1.Risk Factors for Falls among Wheelchair Users in a Long-term Care Health Facility
Masakazu IMAOKA ; Yumi HIGUCHI ; Emiko TODO ; Tomomi KITAGAWA ; Jun YAMAGUCHI
The Japanese Journal of Rehabilitation Medicine 2014;51(1):47-51
Purpose : The purpose of this study was to investigate the risk factors for falls among wheelchair users who were institutionalized in a long-term care health facility. Subjects : The participants were 62 new residents (mean age, 85.4±7.9) of a long-term care health facility. Methods : A longitudinal study of 6 months follow-up for falls was carried out. Baseline data were obtained regarding age, history of falls, functional status, psychological variables, physiological function, medical treatments and economic status. Risk factors for falls were analyzed by logistic regression. Results : During the follow-up, falls by 29 patients (46.8% of participants) were reported. Our analysis showed that four risk factors were significantly associated with falls : the patient had a bent back, a high FIM score, polypharmacy and benzodiazepine use. Logistic regression analysis revealed that a bent back was the best predictor of falls (OR 4.11 ; CI 95% 1.25-13.5).
3.Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
Taku KOBAYASHI ; Hiroaki ITO ; Toshifumi ASHIDA ; Tadashi YOKOYAMA ; Masakazu NAGAHORI ; Tomoki INABA ; Mitsuhiro SHIKAMURA ; Takayoshi YAMAGUCHI ; Tetsuharu HORI ; Philippe PINTON ; Mamoru WATANABE ; Toshifumi HIBI
Intestinal Research 2021;19(4):448-460
Background/Aims:
A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods:
Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results:
Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions
Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)
4.Retrospective Survey of Palliative Sedation Therapy at the End-of-life at a Tertiary Cancer Center in Japan
Shuntaro YASUDA ; Marie NISHIKAWA ; Hiromi TAKADA ; Hiroto ISHIKI ; Daisuke KIUCHI ; Masaki SHIMIZU ; Eriko SATOMI ; Ken SHIMIZU ; Masakazu YAMAGUCHI
Palliative Care Research 2020;15(1):43-50
Although palliative sedation therapy (PST) is considered to alleviate intolerable and refractory symptoms in dying patients with advanced cancer, there have been few studies regarding the situation of tertiary cancer center. We conducted a retrospective survey of the medical records of the patients who died between April 2015 and March 2016 at the National Cancer Center Hospital in Japan. PST was conducted in 75 out of 431 patients (17.4%). The patient demographics were as follows: sex (male/female), 48/27; median age, 61 years (range 5-83; 11 patients (14.7%) were aged under 39 years); and primary sites were lung, 18 (24.7%)/ pancreas, 11 (14.7%)/ hematopoietic organs, 11 (14.7%)/ bones and soft tissues, 8 (10.7%)/ and the others, 27 (36.0%). The main target symptoms for PST were dyspnea (38, 50.7%) and delirium (30, 40.0%). The most commonly used sedative agent was midazolam (72, 96.0%). Continuous deep sedation was intended in 61 patients (81.3%) at the death. Median survival from the start of PST were 2 days (range 0-54). The differences between palliative care team (PCT) intervention group and control group were lower age (58 vs. 62.5, P=0.048) and uniformity of initial midazolam dose (5-12 vs. 9.6-25.2 mg/day). Distinctive feature in this study was large proportion of adolescent and young adult patients with rare cancers. PCT might have different approaches to sedation in comparison to non-PCT medical staffs.
5.A Survey of Experience and Perception of Bereaved Families about Polypharmacy and Oral Medication of Patients with Advanced Cancer
Kentaro ABE ; Tomofumi MIURA ; Noriko FUJISHIRO ; Ayumi OKIZAKI ; Naoko YOSHINO ; Shigeru AOKI ; Akemi NAITO ; Yasunari MANO ; Shinichiro SAITO ; Masakazu YAMAGUCHI ; Tatsuya MORITA
Palliative Care Research 2021;16(1):85-91
Aims: This study aimed at investigating the status of polypharmacy and the experience and perception of bereaved family members of patients with advanced cancer regarding the burden of oral medication. Methods: Self-administered questionnaires were mailed to 303 bereaved family members of patients with advanced cancer, and 102 valid responses were analyzed (response rate, 33.7%). Results: The number of patients in the polypharmacy group (patients taking six or more tablets at a time) was 65 and that in the non-polypharmacy group (patients taking less than six tablets at a time) was 37. The percentage of bereaved family members who felt that the oral administration burden of patients was significantly higher in the polypharmacy group (43.1% vs. 10.8%, p<0.01). The results of the analysis indicated that the bereaved families wanted to reduce the number of tablets taken at a time for alleviating the burden of polypharmacy. The bereaved families of patients in the polypharmacy group were greatly concerned that the number of oral medications was too large. They also expressed the need for medical staff from whom they could seek explanation and counseling regarding the oral medication of patients. Conclusion: It is suggested that medical staff need to be fully aware of the concerns of patients’ families regarding drugs besides checking the compliance status.