治疗多发性硬化症药物临床试验现状及展望

Current Situation and the Trend of Clinical Trials of Drugs for Treatment of Multiple Sclerosis

关键词:  多发性硬化症  药物临床试验  质量影响因素  治疗方法

Key words:  multiple sclerosis  clinical trials of drugs  factors on the quality of clinical trials  therapy

摘要:

多发性硬化症是炎性CD4⁺T细胞介导的中枢神经系统自身免疫脱髓鞘疾病，病程反复且不可逆，已成为除创伤外中国青壮年残疾的主要原因，且在幼儿中发病率逐年上升，给家庭和社会带来了沉重的经济负担。现有药物主要通过抑制免疫系统活性来缓解疾病，但仍无法治愈多发性硬化症。现已开展多项药物临床试验以寻找更为有效的多发性硬化症治疗策略，本文综述了多发性硬化症药物临床试验现状，质量影响因素及临床疗法，并试图阐明多发性硬化症药物临床试验潜在的改进领域和发展前景。

Abstract:

Multiple sclerosis is an autoimmune demyelinating disease of the central nervous system mediated by inflammatory CD4⁺ T cells,characterized by repetitive and irreversible course.Multiple sclerosis has become the main cause of young adults disability in China except trauma,and the morbidity rate among young children is increasing in these years,which has brought heavy economic burden to families and society.The disease-modifying treatments have been employed to relieve the disease by suppressing the activity of the immune system,however,there is no definite cure for multiple sclerosis currently.A number of clinical trials have been carried out to find more effective strategies for multiple sclerosis.This review provides comprehensive overview of current status,quality influencing factors and current therapies in clinical trials of multiple sclerosis treatments,and attempts to clarify the potential improvements and prospects for multiple sclerosis clinical trials.