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新型天然提取物Septimeb对严重脓毒症的影响:一项随机临床试验。

Effect of Septimeb as a new natural extract on severe sepsis: A randomized clinical trial.

作者信息

Pourdast Alieh, Sanaei Maryam, Jafari Sirous, Mohammadi Mostafa, Khalili Hossein, Shafiee Gita, Ahadi Zeinab, Rostami Mahsa, Alizad Saba, Heshmat Ramin, Mohraz Minoo

机构信息

Department of Infectious and Tropical Diseases, Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.

Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Caspian J Intern Med. 2017 Winter;8(1):35-43.

Abstract

BACKGROUND

Septimeb as a herbal medicine has regulatory effects on inflammation. This study set to evaluate the effects of Septimeb among patients with sepsis on inflammatory biomarkers and survival rate.

METHODS

In this randomized clinical trial, 51 patients with sepsis from the ICU and medical ward of Imam Khomeini Hospital were divided into two groups: Septimeb (n=25) and control group (n=26). In the control group, the patients received a standard treatment only for 7 days, while Septimeb group received Septimeb (6cc vial with 500cc serum glucose infusion 5% daily for one to two hours) plus standard treatment of sepsis for 7 days. Then, blood samples were analyzed. APACHE (Acute Physiologic and Chronic Health Evaluation), SOFA (Sequential Organ Failure Assessment), and GCS (Glasgow Coma Score) values were calculated daily.

RESULTS

Treatment with Septimeb showed a significant decrease in SOFA value (1.54±0.83) compared to the control group (2.39±0.88) (P<0.001) and a significant increase in GCS value (14.46±0.88) compared to the control group (12.86±1.78) (P<0.001). Improvements of these values can confirm the potential of Septimeb in the reduction of severity of sepsis (P<0.05). There were significant decreases in lactate and blood sugar and WBC levels. In addition, inflammatory factors such as ESR (Septimeb group: 52.07±34.80, control group: 51.75±42.10, P=0.98) and CRP (Septimeb group: 48.86±23.21, control group: 49.93±36.22, P=0.92) decreased, but did not show a significant reduction.

CONCLUSION

Septimeb has positive effects on reduction of the severity of sepsis which leads to reduction of patients' mortality rates.

摘要

背景

Septimeb作为一种草药对炎症具有调节作用。本研究旨在评估Septimeb对脓毒症患者炎症生物标志物和生存率的影响。

方法

在这项随机临床试验中,将来自伊玛目霍梅尼医院重症监护病房和内科病房的51例脓毒症患者分为两组:Septimeb组(n = 25)和对照组(n = 26)。对照组患者仅接受7天的标准治疗,而Septimeb组患者接受Septimeb(每天用500cc 5%葡萄糖注射液溶解6cc小瓶药物,输注1至2小时)加脓毒症标准治疗7天。然后,对血样进行分析。每天计算急性生理与慢性健康状况评分系统(APACHE)、序贯器官衰竭评估(SOFA)和格拉斯哥昏迷评分(GCS)值。

结果

与对照组相比,Septimeb治疗使SOFA值显著降低(1.54±0.83)(对照组为2.39±0.88)(P<0.001),GCS值显著升高(14.46±0.88)(对照组为12.86±1.78)(P<0.001)。这些值的改善可以证实Septimeb在降低脓毒症严重程度方面的潜力(P<0.05)。乳酸、血糖和白细胞水平显著降低。此外,红细胞沉降率(ESR)(Septimeb组:52.07±34.80,对照组:51.75±42.10,P = 0.98)和C反应蛋白(CRP)(Septimeb组:48.86±23.21,对照组:49.93±36.22,P = 0.92)等炎症因子有所下降,但未显示出显著降低。

结论

Septimeb对降低脓毒症严重程度具有积极作用,从而降低患者死亡率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5b5/5412247/0ffd940d5fc7/cjim-8-035-g001.jpg

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