薬理と治療

筆者がClinical Research Coordinator(CRC) になったのは病院への復職がきっかけである.企業の産業看護師として職員の健康管理やメンタルヘルス対策などに従事していたが,臨床が恋しくなり,2007年に北海道大学病院に再就職した.臨床から離れていたことや子供が未就学児であったことから外来勤務を希望し,看護部から配属されたのが治験管理センタ-であった.治験という言葉もCRC の存在も知らなかった筆者は,知らない単語ばかりが飛び交うなかで,看護師とも違うCRC の業務に何をしたらよいのかわからず,指示待ちをしては怒られてばかりの辛い日々だった.そんななか,ある医師から「CRC は臨床研究を行ううえで,研究者の大事なパ-トナ-なのだから,勉強して一緒にがんばろう」と叱咤激励を受けた.患者さんや患者さんのご家族からは,「治験に参加してよかった」「治験は患者の希望だ」「CRC さんがいてくれて受診の励みになった」と声をかけていただいた.同僚にも支えられ,担当のモニタ-さんにはGood Clinical Practice (GCP)を教えてもらいながら,CRC の道を歩み始めた.1997 年に新GCP が施行され,1998 年より本邦でのCRC 養成研修が始まり,ちょうど10 年が経とうとしていた時期だった.この頃は,院内の配置転換でCRC になった方も多かったのではないかと思う.そんなCRC の情報交換の場として開催されていたのが,「CRC と臨床試験のあり方を考える会議」(以下,CRC あり方会議)である.あり方会議ではCRCの創設期を築いてくださった先輩たちが,壇上で治験・臨床研究のコ-ディネ-ト手法などについて,熱く議論を交わしていた.きらきらと自信に満ち溢れている先輩方をみて,CRCという仕事に対するやりがいや楽しさを教えてもらい,いつか筆者も立派なCRC になりたいと考えるようになった.一般演題の発表では,各施設のさまざまな創意工夫が報告されており,多くのCRC が自施設で力戦奮闘しながら業務にあたっていることを知ることができ,共感を覚えることも多かった.毎年参加するだけではなく,自分たちもがんばっていることを発表しようと,北大の取り組みを一般演題として発表した.発表者となることで他施設のCRC との質疑の機会が増え,さらに知り合いを増やすことができた.他施設の方々とのつながりや,業務のヒント,たくさんの学びを得ることができるこの会議を「いつか札幌で」というのが筆者の一つの目標となり,仲間内の合言葉にもなった.2020 年,CRCあり方会議の代表の公募が始まり,上長である佐藤典宏機構長から,ある団体からの推薦を受けてみるかとのお話があり手続きを終えたころ,懐かしい先輩からの1 本の電話があった.CRCあり方会議の代表に選定されたとのことだった.「いつかは札幌で開催したい」と言っていた夢が目標になる瞬間,後先考えずに「やります」と即答していた.

Objective　This study aimed to evaluate the effects of an exercise intervention and a protein diet on cognitive function and olfactory function. Methods　A before–and–after study was conducted on healthy women aged 65 years and older, with　mini–mental state examination(MMSE)scores ranging from 24 to 30.　　Participants underwent a 24–week intervention consisting of a protein diet containing 8.9 g of protein and a circuit training program, which included 12 exercises and aerobic training, performed three times per week. The primary outcome measures included MMSE scores and olfactory function scores. Olfactory function was assessed using a kit containing a variety of fragrances that have been previously reported to correlate with cognitive function. Participants were asked to identify the scents, and scores were recorded based on their ability to correctly identify each fragrance. Secondary outcome measures comprised a questionnaire survey, ravenʼ s colored progressive matrices(RCPM)and body mass index(BMI). Results　Fifteen participants, with a mean MMSE score of 27.5(ranged 25 to 30)and average olfactory function score of 7.8(ranged 4 to 10), underwent the circuit training intervention. After 24 weeks, MMSE scores increased by 1.1(95% CI:-0.4 to 2.5, P=0.14), and olfactory function scores increased by 0.9(95% CI:0.01 to 1.7, P=0.048). Conclusion　This study suggests that circuit training and protein diet might improve olfactory acuity in healthy older women, but there is no change with cognitive function.(UMIN―CTR ID: UMIN000049147)(Jpn Pharmacol Ther 2025;53:465‒72)

Objective　This study aimed to evaluate the efficacy of Every Support–ORS plus(EORS+)on the absorption and excretion of water and electrolytes in a human dehydration model induced by heat stress in a sauna. Methods　A randomized, open label, two–period crossover comparative trial was conducted involving healthy male participants subjected to heat–stress–induced dehydration via sauna use. Participants consumed either EORS+ or placebo in an amount equivalent to their estimated water loss, as calculated from weight reduction after sauna stress. The primary endpoint was the change in body weight observed over 4 hours post–ingestion. Secondary endpoints included blood and urinary biomarkers, as well as other symptoms, monitored over the same 4–hours period. Results　Twenty–two healthy male participants were enrolled in this study. After 4 hours, the reduction in body weight was 0.45 kg following ingestion of EORS+, compared to 0.61 kg with mineral water(MW), resulting in a between–group difference of 0.14 kg(95% CI　0.06–0.21, P=0.001). Additionally, EORS+ was associated with higher levels of serum sodium(Difference 　1.21 mEq/L, 95% CI　0.73–1.70, P<0.001), chloride(Difference　1.16 mEq/L, 95% CI 0.57–1.74, P<0.001), osmotic pressure(Difference　1.39 mOsm/kg, 95% CI　0.29–2.48, P=0.014), and water balance(Difference　87.72 g, 95% CI　2.53–172.91, P=0.044)at 4 hours post–ingestion. Furthermore, participants who consumed EORS+ demonstrated an earlier recovery in blood biomarkers following sauna–induced dehydration. Scores for subjective symptoms did not differ significantly between the groups. No adverse events related to the test solution were reported in this trial. Conclusions　The findings suggest that EORS+ facilitates early recovery from dehydration induced by sauna–related heat stress in healthy adults by supporting efficient rehydration and electrolyte replenishment.(UMIN ID: UMIN000054399)(Jpn Pharmacol Ther 2025;53:473‒88)　

Objective　This study examined the bowel movement–improving effect of a supplement containing Lactococcus cremoris Flora aid(Flora aid®)in healthy Japanese adults. Methods　This double–blind, placebo–controlled, randomized, parallel–group comparison study was conducted on 36 of consenting participants who defecate 3–5 times per week were randomly assigned to one of three groups(50 billion cells/day, 100 billion cells/day, and placebo;12 per group). The participants were administered either 50 or 100 billion cells/day of Flora aid® or a placebo capsule daily for 4 weeks. The primary outcome was the weekly stool frequency after 4–week consumption and secondary outcomes were the volume of defecation per week; stool shape; stool odor; feeling of defecation; constipation assessment scale scores; fecal bacterial occupancy rate; fecal examination; visual analog scale scores of subjective fatigue; OSA sleep inventory scores; and salivary cortisol and whole blood serotonin levels. Results　A total of 34 participants were analyzed. The mean difference of weekly stool frequency after 4–week consumption versus placebo was 1.8 times(95% CI 0.5–3.0;P=0.009) for 100 billion cells/day and 1.1 times(95% CI -0.1–2.4;P=0.077)for 50 billion cells/day, respectively. No adverse events were observed. Conclusions　Intake of Flora aid® increases the weekly stool frequency. Trial registration　UMIN000051675 Foundation　NICORIO(Jpn Pharmacol Ther 2025;53:489‒521)

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.