Efficacy of Intravenous Immunoglobulin Versus Plasma Exchange in Myasthenic Crisis: A Prospective Open-Label Study Based on Treatment Availability in a Tertiary Center in Syria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (open Lable)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Diagnosis: Patients with newly diagnosed or previously confirmed Myasthenia Gravis (MG) based on clinical evaluation and confirmed by electromyography (EMG).
- •Severity: Patients presenting with myasthenic crisis or severe exacerbation.
- •Age: 18 years and older.
- •Treatment Necessity: Patients requiring rapid immunomodulating therapy (either IVIG or PLEX).
- •Informed Consent: Participants or their legal guardians must be able and willing to provide written informed consent.
排除标准
- •Medical Contraindications: Severe renal failure (contraindication for IVIG) or hemodynamic instability (contraindication for PLEX).
- •Alternative Conditions: Presence of other neuromuscular disorders or congenital myasthenia.
- •Pregnancy: Pregnant or breastfeeding women.
- •Consent: Inability to provide informed consent.
研究组 & 干预措施
IVIG Group
Participants in this group receive Intravenous Immunoglobulin (IVIG) at a total therapeutic dose of 2 g/kg body weight. The dose is administered intravenously over a period of 2 to 5 consecutive days. Clinical improvement is monitored using the Quantitative Myasthenia Gravis (QMG) scale.
干预措施: IVIG (Intravenous Immunoglobulin) (Biological)
PLEX Group
Participants in this group undergo therapeutic plasma exchange (PLEX) sessions. The protocol typically involves 5 sessions, performed every other day, to remove circulating antibodies. This group serves as the active comparator to evaluate the clinical response to treatment.
干预措施: Plasma exchange (PE) (Procedure)
结局指标
主要结局
Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score
时间窗: Day 14 post-initiation of treatment
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.
次要结局
- Presence of Anti-AChR Antibodies.(Day 14 post-treatment)
- Frequency of Myasthenic Crisis Triggers(Through hospital discharge, average 14 days)