Long-term Efficacy of Modified Guilu Erxian Glue for Myasthenia Gravis

Beijing University of Chinese Medicine

Status: Completed

Conditions: Myasthenia Gravis (MG)

Study type: Observational

Funder types: Other

Identifiers

NCT07472777

2023HL-232-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

231 participants in 1 patient group

MG patients