Myasthenia Gravis
Conditions
Interventions
Classical western medicine group:Methylprednisolone + immunoglobulin (specific regimen: based on methylprednisolone 0.4mg-0.8mg/kg body weight, intravenous drip, once daily for 14 days
immunoglobulin 0.4g/kg body weight, intravenous drip, once daily for 5 days)
Integrated traditional Chinese and western medicine group:Methylprednisolone + Immunoglobulin + Astragalus Injection + Doshen Tang (specific protocol: to 1) standard western medicine specific protocol
Doshen Tang, granules to be flushed nasally twice a day
14 days in total).
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients with myasthenic crisis are required to meet the following criteria (inclusive of 1-4): (1) Clinically confirmed myasthenia gravis: fluctuating weakness of generalized or some skeletal muscles, such as extraocular muscles, medullary muscles, limb muscles, etc., showing fluctuating and easily fatigable symptoms: myasthenia gravis symptoms are light in the morning and heavy in the evening, aggravated by continuous activity, relieved or improved by rest; on the basis of the above typical clinical features, at least one or more of the following are present: a. positive neostigmine test; b. low frequency repetitive electrical stimulation wave amplitude c. Antibodies: positive serum test for AChR antibody, MuSK antibody or LRP4 antibody. 2) Severe respiratory muscle weakness with arterial blood gas PaCO2 > 6.65 kPa (50 mmHg) with (or without) PaO2 < 7.89 kPa (60 mmHg), requiring non-invasive/invasive ventilator assisted ventilation. 3) Any gender, age greater than 18 years and less than or equal to 80 years; 4) The patient understands and signs the informed consent form. Satisfy ?+?+?+?.
Exclusion criteria
Exclusion criteria: 1) FVC < 60% or transcutaneous SpO2 < 90% due to a combination of severe primary lung disease or lung infection; 2) Patients who have had or have had serious life-threatening events such as cardiopulmonary arrest or infectious shock in the early stages of the crisis; 3) Patients with combined severe hepatic or renal insufficiency; transaminases more than 5 times above the upper limit of normal and/or eGFR below 60 ml/min. 4) Suffering from psychiatric disorders that prevent cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MG-ADL score at day 30 relative to basel; | — |
Secondary
| Measure | Time frame |
|---|---|
| Days of Mechanical Ventilation;Days of ICU stay;MG-QMG;MG-MMT;MGC; | — |
Countries
CHINA
Contacts
Public ContactCHONGBO ZHAO
Huashan Hospital Fudan University
Outcome results
None listed