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[PMID]:29367485
[Au] Autor:Umigai N; Murakami K; Shimizu R; Takeda R; Azuma T
[Ad] Endereço:Riken Vitamin Co., Ltd.
[Ti] Título:Safety Evaluation and Plasma Carotenoid Accumulation in Healthy Adult Subjects after 12 Weeks of Paprika Oleoresin Supplementation.
[So] Source:J Oleo Sci;67(2):225-234, 2018 Feb 01.
[Is] ISSN:1347-3352
[Cp] País de publicação:Japan
[La] Idioma:eng
[Ab] Resumo:Paprika oleoresin is obtained by solvent extraction from Capsicum annuum L. fruits and contains multiple carotenoids, such as capsanthin, ß-carotene, zeaxanthin, and ß-cryptoxanthin, which are considered protective against various diseases. Herein, we investigated the effect of paprika oleoresin supplementation on plasma carotenoid accumulation and evaluated the safety of the oleoresin. We used a double-blinded, placebo-controlled comparative clinical study design and tested the effects of varying doses in healthy adult subjects. In total, 33 subjects were randomly divided into three groups to take capsules containing 0, 20, or 100 mg of paprika oleoresin daily for 12 consecutive weeks. Plasma carotenoid concentrations were measured at 0, 4, 8, and 12 weeks, and the safety of paprika oleoresin capsules was investigated using analyses of blood biochemistry, hematology, and urine contents. In these experiments, ß-cryptoxanthin and zeaxanthin dose-dependently accumulated in plasma within the dose range of the study over 12 consecutive weeks of paprika oleoresin supplementation. Moreover, ß-cryptoxanthin accumulated to higher levels than the other paprika oleoresin carotenoids. In contrast, capsanthin was not detected in plasma before or during the 12-week treatment period. Finally, no adverse events were associated with intake of paprika oleoresin (20 and 100 mg/day) in safety evaluations. Paprika oleoresin is a suitable source of carotenoids, especially ß-cryptoxanthin.
[Mh] Termos MeSH primário: Capsicum/química
Carotenoides/sangue
Suplementos Nutricionais
Extratos Vegetais/administração & dosagem
Extratos Vegetais/isolamento & purificação
[Mh] Termos MeSH secundário: beta-Criptoxantina/sangue
Suplementos Nutricionais/efeitos adversos
Relação Dose-Resposta a Droga
Método Duplo-Cego
Extratos Vegetais/efeitos adversos
Distribuição Aleatória
Segurança
Solventes
Fatores de Tempo
Zeaxantinas/sangue
[Pt] Tipo de publicação:CLINICAL STUDY; COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Beta-Cryptoxanthin); 0 (Plant Extracts); 0 (Solvents); 0 (Zeaxanthins); 0 (oleoresins); 36-88-4 (Carotenoids)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180126
[St] Status:MEDLINE
[do] DOI:10.5650/jos.ess17155


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[PMID]:29498497
[Ti] Título:Progress towards poliomyelitis eradication: Nigeria, January­December 2017.
[Ti] Título:Progrès vers l'éradication de la poliomyélite au Nigéria, janvier-décembre 2017..
[So] Source:Wkly Epidemiol Rec;93(9):97-104, 2018 Mar 02.
[Is] ISSN:0049-8114
[Cp] País de publicação:Switzerland
[La] Idioma:eng; fre
[Mh] Termos MeSH primário: Erradicação de Doenças
Programas de Imunização
Poliomielite/prevenção & controle
Vacina Antipólio Oral/administração & dosagem
Poliovirus/imunologia
[Mh] Termos MeSH secundário: Seres Humanos
Lactente
Militares
Nigéria/epidemiologia
Poliomielite/epidemiologia
Poliomielite/transmissão
Segurança
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Poliovirus Vaccine, Oral)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180303
[St] Status:MEDLINE


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[PMID]:29386437
[Au] Autor:Nagasato A; Nakamura M; Kamimura H
[Ad] Endereço:Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Sciences, Fukuoka University.
[Ti] Título:[Comparative Study of the Efficacy and Safety of Caffeine and Aminophylline for the Treatment of Apnea in Preterm Infants].
[So] Source:Yakugaku Zasshi;138(2):237-242, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: Methylxanthine is widely administered for the treatment of apnea of prematurity in many countries, and previous reports have clearly established that caffeine is effective for the treatment of apnea of prematurity. In Japan, caffeine has been available since December 2014. Thus, we compared the efficacy and safety of caffeine with that of aminophylline in our hospital. There was no significant difference between the caffeine group and aminophylline group regarding the characteristics of the study patients. The mean efficacy rate from day 1 to day 10 was 89.5% in the caffeine group, and 81.9% in the aminophylline group, although the rate of improvement in apnea episodes each day from day 1 to day 10 was not significantly different between the two groups. On the other hand, the adverse event rates in the caffeine group and the aminophylline group were 70.6% and 75.0%, respectively. No significant difference was observed in the adverse event rates between the two groups. Moreover, suspected abdominal distension due to the drug administration was more frequently observed with the aminophylline group. Our findings indicate that caffeine is as effective as aminophylline, while it is superior to aminophylline regarding its overall safety.
[Mh] Termos MeSH primário: Aminofilina/administração & dosagem
Apneia/tratamento farmacológico
Cafeína/administração & dosagem
Recém-Nascido Prematuro
[Mh] Termos MeSH secundário: Administração Oral
Aminofilina/efeitos adversos
Apneia/etiologia
Cafeína/efeitos adversos
Feminino
Seres Humanos
Recém-Nascido
Infusões Intravenosas
Masculino
Segurança
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
27Y3KJK423 (Aminophylline); 3G6A5W338E (Caffeine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180202
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00144


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[PMID]:29386431
[Au] Autor:Ohashi Y
[Ad] Endereço:Quality & Regulatory Compliance Unit, Chugai Pharmaceutical Co., Ltd.
[Ti] Título:[Safe Use of Recent New Drugs-Current Status and Challenges].
[So] Source:Yakugaku Zasshi;138(2):177-183, 2018.
[Is] ISSN:1347-5231
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo: In Japan and overseas, Chugai Pharmaceutical Company handles numerous biopharmaceuticals, molecular targeted therapies and other pharmaceuticals with innovative modes of action. Expert safety evaluation is essential for promoting the appropriate use of these pharmaceuticals around the world and in gaining acceptance from patients and healthcare professionals (HCPs), while speedy decision-making is crucial for the timely collection and provision of safety information and thus ensuring safety. In 2015, we collected safety information on more than 180000 cases and evaluated it from a medical standpoint. We have established a system for recording the collected information in a global database, and are conducting signal detection of adverse drug reactions using this database. With this system, we promptly disclose information to regulatory authorities in Japan, the US, Europe and Asia. We have in-house medical doctors with abundant clinical experience who conduct expert safety evaluations. Many innovative drugs, such as anticancer drugs or biopharmaceuticals, require wider-ranging, more rigorous management, including the provision of appropriate safety information to HCPs, management of distribution through wholesalers and dispensing pharmacies, and confirmation of conditions of use, in addition to all-case registration surveillance. With progress in the development of individualized medicine and drugs with new modes of action, in order for HCPs to understand the characteristics of these new drugs and use them appropriately, pharmacists and pharmaceutical companies should cooperate in promoting their appropriate use in the spirit of 'All Pharmacists for Patients'.
[Mh] Termos MeSH primário: Bases de Dados de Produtos Farmacêuticos
Serviços de Informação sobre Medicamentos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Preparações Farmacêuticas
Farmacovigilância
Gestão de Riscos
[Mh] Termos MeSH secundário: Biofarmácia
Tomada de Decisões Gerenciais
Indústria Farmacêutica
Seres Humanos
Farmacêuticos
Medicina de Precisão/tendências
Segurança
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180202
[St] Status:MEDLINE
[do] DOI:10.1248/yakushi.17-00174-3


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[PMID]:29351313
[Au] Autor:Rocca CH; Puri M; Shrestha P; Blum M; Maharjan D; Grossman D; Regmi K; Darney PD; Harper CC
[Ad] Endereço:Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, University of California San Francisco, San Francisco, CA, United States of America.
[Ti] Título:Effectiveness and safety of early medication abortion provided in pharmacies by auxiliary nurse-midwives: A non-inferiority study in Nepal.
[So] Source:PLoS One;13(1):e0191174, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Expanding access to medication abortion through pharmacies is a promising avenue to reach women with safe and convenient care, yet no pharmacy provision interventions have been evaluated. This observational non-inferiority study investigated the effectiveness and safety of mifepristone-misoprostol medication abortion provided at pharmacies, compared to government-certified public health facilities, by trained auxiliary nurse-midwives in Nepal. METHODS: Auxiliary nurse-midwives were trained to provide medication abortion through twelve pharmacies and public facilities as part of a demonstration project in two districts. Eligible women were ≤63 days pregnant, aged 16-45, and had no medical contraindications. Between 2014-2015, participants (n = 605) obtained 200 mg mifepristone orally and 800 µg misoprostol sublingually or intravaginally 24 hours later, and followed-up 14-21 days later. The primary outcome was complete abortion without manual vacuum aspiration; the secondary outcome was complication requiring treatment. We assessed risk differences by facility type with multivariable logistic mixed-effects regression. RESULTS: Over 99% of enrolled women completed follow-up (n = 600). Complete abortions occurred in 588 (98·0%) cases, with ten incomplete abortions and two continuing pregnancies. 293/297 (98·7%) pharmacy participants and 295/303 (97·4%) public facility participants had complete abortions, with an adjusted risk difference falling within the pre-specified 5 percentage-point non-inferiority margin (1·5% [-0·8%, 3·8%]). No serious adverse events occurred. Five (1.7%) pharmacy and two (0.7%) public facility participants experienced a complication warranting treatment (aRD, 0.8% [-1.0%-2.7%]). CONCLUSIONS: Early mifepristone-misoprostol abortion was as effective and safe when provided by trained auxiliary nurse-midwives at pharmacies as at government-certified health facilities. Findings support policy expanding provision through registered pharmacies by trained auxiliary nurse-midwives to improve access to safe care.
[Mh] Termos MeSH primário: Aborto Induzido/enfermagem
Enfermeiras Obstétricas
[Mh] Termos MeSH secundário: Abortivos não Esteroides/administração & dosagem
Abortivos Esteroides/administração & dosagem
Aborto Induzido/educação
Aborto Induzido/métodos
Adolescente
Adulto
Feminino
Acesso aos Serviços de Saúde
Seres Humanos
Mifepristona/administração & dosagem
Misoprostol/administração & dosagem
Nepal
Enfermeiras Obstétricas/educação
Farmácias
Gravidez
Enfermagem em Saúde Pública/educação
Segurança
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Abortifacient Agents, Nonsteroidal); 0 (Abortifacient Agents, Steroidal); 0E43V0BB57 (Misoprostol); 320T6RNW1F (Mifepristone)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180221
[Lr] Data última revisão:
180221
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180120
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0191174


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[PMID]:28448562
[Au] Autor:Moots RJ; Xavier RM; Mok CC; Rahman MU; Tsai WC; Al-Maini MH; Pavelka K; Mahgoub E; Kotak S; Korth-Bradley J; Pedersen R; Mele L; Shen Q; Vlahos B
[Ad] Endereço:Aintree University Hospital, University of Liverpool, Liverpool, United Kingdom.
[Ti] Título:The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study.
[So] Source:PLoS One;12(4):e0175207, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To assess the incidence of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) treated with the TNF inhibitors etanercept (ETN), adalimumab (ADL), or infliximab (IFX), and determine the potential relationship with trough drug concentration, efficacy, and patient-reported outcomes. METHODS: This multi-national, non-interventional, cross-sectional study (NCT01981473) enrolled adult patients with RA treated continuously for 6-24 months with ETN, ADL, or IFX. ADA and trough drug concentrations were measured by independent assays ≤2 days before the next scheduled dose. Efficacy measurements included Disease Activity Score 28-joint count (DAS28), low disease activity (LDA), remission, and erythrocyte sedimentation rate (ESR). Targeted medical histories of injection site/infusion reactions, serum sickness, and thromboembolic events were collected. RESULTS: Baseline demographics of the 595 patients (ETN: n = 200; ADL: n = 199; IFX: n = 196) were similar across groups. The mean duration of treatment was 14.6, 13.5, and 13.1 months for ETN, ADL, and IFX, respectively. All ETN-treated patients tested negative for ADA, whereas 31.2% and 17.4% patients treated with ADL and IFX, respectively, tested positive. In ADL- or IFX-treated patients, those with ADA had significantly lower trough drug concentrations. There were negative correlations between trough drug levels and both CRP and ESR in ADL- and IFX-treated patients. DAS28-ESR LDA and remission rates were higher in patients without ADA. The rate of targeted medical events reported was low. CONCLUSION: ADA were detected in ADL- and IFX-treated but not ETN-treated patients. Patients without ADA generally showed numerically better clinical outcomes than those with ADA. TRIAL REGISTRATION: This study was registered on www.ClinicalTrials.gov (NCT01981473).
[Mh] Termos MeSH primário: Anticorpos/imunologia
Antirreumáticos/imunologia
Antirreumáticos/farmacologia
Artrite Reumatoide/tratamento farmacológico
Artrite Reumatoide/imunologia
[Mh] Termos MeSH secundário: Adalimumab/efeitos adversos
Adalimumab/imunologia
Adalimumab/farmacologia
Adalimumab/uso terapêutico
Antirreumáticos/uso terapêutico
Relação Dose-Resposta a Droga
Etanercepte/efeitos adversos
Etanercepte/imunologia
Etanercepte/farmacologia
Etanercepte/uso terapêutico
Feminino
Seres Humanos
Infliximab/efeitos adversos
Infliximab/imunologia
Infliximab/farmacologia
Infliximab/uso terapêutico
Internacionalidade
Masculino
Meia-Idade
Segurança
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies); 0 (Antirheumatic Agents); B72HH48FLU (Infliximab); FYS6T7F842 (Adalimumab); OP401G7OJC (Etanercept)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:180221
[Lr] Data última revisão:
180221
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170428
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0175207


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[PMID]:25815744
[Au] Autor:Kaewboonchoo O; Kongtip P; Woskie S
[Ad] Endereço:Department of Occupational Safety and Health, Faculty of Public Health, Mahidol University, Bangkok, Thailand orawan.kae@mahidol.ac.th.
[Ti] Título:Occupational health and safety for agricultural workers in Thailand: gaps and recommendations, with a focus on pesticide use.
[So] Source:New Solut;25(1):102-20, 2015 May.
[Is] ISSN:1541-3772
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Over 16.7 million workers in Thailand (42 percent of the working population) are engaged in agriculture, disproportionately from the lower socioeconomic strata of Thai society. Most agricultural workers (over 93 percent) work in the informal sector without the protections of regulations or enforcement of labor or health and safety laws or enrollment in a social security system. Although Thailand's use of herbicides, fungicides, and insecticides is growing, there is little regulation of the sale, use, or application of these potentially toxic chemicals. This paper summarizes the research to date on occupational health and safety for Thai agricultural workers, identifies gaps in pesticide regulations and the current systems for occupational health and safety and social support for Thai agricultural workers, and makes recommendations for future policy and research initiatives to fill the identified gaps.
[Mh] Termos MeSH primário: Doenças dos Trabalhadores Agrícolas/epidemiologia
Doenças dos Trabalhadores Agrícolas/prevenção & controle
Exposição Ocupacional/prevenção & controle
Praguicidas/efeitos adversos
Segurança
[Mh] Termos MeSH secundário: Acidentes de Trabalho/prevenção & controle
Acidentes de Trabalho/estatística & dados numéricos
Fazendeiros
Seres Humanos
Capacitação em Serviço/organização & administração
Saúde do Trabalhador
Traumatismos Ocupacionais/epidemiologia
Traumatismos Ocupacionais/prevenção & controle
Resíduos de Praguicidas
Roupa de Proteção
Assistência Pública/organização & administração
Apoio Social
Medicina Estatal/organização & administração
Tailândia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
[Nm] Nome de substância:
0 (Pesticide Residues); 0 (Pesticides)
[Em] Mês de entrada:1601
[Cu] Atualização por classe:180216
[Lr] Data última revisão:
180216
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150328
[St] Status:MEDLINE
[do] DOI:10.1177/1048291115569028


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[PMID]:29189460
[Au] Autor:Morelock SG
[Ad] Endereço:Skip G. Morelock is the manager of compliance and quality at the University of Texas Southwestern Medical Center in Dallas, Tex.
[Ti] Título:The night shift: Follow the evidence to survive and thrive.
[So] Source:Nursing;47(12):46-51, 2017 Dec.
[Is] ISSN:1538-8689
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Recursos Humanos de Enfermagem no Hospital
Tolerância ao Trabalho Programado
[Mh] Termos MeSH secundário: Enfermagem Baseada em Evidências
Nível de Saúde
Seres Humanos
Recursos Humanos de Enfermagem no Hospital/psicologia
Risco
Segurança
Sono
Tolerância ao Trabalho Programado/fisiologia
Tolerância ao Trabalho Programado/psicologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180212
[Lr] Data última revisão:
180212
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:171201
[St] Status:MEDLINE
[do] DOI:10.1097/01.NURSE.0000526889.33176.10


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[PMID]:29304035
[Au] Autor:Frost K; Bertocci G; Smalley C
[Ad] Endereço:Department of Bioengineering, J.B. Speed School of Engineering, University of Louisville, Louisville, Kentucky, United States of America.
[Ti] Título:Wheelchair tiedown and occupant restraint practices in paratransit vehicles.
[So] Source:PLoS One;13(1):e0186829, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The purpose of this study was to characterize wheelchair tiedown and occupant restraint system (WTORS) usage in paratransit vehicles based on observations of wheelchair and scooter (wheeled mobility devices, collectively, "WhMD") passenger trips. A retrospective review of on-board video monitoring recordings of WhMD trips was conducted. Four hundred seventy-five video recordings were collected for review and analysis. The use of all four tiedowns to secure the WhMD was observed more frequently for power WhMDs (82%) and manual WhMDs (80%) compared to scooters (39%), and this difference was significant (p< 0.01). Nonuse or misuse of the occupant restraint system occurred during 88% of WhMD trips, and was most frequently due to vehicle operator neglect in applying the shoulder belt. Despite the absence of incidents or injuries in this study, misuse and nonuse of WTORS potentially place WhMD seated passengers at higher risk of injury during transit. These findings support the need for improved vehicle operator training and passenger education on the proper use of WTORS and development of WTORS with improved usability and/or alternative technologies that can be automated or used independently.
[Mh] Termos MeSH primário: Veículos Automotores
Equipamentos de Proteção/utilização
Cintos de Segurança
Cadeiras de Rodas
[Mh] Termos MeSH secundário: Acidentes de Trânsito/prevenção & controle
Pessoas com Deficiência
Seres Humanos
Kentucky
Estudos Retrospectivos
Segurança
Cintos de Segurança/utilização
Equipamentos de Autoajuda/utilização
Gravação em Vídeo
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180210
[Lr] Data última revisão:
180210
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180106
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0186829


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[PMID]:29374736
[Au] Autor:Sattler T; Bredt C; Surwald S; Rust C; Rieger J; Jakobs T
[Ad] Endereço:Clinic of Diagnostic and Interventional Radiology, Krankenhaus Barmherzige Brueder Muenchen/The Hospital of the Order of St. John of God, Munich, Germany tim.sattler@barmherzige-muenchen.de.
[Ti] Título:Efficacy and Safety of Drug Eluting Bead TACE with Microspheres <150 µm for the Treatment of Hepatocellular Carcinoma.
[So] Source:Anticancer Res;38(2):1025-1032, 2018 02.
[Is] ISSN:1791-7530
[Cp] País de publicação:Greece
[La] Idioma:eng
[Ab] Resumo:BACKGROUND/AIM: To retrospectively evaluate the efficacy and safety of drug eluting bead (DEB) transarterial chemoembolisation (TACE) with microspheres <150 µm for the treatment of hepatocellular carcinoma (HCC) with respect to overall survival, progression-free survival, tumor response and the peri-interventional toxicity. MATERIALS AND METHODS: In this retrospective, single-center study we analyzed 32 HCC-patients (BCLC A: 10 patients, BCLC B: 17 patients, BCLC C: 5 patients), who were treated with (DEB) <15 µm (DCBeadM1®) loaded with epirubicin between 2011 and 2015. We analyzed MRI and CT-scans as well as blood results like AFP, bilirubin and liver enzymes before (t0) and after (t1=first follow-up, t2=last follow-up within 6 months) locoregional treatment. The tumor response was evaluated by MRI and CT considering m-RECIST and the EASL-criteria as well as alpha-fetoprotein (AFP) levels in the peripheral blood. RESULTS: We found a significant tumor response at all follow-up times (p<0.05) according to m-RECIST criteria and a significant tumor response between t0 vs. t1 (p<0.05) and t0 vs. t2 (p<0.05) according to EASL criteria. We observed a significant decrease of the AFP-level between t0 and t1. The objective response rates (ORR) of target lesions were 64.3% and 78.5 % corresponding to m-RECIST and EASL, respectively. The median overall survival (OS) was 30.5 months, the progression-free survival in relation to the target lesion was 14.3 months by using m-RECIST and EASL criteria. In the period of 30 days after treatment we found no grade 5 adverse events (AE). During the follow-up period 1 abscess (3.7%) was observed. In a total of 5 patients, 4 (14.7%) biliomas with no need of treatment and 3 (10.7%) widening of the intrahepatic bile ducts were noted. CONCLUSION: The use of DEB <150 µm (DCBeadM1®) shows promising results in the treatment of HCC without showing substantial hepatic toxicity, but some widening of the intrahepatic bile ducts and one abscess. Further trials are necessary to evaluate the efficacy and toxicity of DEB-TACE with M1®-beads.
[Mh] Termos MeSH primário: Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico
Carcinoma Hepatocelular/terapia
Quimioembolização Terapêutica
Sistemas de Liberação de Medicamentos
Neoplasias Hepáticas/terapia
Microesferas
[Mh] Termos MeSH secundário: Carcinoma Hepatocelular/patologia
Doxorrubicina/administração & dosagem
Epirubicina/administração & dosagem
Feminino
Seguimentos
Seres Humanos
Neoplasias Hepáticas/patologia
Masculino
Prognóstico
Estudos Retrospectivos
Segurança
Taxa de Sobrevida
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
3Z8479ZZ5X (Epirubicin); 80168379AG (Doxorubicin)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180207
[Lr] Data última revisão:
180207
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180129
[St] Status:MEDLINE



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