Clinical Safety Monitoring of 3 035 Cases of Juvenile Feilike Mixture After Marketing in Hospital
10.13422/j.cnki.syfjx.20251196
- VernacularTitle:3 035例肺力咳合剂未成年人群上市后临床安全性的医院集中监测
- Author:
Jian ZHU
1
;
Zhong WANG
1
;
Jing LIU
2
;
Jun LIU
1
;
Wei YANG
1
;
Yanan YU
1
;
Hongli WU
1
;
Sha ZHOU
3
;
Zhiyu PAN
1
;
Guang WU
4
;
Mengmeng WU
4
;
Zhiwei JING
1
Author Information
1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. National Center for Children's Health，Beijing Children's Hospital，Capital Medical University，Beijing 100045，China
3. The Second Clinical Medical College，Guangzhou University of Chinese Medicine，Guangzhou 510006，China
4. The First Clinical Medical College，Henan University of Chinese Medicine，Zhengzhou 450046，China
- Publication Type:Journal Article
- Keywords:
Feilike mixture;
proprietary Chinese medicine;
nested case control;
safety;
real world;
adverse drug reaction
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(10):194-200
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo explore the clinical safety of Feilike Mixture （FLK） in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21，2021 and December 25，2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved，which are distributed across 12 provinces，including one traditional Chinese medicine （TCM） hospital and 28 general hospitals. The average age among the juveniles was （4.77±3.56） years old，and the average weight was （21.81±12.97） kg. Among them，119 cases （3.92%） of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles，with 1 656 cases （54.46%）. FLK was first used in 2 016 cases （66.43%），and 142 juvenile patients had special dosages，accounting for 4.68%. Among them，92 adverse drug reactions （ADRs） occurred，including 73 cases of gastrointestinal system disorders，10 cases of metabolic and nutritional disorders，eight cases of skin and subcutaneous tissue diseases，two cases of vascular and lymphatic disorders，and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea，stool discoloration，and vomiting，and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages （the use of FLK）［odds ratio （OR） of 2.642， 95% confidence interval （CI） of 1.105-6.323］，combined administration： spleen aminopeptide （OR of 4.978， 95%CI of 1.200-20.655），and reason for combined administration： anti-infection （OR of 1.814， 95%CI of 1.071-3.075） were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%，and the severity was mainly mild or moderate. Generally，the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction，suggesting that FLK has good clinical safety.
