Myasthenia Gravis (MG)
Conditions
Keywords
Myasthenia Gravis, Modified Guilu Erxian Glue, Mid- and Long-term Efficacy, Recurrence, Retrospective Study
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Beijing University of Chinese Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinically confirmed diagnosis of myasthenia gravis (MG), with other differential diagnoses excluded * Received standardized conventional Western medicine treatment for MG for at least 1 month (bromopyridostigmine tablets combined with prednisone acetate tablets) * Complete and traceable medical records available for the entire study period
Exclusion criteria
* Complicated with other major systemic diseases, severe functional impairment of the heart, liver or kidney, or a documented history of mental illness * Incomplete medical records that cannot support full data extraction and statistical analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent rate | July 31, 2024 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time for the first reduction of conventional Western medicine dosage | July 31, 2024 | — |
| MGFA classification | July 31, 2024 | 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. |
| MGFA-PIS | July 31, 2024 | 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. |
| TCM syndrome score | July 31, 2024 | 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. |
| HAMA | July 31, 2024 | 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. |
| The incidence rate of myasthenic crisis | July 31, 2024 | — |
| MG-ADL | July 31, 2024 | 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. |
Countries
China
Outcome results
None listed