目的 對地塞米松磷酸鈉注射劑開展上市后安全性研究，為臨床合理用藥和保障公眾健康提供參考。方法 使用《Medical Dictionary for Regulatory Activities》（MedDRA，中文名稱監(jiān)管活動醫(yī)學(xué)詞典）對藥品不良反應(yīng)（ADR）進行編碼；參考“Common Terminology Criteria for Adverse Events，CTCAE”5.0版（常見不良事件評價標(biāo)準(zhǔn)）并結(jié)合病例描述對ADR按嚴(yán)重程度進行級別劃分；采用回顧分析法從合理用藥、ADR特征、人口學(xué)特征、ADR嚴(yán)重程度、風(fēng)險提示等方面開展上市后安全性研究。結(jié)果 本研究納入的病例無超說明書用藥情況；地塞米松磷酸鈉注射劑占比較高的系統(tǒng)器官分類（SOC）包括各類檢查、各類神經(jīng)系統(tǒng)疾病、皮膚及皮下組織類疾病、胃腸系統(tǒng)疾病、血液及淋巴系統(tǒng)疾病，例次數(shù)較高的首選語（PT）包括血葡萄糖升高、失眠、白細胞計數(shù)升高、呃逆、皮疹；不同SOC應(yīng)重點關(guān)注的年齡段和不同年齡段應(yīng)重點關(guān)注的SOC均不盡相同；ADR嚴(yán)重程度主要為1級和2級，但監(jiān)測到部分3級和4級ADR；FDA數(shù)據(jù)庫的風(fēng)險提示與本研究結(jié)果基本契合。結(jié)論 建議關(guān)注地塞米松磷酸鈉注射劑50歲以上用藥人群、未成年患者皮膚及皮下組織類疾病和血液及淋巴系統(tǒng)疾病、各年齡段患者相關(guān)檢查項目；建議結(jié)合ADR風(fēng)險提示對該品種實施分類監(jiān)測。

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

江蘇省市場監(jiān)督管理局2023年度科技計劃項目（KJ2023037）