薬理と治療
Volume 49, Issue 2, 2021
Volumes & issues:
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扉・目次
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TOPIC
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ゲノム編集技術に関する研究開発と特許動向
49巻2号(2021);View Description Hide Description「ゲノム編集技術」とは,生物の遺伝情報に改変を加える技術である。創薬,医療,農業など幅広い産業への応用が期待されているため,実用化に必要な特許の動向についても社会的に注目されている。また,「ゲノム編集技術」(CRISPR/Cas9)を開発したジェニファー・ダウドナ教授(カリフォルニア大学バークレー校)と,エマニュエル・シャルパンティエ教授(マックスプランク感染生物学研究所)が2020 年のノーベル化学賞を受賞したことで,「ゲノム編集技術」への社会的な関心も高まることになった。本稿では,ゲノム編集技術に関する研究開発と特許動向として,特許出願や特許紛争の経緯と現状について分析し,今後の課題について考察する。 -
調整解析の意味
49巻2号(2021);View Description Hide Description多変量解析による調整解析の結果を見るたびに,なんだかブラックボックスのようで信じるしかないと思ったことがあるかもしれません。また,調整と言うけれど,何をやっているのかわからなかったという人もいるでしょう。本稿では,共変量あるいは交絡因子を復習した後,調整解析の意味を考えてみます。そして最後に,共変量の影響を取り除くための方策を述べたいと思います。
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ORIGINAL ARTICLES
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Prescription Optimization for Hospitalized Elderly Patients in Community—based Integrated Care Wards Using a Template for Pharmaceutical Intervention
49巻2号(2021);View Description Hide DescriptionBackground Many elderly patients take numerous medicines for their various ailments. Suspending the administration of unnecessary medicines and potentially inappropriate medications (PIMs)to elderly patients will lead to prescription optimization. It was previously reported that a template used at Tokyo University Hospital for evaluating medicines that patients bring to the hospital(the template) was a useful screening tool for prescription optimization in general hospitals and convalescent rehabilitation hospitals. Methods The template was used to screen patients >65 years old who were admitted to the community-based integrated care wards at 7 hospitals in Fukuoka Prefecture. All patients received pharmaceutical care in the hospital from the pharmacists who also provided prescription support to the doctors. Results Using the template, 434 patients were considered to be Group 1(requiring prescription optimization), while 341 patients were Group 2(not requiring prescription optimization). On admission, the average number of prescriptions was 8.9 in Group 1, which was significantly higher than the number in Group 2(5.8). A total of 196 of the 775 study patients discontinued prescription after a discussion and review of their prescription with pharmacists and physicians; 184 of these were patients in Group 1. The three most frequently prescribed PIMs in Group 1 were hypotensive drugs, antipyretic analgesic drugs and laxatives. Conclusion The results suggest that the template was a useful screening tool for prescription optimization in community-based integrated care hospitals and that pharmaceutical intervention during hospitalization might have contributed to the optimization of prescriptions for elderly patients. -
Short—term Effectiveness of Nexala® in the Treatment of Patients with Gonarthrosis and Coxarthrosis
49巻2号(2021);View Description Hide DescriptionObjectives We have evaluated the short︱term safety and effectiveness of Nexala® in patients with gonarthrosis and coxarthrosis; Nexala®, a formulation containing Theracurmin®(highly bioavailable curcumin), Akbamax®(enriched boswellic acid extract)and Vitamin D3(Cholecalciferol). Methods 30 patients were selected, 20 were recruited and all 20 completed the study. Treatment with Nexala® was well tolerated and did not produce any adverse effects. Results The formulation of Nexala®(2 capsules x day)reduced pain, stiffness and improved functionality significantly(P<0.0001)after a 28-day period of continuous treatment measured by WOMAC and the Lequesne Index. Conclusions Nexala® shows great potential for the treatment of patients with arthrosis; its short-term effectiveness as well as its tolerability profile makes it an ideal candidate when we need to decrease pain and inflammation and improve functionality in patients with gonarthrosis and coxarthrosis. -
【撤回論文】クリアブラックジンジャー® 含有食品の摂取が健康な成人男性のエネルギー代謝に及ぼす影響―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巻2号(2021);View Description Hide Description※著者よりデータ提供者の要望のためとして当該論文の掲載撤回の申し出がありました。Objectives We evaluated the effects of single intake of dietary supplements containing CLEAR BLACK GINGER(Kaempferia parviflora extract)on energy expenditure and metabolism among Japanese healthy adult males. Methods We conducted a randomized, double-blind, placebo-controlled, crossover study. The subjects were 24 healthy adult males, and they were divided into two groups. The subjects took two capsules containing 75 mg of CLEAR BLACK GINGER (Kaempferia parviflora extract, total 150 mg)or placebo. Respiratory metabolism was measured at rest for 15 minutes in a sitting position and during exercise for 30 minutes using an ergometer(20 W, 60 rpm). Energy expenditure was evaluated as the primary outcome. Results Twenty-three subjects completed this study. Single oral intake of the dietary supplements containing CLEAR BLACK GINGER (Kaempferia parviflora extract)significantly increased the energy expenditure during exercise compared to the placebo based on the full analysis set. After excluding, the number of subjects analyzed was 16. The energy expenditure during exercise was significantly higher in the intake of the dietary supplements containing CLEAR BLACK GINGER(Kaempferia parviflora extract)than in the intake of placebo based on the per protocol set. Furthermore, the oxygen consumption and lipid oxidation during exercise were significantly higher and respiratory quotient during exercise were significantly lower in the intake of the dietary supplements containing CLEAR BLACK GINGER(Kaempferia parviflora extract)than in the intake of placebo. There was no significant difference on carbohydrate oxidation during exercise. Conclusion Single intake of dietary supplements containing CLEAR BLACK GINGER (Kaempferia parviflora extract)increased the energy expenditure and the lipid oxidation during exercise, indicating that CLEAR BLACK GINGER(Kaempferia parviflora extract)promote energy expenditure and lipid metabolism in daily life. Thus, these findings demonstrate the utility of dietary supplements containing CLEAR BLACK GINGER(Kaempferia parviflora extract)as a functional food to assist in energy expenditure and lipid metabolism. (Clinical Trial Registration: UMIN 000045383)
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L—テアニンを含むアミノ酸等含有サプリメントの摂取が睡眠に与える影響―ランダム化二重盲検プラセボ対照並行群間比較試験―
49巻2号(2021);View Description Hide DescriptionObjective Improving the quality of sleep is important to reduce fatigue and stress, to maintain well physical and mental condition, and to achieve high performance. Previous study suggested that amino acids-containing food is indicated to improve the quality of sleep and to reduce fatigue by long-term ingestion. Also, L-theanine is reported that it boosts the quality of sleep, and it could be considered that a synergistic effect might be obtained by amino acids-containing food with L-theanine. So the aim of this study was to evaluate the possibility to enhance the effects improving the quality of sleep by their combination. Methods Three types of food capsulated samples were prepared to be containing respectively: sample A; amino acids(arginine, lysine and ornithine at low doses), sample B; sample A with L-theanine, and sample P as placebo. Each sample was ingested for 7 consecutive days. Factors of the quality of sleep were evaluated by OSA sleep inventory MA version and so on. Results By OSA questionnaire, among all groups, no remarkable difference was observed at before or after of ingestion. In each group taking sample A or B, the factors asʻsleepiness at waking upʼandʻrecovery from fatigueʼis significantly improved, and more, in group B, the factors asʻfalling asleep and sleep continuityʼʻ, sleeping periodʼ, and total of factors. Conclusions It is suggested that the combination of amino acid-containing food with L-theanine, both have sleep-improving effects, could enhance the effects improving the quality of sleep.(UMIN000034664) -
バナナの長期摂取がヒト腸内フローラおよび血液生化学に与える効果の研究―ランダム化並行群間比較試験―
49巻2号(2021);View Description Hide DescriptionObjectives The aim of this study is to elucidate the effects of banana intake on healthy subjects on their intestinal flora composition and on blood biochemical markers. Methods A randomized parallel-group comparison study was conducted on 28 healthy adults. Participants were randomized into two groups; one group to take 120 g of banana every day; another group with no test food added to their everyday food, for four weeks. Fecal sample, serum biomarkers, body composition were evaluated for intestinal flora composition and blood chemistry variation before and after the intervention term. Results The blood biochemistry showed statistical increase of magnesium in the banana group. Vitamin B6 showed no statistically significant difference between the two group after four weeks. In intestinal flora test, Akkermansia decreased significantly in banana group. Bilophila decreased significantly in banana group. Megamonas significantly decreased in both banana group and control group. Megasphaera significantly decreased in banana group. Phascolarctobacterium decreased significantly in control group. Roseburia increased significantly in control group. Ruminococcus significantly decreased in banana group. Conclusions The results suggest that taking banana may contribute to increasing magnesium which is a mineral that Japanese peopleʼs intake is lower than recommended volume. Some unfavorable flora may decrease by taking banana. UMIN ID:UMIN000040523 -
Inhibitory Effects on Acute Upper Respiratory Tract Inflammation with Black Tea Consumption―A Randomized Single—blind Parallel—group, Placebo—controlled Study―
49巻2号(2021);View Description Hide DescriptionObjective This research was conducted to investigate whether black tea consumption could inhibit acute upper respiratory tract inflammation. Method We designed a randomized single-blind, parallel-group, placebo-controlled study, with 72 healthy male/female subjects ranging in age from 20 to 60 years old. Subjects who had been preferentially selected having low levels of influenza virus type A╱H1N1 antibody titers and serum NK cell activity, were randomly assigned to receive 3 cups of black tea(n=36)or placebo(n=36)per day for 12 weeks. During the experimental period, each subject recorded their daily responses on WURSS-21 and a self-health check sheet. Influenza virus antibody titers, serum NK cell activity and salivary SIgA concentration were measured before and after the consumption period. Results All 72 subjects completed the study. Two subjects were excluded before efficacy analysis due to applicable exclusion criteria; and the remaining 70 subjects were analyzed. The efficacy of acute upper respiratory tract inflammation inhibition by consumption of black tea was not confirmed in the PPS analysis. However, in the stratified analysis for influenza vaccine non recipients(63 subjects), the incidence rate of acute upper respiratory tract inflammation was significantly lower in the black tea group(3 of 30 subjects; 10.0%)compared to the placebo group(13 of 33 subjects; 39.4%)(OR, 0.17; 95% CI, 0.04-0.68; P=0.009]), and the number of episodes per subject during consumption period was lower in the black tea group as compared to the placebo group(P=0.008). Accumulated severity score of acute upper respiratory tract inflammation symptoms and level of functional impairments to health-related QOL were measured by WURSS-21, and 42 of 63 subjects had symptoms at least once during the consumption period. In the stratified analysis for 42 symptomatic subjects, the black tea group showed significantly lower scores for 5 symptoms and 4 functional impairments to QOL. Serum NK cell activity was significantly increased in the black tea group(P=0.031) compared to the placebo group. Particularly in the subjects having low SIgA concentration baseline, consuming black tea not only increased salivary SIgA concentration higher than the baseline value, but also activated NK cells and reduced risk of incidence and frequency of acute upper respiratory tract inflammation. Conclusion Our results support the conclusion that the daily habitual consumption of black tea could be an effective dietary approach to improve or enhance innate and mucosal immunity. It is considered that these effects work to inhibit foreign antigens such as those that cause acute upper respiratory tract inflammation, and reduce the onset risk, severity of symptoms, and overall risk of physical and mental burden. Trial registration Clinical Trials: UMIN000038168 -
発酵野菜粉末含有食品の便秘状態に及ぼす効果および安全性の検討―プラセボ対照ランダム化二重盲検並行群間比較試験―
49巻2号(2021);View Description Hide DescriptionObjectives The study aimed to verify the efficacy on bowel movements and safety of dietary supplement containing fermented vegetables. Methods A randomized, doble-blind, placebo-controlled, parallel-group study was conducted for 60 participants orally intaked dietary supplement containing 625 mg of the fermented vegetables or placebo for 4 weeks. The Constipation Assessment Scale(CAS-MT), The Patient Assessment of Constipation of Quality of Life scale(PAC-QOL)and Bristol Stool Chart were used for evaluation of bowel movements. Results The CAS-MT and the PAC-QOL were significantly improved between dietary supplement and placebo after 4 weeks. Side effects related to intake of fermented vegetables were not confirmed on this study. Conclusion These results strongly suggest that the dietary supplement containing fermented vegetables can provide improved bowel movements. (Trial Registration: UMIN-CTR: UMIN000036325) -
ターミナリアベリリカ抽出物含有食品の抗肥満作用―プラセボ対照ランダム化二重盲検並行群間試験―
49巻2号(2021);View Description Hide DescriptionObjectives This randomized, double-blinded, placebo-controlled, parallel-group study aimed to evaluate the anti︱obesity effects of Terminalia bellirica extract. Methods One hundred healthy participants(23≤body mass index[BMI]<30)were selected in this study and were randomly assigned into two groups: the test food group and placebo group. The participants consumed either test food containing T. bellirica extract(41.6 mg/day as gallic acid)or placebo food, before meals for 12 weeks. Visceral fat area, subcutaneous fat area, total fat area, body weight, BMI, and waist circumference(primary outcomes)were evaluated. Results The test food group showed a significant reduction in visceral fat area, subcutaneous fat area, total fat area, body weight, and BMI(P<0.05)than the placebo food group. During the study period, no adverse events attributable to the test foods were observed. Conclusions Overall, the findings indicated that the foods containing T. bellirica extract had an anti-obesity effect in healthy participants. UMIN-CTR ID:UMIN000039552 -
Ingestion of Shekwasha Juice for the Maintenance of Body Temperature and Improvement of Blood Flow in Cold—sensitive Individuals―A Randomized, Double—blind, Placebo—controlled, Parallel—group Study―
49巻2号(2021);View Description Hide DescriptionObjective Shekwasha is a citrus fruit that is highly concentrated in hesperidin, a flavonoid purported to improve blood flow. The juice has been used for beverages. In this randomized, double-blind, placebo-controlled, parallel-group study, we evaluated the effect of shekwasha juice on body temperature and peripheral blood flow following a cold load in healthy men and women with cold sensitivity. Methods For a single day and seven consecutive days, participants ingested shekwasha juice or a placebo beverage, then their hands were submerged into 15℃ water for one minute, and changes in skin surface temperature and peripheral blood flow were monitored until 30 minutes later. Results This study showed that participants who ingested shekwasha juice experienced significantly higher recovery rates for skin temperature and blood flow after≤30 minutes following the cold load than those given the placebo beverage in both scenarios. The recovery was also noted from earlier time points in participants with seven-day ingestion than in those with single-day ingestion. Conclusions These findings demonstrate that ingesting shekwasha juice accelerates recovery of skin temperature and peripheral blood flow after a cold load in cold-sensitive individuals. This study was registered at the University Medical Information Network Center(UMINID:UMIN000035593)and ran from January to February of 2019. -
ターミナリアベリリカ抽出物含有食品の食後GLP—1 に及ぼす作用―プラセボ対照ランダム化二重盲検クロスオーバー試験―
49巻2号(2021);View Description Hide DescriptionObjectives A randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the effect of food containing an extract of Terminalia bellirica on the elevation of the postprandial levels of glucagon-like peptide-1(GLP-1). Methods Twelve healthy subjects were enrolled and randomly assigned to two groups. The experimental group ingested food containing an extract of T. bellirica (with 20.8 mg gallic acid), while the control group ingested the unmodified food as placebo; with the loading diet. The levels of GLP-1 were measured before ingestion and 30, 60, 90, 120, and 180 min after ingestion. Results The consumption of food with the T. bellirica extract significantly increased the postprandial levels of GLP-1 versus those of the placebo group. The incremental area under the curve representing the change in the levels of GLP-1 from 0 min was larger in the experimental group compared to that in the placebo group(P<0.05). Moreover, during this study period, no adverse events were observed, which could be attributed to the food containing the T. bellirica extract. Conclusions These results indicate that the ingestion of food containing the T. bellirica extract promotes the increase in the postprandial levels of GLP-1. (UMIN-CTR ID: UMIN000041013) -
Intestinal Environment Improvement by Intake of Lactobacillus plantarum MLP—2020―A Randomized, Double—blind, Placebo—controlled, Parallel—group Study―
49巻2号(2021);View Description Hide DescriptionBackground Lactobacillus plantarum MLP-2020 is a lactic acid bacterium derived from kimchi and is known to improve bowel movements. This study investigated the effect of L. plantarum MLP-2020 on the intestinal environment. Methods This randomized, double-blind, placebo-controlled, parallel-group study enrolled 60 healthy men and women with a usual frequency of 3-5 bowel movements/week. Participants were randomized to either receive a powder containing 40 billion L. plantarum MLP-2020 or to serve as a control and receive a placebo powder not containing the bacterium. Over an 8-week period, the study determined the number of bowel movements/week and performed intestinal flora analysis before and after consumption. Results The final analysis for efficacy included 57 participants after exclusion of 3 participants for noncompliance(1 in the treatment group and 2 controls). Results showed that the number of bowel movements╱week in the treatment versus placebo group was significantly increased after 6 weeks of intake. The number of Bifidobacterium spp. and Lactobacillales in the feces was significantly increased after 8 weeks of intake in the treatment versus placebo group, indicating that L. plantarum MLP-2020 improved the intestinal environment. Conclusion Lactobacillus plantarum MLP-2020 was shown to improve intestinal environment by increasing bifidobacteria. (UMIN Trial ID:000038057)
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INFORMATION
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