Analysis of adverse events of Fufang E′jiao (复方阿胶浆) syrup based on literature
10.3760/cma.j.cn114015-20240614-00444
- VernacularTitle:复方阿胶浆不良事件文献分析
- Author:
Zijia CHEN
1
;
Zhiqing CHEN
;
Wenxi PENG
;
Zhifei WANG
;
Yanming XIE
Author Information
1. 中国中医科学院中医临床基础医学研究所，北京 100700
- Publication Type:Journal Article
- Keywords:
Neoplasms;
Anemia;
Complementary therapies;
Chinese materia medica;
Fufang E'jiao syrup;
Adverse reactions
- From:
Adverse Drug Reactions Journal
2025;27(5):281-287
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the clinical safety of Fufang E'jiao syrup and provide reference for its rational and safe clinical use. Methods:The literature involving Fufang E'jiao syrup in domestic and international databases, as well as the relevant clinical trials on ClinicalTrials.gov and the Chinese Clinical Trial Registry website were searched up to June 1, 2024. Those literature and clinical trials reporting drug adverse events were included, and the basic information about literature/clinical trials (title, publication year, study design, etc.), patients (age, gender, primary diseases, and dosage of Fufang E'jiao syrup), and adverse events (time of occurrence, clinical manifestations, and outcomes) was extracted. The adverse events were standardized and classified using the Medical Dictionary for Regulatory Activities version 25.0, and were also analyzed based on traditional Chinese medicine theory. Results:A total of 19 literature were included in the analysis, including 16 observational/experimental clinical studies, and 3 case reports. The 19 literature reported a total of 430 adverse events involving 398 patients, and the patients were mainly with malignant tumors and anemia. The 430 adverse events involved 11 system organ classes, which mainly included gastrointestinal disorders (260 events, 60.47%, with the most common symptom being dry mouth), respiratory, thoracic, and mediastinal disorders (119 events, 27.67%, with the most common symptom being dry throat), and skin and subcutaneous tissue disorders (16 events, 3.72%, with the most common symptom being mucosal ulcers). Based on traditional Chinese medicine theory, the 430 adverse events were mainly manifested as symptoms of indigestion (nausea, epigastric discomfort, and decreased appetite) and symptoms of "heat" (dry mouth and dry throat).Conclusions:Fufang E'jiao syrup has a relatively good overall safety profile, with the most common adverse events being symptoms of "heat" and gastrointestinal reactions. Patients should not use it blindly, and it should be used with syndrome differentiation in clinical practice.
