薬理と治療

Purpose　This study aimed to clarify whether systematic review (SR) notifications published on the Consumer Affairs Agency’s (CAA) website after April 2024 were appropriately described based on standards using “PRISMA-P (PRISMA 2020 compatible version),” an adaptation made to be consistent with PRISMA 2020. Methods　All submitted papers based on SRs published on the CAA website from April 1, 2024 to September 30, 2024 were eligible. Among these, only SRs that had protocols registered in a research registration database (DB) were included. We used each item on the PRISMA-P (2015) checklist to evaluate protocols, but with the publication of PRISMA 2020, there were some inconsistencies with the PRISMA-P items. Therefore, the content of PRISMA-P was rearranged to reflect the requirements of PRISMA 2020. Results　Of the 40 eligible SRs, eight (20%) had protocol study registrations, all of which were registered with UMIN-CTR. For item #6, rationale in the introduction (preface), seven articles (88%) had deficiencies, and for item #7, purpose, three articles (38%) had deficiencies in outcomes. In the methodology section, there were deficiencies in the eligibility criteria (#8) in five articles (63%), the sources (#9) in seven articles (88%), and the search methods (#10) in seven articles (88%). In the study records, there were deficiencies in the following items: data management (#11a) in seven (88%)studies; risk of bias of individual studies (#14) in seven (88%) studies; and certainty of evidence (#17) in seven articles (88%). Conclusions　All submitted SRs were registered in UMIN-CTR as a DB for research registration. However, UMIN-CTR had significantly fewer items specified as SRs than PRISMA-P (PRISMA 2020 compatible version), which led to incomplete or insufficient entries. To solve this problem, those planning to conduct SRs need to make the protocols public by following these steps: i) create a complete protocol using PRISMA-P (PRISMA 2020 compatible version) as the base format; ii) store the protocol semi-permanently on the cloud or other platform where it can be viewed by anyone and they can obtain its URL; and iii) paste and link the URL when registering the research on UMIN-CTR or other sites. This series of steps emphasizes the importance of making the complete protocol available for anyone to view.

We measured the contents of the main components in Eucommia bark where lignan glucosides pinoresinol diglucoside(PDG), syringaresinol diglucoside(SDG), and the iridoid glucoside geniposidic acid(GEA)were found, respectively. 　　SDG is known as a lignan glucoside which has an anti–stress effect depending on the secretion of β–endorphin. It is predicted that Eucommia bark will also secrete sufficient β–endorphin and have an anti–stress effect in both rats and humans. 　　Therefore, Eucommia bark can surely be considered a tonic herbal medicine as demonstrated in the long history of use in China. 　　It is suggested that the administration of agents which increase circulatory atrial natrium peptide(ANP)levels in plasma might have therapeutic benefits. It is proposed that the coexistence of PDG and GEA in Eucommia bark extract(EBE)secretes ANP in humans, followed by the action to brown adipose tissue(BAT)and white adipose tissue(WAT), showing the anti–obesity effect, which improves the insulin resistance. (Jpn Pharmacol Ther 2025;53:119‒23)

Background　In April 2023, Japanʼs first donepezil transdermal patch(Allydone® Patch)was released. Oral administration can be difficult in patients with Alzheimerʼs disease(AD), and the use of a patch is expected to improve adherence. The efficacy and safety of Allydone® Patch have been verified to be non–inferior to that of donepezil oral formulations, but there have been few reports in clinical practice. Methods　In this study, we retrospectively examined the efficacy and safety of Allydone® Patch early(1–2 months)after administration in 211 AD patients treated at Aoba Hospital, Yojokan Medical Corporation. Results　The retention rate with Allydone® Patch was 75.4%. Discontinuation due to application site disorders was 4.7%, and discontinuation due to gastrointestinal disorders was 0.5%. After administration of Allydone® Patch, the Revised Hasegawa Dementia Scale(HDS–R)scores showed significant increases in total score, delayed recall, and orientation scores. An increase in HDS–R scores was observed regardless of the presence or absence of prior treatment or severity. Conclusions　Since Allydone® Patch can be administered at an effective dose from the start, it is effective from an early stage after administration in real–world clinical practice and can improve cognitive function regardless of the presence or absence of prior treatment or severity. When prescribing, it is important to provide guidance on skin care and measures to prevent skin disorders.(Jpn Pharmacol Ther 2025;53:125‒36)

Background　The stratum corneum of the skin changes with age such as in the stiffness, thickness, hydration, and the barrier function. Accumulation of old stratum corneum can lead to skin roughness, wrinkles, and dullness. For the treatment of these symptoms, peeling of the old stratum corneum at the skin surface has been proposed to be effective since ancient times. Previously, we demonstrated that the daily application of peeling gel or facial wash containing natural ingredients removed facial wrinkles. In this study, we examined the effect of medical peeling mask containing natural ingredients twice a week on the wrinkles around eyes and the condition of the face skin. It is expected that the application method with the mask with longer incubation time could deliver the active ingredients to the skin more effectively, nevertheless the frequency of intervention in this study was reduced. Methods　The study was carried out with 13 healthy female subjects with age ranging between 38 and 59 years. They used Whitening Turulina Sheet, provided by Mʼz Science Corporation, Fukuoka, Japan, only to one side of their faces twice a week. After the trial for 4 weeks, the wrinkles were evaluated from the photo of both sides of their faces by the skilled inspectors, according to the wrinkle grade established by Japanese Cosmetic Science Society. The skin condition of both sides of their faces was also examined by the questionnaire. Results　Judge by the special inspectors from the photos of both sides of the subjectʼs faces indicated the statistical significance of the wrinkles only on the side of the faces using the peeling mask. Comparison of the changes in the wrinkles between the two sides of the faces also supported the difference. The result of the questionnaire showed that the subjects of the study recognized statistical significance not only in wrinkles, but also in the skin condition, moisturization, glowing, transparency, brightness, softness and so on. Conclusions　The peeling mask containing natural ingredients improved the facial wrinkles around eyes and the skin condition, possibly not only by the removal of the old stratum corneum at the skin surface but also rejuvenating the dermal layer of the skin by the various bioactive substrates. (UMIN ID: UMIN000052970)(Jpn Pharmacol Ther 2025;53:137‒46)

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.