ADR/AE early warning analysis of Shujin Jianyao Pills based on spontaneous reporting system.
10.19540/j.cnki.cjcmm.20200507.502
- Author:
Cheng ZHANG
1
;
Pan-Pan LI
2
;
Lian-Xin WANG
1
;
Yan-Ming XIE
1
;
Lin LI
3
Author Information
1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China Shandong University of Traditional Chinese Medicine Ji'nan 250355, China.
3. School of Statistics, Renmin University of China Beijing 100872, China.
- Publication Type:Journal Article
- Keywords:
ADR/AE;
SRS;
Shujin Jianyao Pills;
pharmacovigilance;
risk signals
- MeSH:
Adverse Drug Reaction Reporting Systems;
Aged;
Bayes Theorem;
Drug-Related Side Effects and Adverse Reactions;
Drugs, Chinese Herbal;
Female;
Humans;
Middle Aged;
Pharmacovigilance;
Risk Management
- From:
China Journal of Chinese Materia Medica
2020;45(15):3533-3538
- CountryChina
- Language:Chinese
-
Abstract:
To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.
