Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 377
Filter
1.
Rev. Ciênc. Méd. Biol. (Impr.) ; 21(1): 60-66, maio 05,2022. fig
Article in Portuguese | LILACS | ID: biblio-1370675

ABSTRACT

Introdução: a hanseníase é uma doença de fácil diagnóstico, possuindo tratamento e cura. Quando diagnosticada tardiamente, pode trazer graves consequências para os portadores e seus familiares. Uma vez que o tratamento da hanseníase está inserido no componente estratégico da assistência farmacêutica, são exigidos cuidados e orientação. Há necessidade de intervenção clínica farmacêutica, com objetivo de acompanhar prescrições medicamentosas, analisando a adesão dos pacientes ao tratamento com a promoção de ações de educação em saúde, além de minimizar a ocorrência de eventos adversos relacionados aos fármacos do tratamento com possível redução de custos associados aos agravos. Objetivo: realizar o monitoramento para identificar e tratar as possíveis intercorrências que estão comumente presentes no tratamento de hanseníase. Metodologia: a realização do estudo deu-se com o acompanhamento dos pacientes atendidos no serviço de referência a partir da aplicação de questionários em consultas periódic as, vis to que a adesão ao tratamento, reduç ão dos eventos adver sos e controle dos comunic antes são de suma impor tância para o controle epidemiológico. Resultados: os principais sintomas dos indivíduos acometidos foram dormência e eritema nodoso hansênico. A maioria utilizava como tratamento o esquema multibacilar e talidomida. O acometimento relatado dos pacientes foi em nível moderado. Os pacientes possuíam comorbidades como hipertensão, artrose e diabetes. O acompanhamento clínico foi relatado como positivo pela maioria dos entrevistados. Conclusão: o desfecho do estudo mostra que a adesão do paciente é crucial para o êxito do tratamento e o acompanhamento do farmacêutico clínico constitui um pilar positivo, contribuindo para a prevenção de agravos e conscientização da comunidade.


Introduction: Hansen's disease is an easily diagnosed disease, with treatment and cure available. When diagnosed late, it can bring serious consequences for patients and their families. Since the treatment of Hansen's disease is part of the strategic component of pharmaceutical assistance, care and guidance are required. There is a need for clinical pharmaceutical intervention, aiming to monitor drug prescriptions, analyze patients' adherence to treatment while promoting health education actions, in addition to minimizing the occurrence of adverse events related to treatment drugs with possible reduction in costs associated to grievances. Objective:thus, the present study aimed to monitor, identify, and treat possible complications commonly present in the treatment of Hansen's disease. Methodology: The study was carried out with the follow-up of patients seen at the reference service, through the application of questionnaires in periodic appointments, since adherence to treatment, reduction of adverse events and control of communicants are of short importance for epidemiological control. Results:The main symptoms of Hansen's disease patients were numbness and leprosy nodosum erythema. Most used the multibacillary scheme and thalidomide as treatment. The reported involvement of patients was at a moderate level. Patients had other comorbidities such as hypertension, arthrosis and diabetes. The clinical assistance was reported as positive by most interviewees. Conclusion: The outcome of the study shows that patient's compliance is crucial for the success of treatment and the clinical pharmacist's accompaniment is a positive pillar, contributing to the prevention of complications and community awareness.


Subject(s)
Humans , Male , Female , Pharmacy Service, Hospital , Thalidomide , Drug Therapy , Leprosy , Osteoarthritis , Diabetes Mellitus , Hypertension
2.
Goiânia; SES-GO; jan. 2022. 1-15 p. graf.
Non-conventional in Portuguese | LILACS, ColecionaSUS, CONASS, SES-GO | ID: biblio-1396204

ABSTRACT

A Talidomida é um medicamento de uso controlado, cuja utilização exige uma série de medidas relacionadas à produção, prescrição e dispensação pelos seus efeitos teratogênicos comprovados ­ Resolução n° 11 de 22 de março de 2011


Thalidomide is a drug for controlled use, whose use requires a series of measures related to production, prescription and dispensing for their teratogenic effects proven - Resolution No. 11 of March 22, 2011


Subject(s)
Humans , Pregnancy , Thalidomide/adverse effects , Thalidomide/administration & dosage , Thalidomide/therapeutic use
3.
Hepatología ; 3(1): 106-117, 2022. graf, tab
Article in Spanish | LILACS, COLNAL | ID: biblio-1396357

ABSTRACT

La talidomida fue desarrollada e introducida al mercado por los laboratorios Grünenthal en 1953, siendo usada principalmente como sedante y también para el tratamiento de las náuseas durante el embarazo. Los informes dan cuenta de aproximadamente 10.000 niños que nacieron con focomelia, dando lugar a la denominada "tragedia de la talidomida", que obligó a su retiro del mercado en 1962. Luego de casi 60 años, es nuevamente utilizada en otros campos de la medicina, entre ellos, para el tratamiento de la lepra y del mieloma múltiple, debido a sus propiedades antinflamatorias, inmunomoduladoras y antiangiogénicas, con expresas advertencias sobre su utilización durante el embarazo; no obstante, con su nuevo uso han sido reportados múltiples efectos adversos, entre los que se encuentra la hepatitis aguda o crónica inducida por este fármaco. Se presenta el caso de una paciente de 34 años con lepra, que estaba en tratamiento con talidomida desde hacía 4 años para combatir las lesiones de piel asociadas a esta enfermedad. Presentó malestar general, vómito, pérdida de peso, artralgias, ictericia, edemas de miembros inferiores, ascitis, coluria y acolia. Se sospechó toxicidad por talidomida, por lo que se suspendió su uso, y se trató con ácido ursodesoxicólico y N-acetilcisteína con mejoría sintomática y de laboratorio, desde la primera semana hasta los 41 días de seguimiento. Las entidades clínicas para las cuales se aprobó talidomida en 1998, pueden traer nuevos problemas y desafíos clínicos. Este caso muestra hepatotoxicidad crónica por talidomida, situación que hasta el momento no se había reportado en la literatura.


Thalidomide was developed and introduced to the market by Grünenthal laboratories in 1953, being used mainly as a sedative and also for the treatment of nausea during pregnancy. Reports give account of approximately 10,000 children who were born with phocomelia, giving rise to the so-called "thalidomide tragedy", which forced its withdrawal from the market in 1962. After almost 60 years, it is usedagain in other fields of medicine, including the treatment of leprosy and multiple myeloma, due to its anti-inflammatory, immunomodulatory and anti-angiogenic properties, with clear warnings about its use during pregnancy; however, multiple adverse effects have been reported in patients with leprosy and multiple myeloma, including acute or chronic hepatitis. We present the case of a 34-year-old patient with leprosy, who had been on thalidomide therapy for 4 years to treat skin lesions associated with this disease. She presented general malaise, vomiting, weight loss, arthralgia, jaundice, lower limb edema, ascites, choluria and acholia. Thalidomide toxicity was suspected, so its use was suspended, and treatment with ursodeoxycholic acid and N-acetylcysteine was initiated, with symptomatic and laboratory improvement from the first week up until 41 days of follow-up. The new range of medical conditions for which thalidomide was approved for in 1998 may bring clinical challenges. This case shows chronic hepatotoxicity due to thalidomide, a situation that had not been reported previously in the literature.


Subject(s)
Humans , Thalidomide , Toxicity , Acetylcysteine , Ursodeoxycholic Acid , Hepatitis , Jaundice
4.
Arq. bras. med. vet. zootec. (Online) ; 73(6): 1334-1345, Nov.-Dec. 2021. tab, graf, ilus
Article in English | LILACS, VETINDEX | ID: biblio-1355678

ABSTRACT

The present work evaluated the immunomodulatory effect of thalidomide (Thal) at different doses on tumor-associated macrophages (TAMs) using a mouse model of human breast cancer. Mice were inoculated with 4T1 cells in the left flank and treated with Thal once a day at concentrations of 50, 100, and 150mg/kg body weight from the 5th day until the 28th day of tumor inoculation. The tumors were sized, proliferation index and TAMs count were evaluated in primary tumors and metastatic lungs. In addition, the metastasis rate was evaluated in the lungs. Thal at 150mg/kg significantly decreased tumor growth, proliferation index, and TAMs infiltration in primary tumors. Conversely, a higher number of TAMs and lower proliferation index were observed in metastatic lungs in mice treated with 150mg/kg of Thal. Furthermore, Thal at 150mg/kg significantly decreased the metastatic nodules in the lungs. Our findings demonstrated that Thal treatment considerably decreased the primary tumor and lung metastasis in mice associated with different TAM infiltration effects in these sites.(AU)


No presente trabalho, foi avaliado o efeito imunomodulador de diferentes doses de talidomida em macrófagos associados ao tumor (TAMs), em um modelo murino de câncer de mama. Camundongos foram inoculados com células 4T1, na região do flanco esquerdo, e tratados com talidomida, uma vez ao dia, nas doses de 50, 100 e 150mg/k, por massa corporal, do quinto dia ao 28º dia de inoculação tumoral. Os tumores foram medidos, o índice de proliferação celular e a contagem de TAMs foram avaliados nos tumores primários e nos pulmões com metástases. Além disso, a taxa de metástases pulmonares também foi avaliada. A talidomida na dose de 150mg/kg diminuiu significativamente o crescimento tumoral, o índice de proliferação celular e a infiltração de TAMs nos tumores primários. Por outro lado, maior número de TAMs e menor índice de proliferação celular foram observados nos pulmões metastáticos, em camundongos tratados com 150mg/kg de talidomida. Ademais, a talidomida na dose de 150mg/kg diminuiu significativamente os nódulos metastáticos nos pulmões. Os resultados demonstraram que o tratamento com talidomida diminuiu o crescimento tumoral e as metástases pulmonares em camundongos, associado com diferentes efeitos na infiltração de TAMs nesses locais.(AU)


Subject(s)
Animals , Mice , Thalidomide/analysis , Mammary Neoplasms, Animal/drug therapy , Macrophages/drug effects , Immunomodulation , Neoplasm Metastasis
5.
Ciênc. Saúde Colet. (Impr.) ; 26(9): 4233-4242, set. 2021. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1339578

ABSTRACT

Resumo Estudo de utilização de medicamento que descreve o controle da talidomida no Brasil e sua utilização em Minas Gerais. Questionário online foi enviado às unidades federativas do Brasil para coleta de dados de distribuição, dispensação, cadastro de usuários e eventos adversos da talidomida. Dados de distribuição (2011-2018) e dispensação (2015-2018) de Minas Gerais foram obtidos pelo sistema de gerenciamento da assistência farmacêutica. Análise de variância e teste de Tukey foram empregados para comparações dos dados. Das 16 unidades federativas participantes, 100% e 50% utilizavam sistema eletrônico para distribuição e dispensação, respectivamente, e cerca de 43% cadastravam usuários. Sistemas de notificação de eventos adversos eram escassos. Houve redução de 44% na distribuição em Minas Gerais no período. A dispensação manteve-se constante (média 0,0004 DDD/1000 hab./dia) e ocorreu principalmente para eritema nodoso hansênico e mieloma múltiplo. O uso off-label (2,2%) foi crescente. A maioria dos usuários era do sexo masculino (idade média 56 anos). Das mulheres, 30% estavam em idade fértil. A vigilância da talidomida é um desafio em saúde pública. Apesar da ampliação do uso e obrigatoriedade de controle, não há padronização em nível nacional e a notificação de eventos adversos é incipiente.


Abstract Drug utilization research to describe the control of thalidomide in Brazil and its use in Minas Gerais state. An online questionnaire was sent to the Brazilian federative units to collect data concerning distribution, dispensation, user registration, and thalidomide adverse events. Distribution (2011-2018) and dispensing (2015-2018) data in Minas Gerais were obtained through the pharmaceutical care management system. Analysis of variance and Tukey test were used for data comparisons. Of the 16 participating federative units, 100% and 50% used electronic distribution and dispensing systems, respectively, and about 43% registered users. Adverse event reporting systems were scarce. A 44% reduction was observed in the distribution in Minas Gerais for the period. Dispensing remained constant (mean 0.0004 DDD/1,000 inhabitants/day) and occurred mainly for erythema nodosum leprosum and multiple myeloma. Off-label use (2.2%) was increasing. Most users were male (mean age 56 years) and thirty percent of women were of childbearing age. Thalidomide surveillance is a public health challenge. Despite the increased use and mandatory control, there is no national standardization, and adverse event reporting is incipient.


Subject(s)
Humans , Male , Female , Thalidomide/adverse effects , Drug Utilization , Brazil , Middle Aged
7.
Dermatol. argent ; 27(1): 28-30, ene.-mar. 2021. il
Article in Spanish | LILACS, BINACIS | ID: biblio-1361644

ABSTRACT

El apremilast es un fármaco inhibidor de la fosfodiesterasa-4 que modula, a nivel intracelular, la expresión de citoquinas involucradas en la patogenia inflamatoria de la psoriasis. Su uso está indicado en la psoriasis en placas moderada y severa, con buenos resultados clínicos. Los principales efectos adversos son gastrointestinales y, en menos del 2% de los pacientes, dermatológicos, con exantema y foliculitis. Se presenta el caso de un paciente de 42 años que, luego de tomar el apremilast, desarrolló lesiones faciales que correspondieron clínica e histopatológicamente a una reacción acneiforme, con evolución favorable y resolución total del cuadro posterior a la suspensión del medicamento.


Apremilast is a phosphodiesterase-4 inhibitor that modulates the intracellular expression of cytokines, which are involved in the pathogenesis of psoriasis. Apremilast is indicated in moderate to severe plaque psoriasis, and it has shown good clinical results. The main adverse effects occur at a gastrointestinal level, and in less than 2% at the dermatologic level with exanthema and folliculitis. We present a 42-year-old patient that developed facial lesions after taking apremilast. The facial lesions were clinically and histopathologically correspond to an acneiform eruption. The patient evolved favorably and fully recovered after suspending apremilast.


Subject(s)
Humans , Male , Adult , Psoriasis/drug therapy , Thalidomide/adverse effects , Thalidomide/analogs & derivatives , Acneiform Eruptions , Diarrhea , Minocycline/administration & dosage
8.
Journal of Experimental Hematology ; (6): 1967-1971, 2021.
Article in Chinese | WPRIM | ID: wpr-922233

ABSTRACT

Thalidomide and its derivatives have been used in the treatment of myelodysplastic syndrome (MDS) because of their anti-angiogenic and immunomodulatory effects. In recent years, some studies have found that thalidomide and its derivatives not only showed significant efficacy in lower-risk MDS patients with del (5q), but also showed advantages in non-del (5q) MDS patients. In addition, the discovery of its molecular targets and new substrates makes it possible to develop a new generation of immunomodulatory drugs (IMiDs) and to design IMiDs-based proteolysis-targeting chimeras. In this review, the new progress in mechanism and clinical application of thalidomide and its derivatives were summarized briefly, so as to provide a more scientific, reasonable and effective scheme to the treatment of MDS.


Subject(s)
Humans , Immunomodulating Agents , Myelodysplastic Syndromes/drug therapy , Thalidomide/therapeutic use
9.
Article in Chinese | WPRIM | ID: wpr-880026

ABSTRACT

OBJECTIVE@#To explore the synergistic immunomodulatory mechanism of interferon alpha-1b, interleukin-2 and thalidomide (ITI) regimen on patients with acute myeloid leukemia (AML).@*METHODS@#Sixty eight untreated de novo or relapsed or refractory or maintenance therapy patients with AML admitted in the Affiliated Cancer Hospital of Zhengzhou University and the other 11 medical units from March 2016 to May 2019 were treated with ITI regimen. Peripheral blood specimen per patient was collected into EDTA-K3 anticoagulation vacuum tube before the administration of ITI and 3 months after the treatment; peripheral blood lymphocyte subsets and perforin and Granzyme B expression were analyzed by using flow cytometry; the levels of VEGF, IFN-γ, TNF-α and IL-6 in the plasma were detected by using a cytometric bead array. Thirty-five healthy subjects from the hospital physical examination centre were selected as normal controls.@*RESULTS@#The ratio of CD4@*CONCLUSION@#The ITI regimen can raise the ratio of CD4


Subject(s)
CD8-Positive T-Lymphocytes , Humans , Interferon-alpha , Interleukin-2 , Leukemia, Myeloid, Acute/drug therapy , Perforin , Thalidomide
10.
São Paulo; s.n; 2021. 121 p.
Thesis in Portuguese | LILACS | ID: biblio-1253672

ABSTRACT

O Mieloma Múltiplo é uma neoplasia maligna que acomete a medula óssea, sendo comumente diagnosticado em idosos. Para o tratamento no Sistema Único de Saúde (SUS) seguem-se as Diretrizes Diagnósticas e Terapêuticas do Mieloma Múltiplo do Ministério da Saúde, de 2015. O medicamento lenalidomida é um análogo da talidomida. A talidomida e lenalidomida são indicados para tratamento do mieloma. Ambos medicamentos causam efeitos teratogênicos nos fetos. A lenalidomida teve seu registro sanitário aprovado pela Agência Nacional de Vigilância Sanitária (ANVISA) para uso no país em dezembro de 2017. Os pacientes que necessitam do tratamento com o medicamento lenalidomida ingressam com processos judiciais para obtê-lo visto não constar da lista de medicamentos fornecidos pelo SUS. A diferença de preço dos dois medicamentos à base de lenalidomida fabricados e disponíveis no mundo é extremamente alta (Lenalid® e Revlimid®). No Brasil, somente o medicamento Revlimid® teve seu registro de patente junto ao Instituto Nacional de Propriedade Industrial e seu registro sanitário deferido junto à ANVISA, sendo o único autorizado para a comercialização no país, pela regulamentação da RDC ANVISA 191/2017. Considerando a política de Assistência Oncológica no Sistema Único de Saúde, o presente trabalho visou descrever o perfil dos processos judiciais para fornecimento do medicamento lenalidomida utilizada tratamento de Mieloma Múltiplo por determinações judiciais contra a Secretaria de Estado da Saúde de São Paulo. O perfil dos processos analisados confirma o observado na literatura sobre a judicialização da saúde, que, apesar de heterogênea e com características regionais, em muitos estudos, observa-se maior participação de pacientes oriundos de unidades de saúde privadas e assistentes jurídicos majoritariamente de advogados particulares. Além disso, os dados detectados/encontrados demonstraram que os pacientes são residentes em municípios com alto grau de desenvolvimento, segundo o Índice de Desenvolvimento Humano Municipal (IDHM), o qual atua como um indicador que avalia três dimensões do desenvolvimento humano: longevidade, educação e renda. Constatou-se também, pelo perfil dos processos judiciais descritos, a predominância de pacientes do sexo masculino. Descreveram-se os aspectos de regulamentação e de controle sanitário do medicamento lenalidomida, em comparação à talidomida no Brasil, além das normativas da ANVISA vigentes sobre o controle da substância lenalidomida, diante dos riscos associados (segurança do paciente - teratogênese) e as questões relativas a patente e fenômeno de judicialização da saúde no país.


Multiple myeloma is a malignant neoplasm that affects the bone marrow and is com-monly diagnosed in the elderly. For treatment in the Unified Health System (SUS), the Ministry of Health's 2015 Myeloma Diagnostic and Therapeutic Guidelines are followed. The medication lenalidomide is an analogue of thalidomide. Thalidomide and lenalidomide are indicated for the treatment of myeloma. Both drugs have teratogenic effects on fetuses. Lenalidomide had its health record approved by the National Health Surveillance Agency (ANVISA) for use in the country in December 2017. Patients who need treatment with the drug lenalidomide file lawsuits to obtain it since it is not on the list of drugs provided by SUS. The price difference of the two lenalidomide-based drugs manufactured and available worldwide is extremely high (Lenalid® and Revlimid®). In Brazil, only the drug Revlimid® had its patent registra-tion with the National Institute of Industrial Property and its sanitary registration granted with ANVISA, being the only one authorized for commercialization in the country, by the regulation of RDC ANVISA 191/2017. Considering the policy of Onco-logical Assistance in the Unified Health System, the present study aimed to describe the profile of the legal proceedings for the supply of the drug lenalidomide used in the treatment of Multiple Myeloma due to judicial orders against the São Paulo State De-partment of Health. The profile of the analyzed cases confirms that observed in the literature on the judicialization of health, which, although heterogeneous and with re-gional characteristics, in many studies, there is a greater participation of patients from private health units and legal assistants mostly from private lawyers . In addition, the data detected / found showed that patients are residents of municipalities with a high degree of development, according to the Municipal Human Development Index (MHDI), which acts as an indicator that assesses three dimensions of human devel-opment: longevity, education and income. It was also verified, by the profile of the judicial processes described, the predominance of male patients. The regulatory and sanitary control aspects of the drug lenalidomide were described, in comparison to thalidomide in Brazil, in addition to the ANVISA regulations in force on the control of the lenalidomide substance, in view of the associated risks (patient safety - teratogenesis) and the relative issues the patent and phenomenon of judicialization of health in the country.


Subject(s)
Thalidomide , Unified Health System , Public Health , Drug and Narcotic Control , Teratogenesis , Health's Judicialization , Lenalidomide , Multiple Myeloma , Neoplasms
11.
Biomédica (Bogotá) ; 40(3): 487-497, jul.-set. 2020. tab, graf
Article in Spanish | LILACS | ID: biblio-1131900

ABSTRACT

Introducción. El prurigo actínico es una fotodermatosis crónica. Afecta con mayor frecuencia a la población latinoamericana, predomina en mujeres y compromete la piel expuesta al sol, las conjuntivas y los labios. Objetivo. Actualizar la información sobre las características clínico-epidemiológicas y el tratamiento de pacientes con prurigo actínico en Colombia. Materiales y métodos. Se hizo un estudio de corte transversal que incluyó los registros clínicos de pacientes con prurigo actínico atendidos en el Servicio de Fotodermatología del Hospital Universitario Centro Dermatológico Federico Lleras Acosta entre el 2011 y el 2016, y se describieron sus características demográficas, clínicas e histopatológicas, así como su tratamiento. Resultados. Se incluyeron 108 pacientes, el 71,3 % de ellos mujeres y el 28,7% hombres, con predominio de los fototipos III-IV (70 %). La enfermedad se había iniciado durante la primera década de vida en el 66,4% de los casos y el 25 % de los pacientes tenía antecedentes familiares de la enfermedad. Las lesiones predominaban en el rostro (93,5 %), los antebrazos (79,6 %) y el dorso de las manos (70,4 %). También, se documentó compromiso ocular (87,9 %) y de los labios (88,8 %). Se hizo la prueba de fotoprovocación con radiación ultravioleta A en el 25 % de los casos y biopsia cutánea en el 19,4 %. Todos los pacientes se trataron con protección solar química y física. En los casos leves a moderados, se formularon corticoides tópicos (91,7 %) e inhibidores de la calcineurina (65,7 %), y en los graves, talidomida (33,3 %) y pentoxifilina (14,8 %). Conclusión. Las características de los pacientes colombianos con prurigo actínico son similares a las reportadas en otros países latinoamericanos: inicio temprano de la enfermedad, predominio en mujeres, compromiso frecuente de conjuntivas y labios, y adecuada respuesta al tratamiento tópico y sistémico.


Introduction: Actinic prurigo is a chronic photodermatosis. It affects the Latin American population more frequently, predominantly women, and involves the sun-exposed areas of the skin, conjunctiva, and lips. Objective: To update the information on the clinical-epidemiological characteristics and treatment of patients with actinic prurigo in Colombia. Materials and methods: We conducted a cross-sectional study including the medical records of patients with actinic prurigo treated in the Photodermatology Service of Hospital Universitario Centro Dermatológico Federico Lleras Acosta between 2011 and 2016. We described the demographic, clinical, histopathological, and treatment characteristics of the patients. Results: We included 108 patients, 77 (71.3%) were women and 31 (28.7%) men, mainly with phototypes III-IV (70%). The disease had begun during the first decade of life in 66.4% of the cases and 25% of the patients had a family history with the condition. The lesions predominated on the face (93.5%), forearms (79.6%), and back of the hands (70.4%). Ocular (87.9%) and lip (88.8%) involvement was also documented. A photo-provocation test with UVA was performed in 25% of the cases and skin biopsies in 19.4%. Physical and chemical photoprotection was indicated in all patients. Mild to moderate cases were treated with topical corticosteroids (91.7%) and calcineurin inhibitors (65.7%) while severe cases received thalidomide (33.3%) and pentoxifylline (14.8%). Conclusion: The characteristics of actinic prurigo patients in Colombia are similar to those reported in other Latin American countries: early onset of the disease, predominance in women, frequent involvement of conjunctiva and lips, and adequate response to topical and systemic treatment.


Subject(s)
Prurigo , Photosensitivity Disorders , Thalidomide , Ultraviolet Rays , Photobiology
12.
Hematol., Transfus. Cell Ther. (Impr.) ; 42(2): 118-124, Apr.-June 2020. tab, ilus
Article in English | LILACS | ID: biblio-1134012

ABSTRACT

ABSTRACT Background: The treatment of multiple myeloma (MM) has evolved significantly in the past decade, and new drug combinations have improved the response rates and prolonged survival. Studies comparing different induction chemotherapy regimens have shown that triple combinations have better results than double combinations. However, comparisons among different triple combinations are rare in the literature. Methods: We retrospectively compared two triple combinations comprising bortezomib, cyclophosphamide and dexamethasone (VCD) versus thalidomide, cyclophosphamide and dexamethasone (CTD), and aimed at identifying which of the two combinations would yield better response rates following four induction cycles prior to hematopoietic cell transplantation in patients with untreated multiple myeloma. Results: We retrospectively reviewed the medical records of 311 patients from 24 different centers.The VCD regimen was used as induction therapy by 117 (37.6%) patients, whereas 194 (62.4%) patients received the CTD regimen. After four cycles of induction on an intention-to-treat basis, 54% of the patients in the VCD group achieved at least very good partial response versus 42.8% in the CTD group (p = 0.05). We observed no difference in neuropathy or thrombotic events rates among the two regimens. Conclusion: Our results corroborate the superiority of the triple combination regimes containing bortezomib over the triple combination with thalidomide as pre ASCT induction therapy in MM.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols , Bone Marrow Transplantation , Bortezomib , Multiple Myeloma , Antineoplastic Agents , Thalidomide , Dexamethasone , Cyclophosphamide/therapeutic use
13.
Brasília; s.n; 5 jun. 2020.
Non-conventional in Portuguese | LILACS, BRISA, PIE | ID: biblio-1100288

ABSTRACT

O Informe Diário de Evidências é uma produção do Ministério da Saúde que tem como objetivo acompanhar diariamente as publicações científicas sobre tratamento farmacológico e vacinas para a COVID-19. Dessa forma, são realizadas buscas estruturadas em bases de dados biomédicas, referente ao dia anterior desse informe. Não são incluídos estudos pré-clínicos (in vitro, in vivo, in silico). A frequência dos estudos é demonstrada de acordo com a sua classificação metodológica (revisões sistemáticas, ensaios clínicos randomizados, coortes, entre outros). Para cada estudo é apresentado um resumo com avaliação da qualidade metodológica. Essa avaliação tem por finalidade identificar o grau de certeza/confiança ou o risco de viés de cada estudo. Para tal, são utilizadas ferramentas já validadas e consagradas na literatura científica, na área de saúde baseada em evidências. Cabe ressaltar que o documento tem caráter informativo e não representa uma recomendação oficial do Ministério da Saúde sobre a temática. Foram encontrados 11 artigos e 7 protocolos.


Subject(s)
Humans , Pneumonia, Viral/drug therapy , Coronavirus Infections/drug therapy , Betacoronavirus/drug effects , Ascorbic Acid/therapeutic use , Ribavirin/therapeutic use , Technology Assessment, Biomedical , Thalidomide/therapeutic use , Ceftriaxone/therapeutic use , Methylprednisolone/therapeutic use , Chloroquine/therapeutic use , Interferons/therapeutic use , Enoxaparin/therapeutic use , Azithromycin/therapeutic use , Ritonavir/therapeutic use , Angiotensin II Type 1 Receptor Blockers/therapeutic use , Lopinavir/therapeutic use , Vasopeptidase Inhibitors/therapeutic use , Hydroxychloroquine/therapeutic use
14.
Hist. ciênc. saúde-Manguinhos ; 27(1): 15-32, jan.-mar. 2020.
Article in Portuguese | LILACS | ID: biblio-1090496

ABSTRACT

Resumo O artigo analisa como o periódico Jornal do Médico, editado na cidade do Porto, em Portugal, divulgou o desastre da talidomida. A pesquisa percorreu as páginas da fonte desde o início de 1960 até o final de 1962. Aqui, objetivam-se apontar e discutir duas questões interligadas: a morosidade em publicar matérias sobre os efeitos deletérios do medicamento, vendido no país sob a denominação Softenon®, e a construção discursiva da isenção da responsabilidade do médico no fenômeno da iatrogenia medicamentosa.


Abstract This article analyzes the way the Porto-based journal Jornal do Médico reported on the thalidomide disaster. The pages of the publication are researched from the beginning of 1960 to the end of 1962 with the aim of identifying and discussing two interconnected questions: the delay in publishing news on the harmful effects of the drug, which was sold in the country under the brand name Softenon®, and the discursive construction of a lack of accountability on the part of physicians for the phenomenon of medication iatrogenesis.


Subject(s)
Humans , Female , Pregnancy , Infant, Newborn , History, 20th Century , Periodicals as Topic/history , Teratogens/history , Thalidomide/history , Abnormalities, Drug-Induced/history , Advertising/history , Portugal/epidemiology , Thalidomide/adverse effects , Abnormalities, Drug-Induced/epidemiology , Editorial Policies , Drug and Narcotic Control/history , Stillbirth , Fetus/drug effects , Sleep Aids, Pharmaceutical/adverse effects , Sleep Aids, Pharmaceutical/history
15.
Rev. Soc. Bras. Med. Trop ; 53: e20190454, 2020. tab, graf
Article in English | LILACS, ColecionaSUS, SES-SP | ID: biblio-1136901

ABSTRACT

Abstract INTRODUCTION: Thalidomide is an anti- tumor necrosis factor alpha (TNF-a) drug used mainly in the management of moderate to severe form of Erythema Nodosum Leprosum (ENL). Because of its teratogenic potential it has to be used under proper supervision. Our critical analysis tries to look into the rationale with which it has been used by means of case reports on lepra reaction. METHODS: We looked for the case reports between December 2005 to June 2019 in databases like Pubmed, Embase and other relevant resources. We used search words like "erythema nodosum leprosum(ENL)", "thalidomide", "case report" in different combinations to get relevant reports that focus on thalidomide usage atleast once at any time point during management. The information extracted were indication of thalidomide use, dose, response, outcome, complication if any, along with all the demographic details and geographical distribution. RESULTS: We found 41 case reports eligible for analysis.The information was critically evaluated. From the analysis it was found that 7 of the case report mentioned the exact indication, 4 case report showed irrational use of thalidomide in the case of neuritis without use of steroids, 7 showed proper use of Clofazimine prior to thalidomide initiation, 26 case report showed case report of rationale dose range and in 4 case reports clofazimine was used prior to thalidomide along with the rational dose of thalidomide. CONCLUSIONS: This analysis helps to guide the rationale use of thalidomide focussing on few important points that anyone should keep in mind while managing a case of ENL.


Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Adolescent , Adult , Aged , Young Adult , Leprosy, Lepromatous , Erythema Nodosum , Leprosy, Multibacillary , Thalidomide , Leprostatic Agents , Middle Aged
16.
Braz. J. Pharm. Sci. (Online) ; 56: e18726, 2020. tab, graf
Article in English | LILACS | ID: biblio-1249170

ABSTRACT

In Brazil, thalidomide is manufactured by a public laboratory, distributed by the Unified Health System (SUS), and regulated by the National Health Surveillance Agency (Anvisa). Despite the concerns regarding the adverse effects of thalidomide, few drug utilization studies have been conducted to describe processes and outcomes related to this drug. The aim of this study was to elucidate the issues related to the utilization and control of thalidomide, and patient safety within the scope of SUS. In this cross-sectional study, we evaluated the articulation between an outpatient dermatology service of a referral hospital in infectology, the manufacturer, and Anvisa. Four data sources were used: i) interviews with health professionals; ii) data from the Customer Service of the manufacturer, iii) data on adverse events reported to Anvisa, and iv) adverse events identified in outpatient service. Most health professionals interviewed knew the major thalidomide-related adverse effects. None of them ever reported adverse events to Anvisa or contacted the Customer Service. For over three years, there were 330 calls concerning thalidomide at Customer Service, 7% of which were related to adverse events. During a period of six years, Anvisa was notified of only 15 adverse events. Health professionals were aware of the adverse events associated with thalidomide, but not the necessity to report them. The low number of notifications recorded by Anvisa and the information obtained from Customer Service show that pharmacovigilance remains incipient. A pharmacovigilance system that integrates all the services associated with thalidomide is required to strengthen this activity within the SUS to improve patient safety.


Subject(s)
Humans , Male , Female , Outpatients/classification , Thalidomide/analysis , Unified Health System/classification , Health Surveillance/organization & administration , Brazilian Health Surveillance Agency , Pharmacovigilance , Patient Safety/standards , Pharmaceutical Preparations/administration & dosage , Health/standards , Research Report
17.
Rev. bras. ginecol. obstet ; 41(11): 668-672, Nov. 2019. graf
Article in English | LILACS | ID: biblio-1057879

ABSTRACT

Abstract Objective To analyze the effect of thalidomide on the progression of endometriotic lesions experimentally induced in rats and to characterize the pattern of cell proliferation by immunohistochemical Proliferating Cell Nuclear Antigen (PCNA) labeling of eutopic and ectopic endometrium. Methods Fifteen female Wistar rats underwent laparotomy for endometriosis induction by resection of one uterine horn, isolation of the endometrium and fixation of a tissue segment to the pelvic peritoneum. Four weeks after, the animals were divided into 3 groups: control (I), 10mg/kg/day (II) and 1mg/kg/day (III) intraperitoneal thalidomide for 10 days. The lesion was excised together with the opposite uterine horn for endometrial gland and stroma analysis. Eutopic and ectopic endometrial tissue was submitted to immunohistochemistry for analysis of cell proliferation by PCNA labeling and the cell proliferation index (CPI) was calculated as the number of labeled cells per 1,000 cells. Results Group I showed a mean CPI of 0.248 ± 0.0513 in the gland and of 0.178 ± 0.046 in the stroma. In contrast, Groups II and III showed a significantly lower CPI, that is, 0.088 ± 0.009 and 0.080 ± 0.021 for the gland (p < 0.001) and 0.0945 ± 0.0066 and 0.075 ± 0.018 for the stroma (p < 0.001), respectively. Also, the mean lesion area of Group I was 69.2mm2, a significantly higher value compared with Group II (49.4mm2, p = 0.023) and Group III (48.6mm2, p = 0.006). No significant difference was observed between Groups II and III. Conclusion Thalidomide proved to be effective in reducing the lesion area and CPI of the experimental endometriosis implants both at the dose of 1mg/kg/day and at the dose of 10 mg/kg/day.


Resumo Objetivo Analisar o efeito da talidomida na progressão de lesões endometrióticas induzidas experimentalmente em ratas e caracterizar o padrão de proliferação celular pela marcação imunohistoquímica de Antígeno Nuclear de Célula Proliferativa (PCNA) no endométrio eutópico e ectópico. Métodos Quinze ratas Wistar foram submetidas a laparotomia para indução de endometriose por ressecção de um corno uterino, isolamento do endométrio e fixação de um segmento do tecido ao peritônio pélvico. Após quatro semanas, os animais foram divididos em 3 grupos: controle (I), 10 mg/kg/dia (II) e 1 mg/kg/dia (III) de talidomida intraperitoneal por um período de 10 dias. As lesões foram resseccionadas juntamente com o corno uterino oposto para análise da glândula endometrial e do estroma. O tecido endometrial eutópico e ectópico foi submetido à imunohistoquímica para análise da proliferação celular por marcação com PCNA e o índice de proliferação celular (CPI) foi calculado como o número de células marcadas por 1.000 células. Resultados O grupo I apresentou média de CPI de 0,248 ± 0,0513 na glândula e de 0,178 ± 0,046 no estroma. Em contraste, os grupos II e III apresentaram CPI significativamentemenor, isto é, 0,088 ± 0,009 e 0,080 ± 0,021 para a glândula (p < 0,001) e 0,0945 ± 0,0066 e 0,075 ± 0,018 para o estroma (p < 0,001), respectivamente. Além disso, a área de lesãomédia do Grupo I foi de 69,2mm2, valor significativamentemaior em relação ao Grupo II (49,4mm2, p = 0,023) e Grupo III (48,6mm2, p = 0,006). Não houve diferença estatisticamente significante entre os Grupos II e III. Conclusão A talidomida mostrou-se eficaz na redução da área da lesão e CPI dos implantes de endometriose experimental tanto na dose de 1mg/kg/dia quanto na dose de 10 mg/kg/dia.


Subject(s)
Humans , Animals , Female , Thalidomide/pharmacology , Angiogenesis Inhibitors/pharmacology , Disease Models, Animal , Endometriosis/pathology , Endometrium/pathology , Biomarkers/analysis , Rats, Wistar , Proliferating Cell Nuclear Antigen/analysis , Cell Proliferation/drug effects , Dose-Response Relationship, Drug
18.
Ciênc. Saúde Colet. (Impr.) ; 24(10): 3783-3792, Oct. 2019. tab, graf
Article in English | LILACS | ID: biblio-1039475

ABSTRACT

Abstract In April 2017, the National Sanitary Surveillance Agency (ANVISA-Brazil) approved lenalidomide (LEN) for multiple myeloma (MM) and myelodysplastic syndrome. ANVISA had rejected the first application in 2010, and denied a request for reconsideration in 2012. The reason for rejection was the lack of comparative effectiveness studies proving that LEN was more effective than thalidomide (THAL), a strictly controlled drug regulated by Federal law 10.651/2003 and dispensed to patients (at no costs) through public health system units and hospitals. ANVISA unexplained retreat on the LEN approval for marketing was an unquestionable triumph of the lobbying that ensued the denial, at the forefront of which were politicians, Congress members, patient organizations and medical societies. Two randomized (phase III) trials and three observational (case-control and population-based cohort) compared the effectiveness of THAL- versus LEN-based therapies in MM. Overall, these studies showed no difference in efficacy between LEN- and THAL-based therapies. LEN caused less neuropathy, and more severe hematologic adverse effects. It is much costlier than THAL, and substitution of THAL by LEN shall raise considerably public healthcare costs in Brazil.


Resumo A Agência Nacional de Vigilância Sanitária (ANVISA) aprovou em abril de 2017 a lenalidomida (LEN) para o mieloma múltiplo (MM) e síndrome mielodisplásica. A ANVISA havia negado o registro em 2010, e indeferido um recurso apresentado em 2012. O motivo do indeferimento foi a falta de estudos comparativos de efetividade demonstrando que LEN era mais eficaz do que a talidomida (TAL), um medicamento rigorosamente controlado pela lei federal 10.651/2003 e dispensado gratuitamente a pacientes através de unidades de saúde e hospitais públicos. O recuo não explicado da ANVISA em relação ao registro da LEN foi um inquestionável triunfo do lobby que sucedeu a recusa inicial do registro, a frente do qual estavam políticos, membros do Congresso, associações de pacientes e sociedades médicas. Dois ensaios randomizados (fase III) e três estudos observacionais (caso-controle e coorte de base populacional) compararam a efetividade de terapias para o MM com TAL- e com LEN. Em conjunto, esses estudos mostraram que não havia diferenças quanto a eficácia de tratamentos com LEN- e aqueles com TAL. A LEN causou menos neuropatias, e efeitos adversos hematológicos mais graves. Ela é muito mais cara do que a TAL, e a substituição da TAL pela LEN aumentará muito os custos da assistência pública à saúde no Brasil.


Subject(s)
Humans , Thalidomide/administration & dosage , Angiogenesis Inhibitors/administration & dosage , Drug and Narcotic Control , Lenalidomide/administration & dosage , Thalidomide/economics , Thalidomide/adverse effects , Myelodysplastic Syndromes/economics , Myelodysplastic Syndromes/drug therapy , Brazil , Randomized Controlled Trials as Topic , Treatment Outcome , Drug Costs , Cost-Benefit Analysis , Angiogenesis Inhibitors , Angiogenesis Inhibitors/adverse effects , Lenalidomide/economics , Lenalidomide/adverse effects , Multiple Myeloma/economics , Multiple Myeloma/drug therapy
19.
An. bras. dermatol ; 94(3): 337-340, May-June 2019. graf
Article in English | LILACS | ID: biblio-1011104

ABSTRACT

Abstract: Necrobiotic xanthogranuloma is a rare chronic condition, belonging to the group C non-Langerhans cell histiocytoses, which is relevant due to the possibility of extracutaneous involvement and association with systemic diseases, particularly hematologic malignancies. The case reported here was only diagnosed after nine years of evolution and was associated with plasma cell dyscrasia. After treatment with cyclophosphamide, dexamethasone, and thalidomide, there was a reduction of cutaneous lesions and serum levels of monoclonal protein.


Subject(s)
Humans , Female , Middle Aged , Necrobiotic Xanthogranuloma/drug therapy , Smoldering Multiple Myeloma/drug therapy , Thalidomide/therapeutic use , Dexamethasone/therapeutic use , Treatment Outcome , Cyclophosphamide/therapeutic use , Necrobiotic Xanthogranuloma/complications , Necrobiotic Xanthogranuloma/pathology , Smoldering Multiple Myeloma/complications , Smoldering Multiple Myeloma/pathology , Immunosuppressive Agents/therapeutic use
20.
Journal of Experimental Hematology ; (6): 1907-1911, 2019.
Article in Chinese | WPRIM | ID: wpr-781520

ABSTRACT

OBJECTIVE@#To explore the effects of different concentration of pomalidomide on human multiple myeloma cell line MM1.S and the expression of CRBN.@*METHODS@#CCK-8 method was used for detecting inhibition effect of promalidomide on proliferation of MM1.S cells. Apoptosis rate of MM1.S cells was detected by flow cytometry with Annexin V-FITC/PI double staining. Real-time quantitative PCR was used to determine CRBN gene expression level. Western blot was used to detect the effect of pomalidomide on the protein expression of CRBN in MM1.S cells.@*RESULTS@#Pomalidomide has an inhibitory effect on MM1.S cells with time-and dose-dependent manners. Pomalidomide induced apoptosis in MM1.S cells. When the concentration of pomalidomide was 0, 40 and 80 μmol/L, the expression of CRBN gene after the treatment of MM1.S cells for 72 hours was 1.487±0.340, 0.211±0.054 and 0.055±0.005, by using actin as internal refereme. Pomalidomide significantly reduced CRBN protein expression in MM1.S cells.@*CONCLUSION@#Pomalidomide can inhibit the proliferation of MM1.S cells and promote its apoptosis. A certain concentration of pomalidomide can reduce the expression of CRBN gene and down-regulate its protein expression in MM1.S cells.


Subject(s)
Adaptor Proteins, Signal Transducing , Apoptosis , Cell Line, Tumor , Cell Proliferation , Humans , Multiple Myeloma , Thalidomide
SELECTION OF CITATIONS
SEARCH DETAIL