title: [Post-marketed re-evaluation of fleabane injection and Dengzhan Shengmai capsule study on treatment in patients with ischemic stroke].
abstract: OBJECTIVE
  To verify the efficacy and safety of post-marketed fleabane injection combined with Dengzhan Shengmai capsules in the treatment of ischemic stroke (IS).
  
  
  METHODS
  A multicentre, prospective, practical, randomized controlled study was carried out to compare the efficacy and safety of Dengzhan group (n = 343) and western medicine group (n = 335), appling "clinical study central stochastic system". The treatment of Dengzhan group is using fleabane injection in acute stage and Dengzhan Shengmai capsules in convalescence. The primary indexes of effect evaluation are the important outcome events in 360 days' follow-up, including mortality, recurrence, disability and quality of life to reflect the effect of clinical study. The indexes of safety evaluation involve laboratory examination results and incidence of adverse events.
  
  
  RESULTS
  After 360 days' follow-up, 4 people died of IS in Dengzhan group, and the mortality rate of which is 1.17%, while 16 died in Western medicine group (WM group), and the mortality rate is 4.78%, suggesting that the mortality rate of Dengzhan group is significantly lower than WM group (P<0.05). Eleven cases recurred in Dengzhan group, and the recurrence rate of which is 3.21%, while 12 recurred in WM group, and the recurrence rate is 3.59%, indicating that the recurrence rate of Dengzhan group is slightly lower than WM group. The disability rate of Dengzhan group is 39.53%, among which the rate of severely disabled cases are 1.49%, while the disability rate of WM group is 40.13%, among which the rate of severely disabled cases are 3.13%, suggesting that the disability rate of Dengzhan group is lower and the severity of disability is also lighter than WM group. In the field of quality of life, the activity ability and the upper limb function store of stroke patients in Dengzhan group improved far much better than WM group (P<0.05). Analysis of safety suggested that, adverse events occurred in 11 cases in Dengzhan group, among which 4 cases is related with the drug treatment, the incidence of adverse events of which is 1.17%, and the main manifestations involve fever and chilling, rash, nausea, dizziness, palpitation, etc. which were all appeared after the treatment of fleabane injection, and disappeared 1 to 2 days after drug withdrawal. 13 cases occurred abnormal liver function and 2 cases abnormal kidney function in Dengzhan group. According to the judgment of clinical physicians, 3 case of ALT abnormality is possibly related to the treatment, the others are all unrelated with the treatment.
  
  
  CONCLUSIONS
  Fleabane injection and Dengzhan Shengmai capsules are all safe and effective TCM in the treatment of ischemic stroke.
authors.affiliation: Institute of Basic Research in Clinical Trial, China Academy of Chinese Medical Sciences, Beijing 100700, China. weixu.007@163.com
authors.forename: Xu
authors.initials: X
authors.lastname: Wei
authors.forename: Xiaoqin
authors.initials: X
authors.lastname: Ye
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: D000328:Adult; D000368:Aged; D002545:Brain Ischemia / Q000188:drug therapy*; D002214:Capsules; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D049919:Erigeron / Q000009:adverse effects; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D020521:Stroke / Q000188:drug therapy*
chemical_list: D002214:Capsules; D004365:Drugs, Chinese Herbal