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Nabriva新型抗生素Lefamulin的胃肠道副作用

2018-05-23 MedSci MedSci原创

一项关于成人社区获得性细菌性肺炎(CABP)治疗药物lefamulin的III期临床研究符合其所有主要终点,但该药的胃肠道副作用同样令人担忧

一项关于成人社区获得性细菌性肺炎(CABP)治疗药物lefamulinIII临床研究符合其所有主要终点,但该药的胃肠道副作用同样令人担忧。

Lefamulin是一类名为pleuromutilins天然产物的衍生物,1951年哥伦比亚大学科学家发现了这类天然产物。这类物质主要对革兰氏阳性菌有效,抗菌谱覆盖常见皮肤、肺部感染。但这类药物开发却进展缓慢。诺华前身山多士最先开始构效关系研究(Nabriva是从诺华分出的企业),并在1979年上市一个pleuromutilins类兽用抗生素tiamulin

LEAP-2试验中,783位成年CABP患者被随机分配接受Lefamulin治疗(每日两次,口服)或莫西沙星治疗(每日一次,口服)。Nabriva指出,该研究的主要终点是与莫西沙星相比的非劣效性,用于评估在意向治疗(ITT)患者群体中开始治疗后72小时至120小时的早期临床响应。

结果显示,对于lefamulin和莫西沙星,ITT人群研究开始后72小时和120小时之间的早期临床反应均为90.8%。此外,改良ITT人群中IACR(基于临床反应的研究者评估)发生率为:lefamulin 87.5%,莫西沙星 89.1%,而治愈患者的临床可评价率分别为89.7%和93.6%。


原始出处:

http://www.firstwordpharma.com/node/1566979#axzz5GE3RkkZJ

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