薬理と治療
Volume 43, Issue 1, 2015
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扉・目次
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所感
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TOPICS 第14 回CRC と臨床試験のあり方を考える会議 2014 in 浜松
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- 受賞演題
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Clinical Research Coordinator(CRC)のキャリア開発にむけての現状と課題-やりがい等の意識調査結果より
43巻1号(2015);View Description Hide Description
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ORIGINAL ARTICLES
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クエルセチンの肥満細胞活性化抑制作用
43巻1号(2015);View Description Hide DescriptionThe influence of quercetin on mast cell growth and activation was examined by using an in vitro cell culture technique. Mast cells were induced by long-term culture of spleen cells prepared from specific pathogen free BALB╱c male mice. Quercetin was added to the cultures at seeding and then every 2-3 days, when the culture medium was replaced with fresh one. The influence of quercetin on mast cell growth was evaluated by counting number of cells grown on 16th days. We then examined the influence of quercetin on histamine and inflammatory cytokine secretion from cultured mast cell in response to the stimulation of either chemical substances or concannavalin A. Quercetin could not inhibit mast cell growth, even when spleen cells were exposed to 10μM of quercetin throughout the entire culture periods. Quercetin could suppress histamine release from cultured mast cells in response to non︱immunological stimulations with calcium ionopore and compound 48╱80. Quercetin could suppress inflammatory cytokine, IL︱1β, IL-6 and TNF︱α, secretions from cultured mast cells at more than 0.5μM through the suppression of transcription factor activation and cytokine mRNA expression, which were increased after concannavalin A stimulation. These results may suggest that quercetin modulated the ability of mast cells to secrete inflammatory cytokines and results in improvement of clinical condition of allergic diseases. -
健康成人男性におけるピロカルピン塩酸塩の顆粒剤と錠剤との生物学的同等性試験
43巻1号(2015);View Description Hide DescriptionBackground SALAGEN® tablet, containing Pilocarpine hydrochloride, is on the market under the indication of“improving xerostomia”. To improve the drug adherence in patients, granule formulation of Pilocarpine hydrochloride was developed. Bioequivalence of two formulations was assessed in healthy adult male subjects. Methods The study was an open-label, 2-formulation, 2-period, crossover study in healthy volunteers. Bioequivalence was assessed using 90% confidence interval of the ratios of AUC0-24 and Cmax after dosing under fasting condition. Results A total of 30 subjects was enrolled and 29 subjects completed the study. The 90% confidence interval of AUC0-24 and Cmax were log(1.01)-log(1.09)and log(0.99)-log(1.13), respectively, were within the bioequivalence criteria of log(0.80)-log(1.25). Conclusions Pilocarpine hydrochloride granule 0.5% which is new formulation is concluded to be bioequivalent with SALAGEN® tablet 5 mg. -
トピロキソスタットの尿酸および尿中アルブミンに与える影響―痛風・高尿酸血症を合併したCKD3 患者を 対象としたプラセボ対照二重盲検試験の併用薬・CKD 原疾患別追加解析―
43巻1号(2015);View Description Hide DescriptionBackground Chronic kidney disease(CKD)is highly prevalent in hyperuricemic patients. Cardiovascular events╱kidney failure are more frequent in CKD patients than in patients without albuminuria. Topiroxostat, a selective xanthine oxidase inhibitor, has been reported to reduce the serum urate level and urinary albumin╱creatinine ratio(ACR)in Japanese hyperuricemic patients with stage 3 CKD. We further assessed the effect of topiroxostat on the serum urate and albuminuria. Methods This is a post-hoc, sub-group analysis of data obtained from the previously reported multicenter, randomized, placebo-controlled, double-blind, parallel-group, 22-week study comparing the efficacy and safety of topiroxostat versus placebo in Japanese hyperuricemic stage 3 CKD patients with or without gout. We conducted sub-group analyses of the effects of topiroxostat on the serum urate, ACR, estimated glomerular filtration rate and blood pressure. Results Both in patients receiving╱not receiving renin-angiotensin-aldosterone(RAA)inhibitors╱lipid-lowering drugs, the serum urate level decreased more in the topiroxostat group than in the placebo group. The percent change of the ACR was also significantly lower in the topiroxostat group than in the placebo group in patients receiving RAA inhibitors╱lipid-lowering drugs. In the subgroup analysis of patients with nephrosclerosis, the percent change of the ACR was significantly lower in the topiroxostat group than in the placebo group. Also in the patients with diabetic nephropathy, the percent change of the ACR tended to be lower in the topiroxostat group than in the placebo group(P=0.059 vs. placebo). Conclusion The efficacy of topiroxostat in reducing the serum urate and ACR was maintained when it was administered concomitantly with RAA-blocking agents╱lipid-lowering agents. -
Supplemental Ingestion of Collagen Peptide Improves T—cell—related Human Immune Status ―Placebo—controlled Double—blind Study―
43巻1号(2015);View Description Hide DescriptionObjective The effects on human immunity of oral supplementation with fish-derived collagen peptide were investigated with a placebo︱controlled double-blind trial. Methods Healthy Japanese men and women(30-59 years of age)with daily tiredness and fatigue and relatively low Scoring of Immunological Vigor(SIV)scores, a comprehensive score reflecting immune status, were randomly assigned to two groups(n=25). Each participant ingested 10 g of placebo or collagen peptide every day for 8 weeks. Their immunological functions were measured with the SIV score and other parameters. Results The ingestion of 10 g of collagen peptide for 8 weeks significantly improved the SIV score relative to that of the placebo group (P=0.030). A within︱group analysis showed that the SIV scores(P=0.002)and numbers of T cells(P=0.017), memory T cells(P=0.008), CD8+CD28+ T cells(P=0.039), and NK cells(P=0.038)increased significantly, and CD4/CD8 T cell ratio(P=0.001)and the T-lymphocyte age(P=0.047), an index calculated from the CD8+CD28+ T︱cell number, decreased significantly in the collagen peptide group, but not in the placebo group. Significant improvement in the subjective symptoms of diarrhea(P=0.041)and appetite(P=0.043)were only observed in the collagen peptide group. No adverse effects attributable to collagen peptide ingestion were observed. Conclusions These results suggest that the ingestion of 10 g of collagen peptide for 8 weeks improves the immunological status of humans, especially the number of T lymphocytes and their subsets. -
低分子ヒアルロン酸の経口摂取における美肌効果―プラセボ対照二重盲検並行群間比較試験―
43巻1号(2015);View Description Hide DescriptionObjectives To investigate the safety and efficacy of hyaluronic acid for improving skin condition, a placebo-controlled double-blind comparative study was conducted in women who were concerned about wrinkles and dryness. Methods Twenty-eight women were allocated to one of 2 groups receiving either a hyaluronic acid-containing diet or a placebo diet 3 times daily for 8 weeks. The daily intake of hyaluronic acid was 240 mg. The efficacy endpoints included skin moisture content, skin elasticity, and wrinkle characteristics based on skin replica analysis at baseline(before intake), and 4 and 8 weeks of intake. The safety endpoints included physiological, hematological, and blood biochemical adverse events. Results The hyaluronic acid group(compared to the placebo group)showed a tendency toward improved skin moisture, had significantly improved skin elasticity at 8 weeks of intake compared with baseline, and had significantly improved mean maximum wrinkle depth at the corner of the right eye at 4 weeks of intake. Mean wrinkle area ratio and maximum wrinkle area ratio at the corner of the left eye were significantly increased at 4 and 8 weeks of intake compared with baseline in the placebo group, but not in the hyaluronic acid group. No adverse events related to food intake were observed, suggesting that intake of hyaluronic acid is safe. Conclusions The results suggest the efficacy of a diet containing hyaluronic acid for improving skin moisture, elasticity, and wrinkles. -
Clinical Effects of Ingesting Collagen Hydrolysate on Facial Skin Properties―A Randomized, Placebo—controlled, Double—blind Trial―
43巻1号(2015);View Description Hide DescriptionObjectives The objective of this research was to investigate the effectiveness of daily ingestion of a specific collagen hydrolysate(CH), which contains prolylhydroxyproline(Pro-Hyp)and hydroxyprolylglycine(Hyp-Gly), on facial skin properties. Methods In this randomized, placebo-controlled, double-blind trial, 56 women aged 30-55 years were randomized to receive 2.5 g of CH or 5 g of placebo once daily for 8 weeks, with 28 subjects assigned to each group. The hydration, elasticity and roughness properties of facial skin were measured at week 0 (baseline), week 4 and week 8. Results Levels of skin hydration, elasticity and roughness in subjects who received CH significantly improved between baseline and weeks 4 and 8, while there was no significant improvement in subjects who received placebo. Moreover, the levels of skin elasticity, roughness and the net change of skin hydration improved significantly in the CH group compared to the placebo group by both weeks 4 and 8. Conclusion The present results suggest that daily ingestion of 2.5 g of CH improves facial skin hydration, elasticity and roughness. -
代替医療の利用状況・長所・主観的肯定的変化―慢性疾患患者の視点から―
43巻1号(2015);View Description Hide DescriptionObjectives Changes in disease profiles in Japan have led to an increase in the incidence of chronic diseases, and attention has been drawn to self-care and Complementary and Alternative Medicine(CAM). The aim of the present study was to understand the benefits and Perceived Positive Changes(PPC)by using CAM; elucidating the usage of CAM among Japanese patients with chronic diseases. Methods A mixed method combining qualitative and quantitative research approaches was used in the study. We first interviewed 35 patients aged ≥20 years with chronic diseases, user of CAM from December 2010 to January 2011 for the qualitative assessment of the benefits and PPC associated with CAM. We then distributed self-administered questionnaires among the 920 patients with chronic diseases who belong to the patient associations in Japan from May to July 2011. The responses obtained from 570 patients(valid recovery rate, 62.0%)were quantitatively assessed in terms of the usage rate, benefits, and experience of PPC associated with CAM. Results Of the 570 respondents, 428(75.1%)had used CAM within the past 10 years. Many had used supplements and health foods (47.9%)or massage therapies(46.5%). The respondents reported benefits of CAM, such as:sense of security, self︱care, and pleasant feelings, and experienced PPC including enhanced health knowledge, sense of mental and emotional tranquility, and confidence in health management. Conclusions Majority of the patients with chronic diseases used CAM and also experienced benefits and PPC associated with CAM. Healthcare providers should respect patients perspectives. -
日本人2 型糖尿病患者におけるイプラグリフロジンの長期有効性および安全性:52 週間多施設共同非盲検第Ⅲ相臨床試験―IGNITE Study―
43巻1号(2015);View Description Hide DescriptionIpragliflozin is a selective sodium╱glucose cotransporter 2(SGLT2)inhibitor and shows insulin-independent glycemic control effect by enhancing urinary glucose excretion. We examined the efficacy and safety of ipragliflozin 50 mg(increased dose 100 mg)once daily for 52 weeks in Japanese patients with type 2 diabetes mellitus. To assess effects of food intake on efficiency of the drug, 182 patients were randomized to receive ipragliflozin 50 mg before or after breakfast. At Week 20, 70 patients increased to 100 mg and 98 patients continued on 50 mg. At week 20 and 52, the change from baseline showed significant reduction in HbA1c(%), fasting plasma glucose and body weight were -0.53±0.67%(P<0.001)and -0.51±0.81% (P<0.001), -32.8±30.3 mg╱dL(P<0.001)and -32.7±31.7 mg╱dL(P<0.001), -2.79 ±1.68 kg(P<0.001)and -3.41±2.30 kg(P<0.001), respectively. The proportion of patients reaching HbA1c levels<7.0% increased to 30.4% both Week 20 and Week 52. Treatment-emergent adverse events (TEAEs)were observed in 90.1% of patients. The majority of AEs were mild or moderate in severity. Incidence of hypoglycemia, genital tract infection, and urinary tract infection, AE of special interests, were 1.6%, 2.2%, and 6.0%, respectively. Ipragliflozin given for 52 weeks was well tolerated and showed a sustained efficacy with a safety profile as expected in T2DM patients in both groups. Administration of ipragliflozin before or after breakfast resulted in comparable efficacy and safety.
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Topic
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転換期を迎えた肝炎事情
43巻1号(2015);View Description Hide Description2014 年11 月26 日,アッヴィ合同株式会社主催によりC 型肝炎プレスセミナーが行われた。広島大学大学院医歯薬保健学研究院疫学・疾病制御学教授の田中純子氏が『疫学的視点からみた肝炎ウイルス感染の現状と課題』を,虎の門病院分院長の熊田博光氏が『C 型肝炎治療の進歩~全症例の治癒を目指して~』を,社会福祉法人はばたき福祉事業団事務局長の柿沼章子氏が『C 型肝炎治療を円滑に進めるための就労・生活環境の確保』を講演した。患者の声の発言者として,東京肝臓友の会事務局長の米澤敦子氏も招かれた。前3 者の概要を示す。
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INFORMATION
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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;38:939-949より再掲載)
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