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1.
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
2.
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
3.
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
4.
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
5.
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
6.
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
7.
Ciênc. Saúde Colet ; 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
8.
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
9.
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
10.
Journal of Experimental Hematology ; (6): 1166-1172, 2019.
Article in Chinese | WPRIM | ID: wpr-775747

ABSTRACT

OBJECTIVE@#To study the effects of clinicopathological features, laboratory parameters and treatment regimens on the prognosis of patients with multiple myeloma.@*METHODS@#The clinical data of 97 patients with multiple myeloma treated with chemotherapy in Department of Hematology, the 1st Hospital of Hainan Medical College were analyzed retrospectively. The clinicopathological features (age, sex, severe anemia, light chain type, hypoproteinemia, paraplegia, renal injury, amyloidosis, complex karyotype, bone disease classification, Eastern Cooperative Oncology Group (ECOG) physical status score, complete remission, etc.), laboratory parameters (C-reactive protein, lactate dehydrogenase, blood calcium, serum β2 microglobulin, etc.), and treatment schemes (thalidomide maintenance treatment) were recorded. The patients were followed up for 1-60 months, and their total survival time were recorded. A single factor and multiple factors were used to analyze the factors affecting the total and early mortality of the patients. The survival curves were plotted by the Kaplan-Meier method and the survival analysis was carried out by Log-rank test.@*RESULTS@#Among 97 patients, 29 cases (29.90%) achieved complete remission, and 56 cases (57.73%) achineved partial remission. The total effective rate was 87.63% (85/97). At the end of the follow-up, 19 cases (19.59%) died, and 1, 3 and 5 year survival rates were 80.41%, 71.13% and 37.11% respectively. The median overall survival time was 29 (1-60) months. The results of single factor analysis showed that age, hypoproteinemia, severe anemia, paraplegia, renal injury, amyloidosis, complex karyotype, complete remission and thalidomide maintenance therapy were the factors affecting the prognosis of the patients (all P<0.05). Further multiple factor Logistic regression analysis showed that age and hypoproteinemia, severe anemia, paraplegia, amyloidosis, complex karyotype and thalidomide maintenance treatment were factors affecting the prognosis (P<0.05). Of the 97 patients, 8 cases died early. The results of single factor analysis showed that amyloidosis and severe anemia were risk factors for early death (all P<0.05), and further multivariate Logistic regression analysis showed that amyloidosis was an independent risk factor for early death (P<0.05).@*CONCLUSION@#There are many adverse factors affecting the prognosis of patients with multiple myeloma, such as age, hypoproteinemia, severe anemia, paraplegia, amyloidosis, complex karyotype and so on. The risk of early death in the patients with amyloidosis is higher, and salidomide maintenance therapy can help to prolong the life span of the patient.


Subject(s)
Amyloidosis , Humans , Multiple Myeloma , Prognosis , Retrospective Studies , Thalidomide
11.
Article in Chinese | WPRIM | ID: wpr-774352

ABSTRACT

OBJECTIVE@#To evaluate the quality of life (QOL) on patients with multiple myeloma(MM) during maintenance therapy and to explore the related factors important for QOL.@*METHODS@#The demography, clinical and laboratorial data of 66 MM patients during maintenance therapy were collected and explored by using a cross-sectional question naire(EORTC QLQ C30 V 3.0). The statistical analysis was performed using Nowegram normal mode(NM) and reference values(RV) of MM patients which were used as control.@*RESULTS@#In comparison with Nowegran normal mode, the scores of general health status, physical function, role function and social function of patients during maintenance therapy were lower than those of normal mode (61.3, 73.9, 65.4 and 65.2 vs 75.3, 89.9, 83.3 and 85.8 respectively), while the scores of constipation and financial difficulty were higher than those of normal mode(16.7 and 44.4 vs 10.7 and 9.7 respectively) (P<0.05). In comparison with reference values, the scores of general health status, emotional and coguitive functions of patients during maintenance therapy were significantly higher than those of reference values(61.3, 81.7 and 84.3 vs 55.7, 71.3 and 78.1 respectively) (P<0.05). In addition, the maintenance therapy yet decreasd the scores of fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss and constipation of patients, but increased the score of financial difficulty of patients (P<0.05). The age of initial diagnosis, serum LDH level, peripheral neuropathy, high ratio of own expense and underlying diseases were main factors affecting the general health status of patients (P<0.05), while the decrease of Hb level, increase of blood Ca level and accompanied genetic changes negatively influence the QOL (P<0.05), while the high culture level showed positive effect on QOL (P<0.05). The choise of drugs for maintenace (therapy thalidomide and bortezomib) not had significant effect on QOL of patients.@*CONCLUSION@#The maintenance therapy can improve the QOL of MM patients, the age at initial diagnses, serum LDH level, peripheral neuropathy and high ratio of own expence are the main factors affecting the QOL of MM patients.


Subject(s)
Cross-Sectional Studies , Humans , Multiple Myeloma , Therapeutics , Quality of Life , Thalidomide
12.
Article in Chinese | WPRIM | ID: wpr-774350

ABSTRACT

OBJECTIVE@#To evaluate the prognostic value of R-ISS staging system in patients with newly diagnosed multiple myeloma (NDMM).@*METHODS@#The Chinical data of 412 patients with NDMM in our hospital from May 2010 to May 2016 were retrospectively analyzed. All the patients received conventional chemotherapy or thalidomide or bortezomib-based chemotherapy. All the patients with NDMM were divided into R-ISS-Ⅰ, R-ISS-Ⅱ and R-ISS-Ⅲ groups according to R-ISS staging system on the basis of ISS staging system, cytogenetics and LDH level. The progression-free survival (PFS) time and overall survival(OS) of different groups were compared.@*RESULTS@#Among all 412 patients, 76 were rated as R-ISS-Ⅰ, 259 as R-ISS-Ⅱ and 77 as R-ISS-Ⅲ. The median PFS time in 3 groups were 44, 25 and 14 months respectively (P<0.01). The median OS time of the 3 groups were not reached 54 and 25 months respectively (P<0.01). Further analysis also found that statistically different survival associated with different R-ISS groups in the conventional chemotherapy group (P<0.05), bortezomib-based chemotherapy group (P<0.01), thalidomide-based chemotherapy group (P<0.01), transplantation group (P<0.05), different-age stratified group (≤65y P<0.01, 66-75y P<0.01,≥76y P<0.01), damaged renal function group (P<0.01) and extramedullary infiltration group (P<0.01).@*CONCLUSION@#PFS and OS in the patients with multiple myeloma were different among three distrinct R-ISS stages. The R-ISS staging system has important clinical significance for the prognosis evaluation of multiple myeloma.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Bortezomib , Humans , Multiple Myeloma , Diagnosis , Neoplasm Staging , Prognosis , Retrospective Studies , Thalidomide , Treatment Outcome
13.
Article in Chinese | WPRIM | ID: wpr-771873

ABSTRACT

OBJECTIVE@#To investigate the efficacy of disease control, survival time and safely in treatment of newly diagnosed multiple mycloma patients with different dose of tenalidomide regimens.@*METHODS@#The clinical data of 116 patients with multiple myeloma from June 2011 to June 2015 were collected and analyzed retrospectively. According to doses of used lenalidomide based on dexamethasone plus lenalidomide regimen 116 patients were divided into 2 groups: conventional dose group (58 cases) and low dose group (58 cases). The ORR, PFS rate and OS rate during followed-up for 3 years, KPS score, RNS score and immunophenotypic index before and after treatment and drug toxicity incidence were compared between 2 groups.@*RESULTS@#The ORR for 2 treatment courses of low dose group was significantly lower than that in conventienal dose group (P<0.05). The ORR for 4 and 6 treatment courses was not significantly different between 2 groups (P>0.05). The PFS rate and OS rate during followed-up for 3 years was no significantly different between 2 groups (P>0.05). The KPS score and RNS score after treatment of low dose group were significantly better than those in conventional dose group and before treatment (P<0.05). The levels of immunophenotypic index after treatment of both groups were significantly better than those before treatment (P<0.05). The incidence of III-IV grade hematological toxicity, pulmonary infection and herpes were not significantly different between 2 groups (P>0.05). The incidence of peripheral neuropathy and gastrointestinal reactions in the low dose group were significantly lower than that in conventional dose group (P<0.05).@*CONCLUSION@#Conventional and low doses of lenalidomide possess the same control effects and survival time for treatment of newly dingnosed patients with multiple myeloma; Despite, the initiation of effects from the low dose lenalidomide is relatively slower, it contributes to raise the overall quality of life and reduce the risk of drug toxicity.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Blood Coagulation , Child , Dexamethasone , Humans , Multiple Myeloma , Purpura, Schoenlein-Henoch , Quality of Life , Retrospective Studies , Thalidomide , Thrombelastography , Treatment Outcome
14.
Rev. Soc. Bras. Med. Trop ; 52: e20180385, 2019. tab
Article in English | LILACS | ID: biblio-1041594

ABSTRACT

Abstract INTRODUCTION: Thalidomide, used to treat erythema nodosum leprosum (ENL), is associated with severe adverse events (AEs) and is highly teratogenic. METHODS: A cross-sectional study was conducted on thalidomide-treated patients with ENL. AEs and selected variables were investigated through interviews and assessment of medical records. Odds ratios with 95% confidence intervals were estimated via logistic regression. RESULTS: Peripheral neuropathy symptoms and deep vein thrombosis (DVT) were the most common AEs reported. Although women of reproductive age used contraceptives, <50% of patients reported using condoms. Polypharmacy was associated with all endpoints, except DVT. CONCLUSIONS: Pharmacovigilance is crucial to prevent harmful thalidomide-associated AEs.


Subject(s)
Humans , Male , Female , Thalidomide/adverse effects , Leprostatic Agents/adverse effects , Leprosy/drug therapy , Thalidomide/therapeutic use , Cross-Sectional Studies , Educational Status , Leprostatic Agents/therapeutic use , Middle Aged
15.
An. bras. dermatol ; 93(6): 881-883, Nov.-Dec. 2018. graf
Article in English | LILACS | ID: biblio-973645

ABSTRACT

Abstract: Zoon's plasma cell balanitis is a chronic genital inflammatory dermatosis that affects uncircumcised men, especially the elderly. It's characterized by painless erythematous plaques of orange hue, located on the glans penis and foreskin. Circumcision is the most effective treatment; however, it can be hard for patients to accept. As an alternative, topical calcineurin inhibitors are used, with good response. This article reports the case of a 32-year-old patient, HIV carrier, diagnosed with Zoon's plasma cell balanitis. Treatment with topical tacrolimus was administered, without improvement. A 6-week course of thalidomide resulted in complete remission of the lesions, without recurrence after eight months of follow-up.


Subject(s)
Humans , Male , Adult , Plasma Cells/pathology , Thalidomide/therapeutic use , Balanitis/drug therapy , AIDS-Related Opportunistic Infections/drug therapy , Balanitis/pathology , Treatment Outcome , AIDS-Related Opportunistic Infections/pathology
16.
Rev. méd. Chile ; 146(12): 1444-1451, dic. 2018.
Article in Spanish | LILACS | ID: biblio-991355

ABSTRACT

Thalidomide changed the treatment of patients with multiple myeloma, however, its effectiveness has been compromised due to its side effects. New strategies are needed to specifically target the challenges of multiple myeloma through innovative, more effective, and less toxic therapy. The new immunomodulatory (IMiDs) compounds are structural and functional analogs of thalidomide, which were designed to improve the immunomodulatory and anticancer properties and tolerability profiles. We review the development of second generation IMiDs, lenalidomide and pomalidomide, their immunomodulatory and tumoricidal effects, their mechanisms of action, as well as the influence of dexamethasone on their effect and pharmacological resistance. In conclusion, lenalidomide and pomalidomide demonstrate a powerful activity and they are highly effective and well-tolerated treatment options for patients with myeloma, used alone or in combination with dexamethasone.


Subject(s)
Humans , Thalidomide/analogs & derivatives , Dexamethasone/administration & dosage , Immunomodulation , Lenalidomide/administration & dosage , Immunologic Factors/administration & dosage , Multiple Myeloma/drug therapy , Thalidomide/administration & dosage , Antineoplastic Combined Chemotherapy Protocols
17.
An. bras. dermatol ; 93(1): 104-107, Jan.-Feb. 2018.
Article in English | LILACS | ID: biblio-887163

ABSTRACT

Abstract: Atopic dermatitis is a common inflammatory skin disease. New understanding in disease pathogenesis has led to a considerable number of promising new drugs in development. New topical agents can be especially helpful for children, providing an alternative to the need for chronic topical corticosteroid use. While many patients with mild or moderate disease can be managed with topical treatments, there are unmet needs for recalcitrant and severe cases. New and developing therapies hold promise for real advances in management of this complex disease.


Subject(s)
Humans , Dermatitis, Atopic/drug therapy , Dermatologic Agents/therapeutic use , Thalidomide/analogs & derivatives , Thalidomide/therapeutic use , Administration, Cutaneous , Adrenal Cortex Hormones/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal/therapeutic use
18.
Rev. Soc. Bras. Med. Trop ; 51(1): 99-104, Jan.-Feb. 2018. tab, graf
Article in English | LILACS | ID: biblio-1041441

ABSTRACT

Abstract INTRODUCTION Corticosteroids and/or thalidomides have been associated with thromboembolism events (TBE) in multibacillary (MB) leprosy. This report aimed to determine genetic and laboratory profiles associated with leprosy and TBE. METHODS Antiphospholipid antibodies (aPL), coagulation-related exams, prothrombin and Leiden's factor V mutations, and ß2-glycoprotein-I (ß2GPI) Val247Leu polymorphism were assessed. RESULTS Six out of seven patients with leprosy were treated with prednisone and/or thalidomide during TBE and presented at least one positive aPL. All patients presented ß2GPI polymorphism, and one showed prothrombin mutation. CONCLUSIONS Corticosteroid or thalidomide adverse effects and aPL and ß2GPI polymorphisms may cause TBE in patients with MB leprosy.


Subject(s)
Humans , Male , Female , Adolescent , Aged , Thalidomide/administration & dosage , Antiphospholipid Syndrome/genetics , Antiphospholipid Syndrome/drug therapy , Antiphospholipid Syndrome/blood , Adrenal Cortex Hormones/administration & dosage , Leprosy, Multibacillary/immunology , Polymorphism, Genetic , Thalidomide/adverse effects , Factor V/analysis , Immunoglobulin G/blood , Immunoglobulin M/blood , Prothrombin/analysis , Enzyme-Linked Immunosorbent Assay , Antibodies, Antiphospholipid/drug effects , Antibodies, Antiphospholipid/genetics , Antibodies, Antiphospholipid/blood , Adrenal Cortex Hormones/adverse effects , beta 2-Glycoprotein I/blood , Venous Thromboembolism/drug therapy , Leprosy, Multibacillary/genetics , Leprosy, Multibacillary/drug therapy , Middle Aged , Mutation
19.
Neuroscience Bulletin ; (6): 42-53, 2018.
Article in English | WPRIM | ID: wpr-777083

ABSTRACT

Increasing evidence suggests that cytokines and chemokines play crucial roles in chronic itch. In the present study, we evaluated the roles of tumor necrosis factor-alpha (TNF-α) and its receptors TNF receptor subtype-1 (TNFR1) and TNFR2 in acute and chronic itch in mice. Compared to wild-type (WT) mice, TNFR1-knockout (TNFR1-KO) and TNFR1/R2 double-KO (DKO), but not TNFR2-KO mice, exhibited reduced acute itch induced by compound 48/80 and chloroquine (CQ). Application of the TNF-synthesis inhibitor thalidomide and the TNF-α antagonist etanercept dose-dependently suppressed acute itch. Intradermal injection of TNF-α was not sufficient to evoke scratching, but potentiated itch induced by compound 48/80, but not CQ. In addition, compound 48/80 induced TNF-α mRNA expression in the skin, while CQ induced its expression in the dorsal root ganglia (DRG) and spinal cord. Furthermore, chronic itch induced by dry skin was reduced by administration of thalidomide and etanercept and in TNFR1/R2 DKO mice. Dry skin induced TNF-α expression in the skin, DRG, and spinal cord and TNFR1 expression only in the spinal cord. Thus, our findings suggest that TNF-α/TNFR1 signaling is required for the full expression of acute and chronic itch via peripheral and central mechanisms, and targeting TNFR1 may be beneficial for chronic itch treatment.


Subject(s)
Animals , Chloroquine , Toxicity , Disease Models, Animal , Dose-Response Relationship, Drug , Etanercept , Therapeutic Uses , Ganglia, Spinal , Metabolism , Male , Mice , Mice, Inbred C57BL , Mice, Transgenic , Pruritus , Drug Therapy , Metabolism , Pathology , RNA, Messenger , Metabolism , Receptors, Tumor Necrosis Factor, Type I , Genetics , Receptors, Tumor Necrosis Factor, Type II , Genetics , Signal Transduction , Skin , Metabolism , Spinal Cord , Metabolism , Thalidomide , Therapeutic Uses , Time Factors , Tumor Necrosis Factor-alpha , Genetics , Metabolism , p-Methoxy-N-methylphenethylamine , Toxicity
20.
Journal of Experimental Hematology ; (6): 1854-1857, 2018.
Article in Chinese | WPRIM | ID: wpr-774373

ABSTRACT

Myelofibrosis, a clonal stem-cell disorder which is difficult to cure, The treatment for most of patients is conservative treatment, but the treatment effect is not ideal. Lenalidomide as a novel immunomodulator in the treatment of blood diseases showed good results in recent years, Its studies have shown that lenalidomide in myelofibrosis also showed a certain effect. As companed with single drug lenalidomide, the thalidomide has a higher response rate, clinical symptoms improved significantly. Ruxolitinib, JAK2 inhibitor, combined with lenalidomide not only can improve the quality of life of patients, but also extend the survival of patients. In addition, lenalidomide combined with prednisone for the treatment of bone marrow fibrosis is more effective and more safe, lenalidomide can significantly improve the clinical symptoms of patients, especially anemia, and prednisone can reduce the hematologic toxicity of lenalidomids. The purpose of this review is to evaluate the efficacy and safety of lenalidomide in the treatment of myelofibrosis, and focuses on the newest clinical research and application progress of lenalidomide for myelofibrosis.


Subject(s)
Humans , Lenalidomide , Therapeutic Uses , Prednisone , Primary Myelofibrosis , Drug Therapy , Quality of Life , Thalidomide
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