薬理と治療
Volume 47, Issue 5, 2019
Volumes & issues:
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扉・目次
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TOPICS 第18回CRCと臨床試験のあり方を考える会議 2018 in 富山
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- シンポジウム4 /がん臨床試験の最前線はこれだ!~がん免疫療法を中心としたがん臨床試験の知識を深化する~
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SERIES 機能性表示食品制度における届け出されたレビューの現状
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<第4 回>機能性表示食品制度における届出されたシステマティック・レビューの報告の質―情報源と検索における現状と課題―
47巻5号(2019);View Description Hide Description -
<第5 回>機能性表示食品制度における届出されたシステマティック・レビューの報告の質―バイアス・リスク評価の適正性―
47巻5号(2019);View Description Hide Description
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ORIGINAL ARTICLES
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当帰芍薬散の着床不全モデルラットに対する改善効果
47巻5号(2019);View Description Hide DescriptionBackground Tokishakuyakusan(TSS)is a Kampo medicine, which has been prescribed to treat infertility. Its precise mechanism of action, however, remains unclear. Leukemia inhibitory factor(LIF)in the endometrium plays an indispensable role in embryo implantation and is linked to infertility or implantation failure. Here, we investigated whether TSS promoted endometrial LIF production and ameliorated implantation failure induced by mifepristone(RU-486)in rats. Methods Human endometrial epithelial HEC-1-A cells were treated with TSS or with 31 compounds derived from the constituent crude drug of TSS for 24 h, and the LIF concentrations in cell culture supernatants were measured. To examine the absorption of active components to the blood, plasma samples after oral administration of TSS were analyzed by liquid chromatography-tandem mass spectrometry(LC︱MS╱MS). The implantation failure rat model was developed by subcutaneous administration of RU-486 on day 3 post-coitus. The rats were fed TSS-containing(1% or 3%)or a control diet from day 13 pre-coitus, and subsequently implantation sites were assessed on day 8 post-coitus. Results TSS significantly enhanced LIF production. Ten components, particularly Levistolide A, Atractylodin, and Tumulosic acid, significantly promoted LIF production. Seven active components, including these three components, absorbed into the blood. RU-486 decreased the number of implantation sites in the uterus of the rats in a dose-dependent manner, and the decrease was significantly alleviated by TSS(3%-diet). Conclusion TSS and several of its active components promote endometrial LIF production and TSS ameliorates implantation failure in rats. These findings highlight the beneficial effects of TSS on infertility. -
植物発酵液SW の抗酸化作用
47巻5号(2019);View Description Hide DescriptionObjectives The present study aimed to validate the antioxidant effect of Liquid of Fermented Plant Extract SW(LFPE-SW), containing numerous fruits and vegetables. Methods We evaluated the antioxidant capacity of LFPE-SW using superoxide radicals, hydroxyl radicals, hydrogen peroxide, and free radicals. The scavenging ability of superoxide radicals was evaluated as the superoxide dismutase(SOD)-like activity. We calculated the impact on hydroxyl radicals from the hydroxyl radical antioxidant capacity(HORAC)value. Furthermore, we assessed the eliminating ability of hydrogen peroxides from their catalase-like activity and measured the scavenging ability of free radicals using 2,2-diphenyl-1-picrylhydrazyl(DPPH). Results LFPE-SW scavenged superoxide radicals at ≤0.5% concentration. In addition, LFPE-SW scavenged hydroxyl radicals in a dose-dependent manner, and the HORAC value was 161.9μM GAE╱g. While LFPE -SW at ≥2% concentration eliminated hydrogen peroxides, ≥1% exhibited the scavenging activity for DPPH radicals. Conclusions Although LFPE-SW exhibits low antioxidant ability for hydrogen peroxides, it displays high antioxidant ability in superoxide radicals, hydroxyl radicals, and DPPH radicals, suggesting that LFPE-SW exerts antioxidant effects. -
健常者を対象としたプラズマローゲン摂取による脳機能改善効果―プラセボ対照ランダム化二重盲検並行群間比較試験―
47巻5号(2019);View Description Hide DescriptionObjectives In the study, we investigated the effects of dietary plasmalogen supplementation on cognitive function. Methods We conducted a randomized, double-blind, placebo-controlled parallel-group study. Seventy-five healthy volunteers aged between 50 and 80 years old with memory complaints were randomized the plasmalogen group(intake of plasmalogen 0.5 mg or 1 mg╱day)and the placebo group(UMIN ID:UMIN000031250). To evaluate cognitive function, the subjects visited the clinic on the initiation of the intervention and after 4 and 12 weeks, participated Cognitrax test. Result In the plasmalogen group, some cognitive function indexes were significantly improved compared to those in the baseline period. However, no significant intergroup differences were found. In the subgroup analysis with older aged subjects(≳60 years old), verbal memory index and psychomotor speed index in the plasmalogen group were significantly improved than those in the placebo group. No adverse events attributed to the test samples were observed in this study. Conclusion These results suggest that daily supplementation of plasmalogen may improve the cognitive function in the older population aged above 60 years. -
β—クリプトキサンチンを高含有するミカン果汁の摂取が内臓脂肪面積に及ぼす影響―無作為化二重盲検並行群間比較法―
47巻5号(2019);View Description Hide DescriptionObjectives We investigated the effects of feeding Satsuma mandarin juice containing high content of β-cryptoxanthin for 8 weeks on visceral fat area in healthy volunteers. Methods We conducted a randomized, double-blind, parallel-group comparative study. Subjects whose BMI was 23-30 were divided into the two groups: one receiving concentrated β-cryptoxanthin︱rich juice(β-cryptoxanthin 4.0 mg per 200 mL╱day)and another receiving concentrated β-cryptoxanthin-non-rich juice (β-cryptoxanthin 1.6 mg per 200 mL╱day)for 8 weeks. Results The β-cryptoxanthin-rich juice induced the significant reduction of the visceral fat area after 5 weeks and 8 weeks compared to the start of the feeding. Moreover, the visceral fat area in the β-cryptoxanthin-rich juice group were significantly lower than that in the β-cryptoxanthin-non-rich juice group.Conclusions These result suggested that β-cryptoxanthin-rich Satsuma mandarin juice has the effect to reduce visceral fat area. -
酒粕と米麹を使用した甘酒の摂取による便通へ及ぼす効果―ランダム化プラセボ対照並行群間比較試験―
47巻5号(2019);View Description Hide DescriptionObjectives The aim of this study was to investigate the effect of oral intake of Amazake using the lees and rice koji on bowel movements on slight constipation patients. Methods This placebo-controlled parallel-group comparison study included 38 female adult slight constipation patients. Subjects were divided into 17 subjects who drink 190 g of hot water(control food)for 30 days and 21 drinking 190 g(test food)of Morinaga Amazake, and finally in 12 subjects who took control food intake group and 19 subjects who took test food were included in the analysis. Subjects recorded the number of bowel movements per day and the number of tablets of the magnesium carbonate which ingested per day, and also the amount of stools, the strength of odor, the state of the stool and the sensation after defecation per bowel movement. Results With 30 days of Morinaga Amazake 190 g drinking, number of bowel movements per day, the amount of stools, the state of the stool and the sensation after defecation per bowel movement were improved compared to control food ingested. In addition, it decreased the number of tablets of the magnesium carbonate which ingested per day while making increase of bowel movement. Conclusions Ingestion of 190 g of Morinaga Amazake for 30 days is considered to have an effect of improving bowel movement. -
エイコサペンタエン酸・ドコサヘキサエン酸含有魚油の摂取による手指末梢体温への影響評価―ランダム化プラセボ対照二重盲検並行群間比較試験―
47巻5号(2019);View Description Hide DescriptionObjectives This study aimed to investigate the effect of supplementation with fish oil rich in eicosapentaenoic acid(EPA)and docosahexaenoic acid(DHA)on peripheral temperature and feeling of coldness in healthy women. Methods A randomized, double-blind, placebo-controlled, parallel-design study was conducted for 32 female subjects feeling coldness, aged 20 to 49 years. The subjects consumed either EPA-rich fish oil 2.4 g containing EPA 600 mg and DHA 260 mg╱day or the equivalent volume corn oil containing no EPA and DHA as placebo for 8 weeks. The peripheral temperature and blood flow were measured under staying in an air︱conditioned room and after cold water stress. The questionnaire on related to feeling of coldness was assessed. All examination was measured before and after taking the test supplements, and the questionnaire was also measured after 4 weeks. Results At the resting peripheral temperature after taking the test supplements for 8 weeks, the minimum temperature of fingers significantly increased in the EPA group compared to the placebo group. At resting peripheral blood flow showed no significant difference between the groups before and after the intake of supplements, respectively. The score of the questionnaire on relating to feeling of coldness was significantly reduced in the EPA group compared to the placebo group. Conclusions These results showed that 8 weeks of EPA╱DHA supplementation increased peripheral temperature at the resting in healthy female feeling of coldness. -
健常な閉経後女性におけるゼラチン継続摂取が肌の弾力と主観的評価に及ぼす効果―ランダム化二重盲検プラセボ対照並行群間比較試験―
47巻5号(2019);View Description Hide DescriptionBackground Previous human studies have demonstrated that collagen hydrolysate improved facial skin conditions. However, there are limited studies which evaluate the effect of long-term ingestion of gelatin on human skin. Methods The present randomized, double-blind, placebo-controlled parallel-group, comparison clinical study, evaluated 44 post-menopausal(55-65 years old)healthy volunteers. Gelatin group(n=22)ingested 5 g of gelatin twice daily for 8 weeks. Placebo group(n=22) ingested 5 g of maltodextrin twice daily for 8 weeks. Measurement of facial skin viscoelasticity and subjective evaluation of skin condition(Visual Analogue Scale╱VAS)were carried out before the first ingestion(0 W)and after 8 weeks(8 W)of ingestion. Results At the end of the study, there was no association between gelatin ingestion and skin viscoelasticity. Among volunteers whose skin elasticity (R7) is higher than or equal to 0.3 at 0 W, the placebo group (n=8) showed significant deterioration in R7 value at 8 W (due to environmental factor). On the other hand, the gelatin group (n=9) showed no remarkable deterioration. Furthermore, variation in VAS score of[dark area in lower part of eyes]was significantly improved in gelatin group(n=9)but not in placebo group(n=8). Conclusion These results suggested that continuous ingestion of 10 g of gelatin for 8 weeks improved skin viscoelasticity(R7)and skin condition in post-menopausal healthy volunteers with skin elasticity(R7)higher than or equal to 0.3. No side effects were noted throughout the study.
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CASE REPORT
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バンコマイシン血中濃度モニタリング評価に難渋した血液腫瘍患者2 症例の薬物動態学的評価とその問題点
47巻5号(2019);View Description Hide Description症例1:節外性NK╱T 細胞性リンパ腫の64 歳男性。発熱性好中球減少症(FN)にてバンコマイシン(VCM)を投与。VCM の血中濃度から推測される全身クリアランス(CLsys)はシスタチンC による推算糸球体濾過速から予測されるよりも高値であり,なんらかの要因によりVCM の消失が亢進していると考えられた。 症例2:急性前骨髄性白血病の46 歳女性。FN にてVCM投与が行われた。VCMの推奨最大用量である4 g╱day にてトラフ濃度16μg╱mLが得られたが,用量,腎機能ともに不変にもかかわらず数日後には26μg╱mL へと急激に上昇し,VCM 濃度が偽低値を示していた可能性が考えられた。 本症例同様に,血液腫瘍患者ではVCM の血中濃度が正確に評価できない事例が報告されている。VCM の初回トラフ濃度が用量や腎機能,体格などから想定されるよりも低値の場合には,シスタチンCによる腎機能の再評価やIgM 濃度測定と他の測定法によりVCMの血中濃度を再評価する必要がある。
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COLUMN
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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;38:939-49.より再掲載)
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