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Updated: May 15, 2026
Preparation of Herbal Medicine: Er-Xian Decoction and Er-Xian-containing Serum for In Vivo and In Vitro Experiments
Published on: May 31, 2017
[Systematic analysis on clinical safety of Shuxuetong injection]
Xin-Feng Guo1, Ze-Huai Wen, Yan-Ming Xie
1Guangdong 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
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.