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OBJECTIVE:To investigate the clinical characteristics and regularity of adverse drug reaction (ADR),and to pro-vide reference for rational and safe drug use in the clinic. METHODS:ADR reports collected from our hospital by Guangdong ADR Monitoring Center during Jan. 2014 to June. 2015 were summarized and analyzed statistically. RESULTS:Of 433 ADR cases,there were 185 male cases (42.73%) and 248 female cases (57.27%),with ratio of 1∶1.34. The incidence of ADR was in high level (71.59%) in young and middle-aged patients (20-59 year-old);that of male was significantly lower than that of female (1∶1.37). ADR cases caused by intravenous drip(48.04%)and oral administration(41.57%)were most common. The most ADR cases were re-lated with anti-infective drugs(167 cases,38.57%),mainly were related with cephalosporins(64.07%). Organs/systems involved in ADR were main the damages of gastrointestinal system (262 cases,36.19%) and the lesion of skin and appendants (237 cases, 32.73%). The serious ADR was mainly induced by anti-infective and anti-tumor drugs. CONCLUSIONS:Clinical medical personnel should strengthen the ADR monitoring of cephalosporin antibiotics and anti-tumor drug,and select route of administration carefully.
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OBJECTIVE: To analyze the basic data of adverse drug reactions(ADR) and assess the quality of ADR reports submitted in 2006 in Shenzhen,and to provide bases for ADR monitoring.METHOD: The electronic forms of ADR cases reported in 2006 by different units in Shenzhen that had been subjected to the evaluation of Guangdong provincial center were downloaded,and the related data were subjected to frequency analysis.The three time points(duration of medication,onset time of ADR,turnover time) were used to evaluate the integrity of ADR process recording,and the relevance was evaluated by means of contrast.RESULTS: 19 drug categories and total 465 kinds of medicines were involved in 3 303 ADR cases.The categories of antimicrobials and Chinese herbal preparations and ADR cases induced by these drugs ranked at the first and second among all the drugs.The lesions of ADR involved primarily skin and its accessories,followed by gastrointestinal system.Most ADR cases were caused thorough intravenous route of administration.The majority ADR cases had a favorable turnover.New and severe ADR reports were few.The qualities of most reports were poor.CONCLUSION: The training program for ADR reporters should be strengthened;ADR reporters' reporting awareness and responsibility should be strengthened to enhance ADR reporting quality,and physicians' prescribing behavior should be intervened properly so as to reduce the incidence of ADR.
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OBJECTIVE:To develop a HPLC method for simultaneous determinatio n of ofloxacin and dexamethasone ac?etate in compound ofloxacin ear drops.METHODS:The analysis was carried on a XDB-C 8 ,the mobile phase was composed of methanol-potassium dihydrogen phosphate(0.02mol/L)by gradient elution,the flow rate was1.0ml/min,the column tem?perature was30℃and the detection wavelength was at240nm.RESULTS:The detectable concentrations of ofloxacin and dexamethasone acetate showed good linear correlation in the ranges of100～500?g/ml and10～30?g/ml respectively,the av?erage recoveries of ofloxacin and dexamethasone acetate were100.6%(RSD=0.46%,n=9)and101.3%(RSD=0.72%,n=9)respectively.CONCLUSION:The method is accurate and reproducible and can be used for determination of ofloxacin and dexamethasone acetate in compound ofloxacin ear drops.