ABSTRACT
OBJECTIVE:To evaluate the clinical efficacy and safety of triple therapy in the treatment of type 2 diabetes melli-tus(T2DM),and to open up more effective way to treat T2DM. METHODS:76 patients with T2DM were randomly divided into control group and observation group with 38 cases in each group. The control group received conventional therapy,i.e. oral hypo-glycemic agents Glipizide controlled-release tablet 5 mg,qd+Metformin tablets 5 mg,tid. The observation group was treated with triple therapy,i.e. berberine hydrochloride 0.5 g,tid,for 3 months,on the basis of control group. The biochemical index were compared between 2 groups Before and after treatment,including fasting blood glucose (FBG),postprandial 2 h blood glucose (2 h FPG),glycosylated hemoglobin(HbA1c),insulin(FINS),total cholesterol(TC)and triglyceride(TG),high/low density li-poprotein cholesterol (HDL-C/LDL-C),etc.,to evaluate its safety. RESULTS:After treatment,FBG,2 h FPG,HbA1c,FINS, TC and LDL-C of 2 groups and TG of observation group were all decreased significantly,while the level of HDL-C was increased significantly,with statistical significance(P<0.05);FBG,2h FPG,HbA1c,FINS,TC and LDL-C of observation group were im-proved more significantly than control group,the difference was statistically significant(P<0.05). ADR was found in 4 patients of observation group,and the symptoms were relieved after symptomatic treatment. CONCLUSIONS:In the treatment of T2DM,tri-ple therapy can down-regulate blood lipid and blood sugar stably,have definite therapeutic efficacy and little side effect.
ABSTRACT
OBJECTIVE:To explore the standardized package of Metformin tablets to meet clinical needs. METHODS:Statis-tics was conducted for the utilization data of Metformin tablets in medical and health institutions from 6 cities of China;question-naires were designed to investigate and analyze the evaluation for the suitability of physicians,pharmacists and patients in the pre-scription,deployment and use links to Metformin tablets with different packaging loaded amount in Beijing and Haikou. RE-SULTS:For 0.5 g/tablet,the daily dose of 1.5 g accounted for the largest proportion (32.23%-69.91%) in 5 cities except for Chengdu. Totally 490 questionnaires about package suitability of Metformin tablets in outpatient department were sent out,includ-ing 478 valid questionnaires with effective rate of 97.5%. Results showed that packaging quantity with 4 weeks was considered as appropriate by physicians,pharmacists and patients in Beijing;however,packaging quantity with 1-2 week(s) was considered as appropriate by physicians,pharmacists and patients in Haikou;300-500 tablets of packaging quantity were preferred to be appropri-ate with the matching degree of automatic dispensing machines in both places. CONCLUSIONS:Considering the results in 2 plac-es,for 0.5 g/tablet,2 weeks is appropriate for the packaging loaded amount in outpatient department,that is 0.5 g×45 tablets/box;and 300-500 tablets/box is appropriate for inpatient pharmacies.
ABSTRACT
Bioequivalence studies are the commonly accepted methods displaying therapeutic equivalence between two products .This study was conducted to evaluate the bioequivalence between different formulations of metformin 500 mg and 1000 mg tablets which were marketed in Iran, and innovator brand. Considering that only in vitro bioequivalence studies can predict the in vivo bioequivalence, and to save time and cost, three essential in vitro tests including assay, weight variation and a comparative in vitro dissolution study were performed. In order to compare formulations, dissolution profiles were taken and compared through two model independent methods, difference factor (f1) and similarity factor (f2). All the tested brands released more than 80% drug in 30 minutes and contained 95-96.3% of labeled amount except b and C. The acceptance value in all cases were below 15. Therefore it is evident that test products except brand C were bioequivalent to the reference product, and could be used as a generic substitute for the innovator product. Results emphasize to need for post marketing investigation for new formulations.