本文選題：Ⅲ期臨床試驗(yàn)　切入點(diǎn)：貝洛　出處：《國(guó)際藥學(xué)研究雜志》2015年06期

【摘要】：正默克公司宣布貝洛托單抗(bezlotoxumab)抗難辨梭菌感染復(fù)發(fā)的2項(xiàng)關(guān)鍵性Ⅲ期臨床試驗(yàn)達(dá)到主終點(diǎn),1次靜脈注射12周后,較安慰劑降低了該菌感染復(fù)發(fā)率。這2次全球Ⅲ期、雙盲試驗(yàn)評(píng)價(jià)該藥單藥或與阿托單抗伍用預(yù)防難辨梭菌感染復(fù)發(fā),臨床MODIFYⅠ試驗(yàn)涉及19個(gè)國(guó)家1452名患者(平均65歲);臨床MODIFYⅡ試驗(yàn)涉及17個(gè)國(guó)家1203名患者(平均67歲)。MODIFYⅠ試驗(yàn)中患者除標(biāo)準(zhǔn)抗生素治療外,隨
[Abstract]:Merck announced that two critical phase III clinical trials against the recurrence of Clostridium dystoides by Belotumab decreased the rate of recurrence of Clostridium Reflex infection 12 weeks after a single intravenous injection at the primary end point, compared with placebo. Double blind test was used to evaluate the single drug or the combination with Atto monoclonal antibody to prevent the recurrence of Clostridium Refractoris infection. The clinical MODIFY 鈪，

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