Vasculitis peripheral neuropathy
Conditions
Interventions
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Retrospective research selection criteria: Patients who meet all of the following criteria are eligible to participate in the group study (1) Can understand the research requirements, provide a written informed consent form (including consent to use and disclose research-related health information), be willing and able to comply with the research program procedures (including participating in the required research visits); male or female patients aged >=18 when signing the informed consent form. (2) Meet the diagnostic criteria of vasculitis peripheral neuropathy: 1) Subjectively, there are clinical manifestations of peripheral nerve damage; 2) Electrophysiology suggests the existence of peripheral nerve axon lesions; 3) Pathological examination shows vasculitis manifestations such as axial mutation, perivascular inflammatory cell infiltration, iron-containing hemophin deposition and neovascularization; 4) with/not accompanied by ANCA (+/-), connective tissue disease, viral infection. (3) From January 1, 2015 to December 31, 2025, the diagnosis and treatment records of confirmed or highly suspected vasculitis peri-neuropathy in our hospital. The key diagnosis and treatment retained in our hospital, the evidence is complete and accessible, which can be used for retrospective analysis: complete medical history of the first visit, standardized scale (I-RODS and INCAT scale), neuroelectrophysiological report/imaging examination, diagnosis-related pathology and/or serological examination results, hospitalization/outpatient follow-up records including medical history, standardized scale (I-RODS and INCAT scale), diagnosis and treatment process, neuroelectrophysiological report/serological examination results/imaging examination. (4) Be able to understand the research requirements through offline, remote communication and other means, and agree to participate in this study (see Article 14 for details of the specific informed consent acquisition method). This article does not apply to cases where the exemption from informed consent is applied. 2. Prospective research selection criteria: Only if all of the following criteria are met, the patient is eligible to participate in this study (1) Be able to understand the research requirements, provide a written informed consent form (including consent to use and disclose research-related health information), be willing and able to comply with the research program procedures (including participation in the required research visits); male or female patients aged >=18 when signing the informed consent form. (2) Meet the diagnostic criteria of vasculitis peripheral neuropathy: 1) Subjectively have clinical manifestations of peripheral nerve damage; 2) Electrophysiology suggests that there are peripheral nerve axon lesions; 3) Pathological examination shows vasculitis manifestations such as axial mutation, perivascular inflammatory cell infiltration, iron-containing hemophin deposition and neovascularization; 4) accompanied/not accompanied by ANCA (+/-), connective tissue disease, viral infection. (3) In addition, for patients identified from the retrospective research cohort who meet the above criteria 1-2 and still need and plan regular clinical follow-up in our hospital during the research period, the researchers have evaluated that the condition is stable and suitable for long-term follow-up, and after full informed consent, they can be included in the prospective research part.
Exclusion criteria
Exclusion criteria: 1. Retrospective research exclusion criteria (1) Do not meet the diagnostic criteria of the disease; (2) Patients with active viral infection (viral DNA quantification > normal value), malignant tumors or patients with serious systemic diseases such as liver function and renal failure; (3) Any other disease that can better explain the signs and symptoms of patients; (4) Other medical conditions that may affect the evaluation of vasculitis peripheral neuropathy; (5) Key diagnosis and treatment data are missing and cannot meet the requirements of retrospective analysis; (6) Unable to understand the research requirements and unwilling to comply with the research program procedures (including participating in the required research visits). 2. Prospective research exclusion criteria: If the patient meets any of the following criteria, he should be excluded from the study (1) Patients who do not meet the diagnostic criteria of the disease; (2) Patients with other neurological or serious systemic diseases; (3) Any other diseases that can better explain the signs and symptoms of the patient; (4) Other medical conditions that may affect the evaluation of vasculitis peripheral neuropathy; (5) Cannot understand the research requirements or are unwilling to cooperate with prospective follow-up arrangements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INCAT (Inflammatory Neuropathy Cause and Treatment) Score;I-RODS (Inflammatory Rheumatoid Outcome Disability Scale) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Score (Numerical Rating Scale);MRC Total Score;Neuropathy Impairment Score (NIS);Hand Grip Strength;Neurophysiological Examination Results;Neuroimaging (Brachial and Lumbar Plexus MRI);Cerebrospinal Fluid Biomarkers (Serum/Cerebrospinal Fluid Free Light Chains KFLC, CSF Cytokines IL-6, IL-8, IL-10, etc.);Specific Autoantibodies (e.g., ANCA Subtypes), Inflammatory Cytokine Profile (e.g., IL-6, TNF-a), Lymphocyte Subset Analysis;Demographic Characteristics (Age, Sex, Occupation, etc.);Clinical Characteristics (Age at Onset, Disease Duration, Major Symptoms, etc.);Quality of Life Impact (Based on INCAT and I-RODS Scores);Efficacy of Different Therapies (Induction Therapy, Maintenance Therapy, Antiviral Therapy, etc.);Patient Prognosis (Disease Progression Rate, Treatment Response, Complication Incidence, Survival Rate); | — |
Countries
China
Contacts
Public ContactZhao Yanyin
Huashan Hospital, Fudan University
Outcome results
None listed