Citation

Zhang YL, Liao X, Liu FM, Wang GQ, Xie YM. Zhongguo Zhong Yao Za Zhi 2017; 42(15): 2845-2856.

Affiliation

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.

Copyright

(Copyright © 2017, Zhongguo Zhong yi yan jiu yuan Zhong yao yan jiu suo)

DOI

unavailable

PMID

29139247

Abstract

To systemically evaluate the safety of Xianling Gubao capsule after launching. Computer retrieval of Medline, EMbase, the Web of Science, Clinical Trials. gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM was conducted to collect information on all the research types of Xianling Gubao capsule. The literature was screened according to inclusion and exclusion criteria, and the quality of the studies was assessed according to the internationally accepted quality evaluation standards for data extraction and analysis. A total of 156 papers were included in this study, including 117 randomized control trials, 11 quasi-randomized control trials, 10 non-randomized control trials, 11 case report series, and 7 individual case reports; a total of 167 studies were analyzed. Xianling Gubao capsules were used in 7 496 patients, with an accumulative 377 cases of adverse reactions (ADR) and 4 cases of severe adverse reactions, including 1 death, 1 cerebrovascular accident, 1 case of skin allergy reaction, and 1 case of gastrointestinal discomfort; gastrointestinal system damage was most common in mild ADRs. In this study, we found that the overall safety of Xianling Gubao capsule was acceptable, but it lacked the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study, so the further studies on the safety of drug use should be conducted. Meanwhile, the application scope of Xianling Gubao capsules was beyond the manual, in urgent needs of the relevant departments to formulate norms and provide better guidance for clinical medication.

Copyright© by the Chinese Pharmaceutical Association.

Language: zh

Keywords

Xianling Gubao capsule; evidence-based medicine; safety; systematic review