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Adverse drug reactions of Yunnan Baiyao capsule: a multi-center intensive monitoring study in China

  
@article{ATM23913,
	author = {Bo Li and Shuo Feng and Zhi-Hong Wu and Joey S. W. Kwong and Jing Hu and Nan Wu and Gui-Hua Tian and Hong-Cai Shang and Gui-Xing Qiu},
	title = {Adverse drug reactions of Yunnan Baiyao capsule: a multi-center intensive monitoring study in China},
	journal = {Annals of Translational Medicine},
	volume = {7},
	number = {6},
	year = {2019},
	keywords = {},
	abstract = {Background: Yunnan Baiyao capsule (YBC), a marketed herbal medicine in mainland China, is widely used to control bleeding. This study’s aim was to determine the occurrence of YBC-related adverse drug reactions (ADRs) among users of the medicine.
Methods: This hospital-intensive monitoring study was conducted in 163 hospitals across China. Consumers who used YBC (Z53020799) between June 2015 and December 2016 were included. By face-to-face interview or telephone, the circumstances and experiences of their adverse events (AEs), during drug taking and 14 days after drug withdrawal, were recorded at follow-up and later encoded by International Conference on Harmonisation (ICH) 1997. The Naranjo Adverse Reaction Probability Scale (APS) was used to determine the likelihood of ADRs.
Results: A total of 31,556 participants were included (follow-up rate 99.40%). AEs occurred in 742 participants, of which 561 were reported as “not related with drug use” by their physician-in-charge. Based on the remaining 181 cases, the overall ADR incidence was 1.17% (intention to treat) and 0.58% (per protocol), with abnormal findings mainly concentrated in the digestive system, skin and respiratory system. The top 5 frequently reported reactions were nausea and vomiting (0.1785%, 56 cases of 31,367 participants), functional diarrhea (0.1180%, 37 of 31,367 participants), stomach discomfort (0.0893%, 28 of 31,367 participants), rash (0.0574%, 18 of 31,367 participants) and gastro-esophageal reflux (0.0383%, 12 of 31,367 participants). Among them, functional diarrhea and stomach discomfort were judged as definite ADRs of YBC.
Conclusions: In this large study, treatment of YBC was found to be associated with ADRs with an incidence of 1.17%, although most were relatively mild and not considered to be life-threatening.},
	issn = {2305-5847},	url = {http://atm.amegroups.com/article/view/23913}
}