PMID- 31032273
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 2305-5839 (Print)
IS  - 2305-5847 (Electronic)
IS  - 2305-5839 (Linking)
VI  - 7
IP  - 6
DP  - 2019 Mar
TI  - Adverse drug reactions of Yunnan Baiyao capsule: a multi-center intensive 
      monitoring study in China.
PG  - 118
LID - 10.21037/atm.2019.01.62 [doi]
LID - 118
AB  - 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.
FAU - Li, Bo
AU  - Li B
AD  - Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 
      Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China.
FAU - Feng, Shuo
AU  - Feng S
AD  - Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 
      Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China.
FAU - Wu, Zhi-Hong
AU  - Wu ZH
AD  - Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Peking 
      Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, 
      China.
AD  - Beijing Key Laboratory for Genetic Research of Bone and Joint Disease, Beijing 
      100730, China.
FAU - Kwong, Joey S W
AU  - Kwong JSW
AD  - Department of Clinical Epidemiology, National Center for Child Health and 
      Development, Tokyo, Japan.
FAU - Hu, Jing
AU  - Hu J
AD  - Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 
      Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China.
FAU - Wu, Nan
AU  - Wu N
AD  - Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Peking 
      Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, 
      China.
AD  - Beijing Key Laboratory for Genetic Research of Bone and Joint Disease, Beijing 
      100730, China.
FAU - Tian, Gui-Hua
AU  - Tian GH
AD  - Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, 
      China.
FAU - Shang, Hong-Cai
AU  - Shang HC
AD  - Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, 
      China.
FAU - Qiu, Gui-Xing
AU  - Qiu GX
AD  - Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Peking 
      Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, 
      China.
AD  - Beijing Key Laboratory for Genetic Research of Bone and Joint Disease, Beijing 
      100730, China.
LA  - eng
PT  - Journal Article
PL  - China
TA  - Ann Transl Med
JT  - Annals of translational medicine
JID - 101617978
PMC - PMC6465448
OTO - NOTNLM
OT  - Adverse drug reaction
OT  - Yunan Baiyao capsule (YBC)
OT  - hospital intensive monitoring
COIS- Conflicts of Interest: The authors have no conflicts of interest to declare.
EDAT- 2019/04/30 06:00
MHDA- 2019/04/30 06:01
PMCR- 2019/03/01
CRDT- 2019/04/30 06:00
PHST- 2019/04/30 06:00 [entrez]
PHST- 2019/04/30 06:00 [pubmed]
PHST- 2019/04/30 06:01 [medline]
PHST- 2019/03/01 00:00 [pmc-release]
AID - atm-07-06-118 [pii]
AID - 10.21037/atm.2019.01.62 [doi]
PST - ppublish
SO  - Ann Transl Med. 2019 Mar;7(6):118. doi: 10.21037/atm.2019.01.62.