This study compares the clinical effectiveness of Intravenous Immunoglobulin (IVIG) versus Plasma Exchange (PLEX) in patients experiencing a myasthenic crisis. Clinical response is evaluated 14 days post-treatment using the Quantitative Myasthenia Gravis Score (QMG). Additionally, the study aims to identify and report common precipitating factors for myasthenic attacks, such as respiratory infections or surgical stress.
This open-label prospective study evaluates patients at Al-Mouwasat and Al-Assad University Hospitals in Damascus, Syria. Participants include adult patients diagnosed with Myasthenia Gravis (MG) based on clinical evaluation and confirmed via repetitive nerve stimulation (RNS) or single-fiber electromyography (SFEMG). Participants are assigned to two treatment groups based on the availability of medical supplies at the time of admission: the IVIG group and the PLEX group. The IVIG group receives a total dosage of 2 g/kg administered over 2 to 5 consecutive days. The PLEX group undergoes a series of up to five plasma exchange sessions. The primary objective is to evaluate the change in the Quantitative Myasthenia Gravis Score (QMG) from baseline (Day 0) to 14 days post-treatment. The study also documents precipitating triggers for myasthenic attacks. Statistical analysis is performed using SPSS version 25.0, utilizing T-tests for continuous variables and Chi-Squared tests for categorical variables to compare the treatment methods.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients receive Intravenous Immunoglobulin (IVIG) at a total dose of 2 g/kg body weight. The dose is divided over a period of 2 to 5 consecutive days administered intravenously
Patients undergo therapeutic plasma exchange (PLEX), typically consisting of 5 sessions performed every other day., with a replacement volume of 1 to 1.5 plasma volumes per session.
Damascus University
Damascus, Syria
Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score
The QMG is a validated physician-rated instrument consisting of 13 items that assess ocular, bulbar, respiratory, and limb muscle strength. Total scores range from 0 to 39, where higher scores represent greater clinical impairment. Clinical improvement is defined as a reduction in the mean QMG score from baseline.
Time frame: Day 14 post-initiation of treatment
Presence of Anti-AChR Antibodies.
Evaluation of the frequency of positive anti-acetylcholine receptor (AChR) antibodies among the study population to assess its correlation with the severity of the myasthenic crisis.
Time frame: Day 14 post-treatment
Frequency of Myasthenic Crisis Triggers
Identification and categorization of the most common factors leading to myasthenic crisis, such as respiratory infections or surgical stress.
Time frame: Through hospital discharge, average 14 days
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