Li Bo, Feng Shuo, Wu Zhi-Hong, Kwong Joey S W, Hu Jing, Wu Nan, Tian Gui-Hua, Shang Hong-Cai, Qiu Gui-Xing
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China.
Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China.
Ann Transl Med. 2019 Mar;7(6):118. doi: 10.21037/atm.2019.01.62.
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.
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.
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.
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.
云南白药胶囊（YBC）是中国大陆上市的一种草药制剂，广泛用于控制出血。本研究旨在确定该药使用者中与YBC相关的药物不良反应（ADR）的发生率。
本医院强化监测研究在中国163家医院开展。纳入2015年6月至2016年12月期间使用YBC（Z53020799）的消费者。通过面对面访谈或电话，在随访时记录其用药期间及停药后14天内不良事件（AE）的情况和经历，随后按照国际人用药品注册技术协调会（ICH）1997年的标准进行编码。采用Naranjo药物不良反应概率量表（APS）确定ADR的可能性。
共纳入31556名参与者（随访率99.40%）。742名参与者出现AE，其中561例被其主管医生报告为“与用药无关”。基于其余181例，ADR总发生率为1.17%（意向性分析）和0.58%（符合方案分析），异常表现主要集中在消化系统、皮肤和呼吸系统。报告频率最高的前5种反应为恶心和呕吐（0.1785%，31367名参与者中的56例）、功能性腹泻（0.1180%，31367名参与者中的37例）、胃部不适（0.0893%，31367名参与者中的28例）、皮疹（0.0574%，31367名参与者中的18例）和胃食管反流（0.0383%，31367名参与者中的12例）。其中，功能性腹泻和胃部不适被判定为YBC的肯定ADR。
在这项大型研究中，发现YBC治疗与ADR相关，发生率为1.17%，尽管大多数ADR相对较轻，不被认为会危及生命。
