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주미,현복진,김운학,김옥녀 한국병원약사회 1998 병원약사회지 Vol.15 No.4
Dissolution and content-uniformity tests are very important and essential procedures for the controlling of medication bioavailability. Depends on the bioavailability of medication, the efficacy and safety in patient therapy are different. Currently five different manufactured acyclovir tablets (A, B, C, D and E) are available in Korea. This study performed to evaluate the bioavailability of those acyclovir tablets, and to help the clinicians for valid selection of medication in patient therapy. The study methods were consisted of the dissolution tests and content-uniformity tests of each acyclovir tablet. The dissolution tests were performed six tablets of each acyclovir in the two artificial juices for 30 minutes : (1) a gastric juice with pH 1.2, (2) a enteric juice with pH 6.8. The content-uniformity tests were performed the measurements of ten solutions (200 mcg/㎖) made by each acyclovir tablet, and compared them with the standard solution. All tests were measured by the HPLC method. The results of the dissolution tests showed that both cases ((1) & (2)) were presented on tablet A, B, E, D and C in high dissolution rate order, and also all acyclovir tablets meet for the standard of KP Ⅶ (90% above) in the content-uniformity tests. In conclusion, the good quality of medication is very important to increase the efficacy and safety of patient therapy, and is determined by the bioavailability measurements of each medication. The conducting of bioavailability tests for each medication must be performed on the regular basis.
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배지철,곽수헌,김현진,김상용,황유철,서성환,현복진,차지은,원종철,김재현 대한당뇨병학회 2022 Diabetes and Metabolism Journal Vol.46 No.1
Background: To evaluate the effects of teneligliptin on glycosylated hemoglobin (HbA1c) levels, continuous glucose monitoring (CGM)-derived time in range, and glycemic variability in elderly type 2 diabetes mellitus patients.Methods: This randomized, double-blinded, placebo-controlled study was conducted in eight centers in Korea (clinical trial registration number: NCT03508323). Sixty-five participants aged ≥65 years, who were treatment-naïve or had been treated with stable doses of metformin, were randomized at a 1:1 ratio to receive 20 mg of teneligliptin (n=35) or placebo (n=30) for 12 weeks. The main endpoints were the changes in HbA1c levels from baseline to week 12, CGM metrics-derived time in range, and glycemic variability.Results: After 12 weeks, a significant reduction (by 0.84%) in HbA1c levels was observed in the teneligliptin group compared to that in the placebo group (by 0.08%), with a between-group least squares mean difference of –0.76% (95% confidence interval [CI], –1.08 to –0.44). The coefficient of variation, standard deviation, and mean amplitude of glycemic excursion significantly decreased in participants treated with teneligliptin as compared to those in the placebo group. Teneligliptin treatment significantly decreased the time spent above 180 or 250 mg/dL, respectively, without increasing the time spent below 70 mg/dL. The mean percentage of time for which glucose levels remained in the 70 to 180 mg/dL time in range (TIR70–180) at week 12 was 82.0%±16.0% in the teneligliptin group, and placebo-adjusted change in TIR70–180 from baseline was 13.3% (95% CI, 6.0 to 20.6).Conclusion: Teneligliptin effectively reduced HbA1c levels, time spent above the target range, and glycemic variability, without increasing hypoglycemia in our study population.
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