薬理と治療
Volume 47, Issue 7, 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2> 品質マネジメントって何をすれば良いのでしょう?~従来のQA,QCとの違い,リスクに基づく取組み~
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Risk 評価時のImpact Assessment もしくはRisk Classification における参考情報の入手
47巻7号(2019);View Description Hide Description - <シンポジウム8>「会議代表特別企画」医療機関における治験の品質マネジメント~SMOは品質もマネジメント出来るか?!~
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- <シンポジウム13>CRCとして患者の意思決定をどのように支援するか~患者と共に実施する治験・臨床研究を目指して~
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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8 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―研究の限界および結論の記載における適正性―
47巻7号(2019);View Description Hide Description
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ORIGINAL ARTICLES
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検体検出部位別・検出病棟別による大腸菌および緑膿菌の薬剤感受性の比較検討
47巻7号(2019);View Description Hide DescriptionAntibiograms are an important source of information for initiating empirical antibiotic therapy of infectious diseases. Hospital-wide antibiograms may not sufficiently support the decision-making process for performing the optimal treatment against infection in hospitalized patients. In this study, we investigated the antimicrobial susceptibility rates(SRs)of Escherichia coli and Pseudomonas aeruginosa at various detection sites and from different hospital wards which were collected from inpatients between April 2013 and March 2016 at Fukuoka University Chikushi Hospital. The first isolate collected from each detection site (blood, respiratory tract, gastrointestinal tract, urinary tract and other)for each patient was used. In the E. coli isolates, the SRs of nine antibiotics showed significant differences among detection sites, and most of them were low in respiratory tract and high in gastrointestinal tract. In the P. aeruginosa isolates, isolates from intensive care units showed significantly lower SRs of aztreonam, imipenem, and meropenem than the isolates obtained from general wards(48.8% vs. 69.6%, P<0.01;67.1% vs. 82.2%, P<0.05;and 72.0% vs. 94.1%, P<0.001, respectively). In addition, isolates from blood and respiratory tract specimens showed significantly lower SRs of meropenem in intensive care units in comparison to the same isolates obtained from general wards(55.6% vs. 100%, P<0.05 and 73.6% vs. 90.9%, P<0.05, respectively). We thus found that the SRs of several antibiotics differed depending on the detection site and the type of hospital ward, and this information may therefore be useful for performing optimal empiric therapy in the clinical setting. -
プロトンポンプ阻害薬エソメプラゾール(ネキシウム®カプセル)の長期使用に関する特定使用成績調査報告―非ステロイド性抗炎症薬投与時における胃潰瘍または十二指腸潰瘍の再発抑制―
47巻7号(2019);View Description Hide DescriptionObjective Esomeprazole, the S-isomer of omeprazole, was approved in 2011 in Japan and has since been widely used in clinical practice. Non-steroidal anti-inflammatory drugs(NSAIDs) are also widely used for chronic pain control; however, long-term use of NSAIDs is an established risk factor for peptic ulcer. This specific clinical experience investigation was conducted to confirm the long-term safety and efficacy of esomeprazole for the prevention of NSAID-related peptic ulcer in actual clinical practice. Design Safety and efficacy of esomeprazole were evaluated in the prospective case series setting. Methods Patients receiving long-term NSAIDs therapy for chronic pain control and treated with esomeprazole for the first time for prevention of recurrence of peptic ulcer were enrolled in this survey. Twenty mg of esomeprazole was administrated once a day, and the observation period was set at 1 year. Patients were enrolled via a central registration system. Adverse drug reactions, severe adverse events, ulcer -free rates, subjective symptoms, and factors that may affect safety and efficacy of esomeprazole were investigated from April 2012 to September 2014. Results In the safety analysis set of 1521 patients, 38 events of adverse drug reactions were reported in 26 patients(1.7%). No time-related trend was observed in the adverse drug reaction rate. In the efficacy analysis, ulcer-free rates were 92.7%, 90.7%, and 89.9% at 12 weeks, 24 weeks, and 52 weeks, respectively. Rates of disappearance of subjective symptoms were 90.1% for epigastric pain, 80.6% for anorexia, 80.7% for abdominal bloating, 89.7% for heartburn, 90.0% for nausea, 95.5% for vomiting, and 82.2% for burping. No new issues regarding the safety and efficacy profile of esomeprazole were found in this survey. Conclusion The present survey demonstrated that esomeprazole provides good tolerability and long-term protection against the recurrence of NSAID-related peptic ulcer in actual clinical practice in Japan. -
ヒト腸上皮細胞における植物発酵ペーストSW の抗炎症効果
47巻7号(2019);View Description Hide DescriptionObjective The aim of this study was to examine the anti-inflammatory effect of Paste of Fermented Plant Extract SW(PFPE-SW)on human intestinal epithelial cells. Methods The intestinal epithelial cell line, Caco-2, was differentiated into intestinal epithelial-like cells. PFPE-SW was added to MEM medium(with Earleʼs Salts and L-Glutamine)at a final concentration of 0.5%, 1%, and 2% for 24 hours at 37℃ in 5% CO2. Then, this medium was replaced with a medium containing PFPE-SW in the presence or absence of 100 ng╱mL TNF-α for 24 hours at 37℃ in 5% CO2. The supernatant was collected, and the concentration of interleukin-8(IL-8)was determined using the enzyme-linked immunosorbent assay. Results PFPE-SW inhibited TNF-α-mediated IL-8 production in a concentration-dependent manner(P<0.05). Even without TNF-α stimulation, at concentrations of 2% and 0.5%, PFPE-SW significantly suppressed IL-8 production(P<0.05). Conclusions PFPE-SW suppressed TNF-α-dependent and TNF-α-independent IL-8 production indicating the anti-inflammatory potential of PFPE-SW on human intestinal epithelial cells. -
緑藻クロレラChlorella pyrenoidosa 経口投与によるラット四塩化炭素誘発実験的肝障害に対する予防効果
47巻7号(2019);View Description Hide DescriptionObjective The preventive effects of chlorella on the liver injury in rats induced by the treatment with carbon tetrachloride(CCl4)were investigated. Methods The parameters of liver injuries induced by CCl4 were determined by the changes of several phygiological serum-biochemical, and histopathological examinations. Results The single subcutaneous injection(s. c.)of a high dose CCl4(1 mL╱kg)obviously suppressed the body weight and liver weight. In the groups of pre and post oral administration (p. o.)with chlorella(300, 1200 mg╱kg), the liver injuries induced by the repeated CCl4 0.25 mL╱kg(s. c.)daily for 4 days, decreased on GOT, GPT, hepatic lipid peroxide, and hepatic triglyceride contents. A tendency to inhibit cell necrosis, liver cell vacuolation, and inflammatory cell infiltration by both doses of CCl4 was also shown in histopathological examinations. Conclusions These findings suggest that chlorella might be one of the valuable preparations on hepatocellular phenomena such as cell necrosis, liver cell vacuolation, inflammatory cell infiltration, etc., in human hepatitis. -
健康成人男性を対象としたフラクトオリゴ糖含有チョコレート摂取時の血糖値推移に関する検討―プラセボ対照オープンクロスオーバー比較試験―
47巻7号(2019);View Description Hide DescriptionObjectives The aim of the present study was to investigate the effect of chocolate containing fructooligosaccharides on postprandial blood glucose in healthy males. Methods This was a randomized, open-label, placebo-controlled, crossover study. Ten male subjects(aged 51.3±4.4 years)ingested chocolate with(test diet)or without(control diet) fructooligosaccharides. Blood glucose and plasma insulin levels were measured before and 15, 30, 45, 60, 90, and 120 minutes after ingestion. Results Blood glucose at 30 minutes after ingestion of the test diet was significantly lower than after ingestion of the control diet. Plasma insulin levels at 30 and 60 minutes after ingestion of the test diet were also significantly lower than after ingestion of the control diet. Moreover, the change in area under the curve(ΔAUC)of plasma insulin levels following ingestion of the test diet was significantly lower than that following ingestion of the control diet. Conclusions The results of this study suggest that ingestion of chocolate containing fructooligosaccharides elicits significantly lower blood glucose and plasma insulin levels than ingestion of chocolate that does not contain fructooligosaccharides. -
自覚的な肩こり症状における心理状態をふまえたエゾウコギ食品の影響
47巻7号(2019);View Description Hide DescriptionObjective This study aimed to evaluate the effects of taking Acanthopanax senticosus Harms on the subjective symptom of shoulder muscle stiffness in association with mental conditions. Method A before-after comparative study without placebo was conducted in 13 Japanese male and female subjects aged between 20 and 59 years and who had a subjective symptom of shoulder muscle stiffness. The subjects received Acanthopanax senticosus Harms at 24 tablets daily for 4 consecutive weeks. Shoulder muscle stiffness and mood state were evaluated by VAS scores and POMS scores, respectively, at baseline and at treatment weeks 2 and 4. Results The VAS scores of“shoulder muscle stiffness”and“shoulder tension”significantly decreased at treatment week 4, compared to that at baseline. In addition, the POMS score of “Confusion” significantly decreased at treatment week 4. A significant negative correlation was observed between the decreased“shoulder muscle stiffness”score and the POMS score of “Vigor”at treatment week 4. Conclusion We showed that taking Acanthopanax senticosus Harms improved the subjective symptom of shoulder muscle stiffness, with mood state improvement suggested as the underlying factor. -
アロエステロールの12 週間摂取による肝機能指標における有効性の検討―ランダム化二重盲検プラセボ対照比較試験―
47巻7号(2019);View Description Hide DescriptionObjectives The aim of this study is to examine the effect of food containing Aloe sterols on liver function in 45 male candidates with suspected fatty liver. Methods A randomized, double-blind, placebo-controlled, clinical trial was designed. Adult men with fatty liver tendency were administered two different doses of Aloe sterols(low dose contains lophenol(Lo)38.8μg and cycloartenol (Cy)30.0μg and high dose contains Lo 140.0 μg and Cy 117.6μg)or placebo for 12 weeks. Levels of serum hepatic enzymes(aspartate aminotransferase(AST), alanine aminotransferase(ALT), γ-glutamyltransferase(γ-GTP)) were measured to evaluate the effects of Aloe sterols on liver function. Results ANCOVA revealed statistical differences in levels of serum hepatic enzymes between the Aloe sterol treatment groups and placebo group. Throughout the intervention period, AST and ALT levels did not differ between groups. The level of γ-GTP in high dose Aloe sterol administered group was significantly lower than placebo-control group at 12 weeks of treatment. In addition, no Aloe sterol intake-dependent harmful phenomenon was observed during in intake period. Conclusion It was confirmed that dietary ingestion of Aloe sterols is safe, because no side effects and no significant adverse events in some vital signs and serum parameters were observed. It was also suggested that the hepatic functions of the subject with suspected fatty liver was improved by 12 weeks intake of high dose of Aloe sterol. However, the evidence provided by this trial is not fully convincing because of their poor methodological quality. Therefore, more research and well-designed clinical trials are necessary to address the effects on liver. -
Safety Evaluation of Theracurmin® in Healthy Japanese Adults―A Randomized, Double—blind, Placebo—controlled Parallel—group Study―
47巻7号(2019);View Description Hide DescriptionObjectives We aimed to evaluate the safety in humans of 4-week excessive and 12-week long-term intake of Theracurmin®(highly bioavailable curcumin)through a randomized, placebo-controlled, double-blind, parallel-group study. Methods We conducted two trials from May to July 2018(trialⅠ, excessive intake trial)or May to October 2018(trialⅡ, long-term intake trial). For both trials, participants who provided informed consent and met the inclusion criteria were allocated equally but randomly into either the Theracurmin® group(T group, n=16)or the placebo group(P group, n=16), using a computerized random-number generator. In trialⅠ, participants took 10 capsules of either Theracurmin®(approximately 90 mg of curcumin╱capsule)or placebo twice per day with water after breakfast and dinner (five capsules each meal)for 4 weeks. In trialⅡ, participants took two capsules per day of either Theracurmin® or placebo with water after breakfast and dinner (one capsule after each meal)for 12 weeks. The safety evaluation included physical examination, urinalysis, blood analysis, and subjective symptoms. Results One participant did not have a satisfactory ingestion rate(<90%)and thus was excluded from the analysis; the remaining 31 participants were analyzed as per protocol(T group n=15; P group n=16)in both trialsⅠ and Ⅱ. No adverse effects were reported regarding the test food. Conclusions These trials proved the safety of 4-week excessive and 12-week long-term intake of Theracurmin®. Trial registration UMIN-CTR: UMIN000032640(trialⅠ, excessive intake); UMIN000032641 (trialⅡ, long-term intake) Funding THERAVALUES CORPORATION -
中高年齢の健常者の脂質代謝に及ぼすDHA およびEPA を含む精製魚油摂取の影響―血中トリグリセリド値を用いた層別解析―
47巻7号(2019);View Description Hide DescriptionObjectives The objective of this study was to investigate the effect of purified fish oil-containing DHA and EPA as capsular diet(FO diet)on serum triglycerides(TG)in middle-aged Japanese men and women with normal or mildly high serum TG. Methods A randomized double-blind placebo-controlled clinical trial was conducted in 66 subjects. They were randomly assigned to 2 groups and received either FO diet containing 544 mg DHA and 59.2 mg EPA or placebo once daily for 12 weeks. The effect of FO diet was evaluated by analyzing serum TG collected baseline and after 4, 8 and 12 weeks. The efficacies of FO diet intake were evaluated by comparing the change from baseline between the FO diet and Placebo groups. Results The DHA and EPA containing in FO diet significantly lowered serum TG subsequent to 8 and 12 weeks of supplementation. Next, the subject(n=37)with normal serum TG based on the TG level(<150 mg╱dL); TG levels were substantially decreased in the FO diet group (n=19, P=0.050)after the 12-weeks compared with the Placebo group(n=18). Conclusions The DHA and EPA containing in FO diet may have benefits in lowering serum TG in middle-aged Japanese men and women with normal serum TG.
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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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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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