The Study Of Levofloxacin’s Adverse Drug Reactions And Monitoring Methodology

Objective:The study was conducted to analysis adverse reactions and explored risk of levofloxacin for clinical application, thus trying to establish a method for hospital’s adverse reaction monitoring.Methods:Part I:The study was searched wanfang data, CNKI, CBM for case reports of adverse reactions, and the keywords contained levofloxacin and ofloxacin. Analyzed the case reports that met the eligibility criteria.Part II:The study was selected patients used levofloxacin as subjects in the respiratory department and infectious department during January to December,2012. The study was collected the patients’information included identification, medicines, biochemical data and adverse reactions, and then analyzed the information of patients by statistical methods.Part III:Taking adverse reaction of levofloxacin for example, the study was explored adverse drug reaction monitoring methodology under real environment.Results:Part I:There were355and232case reports of levofloxacin and ofloxacin respectively. There was statistical significance in age, the history of allergy between levofloxacin and ofloxacin (p<0.05). Levofloxacin’s adverse reactions distributed in31provinces throughout the country, but Shandong, Beijing, Hebei provinces were the top three about adverse reactions reported. Average age is48.5±19.8year, and patients who not less than60years old accounted for35.2%. There were37cases with allergic history, and accounted for10.4%. There were315cases intravenous infusion (88.7%) and106cases combined medication (29.9%). There were118(33.2%) cases of systemic damage,105(29.6%)cases of the central and peripheral nervous systemic damage,35(9.9%) cases of cardiovascular and blood system damage.342cases recovered or improved after treatment,5cases dead from adverse reaction and6cases was not better. Adverse reactions of ofloxacin was involved in32provinces and Shandong, Hubei, Hebei were the top three. The average age was44.7±18.8year, and patients who no less than60years old accounted for23.8%. There were35cases with allergic history, and accounted for15.1%. Occurring time of adverse reaction varied from30seconds to20days. There were78(33.6%) cases of systemic damage,68(29.3%) cases of the central and peripheral nervous system damage,23(9.9%) cases of skin and attachment damage.226cases recovered or improved after treatment, one patient dead and five patients was not better.Part Ⅱ:There were total926patients using levofloxacin, and77patients appeared adverse reactions. The rate of adverse reaction was8.32%. The average age was60.2±17.5years and the youngest and oldest patient were19years old and94years old respectively. There were627male and299female, male was2.1times as much as female. The patients who had bad habits were total470cases and accounted for50.8%. The number of patients with allergic history was192and accounted for20.7%. Drug allergy of allergic history was224cases, accounted for80%. Daily dose was varied from0.2g to0.6g and dosing frequent was once or twice a day. The administration time of levofloxacin was varied from1day to53days, and average time was11.5±6.4days. There were22.1%patients used levofloxacin lonely, and77.9%patients used two or more antibiotics simultaneously, among which8cases (0.9%) were combined with three antibiotics,713cases (77.0%) with two antibiotics. There were77patients having drug reactions, the youngest and the oldest patient were20and87years old. The average age was60.4±18.4years old. There were47cases (61%) of adverse reactions occurred in the course of medication and30cases (39%) of adverse reactions occurred after medication. The patients with adverse reactions were cured after treatment. Occurring time of adverse reaction varied from5minutes to23days. There were36cases of skin and attachment damage and28cases of digestive system damage. The patients recovered after treatment.54patients who did not use levofloxacin after having adverse reaction, accounted for70.2%,23patients who did not stopped levofloxacin after having adverse reaction, accounted for29.8%. By univariate analysis, levofloxacin adverse reactions had statistical significance in allergic history, the frequency and time of administration and combined medication (p<0.05). By multivariate analysis, levofloxacin adverse reaction has statistical significant in allergic history and combined medication (p<0.05).Part Ⅲ:According to the hospital situation, we developed a centralized monitoring method. The steps as follows:defining the research subjects, medicines type, the scope of monitoring, selecting department, designing the questionnaire, monitoring by groups, checking cases, collecting data, statistical analysis and conclusion.Conclusions:Part Ⅰ:Adverse reactions appeared diversity in clinical manifestation between levofloxacin and ofloxacin.Part Ⅱ:1. The rate of Levofloxacin’s adverse reaction was8.32%.2. Levofloxacin’s adverse reaction was related to allergic history, combined medicines. The adverse reaction rate of patients with allergic history was1.982times as much as patients without allergic history, and patients with combined medicines were0.566times as much as medicines alone.Part Ⅲ:Taking adverse reaction of levofloxacin for example, the study was developed a centralized monitoring model of drug adverse reaction about hospitalized patients.