论文部分内容阅读
探索中药注射剂不良反应事件的应对策略,为大规模中药致敏成分筛查提供指导依据。主要从中药安全风险信号的发现,“药物-不良反应事件”之间非预期蛋白的识别,潜在致敏物质的计算机虚拟筛查等角度进行阐述。结合国内外致敏物质识别领域的经验,提出建立符合中药注射剂特点的不良反应预警机制,参照证据等级分层次进行致敏物质的筛查。这些证据资料能有效融入到非临床安全性评价及上市前检测,防范高致敏风险的中药通过申请临床研究评审或在最后阶段流入市场。同时,致敏物质虚拟筛查的结果,将有助于中药注射剂过敏反应的进一步分析、验证及有效防控。
To explore the coping strategies of traditional Chinese medicine injection of adverse reaction events, to provide guidance for large-scale screening of traditional Chinese medicine sensitization ingredients. Mainly from the discovery of the safety risk signal of traditional Chinese medicine, the identification of unintended protein between “drug-adverse event”, and computer virtual screening of potential sensitizers. Combined with the experience of allergen identification at home and abroad, we put forward the establishment of an early warning mechanism of adverse reactions in line with the characteristics of traditional Chinese medicine injections, and screened the allergens at different levels according to the level of evidence. The evidence can be effectively integrated into non-clinical safety evaluation and pre-market testing to prevent high risk of traditional Chinese medicine by applying for clinical research review or into the market at the final stage. At the same time, the results of virtual screening of sensitizing substances will help further analysis, verification and effective prevention and treatment of allergic reactions of traditional Chinese medicine injections.