Volume 41,
Issue 10,
2013
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扉・目次
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Source:
薬理と治療 41巻10号, 939-940 (2013);
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ROUNDTABLE DISCUSSION
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Source:
薬理と治療 41巻10号, 943-949 (2013);
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イベント抑制を目的とする糖尿病専門医と,イベント治療を施す循環器専門医が,同じ目線で今後の糖尿病診療を考えることはきわめて重要である。そこで,糖尿病専門医と循環器専門医で今後のあるべき糖尿病治療について意見を交わした。
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REVIEW
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薬理と治療 41巻10号, 951-958 (2013);
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Tocilizumab(TCZ), a humanized monoclonal antibody directed against the IL-6 receptor, has been developed as an intravenous form for the treatment of patients with rheumatoid arthritis (RA). Recently, subcutaneous injection form of TCZ(TCZ-SC)was developed to optimize a patient’s treatment. In a double-blind, double-dummy, parallel-group, comparative phaseⅢ trial(MUSASHI study), the non-inferiority of TCZ-SC to intravenous infusion of TCZ(TCZIV)monotherapy in regard to efficacy was evaluated in Japanese RA patients with an inadequate response to synthetic and/or biologic DMARDs. Patients were randomized to receive TCZ-SC 162 mg/2 weeks or TCZ-IV 8 mg/kg/4 weeks;no methotrexate was allowed during the study. The primary endpoint was to evaluate ACR20 response rates at week 24. The non-inferiority of TCZ-SC to TCZ-IV regarding the ACR20 response rates was tested using an 18% non-inferiority margin. At week 24, ACR20 response was achieved in 79.2%(95% CI 72.9, 85.5)of the TCZ-SC group and in 88.5%(95% CI 83.4, 93.5)of the TCZ-IV group;the weighted difference was -9.4%(95% CI -17.6, -1.2), confirming the non-inferiority of TCZ-SC to TCZ-IV. Both groups had comparable improvements in DAS28-ESR and CDAI. The incidences of all adverse and serious adverse events were 89.0% and 7.5% in the TCZ-SC group and 90.8% and 5.8% in the TCZ-IV group, respectively. Anti-TCZ antibodies were detected in 3.5% of the TCZ-SC group and 0.0% of the TCZ-IV group. In conclusion, this study demonstrated that TCZ-SC had comparable efficacy and safety to TCZ-IV. TCZ-SC could provide additional treatment options for patients with RA.
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BRIEF COMMUNICATION
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Source:
薬理と治療 41巻10号, 959-962 (2013);
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Anti-obesity effects of the fermented wheat extracts with Bacillus subtilis(natto)strain DC15 (DC15-FE)were investigated using mice fed a high-fat diet. Body weights, the amount of abdominal visceral fat, and blood concentrations of triglyceride and glucose were significantly decreased in mice fed a high-fat diet containing 5% DC15-FE. These results suggest that DC15-FE have anti-obesity effects on a high-fat diet conditions.
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ORIGINAL ARTICLES
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薬理と治療 41巻10号, 965-974 (2013);
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Background For the prevention of complications, the Japan Diabetes Society(JDS)recommended an HbA1c level of less than 7.0% as the goal for glycemic control. We assessed the achievement rates of less than 7.0% HbA1c in Japanese type 2 diabetic patients treated with anagliptin. Methods We calculated the goal achievement rates for glycemic control in phaseⅡ, phase Ⅱ/Ⅲ and phaseⅢ trial. A pooled analysis was also performed on phaseⅡ and Ⅲ due to their similar trial design. The goal achievement rates of less than 7.0% HbA1c, fasting plasma glucose of less than 130 mg/dL, plasma glucose levels 2-hr after the load of less than 180 mg/dL as recommended by the Japan Diabetes Society were calculated at 12 weeks and 52 weeks. Results At 12 weeks, goal achievement rates of less than 7.0% HbA1c were over the 50% in the group treated with anagliptin 100 mg BID. Also, the treatment with anagliptin 100 mg BID showed significantly higher achievement rates relative to voglibose treatment. The goal achievement rates of less than 7.0% HbA1c in combination therapy with anagliptin at 12 weeks were 40.3%, 39.4%, 30.0% and 34.8% in α-glucosidase inhibitor, thiazolidine, sulfonylurea, or biguanide treated patients, respectively. In each of these cases, combination therapy group showed significantly higher goal achievement rates relative to the group of placebo. (α-glucosidase inhibitor combination group P<0.01, thiazolidine combination group P<0.01, sulfonylurea combination group P<0.001, biguanide group P<0.001)Conclusions Monotherapy and combination therapy with anagliptin significantly improved the achievement rates of the goal for glycemic control in Japanese patients with type 2 diabetes.
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Source:
薬理と治療 41巻10号, 975-979 (2013);
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Background Since its approval in 2000, lopinavir boosted with ritonavir(LPV/r, Kaletra)has been widely used to treat HIV infection. This post-marketing 10-year observational study was conducted to evaluate the safety of LPV/r in pregnant women who are HIV+ and their infants. Methods Twenty-four pregnant women were enrolled. Safety variables included adverse drug reactions(ADRs)including laboratory abnormalities. The babies were followed up for one year after birth. Results Twenty-one of the 24 women gave birth, all of them by caesarean section. There were no cases of vertical transmission of HIV. The efficacy of LPV/r therapy was evaluated in 19 women whose laboratory data at childbirth were available. ADRs developed in 37.50% of the mothers(9/24). The incidence of ADRs in infants was 28.57%(6/21). Conclusions All 21 infants were born through caesarean section. No case of vertical transmission of HIV was observed. Its established safety profile warrants the use of LPV/r in pregnant women.(ClinicalTrials. gov number, NCT01076985.)
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Source:
薬理と治療 41巻10号, 985-988 (2013);
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We investigated the effects of γ-aminobutyric acid(GABA)on the stress, sleep, and urination of elderly people. Thirty-eight elderly people were given chocolates with 100 mg of GABA or placebo chocolates for four weeks. Salivary cortisol levels were measured as a stress indicator and a questionnaire survey about sleep and quality of life(QOL)was conducted. The GABA group showed only a small rise of cortisol level after 2 and 4 weeks, on the contrary, the placebo group showed significant increase of cortisol. The questionnaire survey showed that there was an improvement in the quality of sleep from the point of view of onset and maintenance of sleep, drowsiness in the morning, and recovering from fatigue in the GABA group after 4 weeks. Furthermore, the frequency of night urination significantly decreased in the GABA group. From the observation, we confirmed that GABA has an effect of easing stress, improving quality of sleep, and decreasing frequency of night urination.
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Source:
薬理と治療 41巻10号, 989-997 (2013);
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Objective A randomized double-blind placebo-controlled study for 4 weeks was conducted to evaluate the safety for excessive intake of the fermented milk containing the probiotic Lactobacillus gasseri(L. gasseri)SBT2055 in healthy adults. Methods Subjects(n=34;14 male, 20 female)were asked to ingest 3cups of fermented milk containing L. gasseri SBT2055 or placebo(100 g/cup)at one time per day for 4 weeks. Results Changes in the body weight, BMI, vital signs and urine parameters were not observed in the test group during intake period. Although statistically significant increase in 3-hydroxybutyric acid, total ketone bodies, uric acid and potassium were observed after 4 weeks of intake in test group and significant difference between two groups was observed in serum calcium after 4 weeks of intake, these were considered to be no clinically concerning changes. No adverse event was observed during intake period in both groups. Conclusions These results indicated the safety of the fermented milk containing L. gasseri SBT2055 in healthy adults when consumed excessively.
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Source:
薬理と治療 41巻10号, 999-1003 (2013);
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Objective The aim of this study was to evaluate the effectiveness of lactic bacteria-containing kimchi on the blood cholesterol level, defecation status, and skin conditions. Methods Thirteen subjects(6 males and 7 females)who had relatively higher serum total cholesterol level(229±17 mg/dL)were enrolled in an open-labeled study, in which selfassessed skin conditions and defecation status as well as blood biochemistry were evaluated following intake of lactic bacteria-containing kimchi for 8 weeks at a daily dose of 50 g. Results The consumption of test food for 8 weeks resulted in a slight reduction of total cholesterol levels with respect to all the subjects(by 2.8±13.4 mg/dL), while, in 5 subjects who had both total cholesterol and LDL-cholesterol levels higher than the guideline levels, the reduction was 11.4±9.9 mg/dL(P=0.062 by Student’s paired t-test). The skin conditions were significantly improved with respect to total satisfaction(at the 4th week), moist feeling(at the 4th week), and texture(at the 4th and 8th weeks)(P<0.05 for all the parameters by Wilcoxon signed-rank test). Significant improvements were also observed with defecation status with respect stool frequency and strain at stool(P<0.05 for both parameters by Wilcoxon signed-rank test).Conclusions The consumption of lactic bacteria-containing kimchi is suggested to improve subjective quality of defecation and skin condition.