Analysis of adverse reactions caused by succinylated gelatin injection based on database of the National Adverse Drug Reaction Monitoring System
10.3760/cma.j.cn114015-20231204-00864
- VernacularTitle:基于国家药品不良反应监测系统数据库的琥珀酰明胶注射液不良反应报告分析
- Author:
Lijian WANG
1
;
Ruoxi FAN
1
;
Xu ZHU
1
;
Yu GUAN
1
;
Lei LI
1
Author Information
1. 吉林省药品安全监测中心，长春 130033
- Publication Type:Journal Article
- Keywords:
Drug-related side effects and adverse reactions;
Adverse drug reaction reporting systems;
Data analysis;
Succinylated gelatin
- From:
Adverse Drug Reactions Journal
2024;26(3):145-149
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the general rules and characteristics of adverse reactions of succinylated gelatin injection and provide reference for safe and rational clinical use.Methods:Adverse reaction reports related to succinylated gelatin injection in National Adverse Drug Reaction Monitoring System database from January 2004 to August 2021 were collected. Retrospective analysis of patients′ gender, age, primary disease, reason for drug use, combined drugs, and time of adverse reaction occurrence from drug use, clinical manifestations, severity and patient outcomes were performed, and classified statistics were performed according to systematic organ class (SOC) and preferred terms of Medical Dictionary for Regulatory Activities. Results:A total of 3 036 adverse reaction reports of succinylated gelatin injection were entered, including 710 serious cases (23.39%), and the top 5 SOCs involved diseases of the immune system, systemic diseases and various reactions at the administration site, skin and subcutaneous tissue diseases, vascular and lymphatic diseases, and respiratory/thoracic and mediastinal diseases. The main symptoms were anaphylactic shock, similar rapid severe allergic reaction, chills, fever, and other rapid severe allergic reactions. Among the 3 036 patients, 1 543 were cured, 1 480 were improved, 3 were not improved, 2 had sequelae, 2 died, and 6 had unknown results. The SOCs involved in adverse reactions and not recorded in labels included ocular organ diseases, various musculoskeletal and connective tissue diseases, metabolic and nutritional diseases, kidney and urinary system diseases, etc.Conclusions:The adverse reactions related to succinylated gelatin injection are mostly associated with anaphylaxis. Severe adverse reactions are consistent with the characteristics of rapid severe anaphylaxis, but there may be related risks not covered in labels.
