Volume 47,
Issue 11,
2019
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扉・目次
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薬理と治療 47巻11号, 1732-1736 (2019);
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ORIGINAL ARTICLES
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薬理と治療 47巻11号, 1753-1764 (2019);
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Objectives In recent years, as health insurance pharmacies have had an increased number of opportunities to handle narcotic prescriptions, a smooth system for supplying medical narcotics is required. However, there have been economic problems due to immobile narcotic stocks and disposal of narcotics. Therefore, we aimed to investigate the actual status of narcotics in health insurance pharmacies and examined the related medical economic problems and their factors. Methods In 2017, we investigated the narcotic stock situation in 97 health insurance pharmacies have narcotic retailer licenses. Results The narcotic immobile inventory amounted to 5,983,026 yen in 79 stores, and the disposed inventory amounted to 3,121,705 yen in 62 stores. Upon adding these inventory management losses to each pharmacyʼs narcotic prescription balance, 93 stores recorded a negative balance. There were many high-dose standards in the immobile stocks, mainly due to changes in prescription and hospitalization or death of patients. On the other hand, many disposed items were rescue drugs. Conclusions This study revealed that narcotic inventory management in health insurance pharmacies led to medical economic losses under the current system, suggesting issues to be addressed for the rationalization of drug distribution.
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薬理と治療 47巻11号, 1765-1789 (2019);
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Background The 3-year prospective STELLA-LONG TERM study is examining the long-term safety and effectiveness of ipragliflozin in Japanese patients with type 2 diabetes mellitus (T2DM)in real-world clinical settings. This 24-month interim report also included an evaluation of the effect of ipragliflozin in patients, stratified by hepatic and renal function. Methods The incidence of adverse drug reactions (ADRs)was assessed in 11,051 patients. Change in glycosylated haemoglobin (HbA1c), fasting plasma glucose(FPG)and body weight were evaluated in the overall efficacy analysis set(n=8762), and estimated glomerular filtration rate (eGFR)was evaluated in subgroups based on baseline eGFR. The effect of ipragliflozin on hepatic enzyme level was examined in patients with or without hepatic dysfunction at baseline. Results The incidence of ADRs and serious ADRs was 17.36%(n=1919)and 1.45%(n=160)of patients, respectively. Between baseline and 24 months, ipragliflozin decreased HbA1c (-0.70%, P<0.05), FPG (-30.2 mg╱dL, P<0.05)and body weight(-3.03 kg, P<0.05). Significant reductions in hepatic enzyme levels were observed in patients with hepatic dysfunction(all P<0.05). In patients with eGFR<60 mL/min╱1.73 m2, eGFR increased significantly (P<0.05 for all timepoints between 3 and 24 months), whereas a sustained decrease in eGFR was observed during 24 months in patients with eGFR≥60 mL╱min╱1.73 m2(all P<0.05). Conclusions Ipragliflozin was well tolerated and effective in Japanese T2DM patients over 24 months in clinical practice, and improved kidney function in those with renal impairment. Significant improvements in hepatic enzyme were observed in patients with abnormal hepatic function(. NCT02479399)
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薬理と治療 47巻11号, 1791-1805 (2019);
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Background STELLA-LONG TERM is a 3-year post-marketing surveillance study in Japanese patients with type 2 diabetes mellitus(T2DM)receiving ipragliflozin in real-world clinical settings. To evaluate the influence of overweight/obesity on the long-term effectiveness and safety of ipragliflozin, a subgroup analysis of STELLA-LONG TERM was undertaken in patients stratified by body mass index(BMI), including BMI≥35.0. Methods Patients were divided into six categories according to their BMI(<18.5, 18.5 to <22.0, 22.0 to <25.0, 25.0 to <30.0, 30.0 to <35.0 and ≥35.0). The incidence of adverse drug reactions(ADRs)and changes in glycated hemoglobin(HbA1c)and body weight were evaluated over 24 months in these subgroups. Results In the safety analysis set(n=11,051), the incidence of ADRs was 18.18%, 14.64%, 15.93%, 20.23%, 20.21% and 20.70%, respectively, in the subgroups of patients with BMI<18.5, 18.5 to <22.0, 22.0 to <25.0, 25.0 to <30.0, 30.0 to <35.0 and ≥35.0. In the efficacy analysis set(n=8762), HbA1c and body weight decreased significantly from baseline to 24 months in all BMI subgroups except patients with BMI<18.5(P<0.05). HbA1c and body weight showed comparable changes from baseline to 24 months among patients with BMI of25.0 to <30.0, 30.0 to <35.0 and ≥35.0 groups. Conclusions The incidence of ADRs with ipragliflozin tended to be higher in T2DM patients with BMI≥25.0 than in those with lower BMI. Ipragliflozin improved glycemic control and reduced body weight over 24 months in Japanese T2DM patients with overweight╱obesity including those with BMI≥35.0(. NCT02479399)
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薬理と治療 47巻11号, 1807-1816 (2019);
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Objective The spread of home medical care is necessary in Japan, where super aging is progressing. Therefore, to clarify the problems of pharmacists in promoting home medical care, we investigated the actual status of pharmacist services regarding home medical care and the needs of patients. Method A questionnaire survey was administered to pharmacists nationwide regarding the implementation rate of services related to home medical care, work items, and factors that hinder home medical care. A questionnaire survey on the degree of satisfaction with home medical care and requests to pharmacists was administered to patients undergoing home medical care. Results Home medical care was implemented in approximately 50% of surveyed pharmacies. Pharmacists who were active in providing home medical care delivered medication to patients and made adjustments to make it easier for patients to take their medication. The biggest obstacle to home medical care was the shortage of pharmacists. Patients requested that pharmacists check the effects and side effects of the medication, in addition to delivering the medication to them and make adjustments to make it easier for them to take it. Conclusion Pharmacists need to improve the efficiency of dispensing services and perform home medical care services that meet patient needs.
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薬理と治療 47巻11号, 1817-1822 (2019);
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We conducted aseptic preparation training for community pharmacists with the aim of having them acquire aseptic techniques for home medical care. There were 79 participants in the training program, 66 of whom had no experience with aseptic preparation. During training, a training device with a pressure sensor that could detect the pressure within vials was used. The pharmacists received a lecture, practical training, and training with the aid of the training device in that order. After the course, the pharmacistsʼ knowledge about the differences between clean benches, safety cabinets, and aseptic preparation procedures increased significantly.Furthermore, pharmacistsʼ technique for keeping the pressure inside vials lower than atmospheric pressure improved as they completed each part of the course: their technique after the lecture was better than before the lecture; their technique after practical training was better than before practical training; and their technique after practice with the training device was better than before using the training device. These findings suggest that our program was effective and useful for the aseptic training of community pharmacists.
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薬理と治療 47巻11号, 1823-1831 (2019);
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Objective The aim of the present study was to evaluate the effects of ingesting Bacillus subtilis C-3102 spores(C-3102)on human intestinal microbiota. Methods A randomized placebo-controlled, double-blind study on 140 healthy Japanese subjects with constipation(defecation 2-4 times/week)was conducted. For 2 consecutive weeks, each subject ingested test tablets containing either C-3102 at a daily dose of 2.4×109 Colony Forming Unit(CFU)(C-3102 group)or placebo tablets without C-3102(placebo group). The composition of fecal microbiota was measured using terminal restriction fragment length polymorphism(T-RFLP)analysis and quantitative PCR(qPCR)analysis. In addition, intestinal conditions such as frequency of defecation, stool quantity, and a refreshed feeling were monitored during the study. Results T-RFLP analyses indicated that the relative abundance of Bifidobacterium in the C-3102 group was significantly higher than in the placebo group after ingestion of C-3102. Also, in subjects with initial numbers of Bifidobacterium less than 1010 CFU╱g, the C-3102 group had a tendency to have increased numbers of Bifidobacterium compared with the placebo group based on qPCR analysis. Defecation frequency significantly increased after ingestion of C-3102; however, the placebo group also showed a significant increase and there was no significant difference between the two groups. Stool quantity in the C-3102 group was significantly increased compared to the placebo group after 1 week of ingesting C-3102. Conclusions These results show that C-3102 could increase Bifidobacterium levels and may improve intestinal function in subjects with constipation.
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薬理と治療 47巻11号, 1833-1840 (2019);
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Objective Phycocyanin, a biliprotein, possesses antioxidant and anti-inflammatory properties, and, thus, is a promising food substance with various functions for health promotion. The present study investigated the effects of phycocyanin derived from Spirulina on skin function in healthy subjects in a randomized, double-blind, placebo-controlled trial. Methods Ninety-six subjects were randomly assigned to the test food 410 mg of phycocyanin (C-phycocyanin 300 mg, allophycocyanin 110 mg)and placebo groups. The test food and placebo were administered to the respective groups for 8 weeks. Transepidermal water loss (TEWL)was the primary outcome, and the visual analogue scale(VAS)was the other outcome. Results Among subjects with a TEWL level between 10 g╱m2╱hr and higher to less than 20 g╱m2╱hr(normal value in healthy human)at 0 weeks, TEWL levels at 8 weeks were significantly lower in the test food group than in the placebo group. In the VAS, scores for skin elasticity and skin gloss at 4 and 8 weeks and those for skin moisture at 8 weeks were significantly higher in the test food group than in the placebo group. Conclusion The administration of 410 mg of phycocyanin(C-phycocyanin 300 mg, allophycocyanin 110 mg)for 8 weeks reduced TEWL and improved skin barrier function in healthy subjects. Furthermore, the effects of phycocyanin on skin function were also detected physically in the VAS. (UMIN ID: 000035205)
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薬理と治療 47巻11号, 1841-1850 (2019);
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Objective The aim of this study was to establish the functionality of oral ingestion of Kaempferia parviflora extract(SIRTMAX®)-containing diet and to examine the safety in case of excessive intake. Methods The study was performed from July 2018 to January 2019. A randomized, double-blind, placebo-controlled parallel-group comparison study was performed on 30 healthy Japanese adults(15 males and 15 females). All subjects were randomly allocated into the test product group(n=15)or the placebo group(n=15)using a computerized random-number generator. The subjects ingested either the placebo or the test product including 100 mg/day SIRTMAX® for 8 weeks, and the effects on fasting blood glucose level as a primary outcome, hemoglobin A1c(HbA1c), glycoalbumin, insulin, and plasma pentosidine levels, vascular age, eye dryness, subjective symptoms, and sirtuin gene expression were examined. In addition, the subjects ingested 5 times the daily dosage of SIRTMAX®( 500 mg╱day)for 4 weeks following the 8-week normal ingestion to examine the safety of excessive intake. Results Twenty-eight subjects completed the trial and 14 subjects in each group were analyzed. In the efficacy test on all subjects, sirtuin expression showed increasing tendency(P=0.08)in the test product group compared to that in the placebo group after the 8-week normal ingestion period. No other factors improved in the test product group compared to those in the placebo group. In the subgroup analysis, HbA1c level of the male test product group decreased significantly(P=0.02)compared to that in the placebo group. In addition, the test product group showed a significant increase in Schirmer value in the left eye(P=0.02)and non-dominant eye (P=0.04) in the analysis of aged subjects. In the female test product group, “conspicuous crowʼs feet”“, dull skin(yellowish and brownish)”and“makeup sitting bad on skin”improved significantly compared to those in the placebo group after the 8-week normal ingestion period(P=0.03, P=0.007, and P=0.008, respectively). In the safety study, no adverse event was observed during the first 8 weeks of ingestion and the subsequent excessive ingestion for 4 weeks. Conclusion The test product improved HbA1c level in healthy male adults and the amount of pertear in aged subjects. Moreover, the results suggested a significant improvement in skin condition such as wrinkles around eyes and makeup sitting in females. In addition, the test product appeared to be safe under the conditions employed in the present study. Trial Registration UMIN-CTR: UMIN000033426 Funding Tokiwa Phytochemical Co., Ltd.
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薬理と治療 47巻11号, 1851-1859 (2019);
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Objective The aim of this study was to evaluate the effects of eating food containing paramylon derived from Euglena gracilis EOD-1, in terms of feelings of fatigue in daily life. Methods A randomized, double-blind, placebo-controlled, parallel-group comparison study was conducted in healthy adults(n=197). The subjects ingested either a placebo or a test food containing 350 mg paramylon derived from Euglena gracilis EOD-1 daily for 4 weeks. Subjects ʼ reported feelings of fatigue were evaluated using the Visual Analog Scale. Results Subjects reported significantly less feeling of physical fatigue after 4 weeks of consuming the test food than after 4 weeks of consuming the placebo food. In addition, the time spent outdoors and the increment of number of walks were significantly higher after the ingestion of the test food than after the ingestion of placebo food. Conclusions These results indicated that ingesting paramylon derived from Euglena gracilis EOD-1 at 350 mg per day in a test food item for 4 weeks reduces feelings of physical fatigue. In addition, prolonged time spent outdoors and increased change rate of number of walks were confirmed, which may be derived from a reduction in the feelings of physical fatigue. (UMIN-CTR ID:UMIN 000036296)
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薬理と治療 47巻11号, 1861-1869 (2019);
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Objective Whey peptide-containing drink(WPD)is expected to be effective for rehydration in human because whey peptide reportedly promotes water absorption in rat intestine. In this study, we aimed to test the effectiveness of WPD for exercise-induced mild dehydration in healthy men. Methods WPD containing 0.3% whey peptides, 17 mM Na, and 0.8% carbohydrates was used as a test solution. Nineteen healthy men were instructed to exercise on treadmills and bicycle ergometers for 1 hour and then to ingest either WPD or mineral water(MW). Blood sampling, physical examinations, and examinations of subjective symptoms were done before and immediately after exercise, and then at 30 and 60 min after ingestion. Changes in plasma volume were calculated and used as primary outcomes.Results Plasma volume change at 30 min after ingestion of WPD was significantly higher than that after ingestion of MW(P<0.05). Furthermore, feelings of fatigue, pain in foot muscles, and a sense of abdominal distension were reduced after ingestion of WPD. Conclusions These results suggested that WPD was absorbed more quickly than MW and an effective treatment for exercise-induced mild dehydration.
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薬理と治療 47巻11号, 1871-1882 (2019);
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Objectives To evaluate the effects of a multi plant-herbal dietary supplement containing 40 mg of Gymnema sylvestre extrac(t containing gymnemic acid), 200 mg of mulberry leaf extract, 200 mg of green tea extract, 100 mg of chitosan, 4.8 mg of kidney bean extract, and 150 mg of Kaempferia parviflora extract on body fat and body weight. Methods A prospective, randomized, double-blind, placebo-controlled, and parallel group comparison study was performed from March 2016 to December 2016 in the National Institute of Nutrition in Vietnam. Six hundred seventy-three participants aged 45-64 years were screened by their body mass index(BMI). The participants were randomized either a multi plant-herbal dietary supplement or placebo tablets, for 12 consecutive weeks. The primary outcome measures were abdominal fat areas, and the secondary outcome measures were body weight, BMI, and body fat percentage. The abdominal fat was assessed by computed tomography method. Results Of 673 participants screened, 112 with their BMI were between 23 and 30(overweight or classⅠ obese)were enrolled in this study. Of these, 46 in the placebo and 44 supplement group subjects completed the study. For the abdominal fat area, significant reduction effects of the dietary supplement were observed in both visceral and total abdominal fat area(P<0.01). Body weight, BMI, and body fat percentage were also decreased by the supplement intake compared with those of placebo. Conclusions Intake of this dietary supplement containing Gymnema sylvestre extract(containing gymnemic acid), mulberry leaf extract, green tea extract, chitosan, kidney bean extract, and Kaempferia parviflora extract reduced both visceral and total abdominal fat and body weight. This supplement will be a new option for improvement of overweight and the prevention of obesity-related disease(. Clinical Trial Registration: UMIN000029053)
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薬理と治療 47巻11号, 1883-1900 (2019);
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Background To investigate the effects of ingestion of Bifidobacterium breve N708(N708)-containing foods on diarrhea deu to stress, a randomized, double-blind, placebo-controlled, parallel-group controlled trial was conducted in healthy Japanese individuals(ages 20-65 years)with daily stress and diarrhea with abdominal pain and discomfort. Methods Subjects(n=70)ingested heat sterilized N708-containing foods(N708 group; n=35)or placebo foods(placebo group; n=35)for 8 weeks. Efficacy was assessed by defection questionnaires, Izumo scale, POMS2 shortened version, serum cytokines[interleukin(IL)-6, IL-10, and tumor necrosis factor(TNF)-α], fecal mucins, and IgAs. The values of the items were compared between the N708 and the placebo groups by Mann-Whitney U-test, Studentʼst-test, or Welch t test. Results Izumo scale score of Question 7(“Are you bothered by early satuation?”)and Question 8(“Are you bothered by post-prandial long-lasting epigastric fullness or nausea?”)related to abdominal fullness were significantly improved in the N708 group compared to the placebo group(P<0.05). No significant differences were observed between the groups for the other items. A subgroup analysis of 20 subjects with higher scores for diarrheal symptoms at the screening showed that the change in scores in the N708 group was significantly improved(P<0.05)for Question 15(“Are you bothered by stress-related diarrhea?”)on Izumo scale related to stress diarrhea compared to the placebo group. Although there were some differences in safety among multiple items, they were all within standard values and were also considered to be within the range of physiological fluctuations due to lifestyle and habits. Conclusions Our results suggest that ingestion of N708 is safe and improves stress-induced diarrhea in subjects with higher scores for diarrheal symptoms. (UMIN000034571)
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薬理と治療 47巻11号, 1901-1912 (2019);
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Background Approximately one-third of the Japanese population suffers from allergic symptoms due to Japanese cedar pollen scattering and the incidence is increasing; therefore, additional solutions are required. It is thought that anti-allergic effects are caused by enhanced IgA secretion. In previous clinical studies, we confirmed that the Lactobacillus pentosus strain B240 can enhance salivary IgA secretion; thus, we hypothesized that consecutive B240 intake could alleviate the allergic symptoms caused by cedar pollen exposure. Methods A randomized, double-blind, placebo-controlled trial was performed on 34 healthy volunteers(20-65 years old)to evaluate the anti-allergy effects of daily B240 tablet intake for 8 weeks. We used a questionnaire based on Japanese Rhino-Conjunctivitis Quality of Life Questionnaire(JRQLQ)No. 1 to evaluate allergic symptoms, including runny nose, sneezing, nasal congestion, itchy nose, itchy eyes, watery eyes, the number of paper handkerchiefs used to wipe a runny nose, and the overall face scale of participants exposed to cedar pollen for 3h in an environmental exposure unit; trial registration number UMIN000034239. Results B240 intake for 8 weeks significantly improved the overall face scale score during cedar pollen exposure for 3h. Moreover, there were significant positive correlations between the overall face scale score and the scores of each symptom. Conclusions B240 has anti-allergic effects and could be a new option for people who develop mild allergic symptoms. Additionally, overall face scale can be used to evaluate both symptoms and quality of life during pollen exposure in an environmental exposure unit.
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薬理と治療 47巻11号, 1913-1917 (2019);
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Objective The objective of this study was to evaluate the safety of excessive intake of chicken leg extract(CLE)in healthy Japanese adult. Methods A randomized, placebo-controlled, double-blind study was conducted in 34 subjects(19 men and 15 women). During 4 consecutive weeks, subjects ingested 1 g/day of CLE or placebo. Physical parameters, blood parameters, urine parameters and subjective symptoms were measured throughout the study. Results No adverse effects and no clinically concerning changes in physical, blood and urine parameters were observed. Conclusion It was suggested that the excessive intake of CLE(1 g/day)was safe in healthy adults.
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薬理と治療 47巻11号, 1921-1928 (2019);
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Background HPV(Human Papillomavirus)is a common sexually transmitted disease, however, most HPV infections are transient. On the other hands, persistent infection of high-risk HPV(HR-HPV)can lead to cellular abnormalities on cervical cells. Untreated cellular abnormalities may gradually turn into cervical cancer. Therefore, early elimination of HPV is desirable. Objectives 12 healthy Japanese adult women with persistent infection of HR-HPV were enrolled in this study. Methods In this open-label study, subjects were administered 3 g of AHCC® daily for 16 weeks. The primary endpoint of this study was persistent infection with HR-HPV, and the secondary endpoint include peripheral blood NK cell activity and fecal secretory IgA(sIgA)level. Results 4 out of 10 subjects in the analysis persistently infected with HR-HPV after 8 weeks of AHCC® administration, and 3 subjects persistently infected after 16 weeks of AHCC® administration. Peripheral blood NK cell activity was significantly increased after 8 weeks compared with before administration(n=11, P=0.013). Fecal sIgA levels were significantly increased after 16 weeks compared with before administration(n=12, P=0.046). Conclusions The rate of persistent infection in these results was lower than that reported by Molano et al., for all HPV types. Therefore, the results suggested that the administration of AHCC® reduced the rate of persistent infection with HR-HPV. In addition, the increases of peripheral blood NK cell activity and fecal sIgA level suggested that the improvement of immune function by AHCC® may be the mechanism of HPV elimination.
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薬理と治療 47巻11号, 1929-1935 (2019);
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Objectives The objective of this study was to analyze the effect of intake of pure sesame oil containing sesamin and sesamolin on serum low density lipoprotein(LDL)cholesterol levels in subjects with borderline and mildly high LDL level using stratified analysis. Methods We conducted a randomized, double-blind, parallel-group, placebo-controlled study, using Kadoya Pure Sesame Oil as the test food. Japanese adults with LDL cholesterol levels of 120-159 mg/dL were enrolled and randomly assigned to 3 groups: placebo, low-dose (10 g of test food daily), and high-dose(14 g of test food daily)(36 subjects for each group). The period of intake was 12 weeks. Levels of serum LDL cholesterol were determined at the baseline and 4, 8, and 12 weeks from the onset of the intake period. The effect of test food intake was analyzed after stratification by LDL cholesterol level at baseline: healthy subjects with borderline LDL levels(120-139 mg╱dL)or subjects with mildly high LDL levels(140-159 mg╱dL). Results In subjects with borderline LDL levels, daily intake of 10 g test food significantly lowered serum LDL levels, but intake of 14 g test food did not have significant effect on serum LDL. On the other hand, in subjects with mildly high LDL levels, serum LDL levels were significantly lowered in high-dose group, but not in low-dose group. Conclusions In healthy adults with borderline serum LDL cholesterol levels, continuous intake of 10 g Kadoya Pure Sesame Oil may improve LDL cholesterol control.
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COLUMN
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薬理と治療 47巻11号, 1939-1943 (2019);
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INFORMATION
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薬理と治療 47巻11号, 1944-1949 (2019);
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薬理と治療 47巻11号, 1950-1950 (2019);
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薬理と治療 47巻11号, 1951-1951 (2019);
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薬理と治療 47巻11号, 1953-1954 (2019);
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