Volume 47,
Issue 10,
2019
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扉・目次
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Source:
薬理と治療 47巻10号, 1563-1565 (2019);
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SERIES プラセボについて考える
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薬理と治療 47巻10号, 1595-1606 (2019);
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ORIGINAL ARTICLES
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薬理と治療 47巻10号, 1607-1612 (2019);
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Objectives Lactobacillus plantarum strain SNK12(SNK), which is isolated from non-salted pickles traditionally consumed in the Kiso area of Nagano prefecture, has potent immunostimulatory effects. In the present study, we verified its protective effects against influenza virus infections by oral administration of the bacteria to mice. Methods The mice were divided into 3 groups: the control group receiving distilled water, Tamiflu group and SNK group. Each group was orally administered with the corresponding sample from 7 days prior to infection until 14 days after infection. Influenza virus was nasally inoculated, and the viral yields in the respiratory tract lavage(BALF)and the lung were tittered at three days after infection. Neutralizing antibody titers in the sera and BALF samples, and virus-specific IgA levels in the BALF and fecal samples were measured, respectively, at 14 days after infection. Results The viral yields in the BALF and lung samples were significantly suppressed in SNK group as compared with the control group at 3 days after infection. The neutralizing antibody titers in the BALFs and sera on day 14 after infection were higher in SNK group than those in the control and Tamiflu groups. IgA levels in SNK were also higher in the SNK group than those in the other groups. Conclusions The activation of innate and/or acquired immune systems by the bacteria might be contributed to the suppression of viral replication and the stimulation of antibody production.
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薬理と治療 47巻10号, 1613-1618 (2019);
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Background Each clinical trial uniquely defines the start and end of the periods of the collection of the new adverse events(AEs)and serious AEs(SAEs). The objective of the present study was to find the current trends of the AE and SAE collections in the clinical studies related to drug treatments. Methods The present survey included original articles published in 2017 in The New England Journal of Medicine, The Lancet, and Journal of the American Medical Association. We picked up the full protocols attached to the original articles and reviewed to analyze the collection periods of the AEs and SAEs. Results Among 118 assessed protocols, 73 were industrial protocols(IPs), and 45 were academic protocols(APs). The AE collection started before the treatment period in 49.3% of the IPs and 24.4% of the APs. On the hands, that of the SAEs was in 86.3% of the IPs and 31.1% of the APs. Interestingly, the collection periods of the AEs and SAEs were unclear in one-fifth of the APs. Also, 28.9% of the APs did not include a schematic diagram of the participant timeline. By contrast, a majority of both protocols demanded the collection of the AEs and SAEs that occurred at≥4 weeks post-treatment. Conclusions The type and the period for collecting the new AEs and SAEs differed among the clinical trials. Thus, it is recommended to describe the APs in further detail.
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薬理と治療 47巻10号, 1619-1630 (2019);
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Objective The study aimed to verify that the ingestion of tea flower extract, mulberry leaf extract, chitosan and Kaempferia parviflora extract would reduce the postprandial blood glucose and triglyceride level of the healthy subjects. Methods In Trial 1, 50 participants whose fasting blood glucose level were less than 125 mg/dL, postprandial blood glucose level were more than 140 mg╱dL were enrolled in randomized, double-blind, placebo-controlled, cross over study. They ate 200 g of rice after ingesting of 150 mL water with tablets containing tea flower extract, mulberry leaf extract, chitosan and Kaempferia parviflora extract(test tablets)or placebo tablets. The blood glucose level was measured before and 30, 60, 90, 120 minutes after the intake of rice. In Trial 2, 60 subjects whose fasting blood triglyceride level were less than 200 mg╱dL were enrolled in randomized, double-blind, placebo-controlled, cross over study. They ate a bowl of soup containing 40.0 g of total fat(high fat diet)after ingesting of 150 mL water with the test tablets or placebo. The blood triglyceride level was measured before and 2, 3, 4, 6 hours after the intake of high fat diet. Results Ingestion of the test tablets suppressed the AUC (area under the curve)values of postprandial blood glucose level(P=0.0011, Trial1)and the AUC values of postprandial blood triglyceride level(P<0.001, Trial 2) Conclusions These results suggest that ingestion of tea flower extract, mulberry leaf extract, chitosan and Kaempferia parviflora extract reduce the postprandial blood glucose and triglyceride level.( UMIN ID:UMIN000036736, UMIN000036737)
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薬理と治療 47巻10号, 1631-1644 (2019);
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Objectives We evaluated the effects and safety of green tea containing mono-glucosylrutin on visceral fat in this randomized, double-blind, placebo-controlled, parallel-group comparative study. Methods Two hundred healthy Japanese people with a body mass index≥23 and<30 were randomly divided into test and placebo groups. Subjects drank the test green tea(containing 65 mg mono-glucosylrutin)or placebo green tea(not containing mono-glucosylrutin)daily for 12 weeks. Physical, blood, and urinary examinations and medical interviews were conducted at weeks 0, 4, 8, and 12, and at 4 weeks after the end of the trial period. Measurement of visceral fat was performed at weeks 0, 8, and 12, and at 4 weeks after the end of the trial period. Results There were no differences in visceral fat between the two groups. However, in younger subjects, the volume of visceral fat was significantly smaller in the test green tea group compared with the placebo green tea group at week 12. No abnormal changes or severe adverse events were observed with physical, blood, and urinary examinations nor reported during medical interviews during the trial. Conclusions Green tea containing mono-glucosylrutin was safe over the long term and might decrease visceral fat in people of a particular age. The biological mechanisms for these results require study(. UMIN000020824)
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薬理と治療 47巻10号, 1645-1653 (2019);
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Objectives The goal of this study is to assess improvement of hair density and hair beauty parameters after 3 months supplementation with a food supplement in healthy Japanese female subjects. The food supplement contains L-cystine, pantothenic acid, biotin and millet dry aqueous extract, ingredients known to improve hair growth and hair appearance. Methods Healthy Japanese female subjects, with non︱illness related, light diffuse hair loss and thinning of hair, were enrolled in the Single center open-label study. Investigational product(IP)was taken four tabs/day from Visit 3(Day 1)to End of Study(EoS)Visit(approx. 90 days of supplementation)to assess hair growth co-efficiency and hair density[total number of hair counts on the test area(per cm2)]with photo-trichogram at Day 90 compared to Day 1 Baseline. Hair quality and beauty parameters(volume, shine, softness, strength, smoothness, thickness, dryness, vitality)were assessed by means of a 10-points-scale by hairstylist at Day 1 Baseline and Day 90 to compare. Results 118 subjects were finally included in the statistical analysis and it was found that overall hair density was significantly increased from 146.82/cm2 to 152.42╱cm2 after 3 months supplementation. Anagen phase hair density was increased from 137.35╱cm2 to 142.81╱cm2 also with significant difference. Hair growth co︱efficiency(A╱T)however showed no significant level change. For the hair appearance and beauty assessment, all parameters were improved significantly after 3 months supplementation. Conclusions The study results suggest that intake of the food supplement which contains L-cystine, pantothenic acid, biotin and millet dry aqueous extract is effective for improvement of hair density and also the overall hair beauty in Japanese women.
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薬理と治療 47巻10号, 1655-1664 (2019);
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Objective The aim of this study was to investigate the effect of oral intake of cocoa on cognitive function on healthy subjects. Methods A randomized, placebo-controlled, double-blind cross-over, comparison study was conducted in 15 healthy subjects(20-39 years old). The subjects were given either the test product(20 g cocoa powder containing 30 mg cacao flavanols in 120 mL hot water)or the control product(placebo powder in hot water)30 min before the Japanese version of the CNS Vital Signs(Cognitrax). Results The cognitrax individual scores of visual memory test(immediate)and response time in 4-part continuous performance test were significantly improved in the test cocoa group compared to the placebo group. Conclusions The results suggested that oral intake of cocoa may be effective for cognitive function(. UMIN-CTR000036896)
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薬理と治療 47巻10号, 1665-1675 (2019);
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Objective Tomato- or citrus-derived dietary fiber has been suggested to attenuate postprandial blood glucose elevation. Here, we investigated the effects of these dietary fibers on postprandial blood glucose in healthy subjects. Methods Two placebo-controlled, crossover studies were conducted. In the study 1, water (W), placebo(P1), tomato fiber-fortified beverage(T1), citrus fiber-fortified beverage (C1) were used at least intervals of 3 days between the tests. Fourteen subjects consumed either of 4 beverages at immediately before eating 150 g of cooked rice, and blood glucose levels were measured 8 times in 180 min. In the study 2, placebo (P2), tomato fiber-fortified beverage (T2), citrus fiber-fortified beverage(C2)were used. The study was conducted in 33 subjects in the same method with the study 1. In each study, blood glucose levels, maximum concentration of Δblood glucose levels(ΔCmax), incremental area under the curve calculated for 60 min or 180 min (IAUC60 min and IAUC180 min, respectively)were compared between placebo group and the other groups. Results In the study 1, T1 and C1 significantly suppressed blood glucose levels at 60 min compared with P1. There were no significant differences among groups for ΔCmax and IAUC. In the study 2, T2 and C2 suppressed blood glucose levels at 15 min and at 30 min, ΔCmax, IAUC60 min compared with P2. Conclusions These results suggest that tomato- or citrus-derived dietary fiber attenuate postprandial blood glucose elevation, especially suppress or delay absorption of glucose in a short time after a meal(. UMIN ID: UMIN000034771, UMIN000036045)
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薬理と治療 47巻10号, 1677-1688 (2019);
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Objective The present study was conducted to explore the effects of a supplementary diet containing heat-killed cells of Bifidobacterium longum N61(BL diet)on memory and other neurocognitive functions in the healthy elderly with perceived memory impairment. Methods Sixty eligible subjects between the ages of 50 and 69 years were enrolled in this randomized, double-blind, placebo-controlled trial and assigned to receive a daily dose of 400 mg of BL diet containing 1010 heat-killed cells of B. longum N61(BL group, n=30)or placebo (placebo group, n =30)for a period of 12 weeks. Efficacy on neurocognitive functions was assessed using a computerized neurocognitive test battery, Cognitrax basic package, at baseline and after 12 weeks of treatment (post-treatment). Statistical analyses followed the per-protocol principle. Results All subjects except one in the BL group completed the study, although three in the placebo group were excluded from the efficacy analyses due to protocol violations. Analysis of the fully evaluable cohort indicated that there were no significant differences between the two groups on any of the neurocognitive domains assessed. However, there were trends favoring BL in scores for 5 of 11 neurocognitive domains(i,e. visual memory, psychomotor speed, reaction time, processing speed, and motor speed), of which the magnitude of improvement of visual memory domain scores reached a near-significant level(P=0.092)at post-treatment. Moreover, subgroup analyses revealed that the BL subset exhibited significantly better performance in the visual memory domain(P=0.040)compared with the placebo subset in healthy old adults with low-normal memory function. During the study, no BL-induced side effects were observed. Conclusion The results suggest that the BL diet may have some beneficial effects on visual memory domain performance in healthy old adults with perceived memory impairment and lowered memory function(. UMIN-CTR╱UMIN000033917)
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薬理と治療 47巻10号, 1689-1702 (2019);
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Objectives The increase in dementia-related diseases such as Alzheimerʼs has become a growing social problem in recent years. Because there are no fundamental methods of treating these diseases once they occur, expectations are being placed on prevention, using foods that people can consume in their daily lives. Epidemiology researchers have reported that individuals who frequently drink green tea show fewer instances of cognitive function disorders; therefore, green tea is expected to have the effect of preventing dementia-related diseases. This study targeted 62 Japanese men and women, aged between 50 and 69 years, who were aware of a decline in their cognitive function. We asked them to drink 2 g of powdered green tea every day for 12 consecutive weeks, and investigated its effects on their cognitive function. Methods To examine the subjectsʼ cognitive function, we used the Cognitrax Test(based on the CNS Vital Signs test battery), of which we performed the following ten tests: Verbal Memory, Visual Memory, Finger Tapping, Symbol Digital Coding, Stroop, Shifting Attention, Continuous Performance, Perception of Emotion, Reasoning, and Four-Part Continuous Performance. The subjectsʼ performances were measured before they started drinking the matcha, and again at 4, 8, and 12 weeks after intake. The subjects completed the MMSE-J before the study began, and those with low scores were selected(starting with 22 points as the lowest score). Results Subjects in the matcha group showed a significant decrease(P<0.05)in the time needed to respond with a correct answer in the Stroop, Shifting Attention, and Four-Part Continuous Performance Tests(Parts 1, 2, and 3). The number of correct answers for the Shifting Attention Test was also significantly higher(P<0.05)in matcha group compared with placebo group. However, the intake of matcha had no influence on other test items. Conclusion Matcha contains theanine and caffeine, which are known to impact the accuracy of attention function, or alertness. Our study also revealed improved reaction time in simple tasks and a greater number of correct answers given in the Shifting Attention Test. Matcha was therefore shown to effectively improve cognitive function, even in middle-aged and older subjects who were aware of a decline in their cognitive function. (UMIN Clinical Trials Registry ID:UMIN000029142)
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INFORMATION
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Source:
薬理と治療 47巻10号, 1705-1708 (2019);
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Source:
薬理と治療 47巻10号, 1709-1719 (2019);
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Source:
薬理と治療 47巻10号, 1721-1724 (2019);
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Source:
薬理と治療 47巻10号, 1727-1728 (2019);
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