Analysis of adverse drug reaction/adverse event and early warning signal mining of Ginkgo biloba Dropping Pills based on SRS data.
10.19540/j.cnki.cjcmm.20200221.502
- Author:
Cheng ZHANG
1
;
Huan LIU
1
;
Yan-Ming XIE
1
;
Qi WANG
2
Author Information
1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
2. School of Statistics, Renmin University of China Beijing 100872, China.
- Publication Type:Case Reports
- Keywords:
Ginkgo biloba Dropping Pills;
adverse drug reactions/adverse event;
pharmacovigilance;
spontaneous reporting system
- MeSH:
Adverse Drug Reaction Reporting Systems;
Aged;
Bayes Theorem;
Drug-Related Side Effects and Adverse Reactions;
Female;
Ginkgo biloba;
Humans;
Male;
Middle Aged;
Neural Networks, Computer;
Pharmacovigilance
- From:
China Journal of Chinese Materia Medica
2020;45(10):2322-2328
- CountryChina
- Language:Chinese
-
Abstract:
In order to understand the characteristics of adverse drug reaction/adverse event(ADR/AE) of Ginkgo biloba Dropping Pills and evaluate the safety of clinical use after marketing, 407 ADR/AE case report data of Ginkgo biloba Dropping Pills collected by National Center for ADR Monitoring System during 2009-2018 was systematically analyzed, and its general characteristics were analyzed using descriptive statistical methods. The results showed that among the 407 cases of spontaneous reporting system(SRS) data, 401 cases were general ADR/AE, accounting for 98.5%, and 6 cases were severe ADR/AE, accounting for 1.5%; there were more females than males(171/150) in ADR/AE, and they were mainly middle-aged and elderly people aged 45-64 years(152 cases, accounting for 37.35%); gastrointestinal system(23.89%) was mostly involved in ADR/AE. The top ten clinical symptoms were nausea(15.49%), dizziness(9.88%), vomiting(8.11%), rash(5.60%), chest tightness(5.46%), palpitations(5.31%), pruritus(4.72%), headache(4.57%), abdominal distension(3.83%), gastric dysfunction(3.54%); proportional reporting ratio(PRR) and Bayesian confidence progressive neural network method(BCPNN) were adopted to mine ADR/AE warning signals. Due to the small sample size, there were only 0-2 ADR/AE cases with various symptoms in many quarters, with no warning signal by PRR and BCPNN methods. The findings suggest that ADR/AE of Ginkgo biloba Dropping Pills based on SRS system was not recorded in the package insert, and further active monitoring studies shall be conducted to improve relevant ADR/AE information and pay attention to its clinical drug safety issues.
