1.Study on Adherence and Safety of Patients Taking Molnupiravir Capsules
Yukiko FUKUDA ; Kouichi HOSOMI ; Shouhei OKANO ; Takahiro YAMAGUCHI ; Hirohisa SHINDOU ; Daichi OKUDA ; Takashi MURATA
Japanese Journal of Social Pharmacy 2024;43(1):40-47
To assess the safety of molnupiravir capsules (MOV) and the adherence of patients taking these capsules, we conducted a survey of patients who were dispensed MOV at the Maruzen Pharmacy from January 1st to September 30th, 2022. In the survey, a sample of 134 patients were requested to complete a questionnaire, from whom we received 56 responses (response rate: 41.8%). Among the respondents, 11 (19.6%) failed to complete their medication, and those aged 60 years or older tended to have poor adherence (P<0.001). Apart from age, we detected no statistical differences with respect to other assessed factors (gender, capsule size, occurrence of side effects, and evaluation of pharmacist’s explanations). Side effects were reported by 11 individuals (19.6%) taking the drug, although these were mainly consistent with those that have been reported in clinical trials. In addition, 20 individuals (35.7%) experienced COVID-19 after-effects after taking MOV. When requested to evaluate pharmacies and pharmacists, five individuals (8.9%) reported feeling dissatisfied. Although the results obtained in this survey are based on a limited number of patients, they do reveal a concerning lack of adherence among patients over 60 years of age; and there are needs for future improvements in the size of MOV capsules.
2.Malnutrition and inflammation status in nonobese patients with inflammatory bowel disease are associated with nonalcoholic fatty liver disease: a retrospective study
Takahiro NAGATA ; Sadahiro FUNAKOSHI ; Daisuke MORIHARA ; Satoshi SHAKADO ; Keiji YOKOYAMA ; Kazuhide TAKATA ; Takashi TANAKA ; Atsushi FUKUNAGA ; Ryo YAMAUCHI ; Hiromi FUKUDA ; Hiroki MATSUOKA ; So IMAKIIRE ; Hideto SAKISAKA ; Satoshi MATSUOKA ; Nobuaki KUNO ; Koichi ABE ; Hideki ISHIBASHI ; Shinya ASHIZUKA ; Fumihito HIRAI
Intestinal Research 2023;21(4):471-480
Background/Aims:
The frequency and details of nonalcoholic fatty liver disease (NAFLD) complications in patients with inflammatory bowel disease (IBD) remain unclear. This study aimed to clarify characteristics of NAFLD in patients with IBD.
Methods:
We retrospectively identified and enrolled patients with IBD diagnosed with or without NAFLD by undergoing abdominal computed tomography (CT) at our institution between 2005 and 2020. The primary endpoint was the complication rate of NAFLD in patients with IBD. Secondary endpoints were the clinical characteristics of nonobese patients with IBD and comorbid NAFLD and their association with nutritional and inflammatory parameters.
Results:
Twenty-one (21.9%) of 96 eligible patients with IBD also had NAFLD. In nonobese patients (defined as patients with a body mass index <25 kg/m2), C-reactive protein (CRP; P<0.001) and alanine aminotransferase (P=0.018) levels were higher and the albumin level (P=0.005) and prognostic nutritional index (PNI; P=0.002) values were lower in patients with NAFLD than in those without NAFLD. The PNI value was positively correlated (P<0.001) and the CRP level was negatively correlated (P=0.001) with the hepatosplenic ratio. However, in the NAFLD combined group, PNI (P<0.05) and CRP values (P<0.001) were improved over time after CT imaging by continuing IBD treatment.
Conclusions
Worsening nutritional and inflammatory status in IBD patients is associated with complications of NAFLD. Diagnosis of NAFLD in IBD patients using CT imaging might be useful not only for early detection of NAFLD but also in assessing the need for therapeutic intervention for IBD.
3.Combined transabdominal and transperineal endoscopic pelvic exenteration for colorectal cancer: feasibility and safety of a two-team approach
Tetsuro TOMINAGA ; Takashi NONAKA ; Akiko FUKUDA ; Toshio SHIRAISI ; Shintaro HASHIMOTO ; Masato ARAKI ; Yorihisa SUMIDA ; Terumitsu SAWAI ; Takeshi NAGAYASU
Annals of Surgical Treatment and Research 2021;101(2):102-110
Purpose:
Pelvic exenteration (PE) is a highly invasive procedure with high morbidity and mortality rates. Promising options to reduce this invasiveness have included laparoscopic and transperineal approaches. The aim of this study was to identify the safety of combined transabdominal and transperineal endoscopic PE for colorectal malignancies.
Methods:
Fourteen patients who underwent combined transabdominal and transperineal PE (T group: 2-team approach, n = 7; O group: 1-team approach, n = 7) for colorectal malignancies between April 2016 and March 2020 in our institutions were included in this study. Clinicopathological features and perioperative outcomes were compared between groups.
Results:
All patients successfully underwent R0 resection. Operation time tended to be shorter in the T group (463 minutes) than in the O group (636 minutes, P = 0.080). Time to specimen removal was significantly shorter (258 minutes vs. 423 minutes, P = 0.006), blood loss was lower (343 mL vs. 867 mL, P = 0.042), and volume of blood transfusion was less (0 mL vs. 560 mL, P = 0.063) in the T group, respectively. Postoperative complications were similar between groups.
Conclusion
Combined transabdominal and transperineal PE under a synchronous 2-team approach was feasible and safe, with the potential to reduce operation time, blood loss, and surgeon stress.
4.A Case of a Super-Elderly Patient Who Underwent Total Arch Replacement Using the Frozen Elephant Trunk Technique for a Thoracic Aortic Aneurysm with a Right-Sided Aortic Arch
Takashi KATO ; Hirotsugu FUKUDA ; Wataru MORIYAMA ; Masataka OHASHI ; Shotaro HIROTA ; Masahiro SEKI ; Masahiro TEDUKA ; Yusuke TAKEI ; Hironaga OGAWA ; Ikuko SHIBASAKI
Japanese Journal of Cardiovascular Surgery 2021;50(5):317-321
The case is that of a 90-years-old man. A previous doctor performed abdominal graft replacement for an abdominal aortic aneurysm 5 years earlier and continued outpatient CT follow-up. Follow-up CT showed the right aortic arch and dilation of the thoracic aortic aneurysm, and the patient was referred to our hospital. Contrast-enhanced CT showed an aortic arch aneurysm ; the aneurysm diameter was 62 mm in major axis and 60 mm in minor axis, which was judged to be suitable for surgery. It was a rare right-sided aortic arch with no congenital heart malformation and no situs inversus. Endovascular treatment was considered because he was 90 years old and very elderly, but there were concerns about the risk of embolism, irregular manipulation and central landing. For the surgical method, we selected total arch replacement using a frozen elephant trunk technique. We succeeded in avoiding serious complications by selecting an appropriate treatment method through careful evaluation.
5.Combined transabdominal and transperineal endoscopic pelvic exenteration for colorectal cancer: feasibility and safety of a two-team approach
Tetsuro TOMINAGA ; Takashi NONAKA ; Akiko FUKUDA ; Toshio SHIRAISI ; Shintaro HASHIMOTO ; Masato ARAKI ; Yorihisa SUMIDA ; Terumitsu SAWAI ; Takeshi NAGAYASU
Annals of Surgical Treatment and Research 2021;101(2):102-110
Purpose:
Pelvic exenteration (PE) is a highly invasive procedure with high morbidity and mortality rates. Promising options to reduce this invasiveness have included laparoscopic and transperineal approaches. The aim of this study was to identify the safety of combined transabdominal and transperineal endoscopic PE for colorectal malignancies.
Methods:
Fourteen patients who underwent combined transabdominal and transperineal PE (T group: 2-team approach, n = 7; O group: 1-team approach, n = 7) for colorectal malignancies between April 2016 and March 2020 in our institutions were included in this study. Clinicopathological features and perioperative outcomes were compared between groups.
Results:
All patients successfully underwent R0 resection. Operation time tended to be shorter in the T group (463 minutes) than in the O group (636 minutes, P = 0.080). Time to specimen removal was significantly shorter (258 minutes vs. 423 minutes, P = 0.006), blood loss was lower (343 mL vs. 867 mL, P = 0.042), and volume of blood transfusion was less (0 mL vs. 560 mL, P = 0.063) in the T group, respectively. Postoperative complications were similar between groups.
Conclusion
Combined transabdominal and transperineal PE under a synchronous 2-team approach was feasible and safe, with the potential to reduce operation time, blood loss, and surgeon stress.
6.Open Repair without Esophagectomy for an Aortoesophageal Fistula after Thoracic Stent Grafting
Takashi OGASAWARA ; Kazuyuki DAITOKU ; Anan NOMURA ; Tomonori KAWAMURA ; Satoshi TANIGUCHI ; Ikuo FUKUDA
Japanese Journal of Cardiovascular Surgery 2019;48(5):345-350
An aortoesophageal fistula is a critical condition with high operative mortality. A case of aortoesophageal fistula following thoracic endovascular aneurysm repair is reported. The patient was a 72-year-old man complaining of dysphagia who underwent stent grafting for a saccular aneurysm of the descending aorta that was compressing the esophagus four months earlier. Endoscopic examination showed perforation of the aneurysm into the esophagus with severe stenosis. The aneurysmal sac was filled with thrombus. Aortography demonstrated a type I endoleak from the lesser curvature of the aortic arch, draining into the aneurysmal sac. The patient was afebrile with moderate elevation of C-reactive protein, and the white blood cell count was normal. The patient underwent closure of the aneurysmal entry with healthy aortic wall and replacement of the descending aortic aneurysm with a prosthetic graft. The graft was isolated from the fistula by an omental flap. The patient's postoperative course was uneventful. Computed tomography performed 4 years after the surgery showed shrinkage of the aneurysmal sac. The patient has had a healthy life for 9 years since the operation.
7.Endoscopic treatment or balloon-occluded retrograde transvenous obliteration is safe for patients with esophageal/gastric varices in Child-Pugh class C end-stage liver cirrhosis
Keiji YOKOYAMA ; Ryo YAMAUCHI ; Kumiko SHIBATA ; Hiromi FUKUDA ; Hideo KUNIMOTO ; Kazuhide TAKATA ; Takashi TANAKA ; Shinjiro INOMATA ; Daisuke MORIHARA ; Yasuaki TAKEYAMA ; Satoshi SHAKADO ; Shotaro SAKISAKA
Clinical and Molecular Hepatology 2019;25(2):183-189
BACKGROUND/AIMS: There is a controversy about the availability of invasive treatment for esophageal/gastric varices in patients with Child-Pugh class C (CP-C) end-stage liver cirrhosis (LC). We have evaluated the validity of invasive treatment with CP-C end-stage LC patients. METHODS: The study enrolled 51 patients with CP-C end-stage LC who had undergone invasive treatment. The treatment modalities included endoscopic variceal ligation in 22 patients, endoscopic injection sclerotherapy in 17 patients, and balloon-occluded retrograde transvenous obliteration (BRTO) in 12 patients. We have investigated the overall survival (OS) rates and risk factors that contributed to death within one year after treatment. RESULTS: The OS rate in all patients at one, three, and five years was 72.6%, 30.2%, and 15.1%, respectively. The OS rate in patients who received endoscopic treatment and the BRTO group at one, three, and five years was 67.6%, 28.2% and 14.1% and 90.0%, 36.0% and 18.0%, respectively. The average of Child-Pugh scores (CPS) from before treatment to one month after variceal treatment significantly improved from 10.53 to 10.02 (P=0.003). Three significant factors that contributed to death within one year after treatment included the presence of bleeding varices, high CPS (≥11), and high serum total bilirubin levels (≥4.0 mg/dL). CONCLUSIONS: The study demonstrated that patients with a CPS of up to 10 and less than 4.0 mg/dL of serum total bilirubin levels may not have a negative impact on prognosis after invasive treatment for esophageal/gastric varices despite their CP-C end-stage LC.
Balloon Occlusion
;
Bilirubin
;
Endoscopy
;
Esophageal and Gastric Varices
;
Hemorrhage
;
Humans
;
Hypertension, Portal
;
Ligation
;
Liver Cirrhosis
;
Liver
;
Prognosis
;
Risk Factors
;
Sclerotherapy
;
Varicose Veins
8.1.A Pilot Program of Implementing Health Technology Assessment to Decision Making in Japan
Japanese Journal of Pharmacoepidemiology 2018;23(1):3-10
Annual medical expenditure in Japan is continuously increasing. This may be caused by technology advancement as well as population ageing. Some new and high cost technologies, including new drugs, have been introduced. In order to balance technology advancement with medical expenditure, economic evaluation of new technologies is one way to approach the issue. In 2016 a pilot program stared at the Central Social Insurance Medical Council to evaluate cost effectiveness of some drugs and medical devices. In the pilot program, companies of selected products were asked to submit primary data and analyses to the Ministry of Health, Labour and Welfare. The ministry, together with some experts, reviewed the submitted data and re-analyzed if necessary. After these assessment process, not only cost effectiveness of each product, but also ethical or social aspects are considered in the appraisal phase. Finally results will be used to adjust reimbursement prices in the 2018 price revision. In the council, some issues toward full implementation of the new system will be discussed by 2019.
9.¹²³I-Labeled oxLDL Is Widely Distributed Throughout the Whole Body in Mice
Atushi NAKANO ; Hidekazu KAWASHIMA ; Yoshinori MIYAKE ; Tsutomu ZENIYA ; Akihide YAMAMOTO ; Kazuhiro KOSHINO ; Takashi TEMMA ; Tetsuya FUKUDA ; Yoshiko FUJITA ; Akemi KAKINO ; Shigehiko KANAYA ; Tatsuya SAWAMURA ; Hidehiro IIDA
Nuclear Medicine and Molecular Imaging 2018;52(2):144-153
PURPOSE: Oxidized low-density lipoprotein (oxLDL) plays a key role in endothelial dysfunction, vascular inflammation, and atherogenesis. The aim of this study was to assess blood clearance and in vivo kinetics of radiolabeled oxLDL in mice.METHODS: We synthesized ¹²³I-oxLDL by the iodine monochloride method, and performed an uptake study in CHO cells transfected with lectin-like oxLDL receptor-1 (LOX-1). In addition, we evaluated the consistency between the ¹²³I-oxLDL autoradiogram and the fluorescence image of DiI-oxLDL after intravenous injection for both spleen and liver. Whole-body dynamic planar images were acquired 10 min post injection of ¹²³I-oxLDL to generate regional time-activity curves (TACs) of the liver, heart, lungs, kidney, head, and abdomen. Regional radioactivity for those excised tissues as well as the bladder, stomach, gut, and thyroid were assessed using a gamma counter, yielding percent injected dose (%ID) and dose uptake ratio (DUR). The presence of ¹²³I-oxLDL in serum was assessed by radio-HPLC.RESULTS: The cellular uptakes of ¹²³I-oxLDL were identical to those of DiI-oxLDL, and autoradiograms and fluorescence images also exhibited consistent distributions. TACs after injection of ¹²³I-oxLDL demonstrated extremely fast kinetics. The radioactivity uptake at 10 min postinjection was highest in the liver (40.8 ± 2.4% ID). Notably, radioactivity uptake was equivalent throughout the rest of the body (39.4 ± 2.7% ID). HPLC analysis revealed no remaining ¹²³I-oxLDL or its metabolites in the blood.CONCLUSION: ¹²³I-OxLDL was widely distributed not only in the liver, but also throughout the whole body, providing insight into the pathophysiological effects of oxLDL.
Abdomen
;
Animals
;
Atherosclerosis
;
CHO Cells
;
Chromatography, High Pressure Liquid
;
Cricetinae
;
Fluorescence
;
Head Kidney
;
Heart
;
Inflammation
;
Injections, Intravenous
;
Iodine
;
Kinetics
;
Lipoproteins
;
Liver
;
Lung
;
Methods
;
Mice
;
Radioactivity
;
Spleen
;
Stomach
;
Thyroid Gland
;
Urinary Bladder
10.¹²³I-Labeled oxLDL Is Widely Distributed Throughout the Whole Body in Mice
Atushi NAKANO ; Hidekazu KAWASHIMA ; Yoshinori MIYAKE ; Tsutomu ZENIYA ; Akihide YAMAMOTO ; Kazuhiro KOSHINO ; Takashi TEMMA ; Tetsuya FUKUDA ; Yoshiko FUJITA ; Akemi KAKINO ; Shigehiko KANAYA ; Tatsuya SAWAMURA ; Hidehiro IIDA
Nuclear Medicine and Molecular Imaging 2018;52(2):144-153
PURPOSE:
Oxidized low-density lipoprotein (oxLDL) plays a key role in endothelial dysfunction, vascular inflammation, and atherogenesis. The aim of this study was to assess blood clearance and in vivo kinetics of radiolabeled oxLDL in mice.
METHODS:
We synthesized ¹²³I-oxLDL by the iodine monochloride method, and performed an uptake study in CHO cells transfected with lectin-like oxLDL receptor-1 (LOX-1). In addition, we evaluated the consistency between the ¹²³I-oxLDL autoradiogram and the fluorescence image of DiI-oxLDL after intravenous injection for both spleen and liver. Whole-body dynamic planar images were acquired 10 min post injection of ¹²³I-oxLDL to generate regional time-activity curves (TACs) of the liver, heart, lungs, kidney, head, and abdomen. Regional radioactivity for those excised tissues as well as the bladder, stomach, gut, and thyroid were assessed using a gamma counter, yielding percent injected dose (%ID) and dose uptake ratio (DUR). The presence of ¹²³I-oxLDL in serum was assessed by radio-HPLC.
RESULTS:
The cellular uptakes of ¹²³I-oxLDL were identical to those of DiI-oxLDL, and autoradiograms and fluorescence images also exhibited consistent distributions. TACs after injection of ¹²³I-oxLDL demonstrated extremely fast kinetics. The radioactivity uptake at 10 min postinjection was highest in the liver (40.8 ± 2.4% ID). Notably, radioactivity uptake was equivalent throughout the rest of the body (39.4 ± 2.7% ID). HPLC analysis revealed no remaining ¹²³I-oxLDL or its metabolites in the blood.
CONCLUSION
¹²³I-OxLDL was widely distributed not only in the liver, but also throughout the whole body, providing insight into the pathophysiological effects of oxLDL.


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