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1.
Crit Care ; 26(1): 129, 2022 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-35534870

RESUMO

BACKGROUND: The prevalence of extracorporeal cardiopulmonary resuscitation (ECPR) in patients with out-of-hospital cardiac arrest (OHCA) has been increasing rapidly worldwide. However, guidelines or clinical studies do not provide sufficient data on ECPR practice. The aim of this study was to provide real-world data on ECPR for patients with OHCA, including details of complications. METHODS: We did a retrospective database analysis of observational multicenter cohort study in Japan. Adult patients with OHCA of presumed cardiac etiology who received ECPR between 2013 and 2018 were included. The primary outcome was favorable neurological outcome at hospital discharge, defined as a cerebral performance category of 1 or 2. RESULTS: A total of 1644 patients with OHCA were included in this study. The patient age was 18-93 years (median: 60 years). Shockable rhythm in the initial cardiac rhythm at the scene was 69.4%. The median estimated low flow time was 55 min (interquartile range: 45-66 min). Favorable neurological outcome at hospital discharge was observed in 14.1% of patients, and the rate of survival to hospital discharge was 27.2%. The proportions of favorable neurological outcome at hospital discharge in terms of shockable rhythm, pulseless electrical activity, and asystole were 16.7%, 9.2%, and 3.9%, respectively. Complications were observed during ECPR in 32.7% of patients, and the most common complication was bleeding, with the rates of cannulation site bleeding and other types of hemorrhage at 16.4% and 8.5%, respectively. CONCLUSIONS: In this large cohort, data on the ECPR of 1644 patients with OHCA show that the proportion of favorable neurological outcomes at hospital discharge was 14.1%, survival rate at hospital discharge was 27.2%, and complications were observed during ECPR in 32.7%.


Assuntos
Reanimação Cardiopulmonar , Oxigenação por Membrana Extracorpórea , Parada Cardíaca Extra-Hospitalar , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Humanos , Japão/epidemiologia , Pessoa de Meia-Idade , Parada Cardíaca Extra-Hospitalar/terapia , Estudos Retrospectivos , Adulto Jovem
2.
Pharmacoepidemiol Drug Saf ; 31(5): 524-533, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35224801

RESUMO

PURPOSE: We aimed to develop a reliable identification algorithm combining diagnostic codes with several treatment factors for inpatients with acute ischemic stroke (AIS) to conduct pharmacoepidemiological studies using the administrative database MID-NET® in Japan. METHODS: We validated 11 identification algorithms based on 56 different diagnostic codes (International Classification of Diseases, Tenth Revision; ICD-10) using Diagnosis Procedure Combination (DPC) data combined with information on AIS therapeutic procedures added as "AND" condition or "OR" condition. The target population for this study was 366 randomly selected hospitalized patients with possible cases of AIS, defined as relevant ICD-10 codes and diagnostic imaging and prescription or surgical procedure, in three institutions between April 1, 2015 and March 31, 2017. We determined the positive predictive values (PPVs) of these identification algorithms based on comparisons with a gold standard consisting of chart reviews by experienced specialist physicians. Additionally, the sensitivities of them among 166 patients with the possible cases of AIS at a single institution were evaluated. RESULTS: The PPVs were 0.618 (95% confidence interval [CI]: 0.566-0.667) to 0.909 (95% CI: 0.708-0.989) and progressively increased with adding or limiting information on AIS therapeutic procedures as "AND" condition in the identification algorithms. The PPVs for identification algorithms based on diagnostic codes I63.x were >0.8. However, the sensitivities progressively decreased to a maximum of ~0.2 after adding information on AIS therapeutic procedures as "AND" condition. CONCLUSIONS: The identification algorithms based on the combination of appropriate ICD-10 diagnostic codes in DPC data and other AIS treatment factors may be useful to studies for AIS at a national level using MID-NET®.


Assuntos
AVC Isquêmico , Algoritmos , Bases de Dados Factuais , Humanos , Classificação Internacional de Doenças , Valor Preditivo dos Testes
3.
BMC Med Inform Decis Mak ; 22(1): 16, 2022 01 19.
Artigo em Inglês | MEDLINE | ID: mdl-35042480

RESUMO

BACKGROUND: For standardization of terms in the reports of medical device adverse events, 89 Japanese medical device adverse event terminologies were published in March 2015. The 89 terminologies were developed independently by 13 industry associations, suggesting that there may be inconsistencies among the terms proposed. The purpose of this study was to integrate the 89 sets of terminologies and evaluate inconsistencies among them using SPARQL. METHODS: In order to evaluate the inconsistencies among the integrated terminology, the following six items were evaluated: (1) whether the two-layer structure between category term and preferred term is consistent, (2) whether synonyms of a preferred term are involved. Reversing the layer-category order of matching was also performed, (3) whether each preferred term is subordinate to only one category term, (4) whether the definitions of terms are uniquely determined, (5) whether CDRH-NCIt terms corresponding to preferred terms are uniquely determined, (6) whether a term in a medical device problem is used for patient problems. RESULTS: About 60% of the total number of duplicated terms were found. This is because industry associations that created multiple terminologies adopted the same terms in terminologies of similar medical device groups. In the case that all terms with the same spelling have the same concept, efficient integration can be achieved automatically using RDF. Furthermore, we evaluated six matters of inconsistency in this study, terms that need to be reviewed accounted for about 10% or less than 10% in each item. CONCLUSIONS: The RDF and SPARQL were useful tools to explore inconsistencies of hierarchies, definition statements, and synonyms when integrating terminolgy by term notation, and these had the advantage of reducing the physical and time burden.


Assuntos
Idioma , Humanos , Japão
4.
Pharmacoepidemiol Drug Saf ; 28(7): 976-984, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31197887

RESUMO

PURPOSE: The purpose of this study is to evaluate the accuracy of gastrointestinal (GI) perforation ICD-10 coding in the Diagnosis Procedure Combination (DPC) database and to examine drug exposure risk factors for GI perforation. METHODS: A total of 100 patients with GI perforation ICD-10 codes were selected randomly from Kagawa University Hospital's DPC database between April 2011 and December 2016. Two experienced specialist physicians independently reviewed the medical records and classified cases as "definite A," "definite B," "probable," or "no GI perforation." The positive predictive values (PPVs) of "definite A/B" cases were calculated after stratification by sex, age, ICD-10 code, and diagnostic information in the DPC data. The number of prescribed drugs with side effects of GI perforation according to historical data was compared between "definite A/B" and "no GI perforation" cases. RESULTS: The overall PPV was 47.0% (95% confidence interval [CI], 36.9-57.2). However, the PPVs for the three categories of diagnostic information in the DPC data ("main diagnosis," "diagnosis causing admission," and "most resource-intensive diagnosis") were each more than 70% after excluding inappropriate patients. Additionally, the PPV focused on these three categories was 76.3% (95% CI, 59.8-88.6). Prescribed drugs with side effects of GI perforation were more frequently detected in "definite A/B" cases (P = .028). CONCLUSIONS: Although the overall PPV for GI perforation based on ICD-10 code was low, our results suggest that the PPV could be improved by appropriate selection of DPC diagnosis category and that use of multiple medications enhances the risk of GI perforation.


Assuntos
Grupos Diagnósticos Relacionados/normas , Hemorragia Gastrointestinal/epidemiologia , Perfuração Intestinal/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Bases de Dados Factuais , Feminino , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Lactente , Recém-Nascido , Perfuração Intestinal/induzido quimicamente , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Farmacoepidemiologia , Valor Preditivo dos Testes , Medicamentos sob Prescrição/efeitos adversos , Fatores de Risco , Adulto Jovem
5.
Pharmacoepidemiol Drug Saf ; 28(5): 601-608, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30945387

RESUMO

PURPOSE: To examine the potential role of Medical Information Database Network (MID-NET® ), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies. METHODS: The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety-related regulatory actions, and drug-associated risks. The five studies were conducted on the following topics: (a) utilization of codeine-containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark® ) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions. RESULTS: The pilot studies were successfully conducted and demonstrated the value of MID-NET® in postmarketing drug safety assessments. In particular, the ability to utilize laboratory test results as objective clinical indicators is a major advantage of this database. Potential limitations include a relatively small sample size and a lack of patient-level data linkages among hospitals. CONCLUSIONS: MID-NET® was confirmed to be a valuable database for postmarketing drug safety assessments. The use of laboratory test results to define clinical outcomes may allow more objective and accurate analyses to be conducted. These studies furthered our understanding of the characteristics of MID-NET® , including its advantages and limitations.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Bases de Dados de Produtos Farmacêuticos/estatística & dados numéricos , Uso de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Vigilância de Produtos Comercializados/métodos , Incidência , Japão , Farmacoepidemiologia , Projetos Piloto , Vigilância de Produtos Comercializados/estatística & dados numéricos , Fatores de Risco
6.
Pharmacoepidemiol Drug Saf ; 28(10): 1395-1404, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31464008

RESUMO

PURPOSE: To establish a new medical information database network (designated MID-NET® ) to provide real-world data for drug safety assessments in Japan. METHODS: This network was designed and developed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency in collaboration with 23 hospitals from 10 healthcare organizations across Japan. MID-NET® is a distributed and closed network system that connects all collaborative organizations through a central data center. A wide variety of data are available for analyses, including clinical and administrative information. Several coding standards are used to standardize the data stored in MID-NET® to allow the integration of information originating from different hospitals. A rigorous and consistent quality management system was implemented to ensure that MID-NET® data are of high quality and meet Japanese regulatory standards (good post-marketing study practice and related guidelines). RESULTS: MID-NET® was successfully established as a reliable and valuable medical information database and was officially launched in April 2018. High data quality with almost 100% consistency was confirmed between original data in hospitals and the data stored in MID-NET® . A major advantage is that approximately 260 clinical laboratory test results are available for analysis. CONCLUSIONS: MID-NET® is expected to be a major data source for drug safety assessments in Japan. Experiences and best practices established in MID-NET® may provide a model for the future development of similar database networks.


Assuntos
Gerenciamento de Dados/organização & administração , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacovigilância , Vigilância de Produtos Comercializados/métodos , Codificação Clínica/organização & administração , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Registros Eletrônicos de Saúde/organização & administração , Humanos , Japão/epidemiologia , Reprodutibilidade dos Testes
7.
J Clin Pharm Ther ; 44(5): 788-795, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31282013

RESUMO

WHAT IS KNOWN AND OBJECTIVE: Since its introduction in April 2012, denosumab has been administered to approximately 7,300 patients as of August 2012, and 32 cases of serious hypocalcaemia after denosumab administration, including two deaths, have been reported in Japan. A Dear Healthcare Professional Letter of Rapid Safety Communication ('Blue letter') was released to warn about the risks of hypocalcaemia associated with denosumab. The goal of this study therefore was to measure the impact of regulatory action on denosumab-induced hypocalcaemia in Japan by using an electronic medical information database (MID). METHODS: We used two different aggregated data sets based on MIDs (data sets one and two). The patients studied were those who were newly prescribed denosumab or zoledronic acid between April 2012 and September 2014. We assessed four indicators: (a) the proportion of patients with calcium supplementation at the initial denosumab treatment, (b) the proportion of patients who underwent a serum calcium test, (c) the average number of serum calcium tests performed and (d) the prevalence of hypocalcaemia. All indices were aggregated by every 3 months. To evaluate the impact of regulatory action, we used difference in difference (DID) analysis. RESULTS AND DISCUSSION: The proportion of patients with calcium supplementation at the initial denosumab treatment increased year by year in both data sets. The average number of serum calcium tests increased year by year in data set two. There was a significant difference in the prevalence of hypocalcaemia in data set two. This suggests that the estimate of impact of the regulatory action may vary according to the database. In DID analysis, however, significant influences of the regulatory action on combination use with a calcium supplement were detected in both data sets. WHAT IS NEW AND CONCLUSION: There was a significant influence on combination use of denosumab with vitamin D and/or calcium supplement in both data sets. That there was no apparent increase in the prevalence of denosumab-induced hypocalcaemia, suggests that the regulatory action had an impact in the clinical setting studied. Such regulatory actions may play an important role in the promotion of drug safety.


Assuntos
Conservadores da Densidade Óssea/efeitos adversos , Denosumab/efeitos adversos , Hipocalcemia/induzido quimicamente , Idoso , Cálcio/sangue , Bases de Dados Factuais , Feminino , Humanos , Hipocalcemia/sangue , Japão , Masculino , Fatores de Risco , Vitamina D/administração & dosagem , Ácido Zoledrônico/uso terapêutico
8.
Gan To Kagaku Ryoho ; 45(1): 85-87, 2018 Jan.
Artigo em Japonês | MEDLINE | ID: mdl-29362316

RESUMO

An 84-year-old man visited our hospital with epigastralgia.Levels of hepatic and biliary enzymes and CRP were elevated, as detected by a blood test.On a CT scan, a swollen gallbladder with stones was detected.The patient was admitted to the hospital with a diagnosis of Grade I acute cholecystitis.Conservative treatment was continued with antibiotic administration and the patient was discharged from the hospital with improvement on day 6 after admission.Three months later, the patient underwent laparoscopic cholecystectomy.In the gallbladder, a 45×45 mm tumor was found.Upon pathological examination, diffuse proliferation of lymphocyte-like heterotypic cells and subserosal invasion were observed.Immunohistochemistry results were negative for MUM1 and positive for CD10 and Bcl6 markers.A malignant diffuse large B-cell lymphoma was diagnosed.We experienced a case of malignant lymphoma of the gallbladder diagnosed after surgery for acute cholecystitis, which we herein report with literature consideration.


Assuntos
Colecistite/diagnóstico por imagem , Colecistite/etiologia , Neoplasias da Vesícula Biliar/complicações , Neoplasias da Vesícula Biliar/diagnóstico , Linfoma Difuso de Grandes Células B/complicações , Linfoma Difuso de Grandes Células B/diagnóstico , Idoso de 80 Anos ou mais , Colecistectomia Laparoscópica , Neoplasias da Vesícula Biliar/patologia , Neoplasias da Vesícula Biliar/cirurgia , Humanos , Linfoma Difuso de Grandes Células B/cirurgia , Masculino , Tomografia Computadorizada por Raios X
9.
Gan To Kagaku Ryoho ; 43(12): 1908-1910, 2016 Nov.
Artigo em Japonês | MEDLINE | ID: mdl-28133172

RESUMO

A 75-year-old man admitted for left lateral abdominal pain was found to have advanced poorly differentiated gastric adenocarcinoma with abdominal para-aortic and Virchow's lymph node metastases, which was diagnosed to be clinical Stage IV (T3N3H0M1[LYM]). As curative surgery was not deemed possible, we started chemotherapy administration using S-1 (120mg/day)administered orally for 3 weeks and cisplatin(CDDP 100mg/body)administered intravenously on day 8. After 6 courses of chemotherapy, a CT scan showed that all lymph nodes metastases had disappeared, resulting in downstaging to clinical Stage II (T3[SE]N0H0P0M0). Thus, we performed total gastrectomy, lymph node dissection(D2), and splenectomy. Histological findings showed no residual tumor cells in any of the lymph nodes. However, cancer cells remained in the primary gastric lesion. The pathological response to chemotherapy was judged to be Grade 2. The patient has been recurrence-free for 5 years after surgery.


Assuntos
Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Terapia de Salvação , Neoplasias Gástricas/tratamento farmacológico , Adenocarcinoma/cirurgia , Idoso , Cisplatino/administração & dosagem , Combinação de Medicamentos , Humanos , Masculino , Terapia Neoadjuvante , Ácido Oxônico/administração & dosagem , Neoplasias Gástricas/patologia , Neoplasias Gástricas/cirurgia , Tegafur/administração & dosagem
10.
J Digit Imaging ; 28(1): 41-52, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25005868

RESUMO

This article summarizes the consensus reached at the Summit on Color in Medical Imaging held at the Food and Drug Administration (FDA) on May 8-9, 2013, co-sponsored by the FDA and ICC (International Color Consortium). The purpose of the meeting was to gather information on how color is currently handled by medical imaging systems to identify areas where there is a need for improvement, to define objective requirements, and to facilitate consensus development of best practices. Participants were asked to identify areas of concern and unmet needs. This summary documents the topics that were discussed at the meeting and recommendations that were made by the participants. Key areas identified where improvements in color would provide immediate tangible benefits were those of digital microscopy, telemedicine, medical photography (particularly ophthalmic and dental photography), and display calibration. Work in these and other related areas has been started within several professional groups, including the creation of the ICC Medical Imaging Working Group.


Assuntos
Cor/normas , Diagnóstico por Imagem/normas , Humanos , Padrões de Referência , Estados Unidos , United States Food and Drug Administration
11.
Stud Health Technol Inform ; 310: 1450-1451, 2024 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-38269691

RESUMO

The purpose of this study was to evaluate the accuracy of deep neural machine translation focused on medical device adverse event terminology. 10 models were obtained, and their English-to-Japanese translation accuracy was evaluated using quantitative and qualitative measures. No significant difference was found in the quantitative index except for a few pairs. In the qualitative evaluation, there was a significant difference and googletrans and GPT-3 were regarded as useful models.


Assuntos
Inteligência Artificial , Falha de Equipamento , Tradução , Terminologia como Assunto
12.
Sci Rep ; 14(1): 7656, 2024 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-38561333

RESUMO

This study focused on the heterogeneity in progress notes written by physicians or nurses. A total of 806 days of progress notes written by physicians or nurses from 83 randomly selected patients hospitalized in the Gastroenterology Department at Kagawa University Hospital from January to December 2021 were analyzed. We extracted symptoms as the International Classification of Diseases (ICD) Chapter 18 (R00-R99, hereinafter R codes) from each progress note using MedNER-J natural language processing software and counted the days one or more symptoms were extracted to calculate the extraction rate. The R-code extraction rate was significantly higher from progress notes by nurses than by physicians (physicians 68.5% vs. nurses 75.2%; p = 0.00112), regardless of specialty. By contrast, the R-code subcategory R10-R19 for digestive system symptoms (44.2 vs. 37.5%, respectively; p = 0.00299) and many chapters of ICD codes for disease names, as represented by Chapter 11 K00-K93 (68.4 vs. 30.9%, respectively; p < 0.001), were frequently extracted from the progress notes by physicians, reflecting their specialty. We believe that understanding the information heterogeneity of medical documents, which can be the basis of medical artificial intelligence, is crucial, and this study is a pioneering step in that direction.


Assuntos
Doenças do Sistema Digestório , Médicos , Humanos , Inteligência Artificial , Pacientes Internados , Processamento de Linguagem Natural , Registros Eletrônicos de Saúde
13.
J Nutr Sci Vitaminol (Tokyo) ; 70(3): 203-209, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38945885

RESUMO

D-Allulose has blood glucose suppression effects in both animal and clinical studies. The mechanism mediating glucose suppression in animals is controlled by several actions including the inhibition of sucrase. To investigate the dose-response effects of D-allulose with a sucrose beverage on glucose tolerance and insulin levels using Thai volunteers. This was a prospective, randomized, double-blinded, crossover study. Subjects had five oral sucrose tolerance tests (OSTT) with escalating doses of D-allulose (0, 2.5, 5, 7.5 or 10 g) with a 50 g sucrose beverage in a random order once a week for five consecutive weeks. The five drinks were consumed in a random order; the order being blinded for both subjects and investigators. Blood samples were drawn immediately before consumption and at 30, 60, 90 and 120 min after consumption of the study product for measurement of plasma glucose and insulin levels. Thirty healthy subjects (11 men and 19 women) completed the study. The peak postprandial glucose (PePPG) and insulin levels (PePPI) were lower when D-allulose was added in a dose-dependent manner. The lowest plasma glucose and insulin levels occurred at 120 min after OSTT in all five products and they were raised when D-allulose was added in a dose-dependent manner. D-Allulose has a suppression response on glucose and insulin shown by the decrease in postprandial plasma glucose and insulin levels following the addition of D-allulose to sucrose in a dose-dependent manner. The more D-allulose added, the less marked the glucose and insulin response occurred.


Assuntos
Glicemia , Estudos Cross-Over , Insulina , Período Pós-Prandial , Sacarose , Humanos , Masculino , Insulina/sangue , Glicemia/metabolismo , Glicemia/efeitos dos fármacos , Glicemia/análise , Adulto , Método Duplo-Cego , Feminino , Adulto Jovem , Tailândia , Sacarose/administração & dosagem , Sacarose/farmacologia , Frutose/administração & dosagem , Frutose/farmacologia , Teste de Tolerância a Glucose , Relação Dose-Resposta a Droga , Estudos Prospectivos , Bebidas , Voluntários Saudáveis , Bebidas Adoçadas com Açúcar , População do Sudeste Asiático
14.
Ther Innov Regul Sci ; 58(4): 746-755, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38644459

RESUMO

BACKGROUND: The Medical Information Database Network (MID-NET®) in Japan is a vast repository providing an essential pharmacovigilance tool. Gastrointestinal perforation (GIP) is a critical adverse drug event, yet no well-established GIP identification algorithm exists in MID-NET®. METHODS: This study evaluated 12 identification algorithms by combining ICD-10 codes with GIP therapeutic procedures. Two sites contributed 200 inpatients with GIP-suggestive ICD-10 codes (100 inpatients each), while a third site contributed 165 inpatients with GIP-suggestive ICD-10 codes and antimicrobial prescriptions. The positive predictive values (PPVs) of the algorithms were determined, and the relative sensitivity (rSn) among the 165 inpatients at the third institution was evaluated. RESULTS: A trade-off between PPV and rSn was observed. For instance, ICD-10 code-based definitions yielded PPVs of 59.5%, whereas ICD-10 codes with CT scan and antimicrobial information gave PPVs of 56.0% and an rSn of 97.0%, and ICD-10 codes with CT scan and antimicrobial information as well as three types of operation codes produced PPVs of 84.2% and an rSn of 24.2%. The same algorithms produced statistically significant differences in PPVs among the three institutions. Combining diagnostic and procedure codes improved the PPVs. The algorithm combining ICD-10 codes with CT scan and antimicrobial information and 80 different operation codes offered the optimal balance (PPV: 61.6%, rSn: 92.4%). CONCLUSION: This study developed valuable GIP identification algorithms for MID-NET®, revealing the trade-offs between accuracy and sensitivity. The algorithm with the most reasonable balance was determined. These findings enhance pharmacovigilance efforts and facilitate further research to optimize adverse event detection algorithms.


Assuntos
Algoritmos , Bases de Dados Factuais , Perfuração Intestinal , Farmacovigilância , Humanos , Japão , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Classificação Internacional de Doenças , Adulto , Idoso de 80 Anos ou mais , Sistemas de Notificação de Reações Adversas a Medicamentos
15.
PLoS One ; 18(4): e0281150, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37023000

RESUMO

D-Allulose is a rare sugar that exists in nature. It is a food ingredient with nearly zero calories (<0.4 kcal/g) and has many physiological functionalities such as attenuation of postprandial blood glucose levels, attenuation of postprandial fat mass accumulation, and anti-aging property. This study focused on the postprandial blood glucose changes in healthy humans by a systematic review and meta-analysis. They were chosen because of its importance to a prevention from diabetes. The study objective was to examine acute blood glucose concentrations of healthy humans after the meal with and without allulose. The study collected all D-allulose related studies from various databases. A forest plot of the comparison between an allulose intake group and the control group showed both 5g and 10g intake groups have the significantly smaller area under the curve of postprandial blood glucose levels. It means that D-Allulose attenuates postprandial blood glucose concentrations in healthy humans. As the result, D-Allulose is a valuable blood glucose management tool for healthy humans and diabetes patients. Allulose Diet enables reduction of sucrose intake through Sugar Reformulation in the future diet.


Assuntos
Glicemia , Frutose , Humanos , Dieta
16.
Ther Innov Regul Sci ; 57(1): 104-108, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35994203

RESUMO

With the rapid technological innovations of the Internet of Things (IoT), the situation surrounding medical devices and medical systems has been changing. Interoperable medical devices-medical devices capable of interoperating in a clinically significant way with other medical devices-have been developed, and interoperable medical systems consisting of two or more interconnected interoperable medical devices are being used in clinical settings. However, general points that need to be considered to ensure safe and effective interoperability have yet to be fully established in Japan. A research project (FY2019-FY2021) to discuss issues associated with ensuring safe and effective interoperability was commissioned by the Japan Agency for Medical Research and Development. A pivotal aspect identified in that project is how to manage the sharing of data and information among interoperable medical devices from different manufacturers. Characteristics and timestamps of data and information need to be exchanged between interoperable medical devices. Risks associated with interoperable devices should be managed in a manner appropriate to the characteristics and the intended use of the interoperable medical devices. In this review, we summarize the aspects of data and information that this study group judged were important to consider for ensuring safety and effective interoperability.


Assuntos
População do Leste Asiático , Humanos , Japão
17.
Stud Health Technol Inform ; 290: 1058-1059, 2022 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-35673204

RESUMO

The purpose of our study is to identify the patterns of vectors in similar/dissimilar pairs of definition sentence created by Word2vec and doec2vec for elaboration of the terminology for Japanese Medical Device Adverse Events. 2-dimension vector space created by t-SNE showed that the pair with true positive located closer in a vector space, especially Doc2vec had a strong tendency. Comparing with Word2vec, Similar vectors in Doc2vec were close and tended to form clusters.


Assuntos
Idioma , Japão
18.
J Infect Public Health ; 15(7): 726-733, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35687982

RESUMO

OBJECTIVES: We provided COVID-19 outbreak trends in South Africa during the Omicron (B.1.1.529), Delta (B.1.617.2), and Beta (B.1.351) variants outbreak periods from November 2020 to March 2022. METHODS: We used the time series summary data of the COVID-19 outbreak for South Africa available in the COVID-19 data repository created by the Center for System and Science and Engineering at Johns Hopkins University and the Our World in Data database by the University of Oxford from January 2020 to March 2022. We used the joinpoint regression model with a data-driven Bayesian information criterion method for analyzing the outbreak trends. In addition, we used density ellipses and partition modeling on the outbreak data. RESULTS: During the Omicron outbreak period, COVID-19 cases in South Africa significantly jumped by 4.7 times from December 01 to December 08, 2021. The average daily growth rate of incidence peaked at 23,000 cases/day until December 16, 2021, which was 18.6 % higher than the peak growth during the Delta outbreak period. South Africa experienced peak growth in COVID-19 cases with 18,611 cases/day (January 04 to January 14, 2021) during the Beta outbreak period and with 19,395 cases/day (July 01 to July 11, 2021) during the Delta outbreak period. Density ellipsoid showed a significant correlation between daily cases and daily death count during the Beta and Delta outbreak period which was not prominent in the Omicron outbreak period. Comparatively higher daily death tolls were reported in days with a recovery rate of less than 89.1 % and 91.9 % in the Beta and Delta outbreak period respectively. The backlog counts may be one of the reasons for the significant increase in daily death tolls during the Omicron period. CONCLUSIONS: During the Omicron period, COVID-19 cases peaked growth was 18.6 % higher than the peak growth during the Delta outbreak period. Despite that fact, growth in death trends in the Omicron outbreak period was found low which might be due to the low mortality rate and case fatality proportion. The emergence of the Omicron variant once again reminds us that- "no one is safe until everyone is safe".


Assuntos
COVID-19 , SARS-CoV-2 , Teorema de Bayes , COVID-19/epidemiologia , Surtos de Doenças , Humanos , África do Sul/epidemiologia
19.
Cancer Inform ; 21: 11769351221085064, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35342285

RESUMO

Objective: In recent years, natural language processing (NLP) techniques have progressed, and their application in the medical field has been tested. However, the use of NLP to detect symptoms from medical progress notes written in Japanese, remains limited. We aimed to detect 2 gastrointestinal symptoms that interfere with the continuation of chemotherapy-nausea/vomiting and diarrhea-from progress notes using NLP, and then to analyze factors affecting NLP. Materials and methods: In this study, 200 patients were randomly selected from 5277 patients who received intravenous injections of cytotoxic anticancer drugs at Kagawa University Hospital, Japan, between January 2011 and December 2018. We aimed to detect the first occurrence of nausea/vomiting (Group A) and diarrhea (Group B) using NLP. The NLP performance was evaluated by the concordance with a review of the physicians' progress notes used as the gold standard. Results: Both groups showed high concordance: 83.5% (95% confidence interval [CI] 74.1-90.1) in Group A and 97.7% (95% CI 91.3-99.9) in Group B. However, the concordance was significantly better in Group B (P = .0027). There were significantly more misdetection cases in Group A than in Group B (15.3% in Group A; 1.2% in Group B, P = .0012) due to negative findings or past history. Conclusion: We detected occurrences of nausea/vomiting and diarrhea accurately using NLP. However, there were more misdetection cases in Group A due to negative findings or past history, which may have been influenced by the physicians' more frequent documentation of nausea/vomiting.

20.
Nutrients ; 14(3)2022 Jan 29.
Artigo em Inglês | MEDLINE | ID: mdl-35276961

RESUMO

We aimed to analyze the temporal trends in the per capita food (kcal/day/person) and protein (g/day/person) availability at the national level in the Southeast Asian (SEA) countries from 1961 to 2018. To avoid intercountry variations and errors, we used a dataset derived from the FAO's old and new food balance sheets. We used the joinpoint model and the jump model to analyze the temporal trends. The annual percentage change (APC) was computed for each segment of the trends. Per capita food and protein availability in the SEA countries increased significantly by 0.8% per year (54.0%) and 1.1% per year (85.1%), respectively, from 1961 to 2018. During the 1960s, 1970s, and 1980s the per capita food availability in mainland SEA did not change significantly and was less than 2200 kcal/person/day. Since the early 1990s, food availability increased appreciably in the mainland SEA countries, except for Cambodia, which has experienced the increasing trend from the late 1990s. Distinct from the mainland, maritime SEA countries showed an up-down-up growth trend in their per-capita food availability from 1961 to 2018. Food-availability growth slowed down for Brunei (since the mid-1980s) and Malaysia (since mid-the 1990s) whereas it increased for Indonesia (1.5% per year), Timor-Leste (0.9% per year), and the Philippines (0.8% per year). Per capita protein availability trends in the mainland SEA countries were similar to the countries' per capita food availability trends. Since the late 1980s, Thailand and since the late 1990s, other mainland SEA countries experienced a significant growth in their per capita protein availability. Since the late 1990s, per capita protein availability in Vietnam increased markedly and reached the highest available amount in the SEA region, following Brunei and Myanmar. Per capita protein availability increased almost continuously among the maritime SEA countries, except for Timor-Leste. Marked inequality did exist between maritime and mainland SEA countries in per capita food-availability growth till the mid-1990s. Considerable increases in per capita food availability have occurred in most of the SEA countries, but growth is inadequate for Timor-Leste and Cambodia.


Assuntos
Declarações Financeiras , Alimentos , Sudeste Asiático , Camboja , Abastecimento de Alimentos , Humanos
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