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临床试验/NCT07038707
NCT07038707尚未招募不适用

Research on the Identification of Early Screening Markers for Herpes Zoster Neuralgia Based on Intestinal Flora Analysis

Tongji Hospital0 个研究点目标入组 150 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
HZ biomarkers

研究概览

简要总结

Herpes zoster (HZ), especially postherpetic neuralgia, is one of the most typical types of clinical neuralgia. The incidence rate of HZ in China is approximately 7.7%. Among them, 29.8% of HZ patients eventually develop PHN. About 20% of PHN patients suffer from severe neuralgia for more than one year, or even ten years. It is worth noting that patients with neuralgia are prone to comorbidities such as depression, anxiety and sleep disorders, which seriously affect their work efficiency and quality of life. This is a great torment to both the patients and their families, and it also imposes a heavy burden on the medical system.

Professor Xiao Lizu, a collaborator of our team, has discovered in clinical practice that spinal cord electrical stimulation for HZ patients can significantly reduce the risk of developing PHN. Other therapies for reducing the risk of PHN include multiple parvertebral injections of local anesthetics/steroids, which require patients to return for repeated visits. Although these intervention measures have good effects, they may bring additional economic burdens to patients, treatment side effects and prolong their hospital stays. Therefore, they are not suitable for all patients. From this perspective, our development of early screening methods and selective non-pharmacological intervention only for high-risk patients will improve the overall treatment status of HZ, effectively reduce the incidence of PHN, and alleviate the burden on medical insurance and the medical system at the same time.

This project aims to conduct the following research by analyzing the intestinal flora of patients: identifying biomarkers with the ability to predict the risk of PHN in patients, constructing a machine learning classifier for risk prediction, and developing an early screening kit based on this.

Furthermore, traditional studies mostly focus on a single pathological link and lack systematic multi-dimensional analysis. In recent years, the cerebral lymphatic system, as a key pathway for the clearance of metabolic wastes in the brain, has attracted widespread attention. Furthermore, the role of the gut-brain axis in pain regulation has gradually been recognized. Therefore, it is of great scientific significance to integrate and explore the pathological mechanism of PHN from three dimensions: the lymphatic system, neuroinflammation, and intestinal flora.

This project assumes that patients with PHN have a pathological triad of "lymphoid dysfunction - neuroinflammatory activation - intestinal flora imbalance". The specific manifestations are as follows: Impaired lymphoid clearance function (decreased DTI-ALPS index and increased free water), activated systemic inflammatory response (elevated TNF-α and IL-6), and disordered intestinal flora structure (decreased α diversity and increased opportunistic pathogenic bacteria). The three interact with each other and have a synergistic effect, jointly participating in the pathogenesis of PHN.The expected outcome of this project may provide new options for pain management of the large group of neuralgia patients, improve their quality of life, and has great practicality and practical value.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The definite diagnoses were PHN (disease course ≤ 1 month), PHN (1 month < disease course < 2 months), and PHN (disease course > 3 months); Age equal to 50 years old; Not accompanied by other chronic pain diseases; Sign the informed consent form.

排除标准

  • There are underlying digestive system diseases such as irritable bowel syndrome and inflammatory bowel disease; There are obvious gastrointestinal discomfort symptoms such as diarrhea and abdominal distension; There is immunosuppression or autoimmune disease; Antibiotics, acid suppressants or drugs that interfere with the intestinal flora have been used within the past month; Have a history of mental illness or abuse of tobacco and alcohol (2 packs per day)

结局指标

主要结局

HZ biomarkers

时间窗: 1 week

DNA was extracted from fecal samples for metagenomic sequencing. Based on the metagenomic sequencing results, we will select the important biomarkers that can distinguish the subgroups of HZ patients

次要结局

  • Lymphatic system function(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuebi Tian

Clinical Professor

Tongji Hospital

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