[Pharmacovigilance of parenterally administered salvianolate based on analysis of spontaneous reporting system data].
Spontaneous reporting system (SRS) is currently a basic method to monitor and find adverse drug reactions (ADR) signals used worldwide. This method can promptly and effectively discover ADR signals and is of great significance to effectively prevent and avoid ADRs. Parenterally administered salvianolate has the functions of activating blood circulation and removing stasis. It is mainly used in the treatment of stable angina pectoris. As the drug is widely used clinically and ADRs are increasingly reported promptly, ADR information in the national ADR monitoring center's SRS database has also increased. How to quickly and effectively identify suspicious ADRs is a major concern. This study uses BCPNN and PRR to detect early warning signals. S739 ADR case reports were identified. There were 106 types, 1 310 events, and 24 serious ADR cases ( 3.25% of 739 case reports) There wre no deaths. The ten most frequent ADRs were: rash, dizziness, itch, headache, chills and breath, nausea, palpitation, anaphylactic reaction and hot. The drugs early warning signs were dizziness, headache, nausea, itchiness and rash estimated using PRR. Early warning signs based on BCPNN were dizziness and headache. The ADRs of dizziness and headache are early warning signals associated with the nervous system.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. zykxylu@sina.cn
Peng-Fei
PF
Lu
School of Statistics, Renmin University of China, Beijing 100872, China.
Yong-Yang
YY
Xiang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yan-Ming
YM
Xie
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Yan-Peng
YP
Chang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhi-Guo
ZG
Wang
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D002681:China / Q000453:epidemiology; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D006801:Humans; D007223:Infant; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects*; D055815:Young Adult
D010936:Plant Extracts; C561960:salvianolate