ITMCTR2000003226尚未招募1 期
Innovative research on the pathogenesis of myasthenia gravis in traditional Chinese medicine
The First Affiliated Hospital of Guangzhou University of TCM0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- Male
入选标准
- •1. Patients with ophthalmic muscle, medulla oblongata or systemic mg18-65 years old and with onset of systemic symptoms or systemic diseases confirmed by neurophysiological tests for no more than 12 months;
- •2. The diagnosis of Mg should be determined according to the following methods (refer to the Chinese myasthenia gravis diagnosis and treatment guidelines in 2015):
- •Clinical nervous system status, motor symptoms are consistent with Mg, and there are at least two conditions: anti acetylcholine receptor antibody (AChR) and / or other myasthenia antibody positive serological test. Typical mg findings using single fiber electromyography (SFEMG) and / or repetitive nerve stimulation (RNs) and / or neurophysiological testing of neuromuscular conduction. As judged by the physician, patients with positive tests with oral / intramuscular cholinesterase inhibitors;
- •3. Patients with MGFA grade II to IV were screened;
- •4. Patients with quantitative mg score (QMG) >=6 at screening;
- •5. Patients with deficiency of spleen and stomach qi based on syndrome differentiation of traditional Chinese medicine: refer to the standard of syndrome differentiation and treatment of traditional Chinese Medicine
- •Deficiency of spleen and Stomach Qi: the main syndrome is ptosis, weakness of limbs, or with diplopia, or with morning light and evening heavy;
- •In the second syndrome, the stomach swells after eating, or the stool is thin or hard before the pond, or the tongue is not thirsty and reddish, the tongue is fat or has teeth marks on the side, and the pulse is thin and weak;
- •The diagnosis can be made by the patients with primary and secondary symptoms;
- •If the diagnosis standard has the main syndrome and one of the secondary syndromes, it can be diagnosed as this syndrome;
- •The establishment of traditional Chinese medicine diagnosis depends on the syndrome differentiation and diagnosis of more than three doctors, three people make the syndrome differentiation and classification of patients separately by means of four diagnosis methods of traditional Chinese medicine, and the diagnosis of syndrome type of traditional Chinese medicine is established after three people have unified opinions;
- •6. Women with fertility must have negative pregnancy test and no planned pregnancy during the study;
- •7. Patients willing to provide written informed consent;
- •8. Patients who are able and willing to follow all study procedures.
排除标准
- •1. Myasthenia only affects patients with ocular or periocular muscles (MGFA grade I) and Mg crisis in screening (MGFA grade V);
- •2. Patients who had thymectomy in the last half year. In order to avoid the difficulty in evaluating the efficacy of the study drug, thymectomy (if necessary) should be scheduled for a follow-up period of 8 weeks;
- •3. Pregnant or nursing patients;
- •4. Patients with serious primary diseases such as liver, kidney, hematopoietic system, cardiopulmonary system, endocrine system and malignant tumor;
- •5. Patients who have used high-dose hormone, gamma globulin and plasma exchange in the past 3 months.
研究者
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