[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.

METHOD:

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.

RESULT:

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%.

CONCLUSION:

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: Xin-Feng Guo, Ze-Huai Wen, Yan-Ming Xie, Shao-Nan Liu, Zhen-Yu Li, Da-Can Chen
• Journal: Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica (Zhongguo Zhong Yao Za Zhi) Vol. 37 Issue 18 Pg. 2782-5 (Sep 2012) ISSN: 1001-5302 [Print] China
• PMID: 23285933 (Publication Type: English Abstract, Journal Article, Research Support, Non-U.S. Gov't, Review)

Chemical References

• Drugs, Chinese Herbal
• shuxuetong

Topics

• Adverse Drug Reaction Reporting Systems
• Clinical Trials as Topic
• Drug Therapy
• Drug-Related Side Effects and Adverse Reactions
• Drugs, Chinese Herbal (administration & dosage, adverse effects)
• Humans