薬理と治療

厚生労働省は,「我が国においては,長時間労働が問題となっており,長時間労働の削減は喫緊の課題である.これに取り組むため,「働き方の見直し」に向けた企業への働きかけや,長時間労働が疑われる事業場に対する監督指導の徹底等を行っている」1)ことをホ-ムペ-ジに明記している.長時間労働がもたらす不利益としては,労災や自殺者の発生(精神障害等),生産性の低下,残業によるコスト増大,労働基準法違反による罰則,企業イメ-ジの低下など,個人だけではなく営業母体に対する悪影響ももたらすこととなる.医療現場で働くCRCにとっても,長時間労働の削減は取り組むべき課題と認知され,個々のCRC あるいは組織全体としての改善案が検討されている.当院では,2012 年に5 日間のCRC の労働調査を行った.当時,CRC は12 名在籍し,1 日あたりの労働時間はCRC の業務時間の中央値は13 時間(最小 10 時間,最大14 時間)であり,個人差が大きい現状にあった.CRCの職種により勤務形態は異なっていたが定時を17 時とすると,大半のスタッフが22 時まで働いているのが常態化しており2),長時間労働の削減につながる業務改善は当院の治験推進部(当時の治験センタ-)としても,取り組むべき優先度が高い課題であった.当時部門長になったばかりの筆者は「残業時間の短縮」「働きやすい環境整備」を目標に掲げた.平成24 年から令和5 年度までの約11 年間にわたって当院での業務改善に向けた取組みを紹介する.業務改善に悩む他医療機関の参考になれば幸いである.

臨床開発の国際化が加速するなか,日本において国際競争力を高めるためには,「Quality」以外に「Cost」や「Speed」を意識しなければならなくなった.東京都健康長寿医療センタ-では,認知症の治験を多く受託しているが,認知症を対象とした治験デザインが年々複雑化するなか,どのようにCRCのパフォ-マンスを向上させるかが大きな課題となっている.また,COVID-19 が流行したことで業務におけるDX 化が一段と加速され,CRC の業務内容にも変化をもたらした.本稿では,業務の効率化の観点から,CRCが未来の医療を支えるために魅力あふれるCRC とはどうあるべきかを考えていきたい.

Background　Cognitive decline negatively affects medication adherence, for which patients require support from family members and healthcare staff. Previous studies that targeted caregivers and family members suggested that transdermal patches could be useful for medication support and interdisciplinary collaboration. Objective　To clarify perceptions of home–visit nurses on the suitability of transdermal patches as dosage for medication support in individuals with dementia. Methods　A web–based survey was conducted for home–visit nurses working at nursing stations, hospitals, or clinics in Japan. Results　A total of 385 valid responses were obtained. Transdermal patches were found to be the most easily administered and supported medication form for individuals with dementia. Most home–visit nurses(75.1%)responded that prescribing transdermal patches led to continued medication in individuals with dementia, and 60.5% reported patients were able to continue pharmacotherapy via switching to transdermal patches. Some respondents(41.0%)expressed a preference for having transdermal patches prescribed as early as possible, and 66.0% responded that prescribing transdermal patches as the initial medication would be a better choice. Additionally, 42.9% of respondents answered that prescribing transdermal patches was suitable for all levels of dementia severity. However, the response to adverse drug events related to transdermal patches may be insufficient even among home–visit nurses. Conclusions　This survey suggests that for individuals with dementia who receive home–based care, transdermal patches may be useful for continuing medication, supporting medication by family members and healthcare staff, and interdisciplinary collaboration.(UMIN000053927)(Jpn Pharmacol Ther 2024;52:1141‒57)

Background　Orally disintegrating tablets(ODTs)are often recognized as suitable primarily for elderly patients; however, the extent to which non-elderly patients(aged 20–<65 years)are satisfied with ODTs remains unclear. This study aimed to evaluate the satisfaction with ODTs among non-elderly patients with type 2 diabetes(T2D)who received diabetes pharmacotherapy. Methods　A web–based survey on ODTs was conducted among individuals aged 20–<65 years who were registered with a healthcare web service for health insurance association members. Satisfaction with ODTs was surveyed among respondents who indicated in a screening survey that they were receiving diabetes pharmacotherapy. The health insurance data of the respondents were used to determine their age, gender, prescription records, and T2D treatment status based on their prescription history and T2D registry. Results　Of the 187 non-elderly respondents with T2D who were aware of and had taken ODTs, 161(86.1%)were satisfied with them. Common reasons for satisfaction with ODTs were“They can be taken without water”(67.7%)“, They are easy to take”(51.6%), and“They can be taken anywhere”(37.3%). However, only 19.0% of the 1315 non-elderly patients with T2D were aware of ODTs. Conclusions　For various reasons, including ease of administration, ODTs were considered acceptable by many of non-elderly patients with T2D who have prior experience taking them. However, ODTs are still not well known among non-elderly patients with T2D. Increased awareness of ODTs may lead to greater use among them.(jRCT1030230612)(Jpn Pharmacol Ther 2024;52:1161‒83)

Objective　AQUASOLITA®(AQS)is a beverage intended to replenish water and electrolytes, containing sodium(35 mEq/L), potassium(20 mEq/L), chloride(33 mEq/L), and glucose (1.1%). In this study, the effect of AQS on water and electrolyte replenishment in healthy adult men with sauna–induced dehydration was evaluated. Method　A randomized, crossover trial, using mineral water (MW)as a control, was conducted in 30 healthy men. All participants underwent three 10–minute sauna bathing sessions. After that, participants ingested either AQS or MW in an amount equivalent to their weight loss. Body weight, serum and urinary electrolytes concentrations, hematological parameters, and blood chemistry values were evaluated from before sauna bathing up to 240 minutes after ingestion. Result　Participants exhibited mild dehydration after sauna bathing. After ingesting the test beverages, the AQS group showed significantly better recovery compared to the MW group in serum Na(30, 60, 120 minutes after ingestion), K(30, 60, 120 minutes), Cl(30, 60 minutes), and FENa(60, 120, 180, 240 minutes), despite no significant difference in body weight change. Especially, the estimated mean group difference of FENa, as an indicator of hydration effect, was the largest at 120 minutes(0.42, 95% CI: 0.31–0.53). Moreover, the estimated mean group differences of Na, K, and Cl at the same time were 0.8(95% CI: 0.39–1.20), 0.15(95% CI:0.04–0.25), and 0.37(95% CI: -0.04–0.78), respectively. Conclusion　Although AQUASOLITA®, an oral dehydration solution, was effective for water and electrolyte replenishment in healthy adults with sauna–induced dehydration, there was no significant difference in body weight change.(Jpn Pharmacol Ther 2024;52:1185‒204)

Objectives　The widespread use of Visual Display Terminals(VDTs), such as monitors and smartphones, has raised concerns about their adverse effects on visual function. This study aims to investigate the extended benefits of ingesting Vaccinium Myrtillus Anthocyanins (VMAs), previously demonstrated to improve ocular blood flow and reduce ciliary muscle strain, on visual function parameters. Methods　A randomized, double–blind, placebo–controlled crossover trial was conducted with 30 healthy adults. Participants were administered either a test food(Standardized Bilberry Extract(SBE)107 mg, as 40 mg VMAs)or a placebo once daily for two weeks. The effects on kinetic visual acuity, depth perception, and night vision after performing tasks on VDTs were observed. Results　The SBE intake group showed significant improvements in kinetic visual acuity(P=0.048), depth perception(P=0.046), and night vision(P=0.0033)compared to the placebo group. Conclusion　This study suggests that SBE intake may extend its benefits to improve kinetic visual acuity, depth perception, and night vision.(UMIN–CTR ID: UMIN000051795)(Jpn Pharmacol Ther 2024;52:1205‒17)

Objectives　The purpose of this study was to evaluate the effects of continuous gum ingestion on oral and physical performance in athletes. Methods　Twenty–two professional soccer players participated in a open–label non–randomized pre–post comparison test. Subjects were measured for oral and physical performance before and after the 1 year gum consumption intervention. Results　Occlusal balance, static balance, and vertical jump improved significantly after intervention. Conclusions　In conclusion, one year of gum consumption suggested improved occlusal balance and physical performance.(Jpn Pharmacol Ther 2024;52:1219‒24)

連続変数同士の関連性は相関係数を使って判断するでしょう.相関係数= 0 を帰無仮説としたt 検定を使うこともあります.また,二値変数同士の関連性なら,2×2 表(クロス表,分割表)でカイ二乗検定を使うでしょう.セルの数字が小さいときは,フィッシャ-の直接確率法(Fisher’s exact test)を使うかもしれません.今回は,この2×2 表の関連性分析について,多くの例を交えて解説します.

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.