Bo Li1, Shuo Feng1, Zhi-Hong Wu2,3, Joey S W Kwong4, Jing Hu1, Nan Wu2,3, Gui-Hua Tian5, Hong-Cai Shang5, Gui-Xing Qiu2,3. 1. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China. 2. Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China. 3. Beijing Key Laboratory for Genetic Research of Bone and Joint Disease, Beijing 100730, China. 4. Department of Clinical Epidemiology, National Center for Child Health and Development, Tokyo, Japan. 5. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
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.
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.
Entities:
Keywords:
Adverse drug reaction; Yunan Baiyao capsule (YBC); hospital intensive monitoring
Authors: Zhao-Xiang Bian; Hao-Yao Tian; Lin Gao; Hong-Cai Shang; Tai-Xiang Wu; You-Ping Li; Bo-Li Zhang; Li Song Journal: J Evid Based Med Date: 2010-02