这次批准的依据是2次前瞻性随机双盲安慰剂控制对照临床研究的数据。
The approval was based on data from 2 prospective, randomized, double-blind placebo-controlled clinical studies.
方法采用前瞻性，随机双盲双模拟，阳性药平行对照，多中心临床研究。
Methods The multicentre prospective, random, double-blind and imitation, positive-drug parallel control clinical trails are used.
纳入标准：经典文献、经严格科学设计的基础实验研究、前瞻性随机性临床研究及病例对照研究。
Inclusion criteria: Typical literatures, basic experimental research that restrictedly and scientifically designed, prospective randomized clinical research as well as case control study.
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