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.
Study Type
OBSERVATIONAL
Enrollment
231
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Recurrent rate
Time frame: July 31, 2024
The time for the first reduction of conventional Western medicine dosage
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: July 31, 2024
The incidence rate of myasthenic crisis
Time frame: 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.
Time frame: July 31, 2024