Systematic review of Kudiezi injection drug safety.
10.19540/j.cnki.cjcmm.20170420.001
- Author:
Shan-Shan GAO
1
;
Rui-Zhao CUI
2
;
Yan-Ming XIE
2
;
Xing LIAO
2
;
Xiao-Yan GAO
1
;
Ji-Dong WANG
3
Author Information
1. School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100102, China.
2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
3. Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China.
- Publication Type:Journal Article
- Keywords:
Meta-analysis;
safety;
systematic review;
Kudiezi injection;
adverse drug reaction/adverse events
- From:
China Journal of Chinese Materia Medica
2017;42(12):2380-2390
- CountryChina
- Language:Chinese
-
Abstract:
To systematically evaluate the safety of Kudiezi injection. Databases such as Cochrane library, Medline, EMbase, Web of Science, Clinical Trials, CBM, CNKI, VIP, Wanfang and Chinese Clinical Trial Register were searched to collect the literature on all the study types of Kudiezi injection. Two researchers screened literature, assessed quality and extracted data according to inclusion and exclusion criteria. All studies were assessed by using internationally recognized methodological quality assessment tools or reporting quality evaluation criteria; Meta-analysis of adverse drug reaction/adverse events (ADR/AE) of Kudiezi injection was performed by using Stata 12.0 software. There were 411 clinical studies included, out of which 315 studies were analyzed finally. 18 072 patients in total used kudiezi injection, and there were 330 cases with ADRs and 13 cases with AEs. The most common ADR related system was the central and peripheral nervous system, with a weighted incidence of 2.9% [95%CI(0.022, 0.036)]. From the current evidence, the overall safety of Kudiezi injection was acceptable. Although data could be collected from all kinds of published reports, there are lack of mechanism experiments or observational studies with large samples of Kudiezi injection. Therefore, it is necessary to carry out further research on the safety of Kudiezi injection. Meanwhile, off label use of Kudiezi injection is common, so it is urgent for relevant governmental departments to formulate drug use specifications and provide better guidance for clinical drug use.
