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

Long-term Efficacy of Modified Guilu Erxian Glue in Treating Patients With Myasthenia Gravis: A Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis (MG)

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.

• Study Type: Observational
• Enrollment (Actual): 231

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • the First Affiliated Hospital of Henan University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

MG patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MG patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrent rate	July 31, 2024

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Myasthenia Gravis; Recurrence; Retrospective Study; Modified Guilu Erxian Glue; Mid- and Long-term Efficacy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Pathological Conditions, Signs and Symptoms; Recurrence; Myasthenia Gravis
• Other Study ID Numbers: 2023HL-232-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No