薬理と治療

Amy C. Edmondson は1999 年「Psychological Safety and Learning Behavior in Work Teams(心理的安全性と職場チ-ムの学習行動)」1)において,心理的安全性の概念を初めて体系的に提唱した.心理的安全性は,「関連のある考えや感情について人々が気兼ねなく発言できる雰囲気」と定義されている.さらには,チ-ムで仕事をするなかで,次のような対人リスクを感じると述べている.①質問したり情報を求めたりすると「無知だと思われる不安」,②間違いを認めたり,支援を求めたりすると「無能だと思われる不安」,③過去や現在の活動や仕事を批判的な目で評価すると「ネガティブだと思われる不安」,④意見や情報や支援を求めると「邪魔をする人だと思われる不安」.職場で働く際にこうした不安についても,チ-ムの心理的安全性が高ければ,不安が緩和され,率直な発言が促進されると報告した.その後,Google によるProject Aristotle2)とよばれる研究にて高パフォ-マンスなチ-ムの要因一つとして,心理的安全性(Psychological Safety)が重要であることが明らかになった.これにより,心理的安全性の言葉は一般に広く知られるようになり,他企業でもチ-ムビルディングや組織文化の改革に応用した取り組みが報告されるようになっている.本邦においても,医療安全3)や離職予防4)に関連する研究にて,心理的安全性を向上させる取り組みが組織の効果的な学習やパフォ-マンス向上につながったことの報告や,田原らは,チ-ムの心理的安全性がワ-ク・エンゲイジメントを介して,パフォ-マンスだけでなく,ストレス低減や職務満足感の増大というメンバ-のメンタルヘルスにも影響する報告を行い,組織内での心理的安全性を向上させることの意義については2021 年以降,多数報告がなされている5).そこで岡山大学病院新医療研究開発センタ-治験推進部(以下,当部)CRC 部門でも,心理的安全性について考え,向上させるための取り組みを検討したため,報告する.

The effect of a single dose of calcium alginate(Ca–Alg)capsules on the postprandial increase in blood triglycerides(TG)was investigated in rats. When rats were treated with 500 mg/kg of corn oil, the difference in plasma TG concentration at 2h post–dose(ΔC2h)and the difference in the area under the plasma concentration–time curve up to 4h post–dose(ΔAUC0–4h)were higher than in the corn oil non–treated group. When rats were administered 500 mg/kg of corn oil followed by Ca–Alg at doses of 5 and 8 mg/body, decreases in plasma TG concentration at two points after administration and in ΔAUC0–4h were observed compared to the Ca–Alg non–treated group. These results suggest that Ca–Alg has an inhibitory effect on the postprandial rise in plasma TG.(Jpn Pharmacol Ther 2025;53:389‒94)

Objective　Tramadol/acetaminophen tablet(T/A)have been reported to be highly effective as a postoperative analgesic in the orthopedic surgery, but various side effects such as nausea occur. Since the equivalence of brand–name and generic drugs is often evaluated only by dissolution tests, and there are few reports on clinical evaluation of safety equivalence, we compared the discontinuation rate of T/A due to nausea between brand–name and generic drugs. Methods　Patients who underwent orthopedic surgery and used brand–name drugs from December 2018 to May 2019 and generic drugs from June 2019 to January 2020 were included. Discontinuations were defined as those patients who were instructed to stop taking medication due to nausea, and the discontinuation rate of T/A due to nausea was compared between the brand and generic groups. The evaluation period was 3 weeks after the start of T/A. Results　The number of patients was 57 in the brand drug group and 62 in the generic group. There were no differences in patient backgrounds between the brand drug and generic drug groups, and there were no statistically significant differences in the discontinuation rate due to nausea during the 3–week period of T/A administration. Conclusions　There were no statistical differences in safety between the T/A brand drug group and the generic drug group, suggesting clinical equivalence in safety. Since this study was conducted in a limited number of patients over a short period of time, further studies are needed to determine whether the safety profile is equivalent over a longer period of time and in a variety of patient groups.(Jpn Pharmacol Ther 2025;53:395‒400)

Objectives　Antimicrobial Stewardship Team(AST)rounds were introduced following the establishment of the Department of Infection Control and Prevention at Fukuoka University Chikushi Hospital. This study, aimed to compare process indicators(i.e., antimicrobial use density [AUD]and days of therapy[DOT])and outcome indicators(i.e., length of stay, 30–day all–cause mortality, and antimicrobial susceptibilities)before and after the implementation of AST rounds among patients monitored by the AST. Methods　In total of 1,044 patients monitored by the AST at our hospital were included in the analysis. The patients were divided into two groups: the pre– and post–AST groups. The two groups were compared. Results　Statistically significant differences were observed in the AUD and DOT for carbapenems between the post–AST and pre–AST groups(2.68 vs. 2.24, P=0.02; 5.10 vs. 4.10, P= 0.02). The length of hospital stay also differed significantly between the two groups(22 vs. 19 days, P=0.003). Furthermore, the susceptibility of Pseudomonas aeruginosa to antibiotics tended to improve for almost all antibiotics, except for meropenem and amikacin, in the post–AST group compared with that in the pre–AST group. Conclusions　This study suggests that the implementation of AST rounds promotes the appropriate use of carbapenem antibiotics and improves outcome indicators such as reduced hospital stays and enhanced susceptibility of P. aeruginosa. We hope that this study encourages the adoption of AST rounds in more healthcare facilities, ultimately improving both process and outcome indicators.(Jpn Pharmacol Ther 2025;53:401‒8)

Objective　The aim of this study was to investigate the effect of Lactobacillus paracasei subsp. paracasei NY1301–containing beverage on sleep quality. Methods　We conducted a randomized, double–blind, placebo–controlled, parallel group study. Healthy Japanese participants over 20 years of age with poor sleep quality were randomized to the placebo or NY1301 groups. Participants received either a NY1301–containing test drink or a placebo drink for 8 weeks. Sleep quality was assessed using the Oguri–Shirakawa–Azumi Sleep Inventory MA version(OSA–MA)and visual analogue scale(VAS)for sleep quality as primary endpoints. Secondary endpoints included an evaluation with a sleep electroencephalograph and an evaluation with an activity tracker that monitors sleep quality by measuring physical condition and physical activity. Results　One hundred and two healthy Japanese participants were included, and the per protocol analysis set was 102 subjects. There were no statistically significant differences in the change in the OSA–MA score(mean difference: -0.3, 95% CI: -2.4, 1.8, P=0.78)and VAS score for sleep(mean difference: 1.0, 95% CI: -8.7, 10.6, P=0.84)between the placebo and NY1301 groups. There were also no statistically significant differences in secondary endpoints between the placebo and NY1301 groups. Conclusions　The results of this study suggest that taking NY1301 for 8 weeks may not improve sleep quality in subjects with poor sleep quality. (UMIN ID: UMIN000051908)(Jpn Pharmacol Ther 2025;53:411‒21)

CONSORT(Consolidated Standards of Reporting Trials: 臨床試験報告に関する統合基準)声明はランダム化比較試験(randomized controlled trial: RCT)の報告を改善するために,世界中で広く用いられている.Kenneth Schulzらは,新たな方法論的エビデンスと蓄積された経験に基づいて改訂した最新版CONSORT 2010を発表した.