Establish And Application Of Intelligent Analysis System Of Adverse Drug Reactions

Objective: To investigate the characteristics and regularity of adversedrug reactions/events(ADR/ADE)occurred in Chongqing，and providereferences for drug safety monitoring, clinical rational medication anddecision-making of Food and Drug Administration.Methods: ADR intelligent analysis system were established based onthe data source mainly collected by Chongqing ADR Monitoring Centerand business intelligence technologies(BI) platform.65900ADRs/ADEsoccurred from2008to2012in Chongqing were analyzed epidemiologically.ADRs/ADEs caused by Cephalosporin antibiotics in2012and Reduninginjection from2010to June2013were intelligent analyzed.Results:①Developed intelligent analysis system with various abilitiesof summary, statistics, query and update;②Among65900ADR/ADEreports, the incidence of ADR/ADE was highest in the elderly patients aged60year-old above. The majority of ADRs/ADEs were caused byintravenous injection. In addition, antimicrobial drugs came first andChinese patent medicine came second among the drugs involved with theADRs/ADEs occurred in Chongqing. The major clinical manifestations were digestive system symptoms，lesion of skin and its appendages andgeneral symptoms. The medical institutions were the main reporters.③Inthe3394patients with ADR/ADE caused by Cephalosporin Antibiotics, theoccurrence of children under10years old were higher, and19.27%ofADR/ADE caused by ceftriaxone. There were119cases of severeADRs(including new and severe ADRs),and oversensitive shocks camefirst in the severe ADR cases involved.④In the125patients withADR/ADE caused by Reduning injection,29(23.2%) patients with ADEwere caused by off-label use of the drug; males were81(64.8%) andfemales were44(35.2%); the occurrence of children under2years oldwere higher (48.0%);89.6%of the ADR/ADE happened within30min ofmedication. Totally207ADR/ADE happened,73.9%of which weredamages on skin and its appendages, such as rash and itching. And20.3%of which were new ADR.Conclusions: Intelligent analysis system can improve the availabilityof ADR/ADE reports information, and mines potential valuableinformation by multi-level, multi-angle analysis and evaluation, and it hasextensive application prospect. In addition, great importance should beattached to antimicrobial drugs and Chinese patent medicine ADR/ADEmonitoring, especially Cephalosporin Antibiotics in which ceftriaxonepredominates. And attention should be paid to clinical features within30min using of Reduning injection. In a word, it is necessary to regulate the use drugs and monitoring of ADR, so as to enhance the medicationsecurity.