ABSTRACT
OBJECTIVE: To investigate the characteristics and regularity of adverse drug reactions (ADR) of out- patients occurred in our hospital. METHODS: 494 cases of ADR cases collected in our out- patient dispensary from 2007 to 2008 were analyzed retrospectively. RESULTS: Of total 494 ADR cases,ADR incidence of female (62.96%) was obviously higher than male (37.04%). 58.50% of ADR cases were induced via intravenouse route drugs and 51.21% were caused by antibiotics,among which 104 cases were caused by fluoroquinolones and 90 cases by macrolide,followed by the cardiovascular and cerebral system drugs (13.97%) and traditional Chinese medicine (13.16%). The main clinical manifestations of ADR cases were lesion of skin and appendant (29.17%),injury of digestive system(22.37%) and nervous system(17.34%). CONCLUSION: More attention should be paid to the ADR monitoring to provide reference for clinical rational use of drug.
ABSTRACT
AIM: To verify the bioequivalence between sustained released tablet of nepopam and normal one. METHODS: 18 volunteers were randomly devided into two groups. Double periodical crossed design was used, and poly dose of nefopam was administered to 18 volunteers following single dose after one week interval. The concentration of nefopam hydrochloride in serum was determinated by HPLC, and the related parameters came out through 3p97 programme. RESULTS: In the single dose test the drug concentration of sustained released tablet maitained 2040 mg?L -1 for 10 h ,c max was ( 45.8 ?15.7) mg?L -1 ,t peak was ( 3.4 ? 0.8) h , and the corresponding parameters of normal tablet were over 20 mg?L -1 for 7.5 h ,( 72.7 ?26.0) mg?L -1 ,and ( 1.6 ? 0.6) h . The AUC was ( 363.4 ? 107.1 ) and ( 374.8 ?125.7) mg?h?L -1 respectively, and F was ( 1.02 ? 0.25 ). In the poly dose test the c max of sustained released and normal one was ( 31.50 ? 12.65 ) and ( 33.68 ?10.51) mg?L -1 ,c min was ( 13.4 ? 4.4 ) and ( 10.9 ?5.4) mg?L -1 , t peak was ( 2.6 ? 0.6 ) and ( 1.22 ? 0.46) h , and FI was ( 0.77 ? 0.26 ) and ( 1.04 ? 0.18 ) respectively. CONCLUSION: The sustained released tablet is credible and the two types of tablet are equieffective in AUC.