title: [Systematic analysis on clinical safety of Shuxuetong injection].
abstract: OBJECTIVE
  To evaluate the clinical adverse drug reactions (ADR) of Shuxuetong Injection (SXTI) comprehensively for its proper use and post-marketing reevaluation.
  
  
  METHODS
  Electronic searching of the online Chinese and English medical databases were carried out from their inception to Feb. 2012, studies were screened and data were extracted according to inclusion and exclusion criteria; total number of ADR were calculated by study type respectively, ADR incidence rate was calculated by number of ADRs in experimental arm of clinical trials with control groups divided by total number of experimental groups.
  
  
  RESULTS
  Eighty and eight papers published concerning ADRs report of SXTI were included, including 65 clinical trials, 20 case reports, and 3 ADRs surveillance or analysis report. 174 ADRs were reported, mainly in circulation system, nervous system, the digestive system, skin and appendages. Adverse reaction type is mainly rash (44.3%) and the digestive system response (23.0%). The incidence rate calculated by data extracted from 65 clinical trials was 4.3%.
  
  
  CONCLUSIONS
  Allergic reaction is the most common ADR type of SXTI. Incidence rate of different studies varies, so a rigorously designed prospectively ADR surveillance study is needed to reevaluate its incidence rate, and analyze reasons of the heterogeneity. Information concerning ADR in literatures is always absent, the quality of reporting is relative poor, thus it is suggested that active, standardized, and systematic ADR reporting should be focused on in clinical trials.
authors.affiliation: Guangdong Provincial Hospital of Chinese Medicine, Second Affiliated Hopital, Medical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou 510120, China. drguoxinfeng@163.com
authors.forename: Xin-Feng
authors.initials: XF
authors.lastname: Guo
authors.forename: Ze-Huai
authors.initials: ZH
authors.lastname: Wen
authors.forename: Yan-Ming
authors.initials: YM
authors.lastname: Xie
authors.forename: Shao-Nan
authors.initials: SN
authors.lastname: Liu
authors.forename: Zhen-Yu
authors.initials: ZY
authors.lastname: Li
authors.forename: Da-Can
authors.initials: DC
authors.lastname: Chen
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002986:Clinical Trials as Topic; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans
chemical_list: D004365:Drugs, Chinese Herbal; C532053:shuxuetong