆固醇和白蛋白肌酐比率显著降低(p<；0.0001和p=0.049)。两组不良事件发生率差异无统计学意义(p=0.238)。脓毒症患者急性应用阿托伐他汀可阻止脓毒症进展。需要进一步的多中心试验来验证这些发现。国际标准随机对照试验登记处ISRCTN64637517。
Several observational studies suggest that statins modulate the pathophysiology of sepsis and may prevent its progression. The aim of this study was to determine if the acute administration of atorvastatin reduces sepsis progression in statin naïve patients hospitalized with sepsis. A single centre phase II randomized double-blind placebo-controlled trial. Patients with sepsis were randomized to atorvastatin 40 mg daily or placebo for the duration of their hospital stay up to a maximum of 28-days. The primary end-point was the rate of sepsis progressing to severe sepsis during hospitalization. 100 patients were randomized, 49 to the treatment with atorvastatin and 51 to placebo. Patients in the atorvastatin group had a significantly lower conversion rate to severe sepsis compared to placebo (4% vs. 24% p = 0.007.), with a number needed to treat of 5. No significant difference in length of hospital stay, critical care unit admissions, 28-day and 12-month readmissions or mortality was observed. Plasma cholesterol and albumin creatinine ratios were significantly lower at day 4 in the atorvastatin group (p < 0.0001 and p = 0.049 respectively). No difference in adverse events between the two groups was observed (p = 0.238). Acute administration of atorvastatin in patients with sepsis may prevent sepsis progression. Further multi-centre trials are required to verify these findings. International Standard Randomized Control Trial Registry ISRCTN64637517.
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DOI：
10.4103/0972-5229.63034
发表时间：
2010-01
期刊：
Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine
影响因子：
--
作者：
Basu S;Bhattacharya M;Chatterjee TK;Chaudhuri S;Todi SK;Majumdar A
通讯作者：
Majumdar A
影响因子：
158.5
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通讯作者：
Williams, Mark D.
影响因子：
37.8
作者：
Almog, Y;Shefer, A;Danon, A
通讯作者：
Danon, A
DOI：
10.1164/rccm.201006-0955oc
发表时间：
2011-03-15
影响因子：
24.7
作者：
Kruger, Peter S.;Harward, Meg L.;Venkatesh, Bala
通讯作者：
Venkatesh, Bala
DOI：
10.1164/rccm.201003-0423oc
发表时间：
2011-03-01
影响因子：
24.7
作者：
Craig, Thelma R.;Duffy, Martin J.;McAuley, Daniel F.
通讯作者：
McAuley, Daniel F.