薬理と治療
Volume 48, Issue 6, 2020
Volumes & issues:
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扉・目次
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TOPIC 第19回CRCと臨床試験のあり方を考える会議 2019 in YOKOHAMAA
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- シンポジウム11 / CRC のマネジメント力 ─症例登録遅延や人手不足などを解決するお役立てツール─
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ORIGINAL ARTICLES
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進行性核上性麻痺の社会的・経済的負担に関する推計
48巻6号(2020);View Description Hide DescriptionBackground Progressive supranuclear palsy(PSP)is a neurodegenerative rare disease leading to a rapid decrease in activities of daily living and progression until death. PSP patientsʼ healthcare requirements vary according to disease progression and result in substantial medical and nonmedical costs. PSP causes productivity loss and a subsequent economic burden for patients/caregivers. Objective To provide the first quantitative report on PSP-related productivity loss and economic burden in Japan. Methods JMDC hospital-based claims data were analyzed to estimate PSP-related medical costs(hospital-based-analysis), and a patient╱caregiver survey was conducted to estimate PSP︱related medical╱nonmedical costs and productivity loss(survey analysis). Medical costs were examined separately in each analysis. The hospital︱based analysis included patients with ≥1 PSP diagnosis and no record of Parkinsonʼs disease medications, and the survey analysis included PSP patients with valid responses. Costs per-patient-per-month were calculated by cost item and three disease stages(“Ambulatory”“, Wheelchair”, and“Bedridden”). Results In the hospital-based analysis, total medical costs increased with disease progression in 229 eligible patients. In the survey analysis, 82 eligible patients had increased medical costs with disease progression, higher nonmedical costs, and lost productivity in the“Wheelchair” stage. The annual economic burden was estimated to be 8.7-10.0 million JPY per patient and 86.9-100 billion JPY in total: 4.7-17.3, 29.1-29.7, and 53.1 billion JPY for medical costs, nonmedical costs, and productivity loss, respectively. Conclusions This report showed the total economic burden for PSP, including medical and nonmedical costs and productivity loss in Japan. -
慢性期または移行期の慢性骨髄性白血病に対する診療実態下におけるニロチニブ(タシグナ® カプセル)の安全性および有効性の検討―特定使用成績調査報告―
48巻6号(2020);View Description Hide DescriptionObjectives Nilotinib hydrochloride hydrate(Tasigna® capsules)is a tyrosine kinase inhibitor (TKI)that is indicated for chronic myeloid leukemia in chronic phase or accelerated phase (CML-CP or CML-AP). Given that the number of Japanese subjects in clinical studies conducted during the development of nilotinib was extremely limited, we investigated the safety and efficacy of the drug and the influence of patient background factors during real-world use. Methods A post-marketing specified drug-use survey of long-term use of up to 3 years was conducted in all patients with CML-CP or CML-AP who received nilotinib during the period of February 16, 2009 to March 31, 2010(safety population: 928 patients, efficacy population: 728 patients). Results Adverse drug reactions were found in 77.6%(720/928)of the patients in the safety population, which was not higher than 97.1%(33/34)in a Japanese phase Ⅱ study(1101 study)in patients with imatinib-resistant CML-CP or CML-AP at time of approval(Tojo A, et al. Int J Hematol 2009; 89: 679). The main adverse drug reactions included thrombocytopenia (14.0%; 130╱928), increased blood bilirubin(12.3%; 114╱928), increased lipase (9.9%; 92╱928), and abnormal hepatic function(9.1%; 84╱928), which differed little from adverse drug reactions seen in clinical studies. Adverse drug reactions that occurred in patients with special backgrounds(elderly patients, patients with hepatic dysfunction, patients with renal dysfunction)did not differ from those seen in clinical studies in terms of type and incidence. Serious arterial occlusive events were found in nine patients: cerebral infarction was found in six patients, angina pectoris in two patients and, acute myocardial infarction in one patient. The complete hematologic response rate in CML-CP patients included in the tabulation of hematologic response was 93.0%(625/672), and the major cytogenetic response rate in patients included in the analysis of cytogenetic response was 75.5% (498╱660). Although there were slight differences in endpoints, these were comparable with those in the 1101 study. During the 3-year period, 2.9%(27╱928) of patients progressed to blast crisis. Conclusions As this survey targeted all CML-CP or CML-AP patients who received nilotinib, it considered to reflect safety and efficacy in patients using nilotinib in Japan. No major differences were seen between the results between clinical studies and the results of this survey. Therefore, it is concluded that efficacy and safety similar to that seen in clinical studies is to be expected in real-world practice. -
Liver Hydrolysate Preserves Muscle Mass and Potentially Attenuates Exercise—induced Oxidative Stress in Humans―A Randomized, Double‒blind, Placebo‒controlled Study―
48巻6号(2020);View Description Hide DescriptionBackground Liver hydrolysate(LH)is obtained via an enzymatic degradation of livers. LH has an anti-fatigue effect. However, it remained unclear whether LH affected muscle mass and exercise-induced oxidative stress in humans. The purpose of this study was to investigate the effects of LH on body composition and exercise -induced oxidative stress in humans. Methods A randomized, double-blind, placebo-controlled study was designed to investigate the effect of LH in Japanese women and men aged 19-21 years. Participants included 16 Japanese subjects recruited from visitors to Chubu University, where the 4-week study was conducted. Participants were randomly assigned to receive either 0 mg/day LH (placebo group)or 600 mg/day LH(LH group)by a controller. We evaluated the efficacy of LH in humans by measuring changes in body composition, maximal oxygen uptake(V4O2max), levels of reactive oxidative metabolites(d-ROMs), and biological antioxidant power(BAP)levels during rest and exercise. Results After 4 weeks, the change in muscle mass was significantly higher in the LH group than in the placebo group. The change in body fat was significantly lower in the LH group than in the placebo group. V4O2max values did not differ between the two groups. d-ROM levels in the rest and end tests were significantly lower in the LH group than in the placebo group. BAP levels did not differ significantly between the groups in the rest and end tests. We calculated changes in d-ROM response to the incremental exercise test from pre- to post-supplementation, i.e., a negative value indicated d-ROM levels decreased after 4 weeks of LH supplementation. The change tended to be lower in the LH group compared to the placebo group. Conclusion LH may be a useful method for improving human exercise performance. (UMIN 000034290) -
乾燥肌を自覚する健常女性の皮膚保湿機能に対するLactobacillus brevis KB290 摂取の有効性の検証―ランダム化プラセボ対照二重盲検並行群間比較試験―
48巻6号(2020);View Description Hide DescriptionObjective We investigated whether intake of Lactobacillus brevis KB290(KB290)could increase skin hydration in healthy females with dry skin. Methods Two randomized, double-blind, placebo-controlled studies were conducted. In the study 1, 70 of relatively young subjects ingested a bottle of the active drink(containing more than 3.5 billion of KB290)or the placebo drink for 4 weeks. Skin conditions including levels of water content in stratum corneum and transepidermal water loss, levels of fecal putrefactive metabolites, and fecal microbiota were evaluated before and after intake. In the study 2, 97 subjects with wide range of age consumed the active drink(containing more than 1.4 billion of KB290)or the placebo drink, and were evaluated the skin conditions before and at the 4 and 8 week of the intervention period. Results In the study 1, 64 subjects were analyzed and the changes of water content in stratum corneum of the forearm and neck were significantly higher in the group consumed the active drink(KB290 group)than the group consumed the placebo drink(placebo group). In addition, change of fecal microbiota composition significantly differed between the two groups. In the study 2, 94 subjects were analyzed and the changes of water content on the forearm and cheek in the KB290 group were significantly higher than the placebo group at the 4 and 8 week of the intervention period. Conclusions These results suggested that intake of KB290 increased skin hydration in healthy females with dry skin, probably via modulation of intestinal microbiota. (UMIN-CTR ID:000034215, 000038300) -
松本市の成人を対象とした血糖値および尿酸値をはじめとする血液検査値と生活習慣に関する横断研究
48巻6号(2020);View Description Hide DescriptionObjectives To investigate the relationship between markers of metabolic health and lifestyle in adults from Matsumoto, Japan. Methods Blood tests and lifestyle questionnaires were administered to 671 subjects(mean age, 54.8 years)in Matsumoto, Japan. The questionnaire included questions on exercise, weight gain, diet, and other lifestyle habits, such as drinking and smoking. Associations between blood test values and lifestyle were assessed using the point-biserial correlation coefficient. Results The overall mean values for fasting plasma glucose, HbA1c, and uric acid were 100.1 mg/dL, 5.64%, and 5.44 mg╱dL, respectively. Fasting insulin was significantly correlated with“weight gain”(r=0.396)and“fast eating”(r=.219). Uric acid was significantly correlated with“weight gain”(r=0.242)“, frequency of drinking”(r=0.203), and“alcohol consumption per day”(r=0.222). Alanine aminotransferase(ALT)levels were significantly correlated with“weight gain”(r=0.350). Gamma-glutamyl transpeptidase(γ-GTP)levels were significantly correlated with“weight gain”(r=0.354)“, frequency of drinking”(r=0.298), and“alcohol consumption per day”(r=0.249). Conclusions These results suggest that weight control, reducing alcohol intake, slow eating, and other lifestyle factors are associated with health maintenance. -
デビルズクローエキス含有食品の継続摂取による膝関節の違和感に対する影響―ランダム化二重盲検プラセボ対照並行群間比較試験―
48巻6号(2020);View Description Hide DescriptionObjective We investigated oral intake of Harpagophytum procumbens extract (Harpagoside 13%). In this study, A randomized double-blind placebo-controlled study was conducted, to assure the effect on discomfort in knee joints. Method 41 Japanese healthy men and women(range 40-74 years old)took either 27 mg/day Harpagoside or placebo, then we measured the subjective scores in accordance with JKOM questionnaires after 8 weeks administration. Results VAS score quantifying discomfort in knee was significantly improved(P<0.05)in Harpagoside group at 8 weeks, and the further statistical analysis verified the correlation between the subjective improvement in knee and effect to reduce physical stress in knee.Conclusion Oral intake of 27 mg Harpagoside via high purified Harpagophytum procumbens extract reduced the discomfort when to bend or stretch knee. (UMIN-CTR ID: UMIN000037556) -
おから摂取が食後血糖値上昇に与える影響―ランダム化プラセボ対照単盲検クロスオーバー試験―
48巻6号(2020);View Description Hide DescriptionObjectives The aim of the present study was to investigate the suppression effect of soybean curd residue on the postprandial blood glucose levels in healthy subjects.Methods The study was a randomized, single-blind, placebo-controlled crossover study in healthy adults subjects who were given bread with or without soybean curd residue. The blood glucose level was measured during the test period, the changes in blood glucose concentration (ΔC)and the area under the curve(ΔAUC)after ingestion were compared. Results ΔC and ΔAUC of the test diet period were significant decreased when compared with the control period in the subjects whose postprandial blood glucose levels were more than 140 mg/dL after ingestion of the control diet. Conclusions These results suggest that the soybean curd residue was useful to suppress the postprandial blood glucose level. -
The Effects of a Tablet Containing Whey Peptide, Carbohydrates, and Electrolytes on Exercise—induced Dehydration ―A Randomized Crossover Clinical Trial―
48巻6号(2020);View Description Hide DescriptionObjective Oral tablets containing carbohydrates and electrolytes are now available and are used for rehydration because of their portability. Our research demonstrated that ingesting whey peptides promotes water absorption in the small intestine; we thus developed a whey peptide tablet(WPT)that contains whey peptides, carbohydrates, and electrolytes. Here, we investigated the WPTʼs effects on the treatment of exercise-induced dehydration in adult males in a randomized crossover trial. Methods Each subject exercised on a cycle ergometer until his body weight reduction reached 1%, and he then drank mineral water with the WPT (WPT trial)or without the WPT (control trial). The volume of mineral water was equal to the subjectʼs body weight loss, and one WPT tablet per 50 mL of mineral water was ingested. Results The plasma volume change at 30 min post-ingestion was significantly higher in the WPT trial compared to the control trial(P<0.01). The body weight change at 120 min post-ingestion was significantly greater in the WPT trial than the control trial(P<0.05). Conclusion Rehydration with the WPT rapidly improved the subjectsʼ hydration status and that the WPT had a mild effect on fluid retention. The WPT was thus suggested to be effective for the treatment for dehydration due to exercise. (UMIN Clinical Trials Registry ID: UMIN000037201) -
アスタキサンチン,ヒハツ由来ピペリンを含むサプリメントの腰の不快感への影響の検討―ランダム化二重盲検プラセボ対照並行群間比較研究―
48巻6号(2020);View Description Hide DescriptionObjective Low back discomfort is one of the factors affecting quality of life(QOL)in Japan. The aim of this study was to investigate the ability of a compound supplement containing astaxanthin and long pepper to improve the low back discomfort. Methods We conducted a randomized double-blind, placebo-controlled, parallel-group study using 79 healthy participants with low back discomfort in daily life aged 21 to 59. They were administered with a supplements containing astaxanthin(6 mg/day)and long pepper extract powder(90μg as piperins╱day)or a placebo food for 8 weeks. The primary outcome was measured by the scores of Japan Low Back Pain Evaluation Questionnaire(JLEQ)and Lumbar range of motion. The secondary outcome was measured by Trunk muscle strength, core temperature, and Visual Analogue Scale(VAS)questionnaire. Results The result with all subjects, the primary outcome(JLEQ and Lumbar range of motion)was not significantly improved in supplement group compared with the placebo at 8 weeks. Although, the changes in VAS questionnaire from baseline for 8week in half rising and lean forward postures(such as face washing)was significantly improved in supplement group compared with the placebo group. (placebo group: -13.1±12.9 mm, supplement group: -24.5±18.0 mm). Next, the subjects“, the degree of low back discomfort was greatly changed during the time before administering”excluded, were analyzed. In this result, JLEQ was significantly improved in supplement group compared with the placebo group at 8 weeks. (placebo group: -12.9±11.2 mm, supplement group: -19.5±11.0 mm)Moreover, the changes in VAS questionnaire from baseline for 8week in half rising and lean forward postures(such as face washing)was significantly improved in supplement group compared with the placebo group. No serious adverse events were observed. Conclusions Administration of astaxanthin and long pepper improves the low back discomfort. Notably, the improvement effect was prominently visible in half rising and lean forward postures(such as face washing). UMIN ID UMIN000036216 -
酵素分解蜂の子による男性更年期症状,勃起機能および関連症状の改善効果
48巻6号(2020);View Description Hide DescriptionObjectives The aim of this study is to evaluate the effect of protease-digested Bee Larvae (pBL)supplementation on aging malesʼ symptoms(AMS)and erectile function, and to assess its safety. Methods An open-label single arm clinical trial was conducted in healthy Japanese men. They were orally treated with pBL for 12 weeks. The AMS score, Sexual Health Inventory for Men(SHIM), Self-rating Depression Scale(SDS), a fatigue Visual Analogue Scale(VAS) and biochemical parameters(serum total- or free︱testosterone and dehydroepiandrosterone sulfate (DHEA-S))were measured. A safety assessment was also performed by blood tests and urinary tests and based on an interview with a medical doctor. The above Measurements were performed at baseline, week 4 and week 12. Results The data obtained from 11 volunteers were analyzed. At week 4 and week 12, the AMS and SHIM scores were significantly improved in comparison with baseline. SDS and a fatigue VAS score were significantly improved in comparison with baseline at week 12. The frequency of early morning erections(number/week)was increased but not significantly different(P=0.062). Serum testosterone and DHEA-S levels were not changed during the test period. No adverse effects were observed throughout the study period. Conclusions These results suggest that pBL is effective and safe in improving subjective sensation of AMS, erectile function, depressive symptoms and fatigue in healthy Japanese adult men. -
イチョウ葉エキス,クルクミン,L—カルニチン,ヒハツエキス,糖転移ヘスペリジン配合ドリンクの摂取による脳賦活・体質改善に及ぼす影響
48巻6号(2020);View Description Hide DescriptionBackground In recent years, the prevalence of neurological diseases such as dementia and depression have become a social problem. If functional food ingredients have an improving effect on a state in which cognitive function is little reduced and depressive condition is very mild, that will be significant from the viewpoint of prevention of onset. Method From 1659 healthy subjects aged over 18 years, using Chinese-medical questionnaire, we screened subjects who were under the Qi deficiency and/or Qi depressive constitutions, and 46 cases who agreed to the test were targeted. We evaluated changes in brain activation status due to language fluency task using functional Near-Infrared Spectroscopy(fNIRS) before and 1 hour after single ingestion of drinks containing ginkgo biloba extract, curcumin, L-carnitine, long pepper extract and trans glycosylated hesperidin. Changes in scores of Chinese-medical constitution and subjective symptoms were also evaluated. Results Integral value of oxygenated hemoglobin in the frontal lobe measured by fNIRS 1 hour after single drink intake was significantly reduced compared to before intake. In the Chinese-medical constitution score, Yang deficiency(warmness dysfunction), Yin deficiency(lack of body fluid), Phlegm wetness(edema tendency), Wet heat(edema+heatization), Blood stasis(peripheral circulation disorder)constitution scores before drink intake was significantly improved after intake. For subjective symptoms, physical fatigue and mental symptoms were significantly improved. No adverse events due to drink intake were observed. Conclusion The decrease in oxygenated hemoglobin integral value by the single drink intake means that oxygen consumption decreased in the task execution. Furthermore, the performance for language fluency task was significantly improved. Therefore, the findings suggest that the drink is believed to have an effective brain activation effect. (UMIN-ID: UMIN000031904) -
サイタイエキス粉末配合食品のヒト皮膚機能に与える効果
48巻6号(2020);View Description Hide DescriptionObjectives The umbilical cord as well as placenta includes many active ingredients necessary to maintain homeostasis in the body and provides excellent materials for health and beauty. In this study, we examined the effects of porcine umbilical cord extract on human skin functions were investigated. Methods Twenty-three Japanese female subjects from 45 years old to 65 years old ingested the umbilical cord extract powder-formulated food for 12 weeks, and the following results were obtained. The skin parameters at the same site on the left cheek were measured before a start, four weeks and 12 weeks later. Results Water content in the stratum corneum significantly increased at both 4 and 12 weeks compared to before ingestion of the test food. Trans︱epidermal water loss significantly decreased at both 4 and 12 weeks compared to before ingestion of the test food. Changes in the index of skin viscoelasticity(R7)were significantly increased at 12 weeks compared to before ingestion of the test food. Brightness L* values were significantly higher at both 4 and 12 weeks compared to before ingestion of the test food. Red-coloured a* values were significantly lower at both 4 and 12 weeks compared to those before ingestion of the test food. The visual judgment score of wrinkles was significantly reduced at both 4 and 12 weeks compared to before ingestion of the test food. Conclusion These results suggested that the skin parameters such as skin moisture content in the stratum corneum, trans-epidermal water loss, skin elasticity, tone of the skin color, were improved by the ingestion of the umbilical cord extract food and moreover the umbilical cord extract food possessed the effects to make the fine wrinkle less noticeable. -
ビフィズス菌BB536 含有ドリンクヨーグルト摂取の通年性アレルギー性鼻炎症状に対する有効性―ランダム化プラセボ対照二重盲検並行群間比較試験―
48巻6号(2020);View Description Hide DescriptionObjectives The aim of this study was to assess whether the ingestion of dairy products containing Bifidobacterium longum BB536 can alleviate the symptoms of perennial allergic rhinitis. Methods A randomized, double-blind, placebo-controlled trial was conducted using 48 adults with perennial allergic rhinitis to consume 200 g of dairy products containing B. longum BB536(4×109 cfu/day)or placebo for 8 weeks. The subjects were examined for nasal symptoms, such as sneezing, rhinorrhea, and nasal congestion and quality of life, and recorded medication use every day. After calculating the nasal symptom-medication score(N-SMS)by averaging the daily symptom score and daily medication use per week, the change ratio of N-SMS to that of one week before starting the intake period was compared between two groups. In addition to the nasal cavity symptoms scored by medical doctors, allergy-related parameters were evaluated, including total immunoglobulin E(IgE), house dust mite-specific IgE, plasma thymus and activation-regulated chemokine(TARC), and nasal eosinophil counts. Results No participant habitually used an anti-allergic agent. The ratio of N-SMS to the baseline score was significantly lower in the BB536 group compared with the placebo group at 7 weeks after ingestion. There was no significant difference between the two groups in symptoms or allergy-related parameters, except for TARC at 8 weeks and nasal eosinophil counts at 0 weeks. Adverse events due to the consumption of dairy products were not observed. Conclusions This study suggests that the continuous intake of dairy products containing B. longum BB536 is a safe and effective approach to relieve the nasal discomfort of perennial allergic rhinitis. -
コラーゲンペプチド,エラスチンペプチド,ヒアルロン酸,パセノールTM 配合飲料の摂取が肌へ及ぼす効果―ランダム化二重盲検プラセボ対照並行群間比較試験―
48巻6号(2020);View Description Hide DescriptionObjectives The aim of this study was to investigate the effect of a drink containing collagen peptides, elastin peptides, hyaluronan and passienolTM on skin condition on healthy subjects. Methods A randomized, double-blind, placebo-controlled parallel-group comparison study was conducted in 43 healthy females(30-69 years old). They were randomly divided into two groups and ingested either test food(125 mL drink containing 10 g collagen peptides, 10 mg elastin peptides, 40 mg hyaluronan, 226 mg passienolTM)or placebo food for 24 days. Skin hydration and viscoelasticity of face were evaluated. Results The amount of increase in skin hydration was significantly higher in the test food group than in the placebo group. Elasticity after intake and the amount of increase in elasticity were also higher in the test food group than in the placebo group. Conclusions These result suggests that intake of collagen peptides, elastin peptides, hyaluronan and passienolTM is effective for skin moisture and elasticity(. UMIN-CTR000039674) -
ターミナリアベリリカ抽出物が食後の血糖値および血中中性脂肪の上昇に与える影響―プラセボ対照ランダム化二重盲検クロスオーバー試験―
48巻6号(2020);View Description Hide DescriptionObjectives This randomized, double-blind, placebo-controlled, cross-over study aimed to evaluate the effect of Terminalia bellirica extract on postprandial blood glucose and triglyceride levels in healthy subjects. Methods Twenty healthy subjects were enrolled and randomly assigned to two groups. The subjects ingested either Terminalia bellirica extract containing 20.8 mg gallic acid or placebo with loading diets. Blood glucose levels were measured before ingestion, as well as 30, 60, 90, and 120 minutes after ingestion. Blood triglyceride levels were measured before ingestion, as well as 120, 180, and 240 minutes after ingestion. Results Compared to placebo, the Terminalia bellirica extract significantly decreased the incremental area under the curve of postprandial blood glucose and triglyceride levels(P<0.05). In addition, blood glucose levels were significantly lower compared to placebo at 60, 90, and 120 minutes after ingestion. Blood triglyceride levels were also significantly lower compared to placebo at 120 and 180 minutes after ingestion (P<0.05). No adverse events attributable to the test food were observed throughout the study period. Conclusions These results indicate that consumption of Terminalia bellirica extract with diets inhibits the absorption of sugar and fat, thus diminishing postprandial elevation in blood glucose and triglyceride levels in healthy subjects(UMIN-CTR ID: UMIN000038956)
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