1.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.
2.Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study
Kazuhide INAGE ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masao KODA ; Yasuchika AOKI ; Toshiaki KOTANI ; Tsutomu AKAZAWA ; Takeo FURUYA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Miyako SUZUKI-NARITA ; Satoshi MAKI ; Shigeo HAGIWARA ; Masahiro INOUE ; Masaki NORIMOTO ; Hideyuki KINOSHITA ; Takashi SATO ; Masashi SATO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Geundong KIM ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Seiji OHTORI
Yonsei Medical Journal 2021;62(9):829-835
Purpose:
In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects.
Materials and Methods:
Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab.
Results:
A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine.
Conclusion
Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.
3.Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study
Kazuhide INAGE ; Sumihisa ORITA ; Yawara EGUCHI ; Yasuhiro SHIGA ; Masao KODA ; Yasuchika AOKI ; Toshiaki KOTANI ; Tsutomu AKAZAWA ; Takeo FURUYA ; Junichi NAKAMURA ; Hiroshi TAKAHASHI ; Miyako SUZUKI-NARITA ; Satoshi MAKI ; Shigeo HAGIWARA ; Masahiro INOUE ; Masaki NORIMOTO ; Hideyuki KINOSHITA ; Takashi SATO ; Masashi SATO ; Keigo ENOMOTO ; Hiromitsu TAKAOKA ; Norichika MIZUKI ; Takashi HOZUMI ; Ryuto TSUCHIYA ; Geundong KIM ; Takuma OTAGIRI ; Tomohito MUKAIHATA ; Takahisa HISHIYA ; Seiji OHTORI
Yonsei Medical Journal 2021;62(9):829-835
Purpose:
In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects.
Materials and Methods:
Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab.
Results:
A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine.
Conclusion
Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.
4.Effect of Pharmacist Intervention in Outpatient Clinic—Pain Evaluation for Nerve Block Patients Using Pain Vision—
Kazutoshi TERAYAMA ; Kunihisa MIURA ; Tamaki WATANABE ; Masao TSUCHIYA ; Nobuhiro YASUNO ; Shigekazu WATANABE
Japanese Journal of Social Pharmacy 2021;40(1):36-42
Pain is a common problem all over the world. A previous report estimated that the prevalence of pain is 40% in Japan. One of the roles of pharmacist is to build evidence with more patient-centered care, but less in region of pain. Our objective was to identify pharmacists’ contributions to patient care through pain-management using PainVision (PV) in an outpatient pain clinic and interventions with polypharmacy. We investigated 28 patients who underwent nerve blocks. Pain were assessed relatively and subjectively using PV and numerical analogue scale (NRS), respectively. The pharmacist intervened pre- and post-nerve block. Interventions focused on evaluations of pain, drug efficacy, complications, blood pressure, pulse rate, and oxygen saturation. Wilcoxon signed-rank test, Spearman rank correlation coefficient and Friedman test were used to analyze the data. The mean age of the patients was 77 (interquartile range 69-84) years, and 12 patients were diagnosed with zoster-associated pain. The pharmacists consulted with patients 213 times and evaluated pain 426 times. We found that the analgesic effect of nerve block were evaluated PV (70; 23-162→20; 5.0-49) and NRS (4; 2-6→1; 0-2) by pharmacist, significantly. It was significant correlation between PV and NRS (r=0.799: P<0.001). Our study showed similar results to previous studies in which doctors and nurses used PV. It is clinically valuable for pharmacists to using PV in outpatient clinics to evaluate pain. Greater roles for pharmacists in hospital outpatient department should be considered, especially pharmacist-led clinical research.
5.Study on Drug Release from 25 Products of NSAIDs for External Use (4 Components) Using the Franz Diffusion Cell
Isao MURAKAMI ; Shigekazu WATANABE ; Masao TSUCHIYA
Japanese Journal of Drug Informatics 2018;20(2):90-97
Objective: An evaluation index for drug release was measured in 25 currently used non‐steroidal anti‐inflammatory drugs (NSAIDs) for external use (4 components: indomethacin, diclofenac sodium, ketoprofen, and suprofen).Methods: All release tests were performed using the Franz diffusion cell with phosphate buffered saline (PBS) as the receptor phase and an artificial membrane to maintain uniform measurement conditions. The receptor phase was collected over time and measured using high performance liquid chromatography (HPLC) to calculate the release rate. The measurement time points were set over 0-4 h based on clinical use. Furthermore, the additives were compared among the products.Results: The release profile of diclofenac sodium was similar among all 8 products. On the other hand, the release rate of IN‐E (15.0% after 4 h) from indomethacin was higher than that from the other 6 products (6.2-9.1% after 4 h). The release rate of KE‐D (39.2% after 4 h) from ketoprofen was higher than that from the cream, KE‐C (30.6 % after 4 h). For suprofen, the release rate of SU‐E from the cream (18.1% after 4 h) was 1.6-1.7‐times higher than that of the other 2 products (10.9-11.3 %). No release was detected from 3 suprofen ointments.Conclusion: Differences in the additives may have been a cause of the observed differences in release over 0-4 h. This study may serve as a useful index for pharmacists to propose and select appropriate drugs.
6.Effect of Patient Characteristics on Vessel Enhancement at Lower Extremity CT Angiography.
Takanori MASUDA ; Takeshi NAKAURA ; Yoshinori FUNAMA ; Tomoyasu SATO ; Toru HIGAKI ; Masao KIGUCHI ; Yukari YAMASHITA ; Naoyuki IMADA ; Kazuo AWAI
Korean Journal of Radiology 2018;19(2):265-271
OBJECTIVE: To evaluate the effect of patient characteristics on popliteal aortic contrast enhancement at lower extremity CT angiography (LE-CTA) scanning. MATERIALS AND METHODS: Prior informed consent to participate was obtained from all 158 patients. All were examined using a routine protocol; the scanning parameters were tube voltage 100 kVp, tube current 100 mA to 770 mA (noise index 12), 0.5-second rotation, 1.25-mm detector row width, 0.516 beam pitch, and 41.2-mm table movement, and the contrast material was 85.0 mL. Cardiac output (CO) was measured with a portable electrical velocimeter within 5 minutes of starting the CT scan. To evaluate the effects of age, sex, body size, CO, and scan delay on the CT number of popliteal artery, the researchers used multivariate regression analysis. RESULTS: A significant positive correlation was seen between the CT number of the popliteal artery and the patient age (r = 0.39, p < 0.01). A significant inverse correlation was observed between the CT number of the popliteal artery and the height (r = −0.48), total body weight (r = −0.52), body mass index (r = −0.33), body surface area (BSA) (r = −0.56), lean body weight (r = −0.56), and CO (r = −0.35) (p < 0.001 for all). There was no significant correlation between the enhancement and the scan delay (r = 0.06, p = 0.47). The BSA, CO, and age had significant effects on the CT number (standardized regression: BSA −0.42, CO −0.22, age 0.15; p < 0.05, respectively). CONCLUSION: The BSA, CO, and age are significantly correlated with the CT number of the popliteal artery on LE-CTA.
Angiography*
;
Body Mass Index
;
Body Size
;
Body Surface Area
;
Body Weight
;
Cardiac Output
;
Humans
;
Informed Consent
;
Lower Extremity*
;
Popliteal Artery
;
Tomography, X-Ray Computed
7.Development and Validation of Generalized Linear Regression Models to Predict Vessel Enhancement on Coronary CT Angiography.
Takanori MASUDA ; Takeshi NAKAURA ; Yoshinori FUNAMA ; Tomoyasu SATO ; Toru HIGAKI ; Masao KIGUCHI ; Yoriaki MATSUMOTO ; Yukari YAMASHITA ; Naoyuki IMADA ; Kazuo AWAI
Korean Journal of Radiology 2018;19(6):1021-1030
OBJECTIVE: We evaluated the effect of various patient characteristics and time-density curve (TDC)-factors on the test bolus-affected vessel enhancement on coronary computed tomography angiography (CCTA). We also assessed the value of generalized linear regression models (GLMs) for predicting enhancement on CCTA. MATERIALS AND METHODS: We performed univariate and multivariate regression analysis to evaluate the effect of patient characteristics and to compare contrast enhancement per gram of iodine on test bolus (ΔHUTEST) and CCTA (ΔHUCCTA). We developed GLMs to predict ΔHUCCTA. GLMs including independent variables were validated with 6-fold cross-validation using the correlation coefficient and Bland–Altman analysis. RESULTS: In multivariate analysis, only total body weight (TBW) and ΔHUTEST maintained their independent predictive value (p < 0.001). In validation analysis, the highest correlation coefficient between ΔHUCCTA and the prediction values was seen in the GLM (r = 0.75), followed by TDC (r = 0.69) and TBW (r = 0.62). The lowest Bland–Altman limit of agreement was observed with GLM-3 (mean difference, −0.0 ± 5.1 Hounsfield units/grams of iodine [HU/gI]; 95% confidence interval [CI], −10.1, 10.1), followed by ΔHUCCTA (−0.0 ± 5.9 HU/gI; 95% CI, −11.9, 11.9) and TBW (1.1 ± 6.2 HU/gI; 95% CI, −11.2, 13.4). CONCLUSION: We demonstrated that the patient's TBW and ΔHUTEST significantly affected contrast enhancement on CCTA images and that the combined use of clinical information and test bolus results is useful for predicting aortic enhancement.
Angiography*
;
Body Weight
;
Cardiac Output
;
Heart
;
Humans
;
Iodine
;
Linear Models*
;
Multivariate Analysis
8.Pharmaceutical Students’ Awareness of Drug Abuse and Assessment of the Effects of Education
Moemi Saito ; Isao Murakami ; Gen-ichi Atsumi ; Masao Tsuchiya ; Hideaki Natsugari
Japanese Journal of Drug Informatics 2014;16(1):1-9
Objective: In this study, we evaluated to examine the short-term educational effects for drug abuse prevention, including lectures and students’ awareness of drug abuse.
Method: A questionnaire consisting of eleven items and SD method-based image survey were conducted three times, prior to and following the lectures and after the summer vacation for first-year students of the Department of Pharmacy.
Results: The numbers of responses to the questionnaire surveys conducted prior to and following the summer vacation were 323 (response rate: 95.8%) and 332 (response rate: 97.9%), respectively. When asked: “Do you think that people should be allowed to use cannabis (illegal herbal drugs) as long as they do not cause any trouble to others”, 2.8 (3.4) and 6.9 (6.6)% of students answered “Yes” after the lectures prior to the summer vacation and following it, respectively; there were both increased. Following the summer vacation, 28.6% of students answered “Yes” to the question: “Have you ever seen or heard of people using cannabis or illegal herbal drugs ?” A total of 2.1% of students had been “solicited to use cannabis or illegal herbal drugs”, and all of them stated that it would be “easy to obtain illegal herbal drugs”. As the reason for drug abuse by young people, 140 students (42.2%) cited “curiosity”, and 81.6%, or 271 students, stated that they would “refuse” to use any illegal drugs even if they were asked to do so. The results of the SD method-based image survey suggested significant changes in students’ awareness of drug abuse during the summer vacation; they had the image of little risk on drug abuse prevention following the vacation.
Conclusion: The effects of learning were not maintained in some first-year students because they faced a variety of temptations during the short summer vacation and their normative consciousness and images of drug abuse easily changed. Therefore, it is necessary to provide lectures for new students to help them acquire accurate knowledge of drug abuse, enhance their normative consciousness, and increase their self-awareness as health care professionals, develop curriculums on a continuing basis, and deploy specialists so that students with psychological problems as identified by the survey, including stress, escapism, mental weakness, and anxiety, can consult them.
9.Attitude Survey of Pharmacy Students before and after Long-term Practical Training, and the Evaluation of Pre-clinical Training
Moemi Saito ; Eri Nakamura ; Yoshitada Nodate ; Tamaki Watanabe ; Shigekazu Watanabe ; Isao Murakami ; Masao Tsuchiya ; Jyunichi Kurihara
Japanese Journal of Social Pharmacy 2013;32(2):54-61
We conducted a questionnaire survey involving 270 interns in the year 2011 at the pharmaceutical department of Teikyo University, in order to clarify pre- to post-practical training changes in: 1) the degree of pre-clinical training’s usefulness, 2) desired workplace in the future, 3) degree of satisfaction, 4) confidence degree of practical training, etc. The degree of pre-clinical training’s usefulness exceeded 80% in all training periods. Regarding the desired workplace in the future, a large proportion of students answered that they want to become a pharmacist in a pharmacy or hospital, both before and after their practical training in all training periods. Also, it was estimated that students decide their career with reference to their practical training experience. In terms of the degree of satisfaction with practical training, the proportions of those who answered “Satisfied” or “Somewhat satisfied” were: 95.1% in the 1st, 95.6% in the 2nd, and 86.1% in the 3rd periods. The confidence degree significantly increased after practical training in all periods. Because the confidence degree showed a tendency to be higher before the 3rd period of training compared to the other two periods, it was considered that students’ experience of practical training led to increased confidence degree. Regarding communication abilities, the degrees of before-after confidence degree and pre-clinical training’s usefulness were low, and, hence, it was suggested that pre-clinical training needs to be further improved regarding these areas.
10.Relationship between the Psychological Stress Responses and Self-Efficacy in Pharmacy Students during Hospital Practical Training
Moemi Saito ; Masao Tsuchiya ; Machiko Watanabe ; Sin-ichi Niwa
Japanese Journal of Drug Informatics 2013;15(1):29-36
Objective: Pharmacy students are considered to experience various forms of stress during long-term practical training in the 6-year pharmacy education. This study examined relationships between psychological stress responses and self-efficacy involving 77 subjects who consented to join this study in practical training conducted at Teikyo University Hospital (2010-2011FY).
Methods: This study used the Profile of Mood States (POMS) for evaluating the psychological response, and an assessment form consisted of 20 items including interpersonal relationships, contents of practical training and health/life/stress coping for self-efficacy before, during, and after the training.
Results: In the POMS, only the state of ‘vigor’ showed a significant difference in a comparison among before, during, and after the training; however, no significant change was observed in other mood states. These results suggested that the students were under mild stress during the training. Their self-efficacy was increased after the training in all 20 items except “contacting university instructors during the training”. The results also showed that there was an association between self-efficacy and psychological stress responses.
Conclusions: It is considered important that instructors and pharmacy technicians involved in pharmacy practice should understand the levels of individual stress responses or interpersonal communication skills to utilize them for coaching and maintaining students’ mental health.


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