The Regulatory Mechanisms of Electroacupuncture Intervention on Immune Cells in Herpes Zoster
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Peripheral blood immune cell levels
研究概览
简要总结
Herpes Zoster (HZ), caused by the Varicella-Zoster Virus (VZV), is a common infection characterized by localized pain and blistering, with higher incidence in females. HZ affects patients' physical health, mental well-being, and quality of life. The immune system is critical in HZ pathogenesis. Studies show acupuncture relieves pain, modulates immunity, and may lower postherpetic neuralgia (PHN) risk. However, evidence is limited on whether electroacupuncture (EA) alleviates HZ by modulating immune cells. Using mass cytometry (CyTOF), this study will analyze peripheral immune cell changes pre- and post-EA to explore its regulatory effects on HZ immunity. This study will recruit HZ patients and healthy controls (HC), dividing patients into medication-only and medication+EA groups to assess EA's potential immunomodulatory effects in HZ treatment.
详细描述
The study will enroll 8 HZ patients who meet the inclusion criteria and 3 age- and gender-matched healthy controls (HC). HZ patients will be randomly assigned in a 1:1 ratio to a medication-only group or a medication plus electroacupuncture group. All participants will receive Valacyclovir Hydrochloride tablets and Mecobalamin tablets. HZ-related immune cells in peripheral blood will be analyzed using CyTOF before treatment (day 0), during treatment (day 4), and after treatment (day 7). Pain intensity and characteristics will be assessed using the Visual Analogue Scale (VAS) and the Douleur Neuropathique 4 (DN4) questionnaire. Lesion healing (time to vesicle cessation, crusting, and scab detachment) and adverse events will also be recorded to evaluate lesion regression in HZ patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meets HZ diagnostic criteria;
- •Female, aged between 50 and 70 years;
- •Disease duration ≤7 days, with no prior antiviral, analgesic, or other treatments;
- •Herpetic lesions limited to the trunk, within 1 to 3 dermatomes;
- •Willing to participate in the trial and has signed the informed consent form.
- •Inclusion Criteria for HC:
- •No history of HZ or major cardiovascular, respiratory, digestive, urinary, hematologic, endocrine, or neurological diseases;
- •Age-matched female HC volunteers for the HZ group;
- •Clear consciousness and ability to communicate normally;
- •Fully understands the study protocol, demonstrates good compliance, and is willing to cooperate with the study;
- •Has signed a written informed consent form.
排除标准
- •Special types of herpes zoster, including ophthalmic, otic, visceral, meningeal herpes zoster, and zoster sine herpete;
- •Women who are planning to conceive, pregnant, or breastfeeding;
- •Patients with severe primary diseases of the circulatory, respiratory, or endocrine systems, or systemic failure;
- •Patients with bleeding tendencies;
- •Use of corticosteroids or immunosuppressants within the past month.
研究组 & 干预措施
Drug group
Control group
干预措施: Drug (Drug)
Drugs combined with electroacupuncture group
Observation group
干预措施: Drug (Drug)
Drugs combined with electroacupuncture group
Observation group
干预措施: Electroacupuncture (Procedure)
结局指标
主要结局
Peripheral blood immune cell levels
时间窗: Before (Day 0), during (Day 4) and after (Day 7) treatment.
1\. Custom Detection Panel: A 42-color detection panel is specifically designed according to the study objectives and target cell subpopulations. 2. Sample Collection and Processing: Peripheral blood (5 ml) is collected from patients into EDTA purple-top anticoagulant tubes, stored/transported at 4°C, and processed within 48 hours using Ficoll to isolate the PBMC layer, yielding a single-cell suspension of PBMCs. PBMCs can be cryopreserved for batch analysis or processed fresh for immediate analysis. 3. Staining and Analysis: Samples are stained and analyzed over two days. Surface antibodies are stained on the first day, followed by membrane permeabilization and intracellular antibody staining on the second day, before proceeding with CyTOF analysis.
次要结局
- Visual Analogue Scale(Before treatment (Day 0) and after each treatment (Day 1- Day 7).)
- Douleur Neuropathique 4 questions(Before treatment (Day 0) and after each treatment (Day 1- Day 7).)
- Lesion Regression Time(Before treatment (Day 0) and after each treatment (Day 1- Day 7).)
- Occurrence of adverse reactions(During the intervention.)
研究者
Yan Shi
Director
First People's Hospital of Hangzhou