TNF-α拮抗剂临床试验注册现状

发布时间：2019-02-20 21:23

【摘要】：目的:总结和分析TNF-α拮抗剂临床试验注册现状。方法:在美国国家卫生研究院(NIH)临床试验登记注册网站上检索2016年8月2日前登记的TNF-α拮抗剂临床试验项目,使用SPSS17.0软件对研究项目数据作统计分析。结果:全球共开展306项TNF临床试验,中国19项,数量均呈逐年增长趋势。主要的研究疾病为骨关节疾病、自身免疫性疾病、感染、血液肿瘤等。TNF-α拮抗剂临床试验以干预性研究为主,其中,干预性研究241项,Ⅱ、Ⅱ/Ⅲ、Ⅲ、Ⅳ期分别有56、7、55、60项,共178项,占73.9%,主要目的为上市后实际应用过程中进一步验证和评价药品的有效性和安全性。结论:TNF-α拮抗剂品种繁多,临床适应症广泛,临床注册试验的设计多样且发展成熟、迅速。
[Abstract]:Objective: to summarize and analyze the registration status of TNF- 伪 antagonist in clinical trials. Methods: the TNF- 伪 antagonist clinical trial items registered before Aug. 2, 2016 were searched on the (NIH) clinical trial registration website of the National Institutes of Health. The data of the research items were statistically analyzed by SPSS17.0 software. Results: a total of 306 clinical trials of TNF were conducted in the world, 19 in China, the number of which showed an increasing trend year by year. The main diseases studied were osteoarticular diseases, autoimmune diseases, infections, blood tumors and so on. The clinical trials of TNF- 伪 antagonists were mainly involved in interventional studies, in which there were 241 cases of interventional studies, 56 cases of stage 鈪，

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