幽门螺杆菌非临床研究试验的评价和思考  

Evaluation and consideration on pre-clinical tests of Helicobacter pylori

作　　者：笪红远[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2013年第15期1746-1748,共3页Chinese Journal of New Drugs

摘　　要：根除幽门螺杆菌(Helicobacter pylori,简称HP)可以明显减低消化性溃疡复发率或使溃疡愈合是被普遍认可的事实,随着对HP研究的深入,认知评判非临床药效学HP试验结果的意义和研究价值逐渐清晰,在研究新药(包括化学药品、中药和天然药物)作用特点、支持临床试验方案设计等方面具有突出意义,众多HP非临床试验研究报道反映的问题值得在新药评价中关注和思考。It is a generally accepted fact that Helicobacter pylori （HP） eradication can reduce the recur- rence of peptic ulcer and promote ulcer healing significantly. The significance of understanding and evaluating the value of the results of pre-clinical pharmacodynamic tests of HP has become progressively clear for investigating the characteristics of drug action （ including chemical drugs, traditional Chinese medicines and natural medicines） and design of clinical trials on HP. The problems reflected by numerous pre-clinical tests on HP are worth of our atten- tion and consideration in new drug evaluation.

关 键 词：幽门螺杆菌 非临床药效学HP试验 新药评价 

分 类 号：R95[医药卫生—药学]