Exploration of the clinical characteristics of adverse reactions and warning signals of Danshen lyophilized powder injection
10.3760/cma.j.issn.1008-5734.2016.04.002
- VernacularTitle:注射用丹参(冻干)不良反应的临床特征及预警信号探讨
- Author:
Shiguang SUN
1
;
Wei FAN
;
Dongmei QI
;
Jian LIU
;
Yuejie TIAN
;
Yanjun XIE
;
Rong SUN
Author Information
1. 250001 济南,山东中医药大学第二附属医院药学部;250001 济南,山东省中西医结合医院药学部
- Publication Type:Journal Article
- Keywords:
Salvia militiorriza;
Drug toxicity;
Data mining
- From:
Adverse Drug Reactions Journal
2016;18(4):243-248
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the clinical characteristics and the warning signals of Danshen lyophilized powder injection (DLPI).Methods The adverse drug reaction (ADR) reports of DLPI from the ADR Spontaneous Reporting Database of Shandong Province from January 1,2005 to December 31,2015 were collected.The clinical characteristics of ADR were analzed by descriptive statistical method.The conceptual data and the data for each year from 2005 to 2015 were analyzed to find out the warning signals of ADR induced by DLPI by the methods of proportional reporting ratio (PRR),reporting odds ratio (ROR),and bayesian confidence propagation neural network (BCPNN).Results A total of 887 reports and 887 patients which comprised 460 males and 427 females with the average age of (57.7 ± 16.6) years (3 d to 91 years) were enrolled into the analysis.The patients whose age ≥45 years accounted for 79.59％ (706/ 887).There were 1 281 times of ADR in 887 patients which involved mainly in skin and cardiocerebrovascular system.Top ten in turn were erythra,pruritus,dyspnea,shiver,nausea,headache,fever,palpitation,dizziness,and injection site reactions,totally 1 152 times of ADR which accounted for 65.89％ (1 152/1 281).The patients stopped to use DLPI when the ADR appeared.Of the 887 patients,557 cases were recovered and 330 had improvement after receiving the symptomatic treatments.The results of analysis on conceptual data and the data for each year by methods of PRR,TOR,and BCPNN showed that erythra (PRR method:conceptual data,from 2008 to 2015;ROR method:conceptual data,from 2008 to 2014;BCPNN method:conceptual data),pruritus (PRR method:conceptual data,2012,2013,2015;ROR method:conceptual data,2012,2013),dyspnea (PRR method:conceptual data,from 2008 to 2014;ROR method:conceptual data,from 2008 to 2014;BCPNN method:conceptual data,2014),shiver (PRR method:conceptual data,from 2007 to 2009;ROR method:conceptual data,from 2011 to 2013;BCPNN method:conceptual data,2012 and 2013) could be warning signals of ADR induced by DLPI.Conclusions ADRs due to DLPI involve mainly skin and cardio-cerebrovascular system.Erythra,pruritus,dyspnea,and shiver can be the warning signals of ADR induced by DLPI.
