Research Of Epidemiological Characteristics Of Adverse Drug Reactionins Of Chongqing

Objective: To establish the adverse drug reaction(ADR) epidemiology analysis system, analyze the epidemiological characteristics of ADRs in Chongqing, and provide references for clinical rational medication and ADR monitoring.Methods: ADR epidemiology analysis system were builded based on ADR cases of Chongqing from 2009 to 2014, using data mining, which including basic database, cases database and statistical analysis database. Using the system, epidemiological characteristics of ADR in Chongqing during 2009-2014 were studied; furthermore the characteristics and patterns of ADR of traditional Chinese medicine injection and Shenxiong glucose were analyzed.Results:(1)The ADR epidemiology analysis system was established.(2)Among 109822 ADRs during 2009-2014 in Chongqing, the proportions of new and serious ADRs were less; Among the people involved in ADRs, the elderly(≥60 years) were more; 36.04% ADRs induced by anti-infective drugs, ADRs were mostly caused by levofloxacin. The largest proportion of serious ADRs was related to antineoplastic drugs; 92.94% ADRs were reported by the medical institution, and ADRs mainly involved the digestive system lesion;(3)In 14714 ADRs induced by traditional Chinese medicine injection, the proportion of ADRs was highest in the elderly(≥60 years) and children(<10years). ADRs induced by Chinese activating blood herbal injection were largest; the ADRs were mostly caused by Xuesaitong、Yanhuning、Qingkailing、Xiangdan and Shenmai; 32.07% serious ADRs were because of off-label use; the significant factors of serious ADRs were age、sex、off-indications and combined medication; ADRs mainly involved the skin and its appendages and generalized lesion. The clinical manifestations were rash, fever, shivering, anaphylactoid reaction and allergic reactions.(4)Among 529 ADRs, there were 262 new ADRs(49.5%);The proportion of the elderly(≥60 years) were largest(49.1%); 86.2% of the ADRs happened within 30 min of medication use; the main clinical manifestations of ADRs were itching, rash, anaphylactoid reaction, palpitation, and nausea.Conclusions: ADR epidemiological analysis system with automatically statistic analyzing, updating and querying, can improve the efficiency of ADR study. The quality of ADR cases has yet to be improved, and we should strengthen the monitoring the use of anti-infection drugs, antineoplastic drugs and traditional Chinese medicine injections, notice the reasonable application of levofloxacin and Xuesaitong. Drug manufacturing enterprises should improve the instruction of Shenxiong glucose injection. It is necessary to pay attention to clinical manifestations within 30 min of injection, so as to enhance the medication security.