Volume 46,
Issue 11,
2018
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扉・目次
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薬理と治療 46巻11号, 1781-1783 (2018);
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TOPIC
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薬理と治療 46巻11号, 1785-1796 (2018);
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ORIGINAL ARTICLES
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薬理と治療 46巻11号, 1799-1815 (2018);
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Objectives To examine the safety and efficacy of sucroferric oxyhydroxide(P-TOL® Chewable tablets)in clinical practice for treating patients with hyperphosphatemia in chronic kidney disease undergoing dialysis. Methods We performed a prospective special drug use surveillance study using a central registration method. Interim analysis was performed 3 months after the start of administration of sucroferric oxyhydroxide to determine patient characteristics and safety and efficacy. Results Our study included 2205 patients. Adverse reactions were observed in 402 patients (18.2%). The most common adverse reactions were gastrointestinal disorders, including diarrhea in 145 patients (6.58%), constipation in 38 patients(1.72%)and loose stools in 37 patients (1.68%). The serum phosphorus levels showed a significant decrease from 6.64 mg╱dL before administration of sucroferric oxyhydroxide to 5.54 mg╱dL at 1 month after administration, and the serum phosphorous levels continued to remain low until 3 months after the administration. Conclusions We observed no remarkable increase in the adverse reactions and no new safety concerns after 3 month administration of sucroferric oxyhydroxide. For the efficacy, serum phosphorus lowering effect was observed during 3 month administration of sucroferric oxyhydroxide. Surveillance will be continued until 18 months, and the final results will be reported in the future.
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薬理と治療 46巻11号, 1817-1839 (2018);
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Background Anagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin hydrochloride, a biguanide, are both effective and widely used drugs for the treatment of type 2 diabetes mellitus. We investigated the efficacy and safety of combination therapies of anagliptin and metformin hydrochloride in the studies with anagliptin as an add-on to metformin hydrochloride(AM1001)and with metformin hydrochloride as an add-on to anagliptin (AM1002). Methods In the study AM1001, a total of 209 subjects with inadequately controlled type 2 diabetes mellitus receiving metformin hydrochloride at doses of 250 or 500 mg twice per day were treated with 100 mg anagliptin or placebo twice per day for 24 weeks. Thereafter, all subjects receiving metformin hydrochloride at a dose of 500 mg twice per day were continued on anagliptin 100 mg twice per day in an open-label extension for 28 weeks. In the study AM1002, a total of 158 subjects with inadequately controlled type 2 diabetes mellitus receiving anagliptin at a dose of 100 mg twice per day were treated with 250 or 500 mg of metformin hydrochloride or placebo twice per day for 24 weeks. The primary endpoint for each study was the change in HbA1c from baseline to the end of the 24-week treatment period. Results After 24 weeks, in the AM1001 study, the HbA1c levels in the anagliptin add-on groups significantly decreased compared to those in the placebo add-on groups. A significant reduction in HbA1c level from the baseline was sustained throughout 52 weeks. After 24 weeks, in the AM1002 study, the HbA1c levels in the metformin hydrochloride add-on groups significantly decreased compared to that in the placebo add-on group. The incidence of adverse events was comparable between the groups treated with the combination therapy of anagliptin and metformin hydrochloride and each administered as a monotherapy. Conclusions We demonstrated that the combination therapy with anagliptin and metformin hydrochloride was effective for the improvement of glycemic control and well tolerated in inadequately controlled type 2 diabetes patients receiving each as a monotherapy. These results suggest that the combination therapy with anagliptin and metformin hydrochloride was effective in treating type 2 diabetes mellitus.
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薬理と治療 46巻11号, 1841-1849 (2018);
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Objectives The aim of this study was to investigate the effect of oral intake of Amazake on skin in healthy women. Methods This randomized, double-blind, placebo-controlled parallel-group comparison study included 40 premenopausal healthy women(aged 35-45 years)with concerns regarding their skin condition. The women were randomly divided into 2 groups, and 2 packs per day of the test product(Amazake)or the control product(placebo drink)were administered for 5 weeks. Five weeks later, pore-sagging, viscoelasticity, brown spots, skin redness and sebum quantity were evaluated. Results Comparison between pre- and post-trial features after 5 weeks showed that pore-sagging was significantly decreased in the Amazake group. A rate of pore︱sagging change was significantly ameriolated in Amazake group compared that in placebo group. Related to elasticity, a significant increase of the R7values at 5 weeks after intervention of Amazake compared that in pre-intervention was found. Change amount of Brown spots and skin redness were significantly improved in the Amazake group. Sebum quantity was significantly decreased in ingested Amazake comparison between pre- and 5 weeks after intervention. Conclusions These results suggest that oral ingestion of Amazake positively affects pore-sagging, brown spots and redness of the skin in healthy adult women(. UMIN-CTR000025663)
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薬理と治療 46巻11号, 1851-1857 (2018);
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Background Sleep quality is known to positively relate to skin condition. In our previous study, we demonstrated that Japanese sake yeast supplementation improves human sleep quality. However, it remains unclear whether sake yeast-mediated sleep improvement improves skin condition. Objectives In this study, we aimed to determine whether sake yeast supplementation as a sleep quality enhancer improves skin condition. Methods In a randomized double-blind placebo-controlled clinical study, healthy 20 subjects with low sleep quality were divided onto two equal groups. Ten subjects in each group ingested either tablets containing 500 mg of sake yeast powder or placebo for 5 weeks. The effects of sake yeast on skin condition were evaluated by cheek collagen intensity, trans-epidermal water loss(TEWL)and elasticity, hydration. Results The amount of change in collagen density(P=0.03), skin elasticity(P<0.01)and TEWL(P=0.04)was significantly improved in the sake yeast group compared with that in the placebo group. Conclusions Intake of Japanese sake yeast as sleep care supplement increases dermal collagen intensity and improve skin condition.
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薬理と治療 46巻11号, 1859-1870 (2018);
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Objective This study was to evaluate the safety of oral intake of fish-derived collagen peptide(FCP)in healthy Japanese adult subjects. Methods A randomized, placebo-controlled, double-blind, parallel-group trial was conducted in 50 healthy volunteers aged 30-59 years who were experiencing daily tiredness and fatigue. Subjects were equally, but randomly, assigned to fish-derived collagen peptide group (FCP group, n=25)and placebo group(P group, n=25) using a computerized random-number generator and ingested 5 g of either FCP as the active food or dextrin as the placebo food, twice per day(after breakfast and dinner)for 8 weeks. Physical examination, blood analysis, urinalysis, and subjective symptoms were examined at baseline and after 8-week ingestion of the test food. Results The analysis set was intention-to-treat including 25 participants(45.9±6.9 years) in the P group and 25 participants(46.3±6.4 years)in the FCP group. No clinically concern was observed in physical examination, blood analysis, urinalysis, and subjective symptoms. Furthermore, no adverse effect attributable to test foods intake was observed. Conclusions The results indicated that continuous oral intake of FCP is safe in healthy Japanese adults under the conditions of this study. Foundation Nippi. Inc.
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薬理と治療 46巻11号, 1871-1881 (2018);
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Objectives To evaluate the safety of long-term intake or excessive intake of the winter savory extract. Methods Randomized double-blind placebo-controlled parallel-group studies were conducted in 40 healthy volunteers(20 males, 20 females)to evaluate the safety of long-term intake. Volunteers were randomly assigned to two groups and given 1 bottle(100 mL)╱day of the test food that either did or did not contain the winter savory extract(0.54 g╱bottle)for 12 weeks. In the excessive intake trial, 36 healthy volunteers(18 males, 18 females)were given 3 bottles of each daily for 4 weeks. Results No adverse event attributed to the test food was found in both studies and No clinically significant changes in the vital signs, body weight, BMI, blood pressure, blood parameters and urine parameters were observed during the study period. Conclusion These results indicated that the winter savory extract was safe for long-term and excessive intake. Trial registration UMIN000028316;UMIN000028315
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薬理と治療 46巻11号, 1883-1893 (2018);
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Objective Cruciferous kale has been reported to have various pharmacological functions. Our previous study indicated that kale containing glucoraphanin may have a positive effect on skin condition. Therefore, we further investigated the effects of daily kale ingestion on skin moisture content and transepidermal water loss(TEWL). Methods In this 12-week, randomized, double-blind, placebo-controlled, parallel-group study, 70 healthy Japanese male and female subjects aged 30-59 years were randomly assigned to a kale group or a placebo group. Skin moisture content and TEWL were measured and visual evaluation was performed by a medical specialist to assess skin condition. Results Skin moisture content at the cheek was significantly increased at 6 weeks after starting ingestion in the kale group compared with the placebo group. TEWL in the kale group was significantly lower at 6 and 12 weeks than at baseline, but there were no significant differences between the groups. In a subgroup analysis of subjects aged 40 years or older, skin moisture content was significantly increased at 6 and 12 weeks in the kale group compared with the placebo group. Scores for visual evaluation of elasticity determined by a medical specialist were significantly improved in the kale group. There were no adverse clinical events due to ingestion of test samples during the study period. Conclusion These results suggest that daily intake of kale containing glucoraphanin can contribute to maintaining healthy skin condition through improvement of skin moisture content and skin barrier function. In particular, kale may be remarkably effective for age-related skin changes. (UMIN000030264)
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薬理と治療 46巻11号, 1897-1907 (2018);
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Background/Aims In todayʼs contemporary society, the number of patients suffering from allergies such as hay fever is increasing year by year. In Hokkaido, pollen from Japanese white birch trees is dispersed into the air every year from April through to June, with increased reports of eye and nose discomfort also increasing around this time. Since antihistamines often come with a risk of side effects such as drowsiness, safe food ingredients are a hot topic in the field. Previous studies into a functional food “BenegutTM” derived from perilla leaves containing flavonoids and rosmarinic acid has seen anti-inflammatory and anti-allergenic properties being reported. We carried out this clinical trial to evaluate the effects of BenegutTM intake upon seasonal eye and nose discomfort. Methods A randomized, double-blind, placebo-controlled, parallel-group comparative study was carried out with individuals who reported eye and nose discomfort in early Spring but were otherwise healthy. The 40 participants were of mixed gender and between the ages of 20 and 65. Participants took BenegutTM orally for 8 weeks, with discomfort being evaluated with the Visual Analog Scale(VAS), and stress and mental state also being evaluated via the Perceived Stress Questionnaire-20(PSQ). Results After regular and continued intake of BenegutTM, a decrease in seasonal nasal discomfort was observed, and an easing of mental nervousness and anxiety along with a more positive outlook was also observed. BenegutTM is a safe functional ingredient, and it can be believed to be useful for the pre-emptive prevention of a worsening in hay fever symptoms in healthy individuals, and thus useful for health maintenance purposes.
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薬理と治療 46巻11号, 1909-1919 (2018);
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Objective Favorable voiding function is essential for women, as well as for men, to keep good sleep quality and general quality of life(QOL). The objective of the present study was to examine the efficacy of quinic acid contained in cranberry juice(Q-CJ)on voiding frequency and associated impairment of sleep quality and general QOL, in healthy women bothering frequent voiding. Methods An open-label clinical study was conducted on 16 women aged between 26 and 69 years, receiving 100 mL of cranberry juice containing 980±20 mg Q-CJ per day for 12 weeks. Safety and compliance were monitored throughout the intervention. To evaluate the efficacy of Q-CJ consumption, Overactive Bladder Symptom Score (OABSS), the Japanese version of Nocturia Quality-of-Life Questionnaire(N-QOL), the Pittsburgh Sleep Quality Index-Japanese version(PSQI-J)and the voiding function-related questionnaire(AVFQ)were tested at baseline and at weeks 4,8, and 12 in all subjects. They were also required to keep urination dairy every day over the intervention period. Results There were statistically significant improvement in OABSS, PSQI-J and AVFQ at all or many evaluation timepoints during the intervention when compared with baseline data. Q-CJ was well-tolerated and safely taken by all subjects, except that a relationship with the intervention cannot be ruled out in one subject who experienced a mild diarrhea over the intervention period. Conclusion The results of the present study are the first finding that Q-CJ may significantly improve frequent daytime and likely improve nocturnal voiding, together with beneficial effects on impaired sleep quality and general QOL(. UMIN-CTR/UMIN000022829)
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SERIES
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薬理と治療 46巻11号, 1923-1927 (2018);
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INFORMATION
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薬理と治療 46巻11号, 1931-1933 (2018);
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薬理と治療 46巻11号, 1934-1944 (2018);
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薬理と治療 46巻11号, 1945-1950 (2018);
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薬理と治療 46巻11号, 1952-1952 (2018);
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薬理と治療 46巻11号, 1953-1954 (2018);
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