中药注射剂起效迅速，在临床急危重症的救治中发挥着重要作用。同时中药注射剂的不良反应也不容忽视，如何快速发掘潜在的不良反应信号，是确保中药注射剂临床安全应用的关键和难点。处方序列对称分析（Prescription Sequence Symmetry Analysis, PSSA）是一种基于大数据和电子处方数据库快速挖掘药品不良反应信号的方法，它通过评价某种特定药物在服用前和服用后事件分布的对称性，来评价药物与事件是否存在关联。当察觉到药品可能存在的风险时，PSSA能够迅速进行风险评估与测量，让安全信号的快速发现成为可能。本文概括了PSSA的原理、国内外的研究现状，以及采用PSSA分析中药注射剂不良反应三个方面的研究思路。目前将PSSA应用于我国电子处方数据库开展研究时仍需要考虑数据量、数据结构、数据整合等问题。随着我国电子医疗数据库的不断完善，PSSA将会得到更好地应用。

Traditional Chinese medicine (TCM) injections are very useful in the treatment of acute and severe diseases due to their rapid onset. While, adverse drug reactions (ADRs) of TCM injections is an important problem, how to quickly detect ADRs signal of TCM injections is a key and difficult issue to make sure the safely application of TCM injections. Prescription sequence symmetry analysis (PSSA) is an effective surveillance tool for drug associated ADRs, through examining the distribution of marker drugs (potentially used for managing ADRs), before and after initiation of index drugs, PSSA can evaluate the causal association of index drugs and ADRs. PSSA can quickly detect ADRs signal based on medical electronic databases or prescription databases, which is suitable for the rapid emergence of ADRs for TCM injections. We described the basic principle and worldwide researches of PSSA, then we introduced the research methods when using PSSA to analyze the three aspects of ADRs for TCM injections. At present, when we use PSSA to detect ADRs signals in electronic prescription databases in China, we still need to think about the number of patients, structure and combination of data. With the development of medical electronic databases in China, PSSA can be more used to detect ADRs signal.

中共中央组织部第二批国家“万人计划”（2016）经费资助项目（W02020052）:第二批国家高层次人才特殊支持计划领军人才，负责人：商洪才；北京市科委北京市科技新星计划（Z171100001117030）：基于适应性设计的“双检验联合”建立中医病证多终点指标临床评价方法，负责人：胡晶；首都医科大学附属北京中医医院许公岩、夏寿人青年人才基金（XX-201707）：中医药临床试验“病证结合”多主要终点评价方法应用指南的制定，负责人：胡晶。