薬理と治療
Volume 46, Issue 9, 2018
Volumes & issues:
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扉・目次
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TOPICS 第17回CRCと臨床試験のあり方を考える会議 2017 in 名古屋
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- シンポジウム4/説明文書,何をどこまで?
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- シンポジウム9/医療現場のニーズから始まる医療機器開発
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REVIEW
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ORIGINAL ARTICLES
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Agaricus blazei Murrill 培養菌糸体由来グルコマンナン(ATOM)のヒト癌型K—ras 遺伝子発現誘導型肺腺癌マウスにおける抗癌効果
46巻9号(2018);View Description Hide DescriptionObjective We investigated the antitumor effect of glucomannan(ATOM: Antitumor Organic substance Mie)from the mycelium of liquid-cultured Agaricus blazei Murrill on oncogenic K-rasG12V mediated lung adenocarcinoma formation in mice. Methods We examined on the antitumor effect and immune-histopathological test by the oral or intraperitoneal, administration using oncogenic K-rasG12V driven lung adenocarcinoma genesis bearing mice. Results The tumor was demonstrated to be oncogenic K-rasG12V driven lung adenocarcinoma. ATOM was glucomannan with a main chain of β-1,2-linked D-mannopyranosyl residues and β-D- gulcopyranosyl-3-O-β-D-gulcopyranosyl residues as a side chain. In the group oral administration with ATOM 250 mg╱kg╱day a highly significant inhibition was observed as compared with the control group. However the intraperitoneal administration at dose of 250 mg╱kg showed a weak antitumor effect. Conclusions These findings suggest that oral administration of ATOM may have a tumor suppressive effect on lung adenocarcinoma formation in vivo. -
Safety Evaluation of Aloe vera Gel Powder Containing Aloe Sterols in a 90—day Feeding Study in Rats
46巻9号(2018);View Description Hide DescriptionWe assessed the repeated-dose oral toxicity of Aloe vera gel powder(AVGP)in male and female Sprague-Dawley rats by dietary administration for 90 days. Concentrations of 0.188%, 0.750%, and 3.000% in the diet resulted in more than 100, 400, and 1000 mg╱kg╱day intakes of AVGP, respectively. Treatment with AVGP did not induce any signs of toxicity in examinations including clinical signs, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, blood chemistry, organ weights, gross pathology, and histopathology. In conclusion, the no observed adverse effect level of AVGP in a 90-day dietary toxicity study was judged to be greater than 1800 mg╱kg╱day(more than 160-fold the human intake in the previously conducted efficacy tests) -
慢性閉塞性肺疾患(COPD)患者に対するシムビコート® タービュヘイラー® の安全性および有効性の検討―長期使用に関する特定使用成績調査―
46巻9号(2018);View Description Hide DescriptionObjectives A clinical experience investigation was conducted in patients with chronic obstructive pulmonary disease(COPD)using Symbicort(R) Turbuhaler(R)(budesonide╱formoterol combination)in order to confirm its long-term safety and efficacy during routine clinical use in the post-marketing phase. Methods Patients were recruited primarily from the internal medicine and respiratory disease departments of medical institutions using the central registration method. Over a 1-year observation period, adverse events were investigated to evaluate safety, and changes in respiratory function test values(FVC, FEV1), COPD-related clinical questionnaire(CCQ)scores, and COPD exacerbations were investigated to evaluate efficacy. Results Adverse drug reactions(ADRs)were reported in 65(5.8%, 82 events)of the 1123 patients included in the safety population. ADRs reported in ≥3 patients were dysphonia, oropharyngeal discomfort, palpitations, bronchitis, oral candidiasis, pneumonia, and cough. Serious adverse events(AEs)were reported in 84 patients(7.5%, 125 events); a drug relationship was ruled out for all but 7 serious AEs: pneumonia in 4 patients, and unstable angina, cardiac failure, and compression fracture in one patient each. ADRs possibly related to the pharmacological effect of a beta2 agonist were reported in 13 patients(1.2%, 14 events), and ADRs possibly related to the pharmacological effect of a corticosteroid were reported in 37 patients(3.3%, 39 events). Serious cardiovascular AEs were reported in 15 patients(1.3%, 16 events), and pneumonia-related AEs were reported in 61 patients(5.4%, 74 events). Statistical significance was reported at all time points(Week 12, Week 26, 1 year, and last patient observation) in terms of mean change from baseline in FVC, FEV1, and CCQ symptom, functional state, mental state, and total scores. COPD exacerbations were reported in 45 patients(4.0%). Conclusion A clinical experience investigation of Symbicort(R) Turbuhaler(R) during routine long-term use revealed no noteworthy new signals in terms of safety and confirmed efficacy for improving symptoms and lung function. -
メマンチン塩酸塩投与による副作用発現の危険因子に関する後方視的調査
46巻9号(2018);View Description Hide DescriptionBackground Alzheimerʼs disease(AD)is a progressive neurodegenerative disease, the core symptom of which is cognitive dysfunction. Memantine(MMT)is a renally excreted drug that is used in the treatment of AD; it is necessary to adjust the dose according to the renal function. However, there are no reports related to the renal function and adverse reactions. Method We retrospectively investigated the medical records of 253 AD patients in whom MMT treatment was started in the Department of Neurology, Fukuoka University Hospital between July 2011 and June 2016(male, n=110;female, n=143;mean age, 81.5 ±7.8 years). In 95 patients(37.5%), MMT treatment was reduced or discontinued within 52 weeks after its initiation. Results Nervous system symptoms were the most common reason for discontinuation╱dose reduction. The risk factors for MMT discontinuation or dose reduction due to adverse reactions included female sex and a maximum MMT dose of≤10 mg. In comparison to the group with a good renal function(eGFR≥45 mL╱min), the rate of MMT discontinuation or dose reduction was significantly higher(P<0.01)in the renal malfunction group(eGFR <45 mL╱min). The rates of discontinuation╱dose reduction according to the creatinine clearance rate(CCr)were as follows: CCr>50 mL╱min, 21.1%;CCr 30-50 mL╱min, 48.1%;and CCr<30 mL╱min, 55.6%. Conclusions The renal function is an important factor in avoiding adverse reactions in MMT-treated patients; thus, it is also suggested that it is more likely to cause adverse reaction by gradual increase of MMT in patients with a CCr of<30-50 mL╱min. -
Effects of Intake of Bacillus coagulans SANK 70258,“ Spore—forming Lactic Acid Bacteria” on Bowel Movement in Healthy Volunteers ―A Randomized, Double—blind, Placebo—controlled, Parallel—group Study―
46巻9号(2018);View Description Hide DescriptionBackground Health benefits of Bacillus coagulans SANK 70258, spore-forming lactic acid bacteria, has been claimed. Preliminary results suggest its benefit on bowel movement. Objective To confirm bowel movement-promoting effect of B. coagulans in a randomized, double-blind, placebo-controlled, parallel-group study.Methods/study design Volunteers(n=60)whose stool frequency was relatively lower were enrolled. Subjects were randomly allocated to B. coagulans-containing food group(group A, n=30)or placebo group(group P, n=30). Stool frequency, stool properties, amount of defecation, and pattern of intestinal flora populations were investigated in the pre-observation period and during the investigational food intake period of 2 weeks, and changes from the pre-observation period values were analyzed. Results The changes in stool frequency between the two periods in the per protocol population(n=58)were 3.0±3.0 and 1.6±2.9 times╱2 weeks in groups A and P, respectively(P=0.09). The intergroup difference was significant in the population(n=53)after excluding subjects who took an antibiotic or experienced a change in eating habit(3.0±3.0 and 1.2±2.8 times╱2 weeks in groups A and P, respectively, P=0.03). No significant intergroup differences were found in the changes in stool properties, defecation amount, and intestinal flora pattern. No serious adverse event related to the active food intake was observed. Conclusion Benefit of B. coagulans intake on bowel movement is suggested. -
アロマ含有キャンディの摂取による風邪症状の緩和効果について―ランダム化プラセボ対照並行群間比較試験―
46巻9号(2018);View Description Hide DescriptionObjective The aim of the present study was to evaluate the effect of aromatic compound and polyphenol-containing candy(hereafter referred as“aroma candy”)on the general observation of cold symptoms. Methods The effects of aroma candy on the specified cold symptoms was evaluated in a randomized, placebo-controlled parallel-group comparison study with fifty-one(51)healthy volunteers. Test article and placebo groups were treated with three(3)drops╱day for twenty-eight(28)consecutive days in which Visual Analogue Scale(VAS)method was used to evaluate the effect of aroma candy on symptomatic aspects accompanied with cold. Results In the VAS evaluation of both groups before the treatment, the test article group showed marginally higher incidence than the placebo group in a discomfort of the throat. In a comparative assessment of cold symptoms between before and after treatment, it was shown that the subjective scoring of a hoarse voice after treatment with the test article was significantly lower than that before treatment. It was also demonstrated that a throat discomfort and sore throat score after treatment with the test article was marginally lower than that before treatment, however the placebo group did not show any significant difference, even though in a marginal manner, in the comparative before-after evaluation. Conclusions The above-mentioned observation suggests that the aroma candy taken as a daily diet is beneficial candidate to relieve symptoms resulting from a cold. -
乳酸菌B240 の継続摂取が健常成人の唾液成分および性状に及ぼす影響―無作為化二重盲検プラセボ対照比較試験―
46巻9号(2018);View Description Hide DescriptionObjectives The aims of this study were to investigate the effect of B240 on saliva secretion on the different target age and dosage form from previous study, and to obtain knowledge about the mechanisms of saliva secretion. In addition, it was aimed at examining the possibility of the biological defense function of the oral cavity by B240. Methods The study was a randomized, double-blind, placebo-controlled study with 60 male and female healthy adults between 40 and 65 years old. All the subjects consumed their test tablets at breakfast for 28 days. Saliva weight, mucin content, pH, buffer capacity and cortisol concentration were measured. Results The intake of the B240 tablets increased the saliva weight and mucin content. However, the pH, buffer capacity and cortisol concentration were unchanged. Conclusions These findings suggest that B240 contributes to the production of substances related to the oral cavity defense. These results suggest that B240 has a potential to maintain the health of the oral cavity. -
微細藻類ドナリエラ・バーダウィル由来β—カロテン摂取による日本人の視機能に対する影響―ランダム化二重盲検プラセボ比較試験―
46巻9号(2018);View Description Hide DescriptionIn a recent Japanese daily life style, eyes have to work hard, such as seeing a LCD screen, driving a car, etc. These life styles are considered as one of factors, which lead to vision deterioration. In this study, we let a young generation take beta-carotene derived from microalgae Dunaliella bardawil (hereinafter “Dunaliella beta-carotene”), which can give the effect on retinal visual function, and investigated the effect on the visual function in a double-blind placebo comparison study. Dunaliella beta-carotene is reported that it can improve visual function, especially expanding of a visual field, and can improve vision on retinitis pigmentosa patients. Therefore, in this study, we conducted the placebo control double︱blind study about the effect on suppress of low vision and on improvement of various symptoms of eyes in the daily life. As a result, it showed improvement tendency about bleariness, good vision in the evening and night, dry eye, headache frequency, facilitating to watch a hand and facilitating to watch a sign and a billboard at night. In addition, we recognized significant improvement on visual recovery, comparing between placebo group and treatment group by Dunaliella beta-carotene intake(. P<0.01)Therefore, we would like to report the result(. UMIN-CTR000030606) -
濃縮紅麹カプセルの摂取によるコレステロール調節効果の評価―無作為化二重盲検プラセボ対照並行群間比較試験―
46巻9号(2018);View Description Hide DescriptionFor the purpose of examining the effect of serum cholesterol regulation when we consecutively administered concentrated red malt containing 3.75 mg of Monacoline K per 2 capsules╱day for 12 weeks, a randomized double-blind placebo-controlled parallel group comparison study was conducted with healthy 30 to 59 years old male and female who are high in serum cholesterol. We conducted efficacy tes(t serum cholesterol test)and safety tes(t physical measurement, measurement of blood pressure and pulse, blood test), and as a result, serum cholesterol regulatory effect was observed. In addition, no adverse events and no problems were confirmed during the examination, so the safety of the concentrated red malt capsule was confirmed. Red malt can be said to be a food material that can be taken safely in everyday diet and can expect serum cholesterol regulation. -
Regulation of Adiposity by Para—metabobiotic Lactobacillus amylovorus CP1563 in Healthy Normal and Pre—obese Adult Individuals―A Randomized Controlled Trial―
46巻9号(2018);View Description Hide DescriptionObjectives We aimed to evaluate the effect of daily ingestion of CP1563 on the reduction of abdominal visceral fat area(VFA)and subcutaneous fat area(SFA) and to confirm the benefits for ordinary people in their body mass indices(BMIs)from 23 or more but less than 30. Method This study was investigated in a double-blind, randomized controlled trial of 200 healthy adults with wide variations in their BMIs from 23 or greater to less than 30 and including normal to pre-obese ranges according to the criteria of the World Health Organization(WHO). Result In the CP1563 group, the abdominal VFA and total fat area(TFA) were significantly decreased, and Apolipoprotein A-I(Apo A-I)plasma concentration was also significantly increased compared with those in the placebo group during the 24-week trial period. In stratified analyses, in Cluster I which included participants with a visceral fat area of less than 100 cm2, body weight(BW), BMI, VFA, SFA and TFA were significantly decreased. Moreover, plasma concentration of Apo A-I was simultaneously increased in the CP1563 group compared with those in the placebo group. In Cluster Ⅱ included participants without metabolic syndrome(MetS)and adiposity, the BW, BMI, VFA, TFA and apolipoprotein B(Apo B)╱Apo A-I ratio were significantly decreased. In addition, Apo A︱I plasma concentration was significantly increased in the CP1563 group compared with those in the placebo group. Conclusions The fragmented para-probiotic CP1563 described in this report is effective in reducing VFA. (Trial registration:UMIN 000022842) -
乳酸発酵卵白は健常な日本人成人の内臓脂肪型肥満を改善する
46巻9号(2018);View Description Hide DescriptionBackground Previously, we reported that lactic fermented egg white(LE)improves visceral fat obesity. Objective We excluded diagnosed patients with obesity, impaired glucose tolerance, dyslipidemia and hypertension in the previously published study1) and reanalysis was conducted for the purpose of prevention of metabolic syndrome. Methods Participants included 26 adult males and females aged ≥40 years(Visceral fat area (VFA)at navel ≥100 cm2). They were divided into two groups: the control group(n=13)and LE group(n=13). The control and LE groups consumed drinks containing whey and LE, respectively, for 12 weeks (providing 8 g protein╱day). LE drink included 4.17 g╱day ovalbumin. VFA was measured at baseline and at week 12 of intake. Results Due to ingestion of LE, change in visceral fat area(Δcm2)around the umbilicus was -10.4 cm2, which was significantly lower than before ingestion. This value was significantly lower than that of the control group(+0.2 cm2)(P<0.05). In the group which ingested LE, the ratio of visceral fat area to subcutaneous fat area was also significantly improved compared to both before ingestion and the control group(P<0.05). Conclusions We demonstrated that LE also decreased visceral fat area in healthy subjects and that the ratio of VFA to subcutaneous fat area also improved. These results indicate that LE could be used for the prevention of visceral fat obesity(. UMIN 000026949)
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COLUMN
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INFORMATION
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臨床試験を報告するための指針−CONSORT 声明に準拠して論文を執筆するための15 項目(薬理と治療2017; 45: 339-44. より再掲載)
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