塞替比星对严重脓毒症死亡率的积极影响：一种新型非抗生素策略。

Positive effect of septimeb™ on mortality rate in severe sepsis: a novel non antibiotic strategy.

机构信息

Faculty of Pharmacy and Pharmaceutical Sciences Research Centre, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Daru. 2012 Sep 25;20(1):40. doi: 10.1186/2008-2231-20-40.

BACKGROUND

Septimeb is a new herbal-derived remedy, recently approved for its potential immunomodulatory effects. Regarding the key role of immune system in the pathogenesis of severe sepsis and lack of any standard treatment for improving survival of these patients; we evaluated the effect of Septimeb -as an adjutant to standard treatment-on inflammatory biomarkers and mortality rates in patients with severe sepsis.

METHODS

In this multicenter, randomized, single-blind trial, we assigned patients with severe sepsis and Acute Physiology and Chronic Health Evaluation (APACHE II) score of more than 20 to receive standard treatment of severe sepsis (control group) or standard treatment plus Septimeb. This group was treated with Septimeb for 14 days then followed up for another14 days. APACHE score, Sequential Organ Failure Assessment (SOFA) and Simplified Acute Physiology Score (SAPS) were calculated daily. Blood samples were analyzed for interleukin 2 tumor necrosis factor-α, total antioxidant power, platelet growth factor and matrix metalloproteinase 2.

RESULTS

A total of 29 patients underwent randomization (13 in control group and 16 in Septimeb group). There was significant difference between the Septimeb and control group in the 14 days mortality rate (18.8% vs. 53.85 respectively, P=0.048). Compared to control group, Septimeb was significantly effective in improving SAPS (P= 0.029), SOFA (P=0.003) and APACHE II (P=0.008) scores. Inflammatory biomarkers didn't change significantly between the two groups (P>0.05).

CONCLUSION

Septimeb reduces mortality rates among patients with severe sepsis and it could be added as a safe adjutant to standard treatment of sepsis.

背景

Septimeb 是一种新的草药衍生疗法，最近因其潜在的免疫调节作用而获得批准。鉴于免疫系统在严重脓毒症发病机制中的关键作用，以及缺乏任何改善这些患者生存率的标准治疗方法；我们评估了 Septimeb-作为标准治疗的辅助药物-对严重脓毒症患者的炎症生物标志物和死亡率的影响。

方法

在这项多中心、随机、单盲试验中，我们将患有严重脓毒症和急性生理学和慢性健康评估 (APACHE II) 评分超过 20 的患者随机分为接受严重脓毒症标准治疗（对照组）或标准治疗加 Septimeb 的治疗组。该组接受 Septimeb 治疗 14 天，然后再随访 14 天。每天计算 APACHE 评分、序贯器官衰竭评估 (SOFA) 和简化急性生理学评分 (SAPS)。分析白细胞介素 2、肿瘤坏死因子-α、总抗氧化能力、血小板生长因子和基质金属蛋白酶 2 的血液样本。

结果

共有 29 名患者接受了随机分组（对照组 13 例，Septimeb 组 16 例）。14 天死亡率在 Septimeb 组和对照组之间有显著差异（分别为 18.8%和 53.85%，P=0.048）。与对照组相比，Septimeb 组 SAPS（P=0.029）、SOFA（P=0.003）和 APACHE II（P=0.008）评分明显改善。两组间炎症生物标志物无明显变化（P>0.05）。