Long-term Efficacy of Modified Guilu Erxian Glue in Treating Patients With Myasthenia Gravis: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Recurrent rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MG patients
结局指标
主要结局
Recurrent rate
时间窗: July 31, 2024
次要结局
- The time for the first reduction of conventional Western medicine dosage(July 31, 2024)
- MGFA classification(July 31, 2024)
- MGFA-PIS(July 31, 2024)
- TCM syndrome score(July 31, 2024)
- HAMA(July 31, 2024)
- The incidence rate of myasthenic crisis(July 31, 2024)
- MG-ADL(July 31, 2024)
研究者
Ruge Liu
Doctor
Beijing University of Chinese Medicine