2.Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer
Naoya MURAKAMI ; Miho WATANABE ; Takashi UNO ; Shuhei SEKII ; Kayoko TSUJINO ; Takahiro KASAMATSU ; Yumiko MACHITORI ; Tomomi AOSHIKA ; Shingo KATO ; Hisako HIROWATARI ; Yuko KANEYASU ; Tomio NAKAGAWA ; Hitoshi IKUSHIMA ; Ken ANDO ; Masumi MURATA ; Ken YOSHIDA ; Hiroto YOSHIOKA ; Kazutoshi MURATA ; Tatsuya OHNO ; Noriyuki OKONOGI ; Anneyuko I. SAITO ; Mayumi ICHIKAWA ; Takahito OKUDA ; Keisuke TSUCHIDA ; Hideyuki SAKURAI ; Ryoichi YOSHIMURA ; Yasuo YOSHIOKA ; Atsunori YOROZU ; Naonobu KUNITAKE ; Hiroyuki OKAMOTO ; Koji INABA ; Tomoyasu KATO ; Hiroshi IGAKI ; Jun ITAMI
Journal of Gynecologic Oncology 2023;34(3):e24-
Objective:
The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial.
Methods:
Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30–30.6 Gy in 15–17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50–50.4 Gy in 25–28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%.
Results:
Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9–52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%–88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met.
Conclusion
The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.
3.A Case of Lung Squamous Cell Carcinoma Retroperitoneal Lymph Node Metastasis Whose Lymphedema Was Improved by Radiation Therapy and Was Temporarily Discharged from the Hospital
Shuji KODAMA ; Naoko SANUKI ; Mikiko SAKAI ; Tomokazu YAMAKAWA ; Shoko MIYAMOTO ; Wakana FUJII ; Izumi HATA ; Tomomi KITAYAMA ; Masahiro IMADE ; Masamichi YOSHIDA
Palliative Care Research 2023;18(2):111-116
The patient was a 73-year-old woman. She had been treated for squamous cell carcinoma of the lung (cT3N3M0, Stage IIIC) at our department. The patient had low back pain due to retroperitoneal lymph node metastasis; in June 2022, this was exacerbated as lung cancer progressed. She had difficulty in body movements due to edema in both lower limbs, in addition to the pain. Consequently, she was urgently admitted on July 8 and received radiotherapy (30 Gy/10 fractions) for retroperitoneal lymph node metastasis. She was being given tapentadol at a dose of 200 mg/day for relief of her pain. However, she was switched to fentanyl patch at a dose of 1200 µg/day during her hospitalization, which resulted in relief of low back pain. The underlying disease causing the edema was investigated. Based on physical and laboratory findings and medical history, lymphedema associated with retroperitoneal lymph node metastases was diagnosed. On day 31 of hospitalization, the patient was allowed to be temporarily discharged from the hospital because the edema had improved and the activity of daily living around the bed had increased. Treatment methods for lymphedema associated with lymph node metastasis have not been established, but the efficacy of radiotherapy has been reported. We have herein reported a case of lymphedema that was improved by radiotherapy after it was differentiated from other diagnoses.
4.Urinary N-terminal pro-B-type natriuretic peptide as a biomarker for cardiovascular events in a general Japanese population: the Hisayama Study.
Keisuke YAMASAKI ; Jun HATA ; Tomomi IDE ; Takuya NAGATA ; Satoko SAKATA ; Daigo YOSHIDA ; Takanori HONDA ; Yoichiro HIRAKAWA ; Toshiaki NAKANO ; Takanari KITAZONO ; Hiroyuki TSUTSUI ; Toshiharu NINOMIYA
Environmental Health and Preventive Medicine 2021;26(1):47-47
BACKGROUND:
Epidemiological evidence has shown that serum N-terminal pro-brain natriuretic peptide (NT-proBNP) concentrations, a diagnostic biomarker for heart failure, are positively associated with cardiovascular risk. Since NT-proBNP in serum is excreted in urine, it is hypothesized that urinary NT-proBNP concentrations are correlated with serum concentrations and linked with cardiovascular risk in the general population.
METHODS:
A total of 3060 community-dwelling residents aged ≥ 40 years without history of cardiovascular disease (CVD) were followed up for a median of 8.3 years (2007-2015). Serum and urinary concentrations of NT-proBNP at baseline were compared. The hazard ratios (HRs) and their 95% confidence intervals (CIs) for the association between NT-proBNP concentrations and the risk of developing CVD were computed using the Cox proportional hazards model.
RESULTS:
The median values (interquartile ranges) of serum and urinary NT-proBNP concentrations at baseline were 56 (32-104) pg/mL and 20 (18-25) pg/mL, respectively. There was a strong quadratic correlation between the serum and urinary concentrations of NT-proBNP (coefficient of determination [R
CONCLUSIONS
The present study demonstrated that urinary NT-proBNP concentrations were well-correlated with serum concentrations and were positively associated with cardiovascular risk. Given that urine sampling is noninvasive and does not require specially trained personnel, urinary NT-proBNP concentrations have the potential to be an easy and useful biomarker for detecting people at higher cardiovascular risk.
Adult
;
Aged
;
Aged, 80 and over
;
Biomarkers/urine*
;
Cardiovascular Diseases/urine*
;
Female
;
Heart Failure/diagnosis*
;
Humans
;
Incidence
;
Japan/epidemiology*
;
Male
;
Middle Aged
;
Natriuretic Peptide, Brain/urine*
;
Peptide Fragments/urine*
;
Prospective Studies
;
Risk Assessment
5.Report on the First 5 Years of the "Generalist 80 Universities Angya Project"
Satoshi KANKE ; Tomomi KISHI ; Akiko NAKAYAMA ; Shin YOSHIDA ; Maki SUGITANI ; Ken HORIKOSHI ; Hisashi YOSHIMOTO
An Official Journal of the Japan Primary Care Association 2018;41(3):110-117
The Young Primary Care Doctors' Organization of the Japan Primary Care Association (JPCA) launched the "Generalist 80 Universities Angya Project" in 2011 to increase contact between generalists and medical students or residents interested in general hospital medicine, family medicine and primary care. The project targeted students interested in family medicine, primary care and hospital general medicine who do not participate in nationwide seminars. The project helps medical students and residents hold voluntary seminars at their university campus about family medicine, primary care and hospital general medicine. From 2011 to 2016, the project supported 129 seminars attended by 3,569 people at 63 universities. A questionnaire survey on 11 seminars between September 2013 and February 2014 revealed that 66% of medical students had never participated in JPCA family medicine summer seminars for students and residents. By holding seminars at university campuses, we targeted different participants from those at the nationwide seminar.
6.Bilateral Cochlear Implantation for Children in Nagasaki, Japan.
Yukihiko KANDA ; Hidetaka KUMAGAMI ; Minoru HARA ; Yuzuru SAINOO ; Chisei SATO ; Tomomi YAMAMOTO-FUKUDA ; Haruo YOSHIDA ; Akiko ITO ; Chiharu TANAKA ; Kyoko BABA ; Ayaka NAKATA ; Hideo TANAKA ; Haruo TAKAHASHI
Clinical and Experimental Otorhinolaryngology 2012;5(Suppl 1):S24-S31
OBJECTIVES: The number of patients with bilateral cochlear implant (CI) has gradually increased as patients and/or parents recognize its effectiveness. The purpose of this report is to evaluate the efficacy of 29 bilateral CI out of 169 pediatric CI users, who received auditory-verbal/oral habilitation at our hearing center. METHODS: We evaluated the audiological abilities 29 Japanese children with bilateral CIs including wearing threshold, word recognition score, speech discrimination score at 1 m from front speaker (SP), 1 m from second CI side SP, speech discrimination score under the noise (S/N ratio=80 dB sound pressure level [SPL]/70 dB SPL, 10 dB) at 1 m from front SP, word recognition score under the noise (S/N ratio=80 dB SPL/70 dB SPL, 10 dB) at 1 m from front SP. RESULTS: Binaural hearing using bilateral CI is better than first CI in all speech understanding tests. Especially, there were significant differences between the results of first CI and bilateral CI on SDS at 70 dB SPL (P=0.02), SDS at 1 m from second CI side SP at 60 dB SPL (P=0.02), word recognition score (WRS) at 1 m from second CI side SP at 60 dB SPL (P=0.02), speech discrimination score (SDS) at 1 m from front SP under the noise (S/N=80/70; P=0.01) and WRS at 1 m from front SP under the noise (S/N=80/70; P=0.002). At every age, a second CI is very effective. However, the results of under 9 years old were better than of over 9 years old on the mean SDS under the noise (S/N=80/70) on second CI (P=0.04). About use of a hearing aid (HA) in their opposite side of first CI, on the WRS and SDS under the noise, there were significant differences between the group of over 3 years and the group of under 10 months of HA non user before second CI. CONCLUSION: These results may show important binaural effectiveness such as binaural summation and head shadow effect. Bilateral CI is very useful medical intervention for many children with severe-to-profound hearing loss in Japan as well as elsewhere.
Asian Continental Ancestry Group
;
Child
;
Cochlear Implantation
;
Cochlear Implants
;
Head
;
Hearing
;
Hearing Aids
;
Hearing Loss
;
Humans
;
Japan
;
Noise
;
Parents
;
Speech Perception
7.What Factors Are Associated with Good Performance in Children with Cochlear Implants? From the Outcome of Various Language Development Tests, Research on Sensory and Communicative Disorders Project in Japan: Nagasaki Experience.
Yukihiko KANDA ; Hidetaka KUMAGAMI ; Minoru HARA ; Yuzuru SAINOO ; Chisei SATO ; Tomomi YAMAMOTO-FUKUDA ; Haruo YOSHIDA ; Akiko ITO ; Chiharu TANAKA ; Kyoko BABA ; Ayaka NAKATA ; Hideo TANAKA ; Kunihiro FUKUSHIMA ; Norio KASAI ; Haruo TAKAHASHI
Clinical and Experimental Otorhinolaryngology 2012;5(Suppl 1):S59-S64
OBJECTIVES: We conducted multi-directional language development tests as a part of the Research on Sensory and Communicative Disorders (RSVD) in Japan. This report discusses findings as well as factors that led to better results in children with severe-profound hearing loss. METHODS: We evaluated multiple language development tests in 33 Japanese children with cochlear implants (32 patients) and hearing aid (1 patient), including 1) Test for question and answer interaction development, 2) Word fluency test, 3) Japanese version of the Peabody picture vocabulary test-revised, 4) The standardized comprehension test of abstract words, 5) The screening test of reading and writing for Japanese primary school children, 6) The syntactic processing test of aphasia, 7) Criterion-referenced testing (CRT) for Japanese language and mathematics, 8) Pervasive development disorders ASJ rating scales, and 9) Raven's colored progressive matrices. Furthermore, we investigated the factors believed to account for the better performances in these tests. The first group, group A, consisted of 14 children with higher scores in all tests than the national average for children with hearing difficulty. The second group, group B, included 19 children that scored below the national average in any of the tests. RESULTS: Overall, the results show that 76.2% of the scores obtained by the children in these tests exceeded the national average scores of children with hearing difficulty. The children who finished above average on all tests had undergone a longer period of regular habilitation in our rehabilitation center, had their implants earlier in life, were exposed to more auditory verbal/oral communication in their education at affiliated institutions, and were more likely to have been integrated in a regular kindergarten before moving on to elementary school. CONCLUSION: In this study, we suggest that taking the above four factors into consideration will have an affect on the language development of children with severe-profound hearing loss.
Aphasia
;
Asian Continental Ancestry Group
;
Child
;
Child Development Disorders, Pervasive
;
Cochlear Implants
;
Communication Disorders
;
Comprehension
;
Hearing
;
Hearing Aids
;
Hearing Loss
;
Humans
;
Japan
;
Language Development
;
Mass Screening
;
Mathematics
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Rehabilitation Centers
;
Vocabulary
;
Weights and Measures
;
Writing
8.Measurement of Glomerular Filtration Rate by Rapid Intravenous Injection of a Newly Developed Inulin Fraction
Yoshitaka Maeda ; Yuya Araki ; Tomomi Uno ; Akiko Yoshida ; Keisuke Nishigaki ; Naoto Inaba ; Hiroaki Hayashi ; Yoshiharu Deguchi ;
Journal of Rural Medicine 2011;6(1):9-15
Objective: Since the conventional drip-infusion method for measuring inulin clearance (Cin) has problems related to its accuracy and performance, we explored a more accurate and concise method by rapid intravenous injection of a newly developed inulin fraction (Inulead®), in which spot urine sampling was omitted and the administration period of inulin was shortened from 120 to 5 minutes. Patients and Methods: Twenty seven patients (M/F: 15/12, 67.8 ± 12.9 years old) admitted to the Nephrology ward were enrolled in this study. Inulead®, 1500 mg dissolved in 150 mL of saline, was intravenously administered in 5 minutes. Then, sequential blood samplings and urine collection were performed for 24 hours. Cins were calculated by the following three formulae: (1) a pharmacokinetic analysis using a two compartments model based on the plasma inulin concentration to determine Cin, which was the administered dose divided by the area under the curve (AUC) from 0 to ∞, (2) urinary inulin excretion divided by the AUC for 24 hours and (3) the Bayesian method using a three-point set of plasma inulin concentrations to predict the change of inulin concentration to determine Cin as in 1. These Cins were compared with levels of estimated GFR (eGFR), creatinine clearance (Ccr), serum β2 microglobulin (β2MG) and serum cystatin C (Cys C). Results: Cins obtained by the above three methods were well correlated with each other (r. = 0.9088 – 0.9998) and with eGFR (r. = 0.8286 – 0.8650), Ccr (r. = 0.821 – 0.864), 1/β2MG (r. = 0.631 –0.752) and 1/CysC (r. = 0.830 – 0.857). The averaged differences of each Cin from eGFR were distributed between –4.4 and –4.5 mL/min. Conclusion: Since the Cins by rapid inulin injection showed satisfactory correlation and differences with other GFR parameters, this method will be a good alternative to the drip infusion method, and may reduce the burden of patients and medical staff.
9.An Attempt to Curb Overuse of Dialysis
Tatsuo SHIIGAI ; Naganori SATOH ; Yoshitaka MAEDA ; Naoto INABA ; Akiko FURUKAWA ; Akiko YOSHIDA ; Tomomi UNO
Journal of the Japanese Association of Rural Medicine 2011;60(2):85-95
The number of dialysis patients in Japan is increasing every year. The medical expense for dialysis patients has now surpassed well over 7 per cent of all medical costs. This has become a great burden on national finance. The D3-30 project was started in April 2006 for Toride city residents. The purpose of this project was a 30% reduction of the yearly number of new dialysis patients in three years. Toride city is located in southern Ibaraki prefecture; it had a population of 112, 152 in fiscal 2006, and 19% of the residents were over 65 years of age. The treatment procedure for chronic kidney disease (CKD) patients at the predialysis stage comprised the following four parts: 1. control of blood pressure, 2. mild restiction of protein and sodium intake, 3. administration of antiproteinuric drugs (angiotensin receptor blocker, angiotensin converting enzyme inhibitor, some calcium channel blocker, etc.), and 4. multifactorial treatment. CKD patients were recruited through introductions from hospital registered doctors and public health nurses. Some patients entered voluntarily. The number of patients that started dialysis was counted by inquiring at the dialysis center of Toride Kyodo General Hospital and eighteen neighboring dialysis centers. In 2005, before intervention, 36 patients started dialysis; subsequently, the number of patients was 30 in 2006, 33 in 2007, 22 in 2008, and 23 in 2009. The rate of decrease was 39% in 2008 and, 36% in 2009, so the aim of the project was achieved. If this treatment becomes widespread, it will contribute greatly to the curtailment of medical expenses. However, the difficulty of the treatment may hamper its spread. For it to spread, it is necessary to add the new medical fee for guidance and management for CKD patients.
10.Immersion in Warm Water is Beneficial for Renal Function
Yoshihiro YOSHIDA ; Harutoshi SAKAKIMA ; Fumiyo MATSUDA ; Shun-ichi UENO ; Tomomi KAMIZONO ; Kimiko IZUMO ; Miyuki TOGOU ; Azusa TAKAHASHI
The Journal of The Japanese Society of Balneology, Climatology and Physical Medicine 2008;71(2):124-130
Renal plasma flow (RPF) and glomerular filtration rate (GFR) are decreased in patients with heat stroke. Heat stroke after prolonged exercise under high temperatures is usually associated with hypotension and dehydration, leading to decreased RPF. However, whether renal blood flow (RBF), RPF, and GFR are increased or decreased during immersion in mild warm water remains unknown.
Para-aminohippurate clearance (CPAH), sodium thiosulfate clearance (Cthio), and creatinine clearance (Ccr) were determined in 14 healthy men aged 19 to 27 years old (mean±SD, 22±2), 161 to 181cm (171.5±6.3) tall, and weighing 52 to 78kg (64.2±7.4) without immersion at about 25°C (room temperature) and during immersion in water at 41±0.5°C.
CPAH, Cthio, and RBF significantly increased during immersion compared with those without immersion (P<0.0001, P<0.03, P<0.0001, respectively). Ccr did not change (P=0.108). The filtration fraction (FF) was significantly decreased (P<0.001). Levels of plasma atrial natriuretic peptide, aldosterone, anti-diuretic hormone and renin did not significantly differ between these two conditions.
This investigation suggests that daily immersion at 41°C is beneficial for renal function.


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