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Through a retrospective cohort study method, the influence of Gu-Lu Er-Xian Decoction with modified formula on the long-term therapeutic effect of patients with myasthenia gravis was analyzed, and the related factors affecting recurrence were also explored.
Screen the medical records of MG patients who visited the hospital from January 2020 to January 2024. By July 31, 2024, the final follow-up for the patient outcomes was completed. Taking the cumulative use of Gui鹿 Erxian Jiawo Formula for ≥ 1 month per year as the exposure factor， the included patients were divided into the exposure group and the non-exposure group. The clinical characteristics and medium-to-long-term efficacy of the two groups were compared. The primary outcome was the recurrence rate， and the secondary outcomes included the time for the first reduction of conventional Western medicine dosage， MGFA classification， GFA-PIS， TCM syndrome score， HAMA， the incidence of myasthenic crisis， and MG-ADL. Through Cox multivariate regression analysis， the factors related to MG recurrence were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrent rate | July 31, 2024 |
| Measure | Description | Time Frame |
|---|---|---|
| The time for the first reduction of conventional Western medicine dosage | July 31, 2024 | |
| MGFA classification | Unabbreviated Scale Title: Myasthenia Gravis Foundation of America (MGFA) Clinical Classification for Myasthenia Gravis Scale Range: Class I (ocular-only involvement, mildest) to Class V (mechanical ventilation required, most severe), total 5 hierarchical classes Interpretation: Higher classification grade indicates more severe myasthenia gravis and worse clinical outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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MG patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Chinese Medicine | Zhengzhou | Henan | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2023 | Mar 6, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| July 31, 2024 |
| MGFA-PIS | Unabbreviated Scale Title: Myasthenia Gravis Foundation of America Post-Intervention Status (MGFA-PIS) Scale Scale Range: 7 hierarchical grades, ranging from Complete Stable Remission (Grade 1, best treatment response) to Disease Exacerbation (Grade 7, worst treatment response) Interpretation: Higher grade indicates poorer treatment response and worse clinical outcome of myasthenia gravis. | July 31, 2024 |
| TCM syndrome score | Unabbreviated Scale Title: Traditional Chinese Medicine Syndrome Score for Myasthenia Gravis (formulated in accordance with the Guiding Principles for Clinical Research of New Chinese Medicines) Scale Range: Total score ranges from 0 to 36 points; each core symptom is rated on a 4-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe) Interpretation: Higher total score indicates more severe TCM syndrome manifestations and worse clinical condition. | July 31, 2024 |
| HAMA | Unabbreviated Scale Title: Hamilton Anxiety Rating Scale Scale Range: Total score ranges from 0 to 56 points; 14 items are each rated on a 5-point scale (0 = no symptom, 1 = mild, 2 = moderate, 3 = severe, 4 = extremely severe) Interpretation: Higher total score indicates more severe anxiety symptoms. | July 31, 2024 |
| The incidence rate of myasthenic crisis | July 31, 2024 |
| MG-ADL | Unabbreviated Scale Title: Myasthenia Gravis-Activities of Daily Living (MG-ADL) Scale Scale Range: Total score ranges from 0 to 24 points; 8 items are each rated on a 4-point scale (0 = normal function, 3 = severe functional impairment) Interpretation: Higher total score indicates worse activity of daily living ability and more severe myasthenia gravis-related functional impairment. | July 31, 2024 |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |