薬理と治療

創刊以来約40年にわたり幅広い購読層から信頼されてきた医薬原著論文投稿誌。読者対象は各科臨床医,薬剤師,医薬品開発担当者・研究者。
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TOPIC:第20回CRCと臨床試験のあり方を考える会議 2020 in 長崎
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- 受賞演題
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REVIEW
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A Consideration on the Protective Effect of Masks Against Infection of New Coronavirus(SARS—CoV—2)
49, 3(2021);View Description
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A new coronavirus infectious disease(COVID-19)emerged at the beginning of 2020, and since then has widely spread worldwide through sneeze, cough, conversation and others, resulting in tens of millions of infections and millions of deaths. Droplet shedding is common with sneezing, coughing, and talking, in that order, and sometimes amount of the virus particles expelled reach 2×108. Some specialists say that infection could be spread by particle as small as 1000 as in number. It is said that wearing a mask is important for preventing infection, however, it is uncertain whether it depends on inhibition of splash expelled from spreader or prevention of inhalation by the receiver. Non-woven masks are widely available and are reported to inhibit the inhalation of particles with a 0.3μm in a diameter by 99%. Based on a supercomputer simulation, although inhalation of small droplets could not be inhibited well once some gaps remain between the mask and the face with non-woven masks, it inhibited the inhalation of the particles with a size of 0.3-50 μm once tightly shielded. On the other hand, an actual infection study with SARS-CoV-2 showed that even N95 masks which are superior to the non-woven masks in the filtration capability could not completely inhibit the inhalation of the droplets even when tightly shielded. Also, in a randomized controlled trial with nearly five thousand participants in Denmark( DANMASK-19), no clear protective effect was demonstrated against infection in the surgical mask wearers. Although adherence of masks to oneʼs face is an influencing factor, it is not considered sufficient for prevention to wear masks only. We should not rely on the preventive effect of masks too much, and instead keep distance from others as if they are potentially infected until a complete preventive method or medical treatment is established.
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ORIGINAL ARTICLES
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マウス子宮腺筋症に与える黄体ホルモン抑制効果
49, 3(2021);View Description
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Background The suppressive effects of progesterone on uterine endometriosis, adenomyosis and leiomyomas have been known world-widely. As previously reported, progesterone inhibited DNA synthesizing activity enhanced by estradiol in immature rat endometrium, and danazol(an isoxazol derivative of the synthetic steroid 17α-ethinyltestosterone)lowered plasma gonadotropin levels with ovarian hypofunction, resulting in the decrement of DNA synthesizing activity in matured rat uterus. Methods We investigated the effects of medroxyprogesterone acetate (17α-acetoxy-6α-methylprogesterone), danazol and mifepristone(an anti-progestin as a progesterone-receptor-blocker)on uterine adenomyosis(UA)in SHN virgin mice, which were known to have a high potential of the spontaneous development of UA. Results Long-term administration of medroxyprogesterone acetate suppressed the development of UA with the ovarian hypofunction and the reduction of the circulating progesterone levels in mice. Danazol reduced the development of UA, resulted in the ovarian hypofunction with undetectable plasma levels of luteinizing hormone in mice. Mifepristone suppressed the development of UA with the shrinkage of the endometrial vascular system in mice. Conclusions Inhibition of progesterone or administration of anti-progestin demonstrated the suppressive effects on the development of UA in SHN virgin mice. -
Effects of D—Allulose on Postprandial Energy Expenditure in Healthy Humans―A Randomized, Single—blind, Placebo—controlled Crossover Trial―
49, 3(2021);View Description
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Background D-Allulose, a C-3 epimer of D-fructose, has been reported to enhance fat oxidation in healthy humans in the sitting position and during exercise. However, no studies have so far reported that D-allulose increases energy expenditure in healthy humans, although animal studies using Wistar and Sprague-Dawley rats have reported this finding. Energy metabolism has been reported to differ according to various postures in humans. Objectives We examined the effects of a single dose of D-allulose on postprandial energy metabolism in the supine position in healthy humans. Methods A randomized, single-blind, placebo-controlled crossover trial was conducted by including 6 healthy male and female volunteers. Overnight-fasted participants ingested a standardized breakfast for 30 min after taking 5 g D-allulose or 10 mg aspartame(not containing D-allulose)as a placebo, and subsequently energy metabolism in the supine position was evaluated by a breath-by-breath method using a respiratory gas analyzer. Results In the D-allulose-treated group compared with the placebo group, the area under the curve of energy expenditure(20.6±1.1 vs. 19.9±0.9 kJ/4h/kg body weight(BW), P<0.05) and fat oxidation(14.8±1.2 vs. 13.0±1.4 kJ╱4h╱kg BW, P<0.05) significantly increased, whereas that of carbohydrate oxidation slightly decreased but without a significant difference. Furthermore, there were no adverse effects in the D-allulose group. Conclusions Ingestion of a single dose of 5 g D-allulose enhanced postprandial energy expenditure and fat oxidation in the supine position, suggesting that repeated intake of D-allulose may serve to prevent obesity in healthy humans. (UMIN Clinical Trials Registry ID: UMIN000016365) -
健康成人を対象としたクロセチン・イチョウ葉エキス配合サプリメント摂取による視機能への影響―ランダム化二重盲検プラセボ対照クロスオーバー比較試験―
49, 3(2021);View Description
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Background Owing to the escalated use of smartphones, visual display terminal (VDT)exposure time has become extremely long. Temporary myopia-like changes occur due to the load on the eyes caused by VDT activity. It is expected that temporarily impaired visual function can improve by suppressing axial length elongation, suppressing choroidal thinning by crocetin, and improving blood flow by the use of Ginkgo biloba extract. Objective This clinical research evaluates whether a crocetin plus Ginkgo biloba extract supplement(CG)improves temporarily impaired visual function. Study design This was a randomized, placebo-controlled, double-blind crossover study. Healthy individuals between the ages of 20 and 40 years and engaged in VDT activity on a daily basis, were given the CG or a placebo for 4 weeks each, and their eye function examined. Results The equivalent spherical power was significantly higher values in the CG group compared in the placebo group at week︱4(P<0.05). No significant difference between the two groups was observed in axial length or in choroidal thickness, but stratified analyses showed significant suppression of axial length elongation and increase in choroidal thickness. Conclusion Ingestion of CG for 4 weeks increases the equivalent spherical power, suggesting that CG ingestion may improve temporarily impaired visual function. (UMIN000040010) -
Licorice Flavonoid Oil Concentrate Solution Reduced Visceral Fat and Total Abdominal Fat in Healthy Subjects in a Randomized, Double—blind, Placebo—controlled Trial
49, 3(2021);View Description
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Objectives Ingestion of licorice flavonoid oil(LFO)has been shown to reduce abdominal fat and/or total body fat. We conducted a randomized, double-blind, placebo-controlled trial to confirm the effects of LFO on abdominal visceral╱total fat area, body fat mass, body weight, body mass index(BMI), waist╱hip circumference, and safety parameters in healthy Japanese subjects. Methods Participants of both sexes aged≥20 to<65 years with a BMI of≤23.0 to<30.0 were enrolled and assigned to two groups and administered either a daily dose of placebo or LFO concentrate solution containing 3% glabridin(LFO(3%))100 mg for 12 weeks. Body fat mass was determined by dual-energy X-ray absorptiometry and abdominal total╱subcutaneous ╱visceral fat area was measured by computed tomography at the predetermined time points. Hematologic╱biochemical analyses, urinalysis, and adverse events╱reactions were also evaluated. Results A total of 200 participants were enrolled(100 per group), of whom 160 were included in the efficacy analysis(placebo n=81, male 25; LFO(3%)n=79, male 24). LFO (3%)ingestion significantly reduced abdominal total╱visceral fat area from baseline, with a significant difference between the groups. Stratified analysis demonstrated that LFO(3%) tended to increase lean body mass in men but not in women. No clinically relevant adverse events related to LFO(3%)ingestion were observed. Conclusions LFO(3%)100 mg(3 mg glabridin)reduced abdominal total╱visceral fat in healthy volunteers. (UMIN000034521) -
Effects of Licorice Flavonoid Oil Concentrate Solution Supplementation on Body Weight and Abdominal and Total Body Fat in Japanese Healthy Volunteers ―A Randomized, Double—blind, Placebo—controlled Study―
49, 3(2021);View Description
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Objectives To evaluate the effects of licorice flavonoid oil concentrate solution containing 3% glabridin(LFO(3%))on the abdominal total/subcutaneous/visceral fat area, body fat mass, body weight, body mass index(BMI), waist╱hip circumference, and safety parameters in Japanese healthy subjects. Methods In this randomized, double-blind, placebo-controlled trial, participants of both sexes aged 20≤to<65 years with a BMI of≤23.0 to<30.0, were assigned to two groups and received a daily dose of placebo or 300 mg LFO(3%)(9 mg glabridin)for 12 weeks, respectively. Body fat mass was measured by dual-energy X-ray absorptiometry and abdominal total╱subcutaneous╱visceral fat area by computed tomography scan at baseline, 8 and 12 weeks after LFO(3%)ingestion. Body weight, BMI, hematologic╱biochemical analyses, and urinalysis were performed at the same time as the scans, and 4 weeks after ingestion and 4 weeks after cessation of ingestion. Adverse events╱reactions were evaluated on the basis of participantsʼ diaries. Results Of 200 participants(100 per group), 172 were included for the efficacy analysis(placebo n=89, male=39; LFO(3%)n=83, male=38). Ingestion of 300 mg LFO(3%)significantly reduced abdominal total╱visceral fat area, waist circumference, and significantly suppressed the increase in abdominal subcutaneous fat area and body fat mass compared with the placebo group. In addition, 300 mg LFO(3%)significantly decreased fasting blood glucose compared with the placebo group. No clinically relevant adverse events related to the ingestion of 300 mg LFO(3%)were observed. Conclusion LFO(3%)may be useful for the prevention of fat accumulation and hyperglycemia. (UMIN000038570) -
SOYLAX®(大豆タンパク質酵素分解物)および GPX®(低分子量コラーゲンペプチド)配合タブレット錠摂取によるストレス反応軽減効果 ―ランダム化プラセボ対照クロスオーバー比較試験―
49, 3(2021);View Description
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Objectives The aim of the present study was to investigate effects of tablets containing soy-derived peptide(SOYLAX®)and collagen-derived peptide(GPX®)on responses to mental stresses in healthy human. Methods In this crossover trial, 10 healthy volunteers were recruited. In the 1st phase, test articles(containing 1000 mg of SOYLAX® and 1000 mg of GPX® per 3 tablets)were administered to half of subjects and placebo tablets were administered to the other half subjects. After one-week washout period, opposite order of tablets were administrated respectively in the 2nd phase. In each trial, Visual Analogue Scale(VAS), Profile of Mood State 2nd Edition-Adult Short(POMS)and State-Trait Anxiety Inventory (STAI), concentration of salivary cortisol, blood pressure, pulse rate, electroencephalogram and electrocardiogram were repeatedly evaluated after administrations. Kraepelinʼs arithmetic test was carried out between each evaluations as mental stress tasks. Results In the test articles group, lower POMS score of“Tension-Anxiety”, lower concentration of salivary cortisol, and decreased levels of fast frequency components on electroencephalogram were observed compared to those in the placebo group. Conclusions The tablet containing SOYLAX® and GPX® showed health benefits against task induced negative mood and would alleviate mental stresses without any side effects. (UMIN Study ID: UMIN000040411) -
Skin—moisturizing Effect of an Oral Supplement Containing Salmon Nasal Cartilage Proteoglycan ―A Randomized, Double—blind, Parallel—group, Placebo—controlled Study―
49, 3(2021);View Description
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Objectives The purpose of this study was to investigate the effects of dietary supplements containing salmon nasal cartilage proteoglycan(SPG)on the skin moisturization of healthy subjects worried about dry skin due to office air conditioning. Methods A randomized, double-blind, placebo-controlled trial of 56 healthy subjects(aged 20-58 years)was studied. Subjects were randomly divided into two groups, a proteoglycan and a placebo group. The proteoglycan group ingested a supplement containing 5 mg of SPG a day for 6 weeks, and the placebo group took an equivalent amount of dextrin. In order to verify the change in skin condition due to SPG intake, the skin moisture content and transepidermal water loss(TEWL)of the cheek, neck, and leg parts were measured. Results Regarding the cheeks of the subjects in their 40 s, there was a significant increase in skin moisture content after 6 weeks in the proteoglycan group compared to the placebo group. In female legs, there was significant TEWL suppression in the proteoglycan group after 3 weeks. In subjects aged 40 years and older with TEWL ≤22 g/h/m2, the proteoglycan group showed a significant increase in skin moisture content in the neck after 6 weeks and a significant TEWL suppression in the legs after 3 weeks. Conclusion These results suggest that SPG intake has a moisturizing effect on the skin by improving skin hydration and TEWL. (UMIN-CTR ID;UMIN000042097)
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