Post-marketing safety reevaluation of Xiyanping injection(喜炎平注射液)
10.3760/cma.j.issn.1008-5734.2018.01.004
- VernacularTitle:喜炎平注射液上市后安全性再评价
- Author:
Jianxiong DENG
1
;
Zhifei WANG
;
Yanming XIE
;
Bing LI
;
Lin MA
;
Jincun WANG
;
Xinjing ZHANG
;
Hui WU
Author Information
1. 510080 广州,广东省药品不良反应监测中心;广东省药理学会
- Publication Type:Journal Article
- Keywords:
Drug evaluation;
Xiyanping injection
- From:
Adverse Drug Reactions Journal
2018;20(1):15-22
- CountryChina
- Language:Chinese
-
Abstract:
Objective To revalue the post-marketing safety of Xiyanping injection. Methods The research was carried out by prospective hospital based monitoring method. The leading organizations were Guangdong Medicine Adverse Reaction Monitoring Center and Chinese of Basic Research in Clinical Medicine Institute. The participants were 21 hospitals in 6 provinces/municipality directly under the Central Government which located in Northeast China,Central China,South China,and Southwest China. Monitoring objects were all patients who used Xiyanping injection when they were hospitalized. The set sample size was not fewer than 30 000 cases. Every patient who used Xiyanping injection filled in Xiyanping injection screening card(screening card)by research staff manually. The patient who developed adverse reactions(ADR)after using Xiyanping injection filled in Xiyanping injection monitoring table(monitoring table)by clinical pharmacist manually. All the hospital should report the screening card and the monitoring table to Guangdong Provincial Drug Reevaluation Report Management System(Reevaluation Report Management System)every month.The monitoring study ended when the number of screening cardrunning up to 30 000. The reported data were collected and the incidence rate of Xiyanping injection were calculated. The clinical characteristics of adverse reactions were analyzed. Results Data were collected through the Reevaluation Report Management System till January 23,2015. The monitoring study ended. Five hospitals stopped participation in the monitoring study because of discontinuity of cases′ data from March to August, 2013. A total of 30 759 screening cards and 23 monitoring tables which were from 16 hostipals were collected finally. There were 18 295(59.48%)male and 12 464(40.52%)female in 30 759 patients. Of them the number of patients whose age <4 years were 16 501(53.64%). The patients′primary diseases were mainly respiratory disease,infectious disease,parasitic disease,and digestive system disease. All the patients used Xiyanping injection with standard doses according to the instructions. Two thousands and eight hundred-ten (9.02%)patients did not use prescriptive menstruums. There were 28 353 patients(90.98%)who were treated with combined drugs at the same time. The top 4 combined drugs were antimicrobial agents, electrolyte acid-base balance and nutrition drugs,respiratory system drugs,and digestive system drugs successively. Twenty-three of 30 759 patients developed ADR related to Xiyanping injection,the ADR incidence rate was 0.75‰,95% confidence interval(CI)was 0.47‰ to 1.12‰. The results of deciding the relevance of ADR with Xiyanping injection as "in all probability","possible" and "unable to judge"were 12(51.27%),10(43.48%)and 1(4.35%)cases,respectively. Thirty-four ADR soccurred in 23 patients.The main clinical manifestations of ADR were erythra(19 cases),pruritus(7 cases),shiver with cold(4 cases),fever(3 cases),and cyanotic lips(1 case). The degree of adverse reactions were all general.Nineteen patients improved or recurred on the same day of drug withdrawal and treatment of antianaphylaxis. Three patients improved or recured within 2 days. One patient improved on the day 14 of drug withdrawal and treatment of antianaphylaxis. Conclusion The incidence of ADR due to Xiyanping injection from 2012 to 2015 were lower and have better safety.
