薬理と治療
Volume 49, Issue 5, 2021
Volumes & issues:
-
扉・目次
-
-
-
TOPIC 第20回CRCと臨床試験のあり方を考える会議 2020 in 長崎
-
- 受賞演題
-
-
ORIGINAL ARTICLES
-
-
剝がれの起点に着目した新しい剝離特性評価法による貼付剤の評価
49巻5号(2021);View Description Hide DescriptionObjectives The aim of this study is to evaluate the suitability of the evaluation method focusing on the force applied to the edge of transdermal patches as a method of predicting the in vivo adhesion properties of the patches on human skin. Methods Four different formulations have been evaluated using a novel method based on the use of a creep meter. The load that causes peeling was calculated from the set value of the vertical load, when several formulations are peeled from artificial skin. The analysis of the obtained data were developed based on the parameter: load to generate peeling. In addition to the in vitro evaluation, the data were compared with the in vivo adhesive properties in humans that had already been reported by other groups. Results The values of in vitro peeling force that is based on 90°peel test and in vivo performances didnʼt necessarily match. Whereas the results in vitro load to generate peeling were consistent with the in vivo performance. In both test methods, the longer the crimping time with a 2 kg weight, the greater the values. Conclusions The results of this novel in vitro evaluation method correlated with the results of two different in vivo human adhesive evaluations. These evaluations might predict in vivo performance of transdermal patches. This method would be a helpful approach during the development of transdermal patches that could contribute to improved patient adherence. -
日本におけるバイオ医薬品市場の将来推計とバイオシミラーによる医療費適正化効果の検討
49巻5号(2021);View Description Hide DescriptionBackground An increase in healthcare expenditure is a common problem for countries around the world, including Japan. Promotion of switching biopharmaceuticals to biosimilars is considered to have a large impact on healthcare expenditure, while the switch remains slow for some products, including antibody drugs. A new incentive in the medical fee schedule for adopting biosimilars for subcutaneous injection was introduced in April 2020, but there are no incentives for other formulations. Methods In this study, we estimated the market size of biopharmaceuticals and biosimilars based on published data. Also, by assuming new incentives being established for adopting biosimilars, such as intravenous injections, we simulated the impact of the new incentives on future medical expenditure by comparing medical expenditure reduction by switching to biosimilars and additional medical reimbursement for providing the new incentives. Results Estimated size of the biosimilars market and biopharmaceuticals with biosimilars market was 393.9 billion yen in 2025(fiscal year). By examining the breakdown in usage rate of biosimilars by formulation, results showed that biosimilars for subcutaneous injection and intravenous injection of monoclonal antibodies need to increase usage in the next five years to reach 80% volume share. Moreover, the effect of medical expenditure reduction would be much greater than the amount of the additional reimbursement, and the effect of biosimilars on managing medical expenditure would be up to 120.2 billion yen in a single year. Conclusions These results suggest that it might be effective to introduce new incentives for biosimilars other than subcutaneous injections to promote biosimilars usage and reduce medical expenditure. -
Effects of Isomaltodextrin on Satiety and Appetite Regulating Hormones―Two Randomized, Double‒blind, Placebo‒controlled, Crossover Studies―
49巻5号(2021);View Description Hide DescriptionObjectives We investigated the effect of isomaltodextrin(IMD)intake on appetite in humans, and considered the mechanism based on animal study. Methods Two randomized, double-blind, placebo-controlled, crossover studies were conducted as human study. 1)Thirty subjects received a test meal and water containing either 3.75 g of IMD or maltodextrin(MD). Hunger, satiety, fullness, and prospective intake were measured by visual analog scales(VAS)until 240 min after intake. 2)Breakfast was served in the same method as 1). Lunch was served 3 hours after the breakfast, and the amount of lunch consumed was compared. A following animal study was conducted. 3)IMD or MD(2 g/kg-body weight)were administer to rats, and blood concentration of glucagon-like peptide-1(GLP-1[biologically active forms])and peptide YY(PYY)were determined. Results 1)For satiety and fullness, the VAS and the area under the curve(AUC0-240 min)after IMD intake were significantly higher compared with ones after MD intake. 2)Co-ingestion of IMD with breakfast lowered the caloric intake at lunch significantly compared to when MD was ingested with breakfast in group who consumed above mean caloric intake at lunch on the day of MD. 3)After administration, GLP-1 and PYY concentration in the IMD group was significantly higher than in the MD group. Conclusions These results suggest that prandial consumption of 3.75 g of IMD sustained satiety in healthy humans. IMD was considered to affect satiety via a mechanism related to the stimulated production of satiety hormones. -
T—1 乳酸菌が健常な日本人成人男女の便通に与える影響―ランダム化プラセボ対照二重盲検並行群間比較試験―
49巻5号(2021);View Description Hide DescriptionObjective This study determined the effects of the T-1 lactic acid bacteria(T-1LAB: Streptococcus thermophilus AK and Lactobacillus delbrueckii subsp. bulgaricus KD)on the bowel movements of healthy Japanese adults with mild constipation. Methods This study was a randomized, placebo-controlled, double-blind, parallel-group study conducted on healthy Japanese subjects(n=44)who defecated three to five times a week. Subjects were randomly allocated into two groups(n=22 in each group). The T-1LAB group consumed a soy milk product fermented with T-1LAB. The Placebo group consumed a soy milk product containing lactic acid and gelatin but without T-1LAB; the subjects consumed 100 g of the assigned products daily for two weeks. The primary outcome was defecation frequency per week. The secondary outcomes were the number of days and the amount of defecation in a week, shape of stool, subjective symptoms for constipation, the Bristol Stool Scale, profile of gut microbiota, total number of bifidobacteria, fecal analysis data(pH, water content, organic acids, putrefactive products, and bile acids), facial skin assessment, skin moisture, and transepidermal water loss. Results In each group, 21 subjects were finally analyzed for efficacy. In the T-1LAB group, the defecation frequency and the number of days of defecation in a week were significantly increased, and skin pigmentation and crowʼs feet were significantly improved compared with the Placebo group(P<0.05). There were no adverse events related to the test products. Conclusions These results suggest that T-1LAB consumption may improve bowel movements in healthy Japanese subjects with mild constipation. Trial registration UMIN-CTR: UMIN000038362 Foundation KIKKOMAN SOYFOODS COMPANY. -
中強度の運動を行った際のピセアタンノール摂取による脂肪燃焼促進効果―プラセボ対照ランダム化二重盲検クロスオーバー比較試験―
49巻5号(2021);View Description Hide DescriptionObjectives This study aimed to evaluate the effect of oral intake of piceatannol on fat burning during moderate-intensity exercise in healthy subjects, using a randomized, double-blind, placebo-controlled, crossover comparative method. Methods Twelve healthy volunteers consumed test food containing 10 mg of piceatannol or placebo food for 14 days before and after the washout period. Then, breath gas and pulse rate were measured during exercise for 30 minutes using a cycle ergometer(50% V 4 O2max, 50 rpm). Fat burning and respiratory quotient (RQ)were calculated by breath gas composition. Results Oral intake of test food containing piceatannol significantly increased fat burning and decreased RQ during moderate-intensity exercise compared with that of placebo. No change in energy expenditure and pulse rate was observed between the test food and placebo. Conclusions These results suggested that oral intake of food containing piceatannol increased fat burning during moderate-intensity exercise. (Unique ID issued by UMIN; UMIN000041607) -
サラシアエキス配合食品による食後血糖上昇抑制効果―ランダム化二重盲検プラセボ対照クロスオーバー試験―
49巻5号(2021);View Description Hide DescriptionObjective The study aimed to evaluate the effect of Salacia extract on postprandial blood glucose. Methods A randomized, double-blind, placebo-controlled, cross-over study was conducted for 33 healthy volunteers. The subjects were randomly divided into three groups and took a placebo food or test food containing Salacia extract(low dose or high dose)on each of the 3 experimental periods. The blood glucose and insulin levels were measured before and 30, 60, 90 and 120 minutes after meal. Results The test food containing high dose of Salacia extract significantly suppressed the AUC of blood glucose levels and postprandial blood glucose levels at 30 minutes after meal. The high dose also significantly suppressed the AUC of blood insulin levels and postprandial blood insulin levels at 30, 90 and 120 minutes after meal. Additionally, in the subgroup analysis with higher postprandial blood glucose levels, the suppressive effect on postprandial blood glucose were greater. On the other hand, the low dose didnʼt suppress postprandial blood glucose significantly. However, in the subgroup analysis, the low dose significantly suppressed postprandial blood glucose levels at 60 minutes after meal and tended to suppress the AUC of blood glucose levels. Conclusion These results suggest that the ingestion of Salacia extract suppresses the postprandial blood glucose and insulin in healthy subjects. (UMIN-CTR ID: UMIN000042049) -
朝のスケトウダラの速筋タンパクの摂取が高齢者の骨格筋量および筋力に及ぼす影響―ランダム化二重盲検並行群間比較試験―
49巻5号(2021);View Description Hide DescriptionBackground The effect of Alaska pollack protein(APP)intake on improving physical function has not been clarified. Objectives The aim of this study was to determine the effect of APP supplementation at breakfast for 12 weeks beyond habitual intakes on muscle mass and muscle strength in elderly people needing support. Methods Twenty-five elderly needing support males and females underwent 12 weeks of intervention. We applied the 4.5 g milk protein(MP)or 4.5 g APP as nutritional supplementation. Subjects were divided into two groups: APP intake(APP group, n=14), milk protein intake(MP group, n=11). The human trial of the present study is registered at www.umin. ac.jp/ctr/asUMIN000033941 Results There were no significant changes in skeletal muscle mass and skeletal muscle mass index before and after the intervention for both groups. However, in women who were judged to be able to walk alone, a significant increase in skeletal muscle mass(P<0.05)and skeletal muscle index(P<0.05)were observed after the intervention compared to before the intervention only in the APP group. Furthermore, as a result of calculating and comparing the amount of change in the skeletal muscle index before and after the intervention in both groups, APP group was found to be significantly higher than MP group(P<0.05) Conclusions These results suggested that APP supplementation at breakfast for 12 weeks was effective in increasing skeletal muscle mass in elderly women in need of support. -
機能成分の耐酸性を向上させた新規ハードカプセル製剤の腸内崩壊部位の観察―オープン試験―
49巻5号(2021);View Description Hide DescriptionObjective The objective of this study was to know the site of gastrointestinal disintegration of new developed hard capsule designed to disintegrate in the intestine. Methods For 10 healthy men, the disintegration property of the test food capsule with barium sulfate 150 mg is confirmed by sequential X-ray photography. Results In all subjects, the test food capsules completely disintegrated 1 to 3 hours after ingestion. The sites of complete collapse were the small intestine in 6, the duodenum in 1, the small intestine/cecum in 1, the ascending colon in 1, and the transverse colon/descending colon in 1. Conclusions These results show that the new hard capsule has a formulation processing technology that completely disintegrates in the intestine as designed in the human body. In the future, it is expected to be applied to various developed products. (UMIN ID: UMIN000039510) -
カテキン含有飲料摂取によるメタボリックシンドローム関連因子への有効性に関する試験―プラセボ対照二重盲検ランダム化並行群間比較試験―
49巻5号(2021);View Description Hide DescriptionObjective To examine the effect of long-term intake of catechin on metabolic syndrome-related factors in healthy adult men and women over the age of 20. Trial design Placebo-controlled, double-blind, randomized, parallel-group controlled trial. Methods 38 subjects were randomly allocated into two groups and given a catechin-containing supplement group or placebo group for 12 weeks. Physical examinations, blood tests, and urine tests were performed on the subjects before and 4, 8 and 12weeks after the experiment. Results Ingestion of the test beverage resulted in weight loss and regulation of lipid metabolism. On the other hand, weight gain and worsening of lipid metabolism were observed in the placebo group.Conclusion Ingestion of catechin-containing supplements for 12 weeks suggested an improving effect on metabolic syndrome-related factors. -
イクラオイル,アスタキサンチンおよび精製深海鮫肝油含有食品の過剰摂取における安全性評価
49巻5号(2021);View Description Hide DescriptionObjective The aim of this study was to evaluate the safety of salmon roe oil, astaxanthin and shark liver oil in healthy adult human. Methods Non-randomized, open-labeled trial were conducted in 20 healthy adult subjects. All subjects were given test products for 4 weeks. Daily intake of the test product was contained 5 g of salmon roe oil(DHA 750 mg, EPA 300 mg), 1000μg of astaxanthin and shark liver oil(DAGE 1800 mg). Safety was evaluated every 2 weeks by interview, physical examination, hematology and urinalysis. Results There were no adverse events associated with the test products during the study. 20 subjects complete the study without abnormal change in physical examinations, hematological analyses, blood biochemical tests or urinary analyses. Conclusions This study suggests that the excessive dose of salmon roe oil, astaxanthin and shark liver oil is safe for healthy adults. (UMIN ID: UMIN000041538)
-
-
COLUMN
-
-
-
INFORMATION
-
-
-
CONSORT 2010声明—ランダム化並行群間比較試験報告のための最新版ガイドライン—(薬理と治療2010;38:939-49.より再掲載)
49巻5号(2021);View Description Hide Description -
-
-