【摘要】：目的:總結(jié)和分析TNF-α拮抗劑臨床試驗注冊現(xiàn)狀。方法:在美國國家衛(wèi)生研究院(NIH)臨床試驗登記注冊網(wǎng)站上檢索2016年8月2日前登記的TNF-α拮抗劑臨床試驗項目,使用SPSS17.0軟件對研究項目數(shù)據(jù)作統(tǒng)計分析。結(jié)果:全球共開展306項TNF臨床試驗,中國19項,數(shù)量均呈逐年增長趨勢。主要的研究疾病為骨關(guān)節(jié)疾病、自身免疫性疾病、感染、血液腫瘤等。TNF-α拮抗劑臨床試驗以干預(yù)性研究為主,其中,干預(yù)性研究241項,Ⅱ、Ⅱ/Ⅲ、Ⅲ、Ⅳ期分別有56、7、55、60項,共178項,占73.9%,主要目的為上市后實際應(yīng)用過程中進(jìn)一步驗證和評價藥品的有效性和安全性。結(jié)論:TNF-α拮抗劑品種繁多,臨床適應(yīng)癥廣泛,臨床注冊試驗的設(shè)計多樣且發(fā)展成熟、迅速。
[Abstract]:Objective: to summarize and analyze the registration status of TNF- 偽 antagonist in clinical trials. Methods: the TNF- 偽 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- 偽 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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