目的 对地塞米松磷酸钠注射剂开展上市后安全性研究，为临床合理用药和保障公众健康提供参考。方法 使用《Medical Dictionary for Regulatory Activities》（MedDRA，中文名称监管活动医学词典）对药品不良反应（ADR）进行编码；参考“Common Terminology Criteria for Adverse Events，CTCAE”5.0版（常见不良事件评价标准）并结合病例描述对ADR按严重程度进行级别划分；采用回顾分析法从合理用药、ADR特征、人口学特征、ADR严重程度、风险提示等方面开展上市后安全性研究。结果 本研究纳入的病例无超说明书用药情况；地塞米松磷酸钠注射剂占比较高的系统器官分类（SOC）包括各类检查、各类神经系统疾病、皮肤及皮下组织类疾病、胃肠系统疾病、血液及淋巴系统疾病，例次数较高的首选语（PT）包括血葡萄糖升高、失眠、白细胞计数升高、呃逆、皮疹；不同SOC应重点关注的年龄段和不同年龄段应重点关注的SOC均不尽相同；ADR严重程度主要为1级和2级，但监测到部分3级和4级ADR；FDA数据库的风险提示与本研究结果基本契合。结论 建议关注地塞米松磷酸钠注射剂50岁以上用药人群、未成年患者皮肤及皮下组织类疾病和血液及淋巴系统疾病、各年龄段患者相关检查项目；建议结合ADR风险提示对该品种实施分类监测。

Objective To conduct a post-marketing safety study on Dexamethasone Sodium Phosphate Injection, in order to provide a reference for the rational use of drugs in clinical practice and the protection of public health. Methods Adverse drug reactions (ADRs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA), and the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Common Adverse Events Criteria for Adverse Events, CTCAE) was used as a reference. ADRs were coded in MedDRA, the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was used to categorize ADRs according to their severity, and a retrospective analysis was used to conduct the post-marketing safety study in terms of the rational use of medication, the characteristics of ADRs, the demographic characteristics, the severity of ADRs, and the risk indication. ResultsThere was no overdose in the cases included in the study, the system-organ classifications (SOC) with a higher percentage of Dexamethasone Sodium Phosphate Injection included all types of examinations, all types of neurological disorders, skin and subcutaneous tissue-like disorders, gastrointestinal disorders, and hematological and lymphatic disorders, and the preferred terms (PT) with a higher number of cases included elevated blood glucose, insomnia, elevated white blood cell count, ergochromatosis, and skin rashes. The age groups that should be focused on for different SOCs and the SOCs that should be focused on for different age groups varied. The severity of ADRs was mainly grades 1 and 2, but some grade 3 and 4 ADRs were monitored, and the risk alerts in the FDA database were generally compatible with the results of this study. Conclusion It is recommended to pay attention to Dexamethasone Sodium Phosphate Injection over 50 years of age medication population, minor patients with skin and subcutaneous tissue diseases and blood and lymphatic system diseases, patients of all ages related to the examination program. It is recommended to combine with the risk of ADR prompts for the implementation of the classification of this variety of monitoring.

R977.1

江苏省市场监督管理局2023年度科技计划项目（KJ2023037）