Fu Chang-Kuan, Liu Huan, Wang Lian-Xin, Zou Yi-Huai, Li Ming-Quan, Lin Ya-Ming, Sun Wei-Hong, Wei Xu, Hu Yu-Er, Xie Yan-Ming, Li Yuan-Yuan
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2024 Aug;49(16):4279-4284. doi: 10.19540/j.cnki.cjcmm.20240423.501.
In 2019, the newly revised Drug Administration Law of the People's Republic of China was issued and implemented,clearly proposing that China should establish a pharmacovigilance system. As a new traditional Chinese medicine(TCM) dosage form created in China, TCM injections have been widely used in clinic, and its pharmacovigilance has attracted much attention. In response to this situation, the project team convened a group of clinical, pharmaceutical and evidence-based medicine experts from all over the country to form an expert group, which formulated the Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections in strict accordance with the requirements of the group standards of the Chinese Association of Chinese Medicine.From the perspective of clinical application and considering the key elements of pharmacovigilance for clinical application of TCM injections, the guidelines put forward suggestions on the decision making of pharmacovigilance for clinical application of TCM injections from four key links, namely the monitoring and reporting, signal recognition, risk assessment and risk control, according to China's pharmacovigilance regulations and learning from foreign pharmacovigilance guidelines.
2019年，新修订的《中华人民共和国药品管理法》颁布实施，明确提出我国要建立药物警戒制度。中药注射剂作为我国创制的新型中药剂型，已在临床上广泛应用，其药物警戒备受关注。针对这一情况，项目组召集了全国一批临床、药学及循证医学专家组成专家组，严格按照中华中医药学会团体标准要求，制定了《中药注射剂临床应用药物警戒指导原则》。该指导原则从临床应用角度出发，结合中药注射剂临床应用药物警戒的关键要素，依据我国药物警戒法规并借鉴国外药物警戒指导原则，从监测与报告、信号识别、风险评估和风险控制四个关键环节，对中药注射剂临床应用药物警戒决策提出了建议。
