title: [Post-marketing re-evaluation of Kudiezi injection study on early treatment in patients with ischemic stroke].
abstract: OBJECTIVE
  To study the effect and safety of Kudiezi injection on patients with acute ischemic stroke.
  
  
  METHODS
  Seven hundreds patients were divided into two groups by central randomization system. The study group, 346 cases, was treated with kudiezi injection plus traditional Chinese medicine (TCM) synthesis rehabilitation project, and the control group, 354 cases, was treated with synthetic rehabilitation project. The patients were treated for 10 to 21 days. Before treatment and at the 7th, 14th and 21th day of treatment, the indexes include NIHSS used for evaluating the neurological deficit degree and the motor function score (Fugl-Meyer) for evaluating motor function were observed. The safety index is defined by adverse observation event and laboratory test. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time.
  
  
  RESULTS
  Application of generalized estimating equation model, we found that as the treatment time, NIHSS score and FMI score of the two groups showed a trend of improvement. And at the 14th days and 21th days of treatment, compared to the control group the treatment group showed significant statistical difference on the impact of NIHSS and FMI (P<0.05). No serious adverse events were observed.
  
  
  CONCLUSIONS
  Kudiezi injection plus TCM rehabilitation project of ischemic stroke showed some superiority to western medicine rehabilitation program on improving the neurological deficit and motor function. Kudiezi injection is safe and effective in the treatment of acute ischemic stroke.
authors.affiliation: Post-doctoral Station of China Academy of Chinese Medical Sciences, Beijing 100700, China. xiaoqinye2000@126.com
authors.forename: Xiaoqin
authors.initials: X
authors.lastname: Ye
authors.forename: Xu
authors.initials: X
authors.lastname: Wei
authors.forename: Yanming
authors.initials: Y
authors.lastname: Xie
authors.forename: Yihuai
authors.initials: Y
authors.lastname: Zou
authors.forename: Xingquan
authors.initials: X
authors.lastname: Zhao
authors.forename: Jianhua
authors.initials: J
authors.lastname: Han
authors.forename: Xinzhi
authors.initials: X
authors.lastname: Wang
authors.forename: Yunzhi
authors.initials: Y
authors.lastname: Ma
authors.forename: Qi
authors.initials: Q
authors.lastname: Bi
authors.forename: Qingfan
authors.initials: Q
authors.lastname: Xie
authors.forename: Jianjun
authors.initials: J
authors.lastname: Zhao
authors.forename: Xiaolan
authors.initials: X
authors.lastname: Cao
authors.forename: Hongxia
authors.initials: H
authors.lastname: Chen
authors.forename: Shizhong
authors.initials: S
authors.lastname: Wang
authors.forename: Rongmei
authors.initials: R
authors.lastname: Yan
authors.forename: Zucheng
authors.initials: Z
authors.lastname: Han
authors.forename: Danhui
authors.initials: D
authors.lastname: Yi
authors.forename: Yongyan
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000188:drug therapy*; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008516:Medicine, Chinese Traditional / Q000009:adverse effects; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D020521:Stroke / Q000188:drug therapy*
chemical_list: D004365:Drugs, Chinese Herbal