2.The Association between Statin Use and the Risk of Sleep Disturbances: Data Mining of Claims Database
Mai Fujimoto ; Masashi Takamoto ; Kouichi Hosomi ; Mitsutaka Takada
Japanese Journal of Drug Informatics 2014;16(2):53-62
Objective: To examine the association between statin use and the risk of sleep disturbances, data mining was performed on a claims database.
Methods: Symmetry analysis was carried out to identify the risk of sleep disturbances after statin use during the period from January 2005 to December 2011. Statin use in combination with hypnotic drugs was examined by prescription sequence symmetry analysis. In this study, hypnotic drugs that are commonly prescribed for the treatment of insomnia were used as markers of sleep disturbances produced by statins. Likewise, event sequence symmetry analysis was undertaken to evaluate the association between statin use and the diagnosis of sleep disturbances.
Results: Significant associations of statin use with short-acting hypnotic drugs were found, with an adjusted SR (sequence ratio) of 1.23 (95%CI: 1.04-1.45) at an interval of 12 months. Otherwise, significant associations between individual statin use and hypnotic drug use were not found. Significant associations between use of statins and the diagnosis of sleep disturbances were not also found in this study.
Conclusions: Analysis of the claim database demonstrated that statin therapy might be associated with an emergence of sleep disturbances. Therefore, individuals prescribed statins should be considered as having an increased risk of sleep disturbances.
3.Improvements in Intractable Lumbar and LowerExtremity Symptoms after Systemic Administration of Tocilizumab, an Anti-interleukin-6 Receptor Antibody
Takeshi SAINOH ; Takeshi SAINOH ; Sumihisa ORITA ; Sumihisa ORITA ; Masayuki MIYAGI ; Masayuki MIYAGI ; Miyako SUZUKI-NARITA ; Miyako SUZUKI-NARITA ; Yoshihiro SAKUMA ; Yoshihiro SAKUMA ; Yasuhiro OIKAWA ; Yasuhiro OIKAWA ; Go KUBOTA ; Go KUBOTA ; Jun SATO ; Jun SATO ; Yasuhiro SHIGA ; Yasuhiro SHIGA ; Kazuki FUJIMOTO ; Kazuki FUJIMOTO ; Yawara EGUCHI ; Yawara EGUCHI ; Masao KODA ; Masao KODA ; Yasuchika AOKI ; Yasuchika AOKI ; Tsutomu AKAZAWA ; Tsutomu AKAZAWA ; Takeo FURUYA ; Takeo FURUYA ; Junichi NAKAMURA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Hiroshi TAKAHASHI ; Satoshi MAKI ; Satoshi MAKI ; Masahiro INOUE ; Masahiro INOUE ; Hideyuki KINOSHITA ; Hideyuki KINOSHITA ; Masaki NORIMOTO ; Masaki NORIMOTO ; Takashi SATO ; Takashi SATO ; Masashi SATO ; Masashi SATO ; Masahiro SUZUKI ; Masahiro SUZUKI ; Keigo ENOMOTO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Norichika MIZUKI ; Takashi HOZUMI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Ryuto TSUCHIYA ; Geundong KIM ; Geundong KIM ; Takuma OTAGIRI ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Takahisa HISHIYA ; Seiji OHTORI ; Seiji OHTORI ; Kazuhide INAGE ; Kazuhide INAGE
Asian Spine Journal 2022;16(1):99-106
Methods:
This prospective, single-arm study included 11 patients (eight men; mean age, 62.7 years) with ≥3-months’ chronic pain history due to lumbar disease. Subcutaneous TCZ injections were administered twice, at a 2-week interval. We evaluated low back pain, leg pain, and leg numbness using numeric rating scales and the Oswestry Disability Index (ODI; baseline and 6 months postinjection); serum IL-6 and tumor necrosis factor-α levels (baseline and 1 month postinjection); and clinical adverse events.
Results:
Intractable symptoms reduced after TCZ administration. Low back pain improved for 6 months. Improvements in leg pain and numbness peaked at 4 and 1 month, respectively. Improvements in ODI were significant at 1 month and peaked at 4 months. Serum IL-6 was increased at 1 month. IL-6 responders (i.e., patients with IL-6 increases >10 pg/mL) showed particularly significant improvements in leg pain at 2 weeks, 1 month, and 2 months compared with nonresponders. We observed no apparent adverse events.
Conclusions
Systemic TCZ administration improved symptoms effectively for 6 months, with peak improvements at 1–4 months and no adverse events. Changing serum IL-6 levels correlated with leg pain improvements; further studies are warranted to elucidate the mechanistic connections between lumbar disorders and inflammatory cytokines.
4.Report on the Implementation of an Interactive Online Hands-on Seminar for Making Rehabilitation Orthosis with Vietnam in the Period of Travel Restriction
Kazuki MIYAZAKI ; Ayumi MIYAGI ; Hitomi KARAKI ; Ayumi MORIYAMA ; Masashi FUJIMOTO ; Yuriko EGAMI ; Junko FUJITANI ; Tetsuo HARA
Journal of International Health 2023;38(4):193-201
Background and Objective The Projects of Global Growth of Medical Technologies, implemented by NCGM since 2015, have contributed to human resource development through on-site training in partner countries and training in Japan. However, since 2020, online training has become mainstream due to the travel restrictions by COVID-19 impact. As one of the projects, the NCGM and Bach Mai Hospital rehabilitation departments in Vietnam held an interactive online hands-on seminar in FY2022 for Vietnamese occupational therapists and others to provide technical guidance for making splint orthoses to rehabilitate patients with hand dysfunction. This paper aims to report on the preparation and implementation process of the seminar and its results.Preparation and Implementation of the Seminar NCGM (the instructor) and Bach Mai Hospital (the site of the hands-on training) prepared the seminar through regular online meetings, fostering ownership and collaborative planning on the Vietnamese side, and discussed the program development, necessary materials, participant selection, and obtaining authorization from the Vietnamese Ministry of Health. To ensure the quality of the technical instruction, the seminar was connected via Zoom to both NCGM and Bach Mai Hospital, where the live video of the splinting technique was conducted, along with explanations and Q&A sessions. The post-training evaluation was carried out through a questionnaire with self-assessment of the participants about the knowledge and skills they obtained. Outcome and Discussion As a result, 96% (27/28) of the participants answered that the seminar was “useful for clinical practice,” suggesting that the interactive online hands-on seminar regarding technical instruction in making splint orthosis was as good as or better than the face-to-face training. We found that the Vietnamese side took ownership from the preparatory stage by establishing a regular online meeting system; the quality of the training was assured by live video by both sides, which enabled detailed technical instruction; the training provider’s skills were improved by more detailed preparation; training was cost-effective compared to on-site training or training in Japan; and the materials used and the training videos can be used as teaching materials, which is expected local benefits and sustainability. These findings can be applied to face-to-face training to make the training more effective and extended as a useful method when similar activities are developed in other countries.