Lectro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Proportion of T lymphocyte subsets(%)
研究概览
简要总结
The purpose of this study was to investigate the biochemical and clinical effects of electro-acupuncture in patients with sepsis.
详细描述
Patients were randomly divided into an electro-acupuncture (EA) group and a Western medicine group(WM group) using restricted block randomization (1:1 ratio).
Patients in the Western medicine group received conventional treatment with Western medicine. According to the International Guidelines for Management of Sepsis and Septic Shock: 2016, conventional treatment includes antibiotics and other anti-infection measures, fluid management, mechanical ventilation, and nutritional support, but did not include the use of immunosuppressants or immune enhancers including hormones, gamma globulin, and thymosin. Patients in the electro-acupuncture group were treated with Western medicine and electro-acupuncture. Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total.
The indicators of immune dysfunction including the percentage of T lymphocyte subsets, percentage of natural killer (NK) cells, and serum soluble programed cell death protein (sPD-1) level, and clinical effect including APACHE-II and SOFA score, whole blood analysis, levels of tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP), were determined before treatment and after treatment for 5 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sepsis;
- •Signed the informed consent form.
排除标准
- •Pregnancy or psychiatric disorder;
- •Immune deficiency or using immunosuppressants or immune enhancers;
- •History of malignancy;
- •HIV positive;
- •Unwilling to participate in the study or cooperate with the treatment. Patients who cannot tolerate electroacupuncture treatment or loss of follow-up for complicating with other diseases during the study would be dropped off.
结局指标
主要结局
Proportion of T lymphocyte subsets(%)
时间窗: 5 days after treatment was begun (at the 6th day)
Detect proportion of CD3-T lymphocyte and CD4-T lymphocyte(%) in total T lymphocytes in blood by flow cytometry .
Level of sPD-1 level(pg/ml)
时间窗: 5 days after treatment was begun (at the 6th day)
Serum soluble programed cell death protein (sPD-1) level in blood was measured with ELISA.
Proportion of natural killer(NK) cells(%)
时间窗: 5 days after treatment was begun (at the 6th day)
Detect proportion of NK cells in total lymphocytes in blood by flow cytometry.
次要结局
- Level of C-reactive protein (CRP) (mg/L)(5 days after treatment was begun (at the 6th day))
- Acute Physiology and Chronic Health Evaluation-Ⅱ(APACHE-Ⅱ) score(5 days after treatment was begun (at the 6th day))
- Sequential Organ Failure Assessment (SOFA) score(5 days after treatment was begun (at the 6th day))
- Neutrophils/Lymphocytes(N/L) ratio(%)(5 days after treatment was begun (at the 6th day))
- Level of Tumor necrosis factor-α (TNF-α) (pg/ml)(5 days after treatment was begun (at the 6th day))
研究者
Guang Yang
Director
Guangdong Provincial Hospital of Traditional Chinese Medicine