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Abstract Background: Thalidomide is the drug of choice for the treatment of type 2 leprosy reactions and is often associated with corticosteroids. The use of these drugs in multiple myeloma is associated with the risk of cardiovascular events, but there have been few studies assessing this risk in leprosy patients. Objective: To evaluate the occurrence of cardiovascular events in patients with multibacillary leprosy and their correlation with the use of thalidomide and prednisone. Methods: Analytical cross-sectional study of all patients diagnosed with multibacillary leprosy treated at the Dermatology Service between 2012 and 2022, using electronic medical records. Thromboembolic vascular events, both arterial and venous, including acute myocardial infarction, were considered. The main independent variable was the concomitant use of thalidomide and prednisone during follow-up. Results: A total of 89 patients were included, of which 19 used thalidomide and prednisone concomitantly. There were five cardiovascular events (26.3%), three of which of deep venous thrombosis. The combined use of medications was associated with the events (PR = 6.46 [3.92 to 10.65]; p<0.01). Study limitations: Small number of events, single-center retrospective study. Conclusion: The hypothesis of an association between cardiovascular events and the concomitant use of thalidomide and prednisone is supported, but more robust prospective studies are required for a better assessment.
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OBJECTIVE To systematically evaluate the efficacy and safety of thalidomide combined with aclacinomycin， granulocyte colony-stimulating factor and cytarabine （CAG） regimen in the treatment of elderly patients with acute myeloid leukemia （AML）. METHODS CNKI， Wanfang data， VIP， Sino Med， PubMed， Embase， the Cochrane Library and Web of Science were searched comprehensively from the inception to Aug. 27th， 2023. Randomized controlled trials （RCTs） about thalidomide combined with CAG regimen （trial group） versus CAG regimen （control group） in the treatment of elderly AML patients were collected， and RevMan 5.3 software was used for meta-analysis of included studies. RESULTS Finally， 7 RCTs were included， with a total of 601 patients， including 307 patients in the trial group and 294 patients in the control group. Meta-analysis results showed that the trial group was superior to the control group in enhancing the overall response rate [Z＝4.75， P＜0.000 01， OR＝2.80， 95%CI （1.83，4.28）]， complete remission rate [Z＝2.82， P＝0.005， OR＝1.61， 95%CI （1.16， 2.25）]， and improving platelet count [Z＝2.70， P＝0.007， MD＝64.02， 95%CI （17.53， 110.51）]， vascular endothelial growth factor [Z＝13.63，P＜0.000 01， MD＝－65.17， 95%CI（－74.54， －55.80）]， vascular endothelial growth factor receptor [Z＝12.03， P＜ 0.000 01， MD＝－499.01， 95%CI （－580.31， －417.71）] and basic fibroblast growth factor [Z＝4.17， P＜0.000 1，MD＝－0.23， 95%CI（－0.35， －0.12）]. And there was no statistical difference between the trial group and the control group in the incidence of adverse drug reaction [Z＝0.99， P＝0.32， OR＝0.52， 95%CI（0.14，1.89）]， nausea and vomiting [Z＝ 1.06， P＝0.29， OR＝0.66， 95%CI （0.30，1.43）]， constipation or diarrhea [Z＝0.92， P＝0.36， OR＝0.65， 95%CI（0.26， 1.63）]， drowsiness [Z＝1.38， P＝0.17， OR＝0.57， 95%CI（0.26， 1.27）] or myelosuppression [Z＝0.88，P＝0.38，OR＝0.68，95%CI（0.28， 1.62）]. CONCLUSIONS The combination of thalidomide and CAG regimen in the treatment of elderly AML patients can significantly improve clinical efficacy and has high safety.
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Objective:To analyze and summarize the efficacy and safety of thalidomide in the treatment of refractory systemic juvenile idiopathic arthritis（sJIA）.Methods:The clinical data of ten patients with refractory sJIA admitted to Department of Nephrology and Immunology in Children's Hospital of Hebei Province from January 2015 to March 2022 were collected，and the clinical manifestations，efficacy and safety of thalidomide in the treatment of refractory sJIA were analyzed retrospectively. Systemic juvenile arthritis disease activity score（sJADAS）was used to evaluate the efficacy of the treatment. Statistical analysis was performed by repeated measurements using general linear models.Results:Among the 10 children（4 males and 6 females）with refractory sJIA，the average age of onset was（7.5±3.3）years. Seven patients were complicated with macrophage activation syndrome at an early stage of disease.The average course of disease was（4.4±1.7）years，and the longest course of disease was 8.3 years. Before the application of thalidomide，all the 10 children experienced relapses（ranging from 2 to 10 times）. The indices of 10 children treated with thalidomide at 6 months and 12 months were compared with those before treatment. Peripheral blood leukocytes［（10.19±3.67）×10 9/L，（8.53±2.83）×10 9/L vs.（16.11±7.81）×10 9/L， F=7.918，11.084， P=0.020，0.009］，C-reactive protein［19.13（0.38，35.21）mg/L，8.05（0.10，18.00）mg/L vs. 59.34（24.20，131.90）mg/L， F=7.030，12.731， P=0.026，0.006］，sJADAS scores［6.00（1.50，12.50）scores，3.00（0，12.50）scores vs. 20.00（11.50，28.00）scores， F=14.710，17.870， P=0.004，0.002］were decreased significantly. The doses of prednisone［0.13（0，0.45）mg/（kg·d），0.02（0，0.06）mg/（kg·d）vs. 0.42（0.16，1.47）mg/（kg·d）， F=5.890，7.623， P=0.041，0.022］were significantly decreased.All the differences were statistically significant. Prednisone was successfully discontinued in 7 cases. Tocilizumab was gradually withdrawn in 3 cases，and tocilizumab administration interval was prolonged in 1 case. None of the 10 children had serious adverse reactions. Conclusion:Thalidomide is clinically effective in the treatment of sJIA，and can reduce the required dose of prednisone and prolong the tocilizumab free remission.
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Objective@#To investigate the application of mycophenolate mofetil (MMF) in oral mucosal pemphigoid and provide a clinical reference.@*Methods@#One case of glucocorticoids combined with MMF in the treatment of oral mucosal pemphigoid was reported, and the clinical application of MMF in oral mucosa-related bullous diseases was discussed.@*Results@#One patient with a clinical diagnosis of “oral mucosal pemphigoid” was treated with methylprednisolone (36 mg, qd, morning dose) or combined hydroxychloroquine sulfate (0.1 g/time, bid) and thalidomide capsules (50 mg, qd, bedtime) and other drugs. The patient’s disease was slowly controlled but prone to recurrence. The treatment regimen was immediately adjusted, i.e., methylprednisolone (36 mg, qd, morning dose) was combined with MMF (0.5 g/time, bid) for 2 weeks, which resulted in ideal lesion healing control. After 8 weeks of methylprednisolone combined with MMF, the dose of methylprednisolone was gradually reduced to 12 mg, qd, and MMF was reduced to 0.5 g, qd, the patient’s symptoms improved significantly, and no obvious lesions were found in the mouth. The dose was then reduced and maintained according to the principle of pemphigoid treatment. Methylprednisolone (8 mg, qd, morning dose) and MMF (0.5 g, qd) have been used for 6 months of maintenance treatment, and they are still being followed up. As yet, the patient’s condition is stable without obvious lesions and new blisters, and no obvious side effects have been observed. A review of the literature shows that MMF is widely used in the field of dermatology to treat a variety of immune diseases, such as connective tissue diseases and autoimmune blistering diseases. According to the reports of adverse reactions to MMF, digestive system reactions are the most common adverse reactions; therefore, patients with active gastrointestinal diseases should be treated with caution, followed by bone marrow suppression, and it is recommended to monitor liver function and blood routine in patients using MMF. The safety and efficacy of MMF for treating pemphigoid involving the skin have been reported in the literature, but oral mucosal doctors still lack experience for treating mucous membrane pemphigoid.@*Conclusions@#As a new immunosuppressant, MMF has high safety and no obvious side effects and can be considered as a combination adjuvant drug for patients with severe clinical disease and refractory oral mucosal pemphigoid.
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ObjectiveTo investigate the efficacy and safety of cinobufagin tablets combined with thalidomide/dexamethasone （TD） regimen in the treatment of newly diagnosed multiple myeloma （NDMM） with phlegm and stasis obstruction. MethodsThe clinical data of 50 patients with NDMM of phlegm and stasis obstruction who were hospitalized at the Jiangsu Province Hospital of Chinese Medicine from June 1st， 2015 to July 31th， 2019 were retrospectively analyzed， and they were divided into a control group （bortezomib/dexamethasone-containing regimen， 27 cases） and an observation group （cinobufagin tablets combined with TD regimen， 23 cases）. The clinical efficacy and safety were compared between the two groups after two or three courses of treatment. The primary outcomes were clinical remission rate including overall response rate and deep remission rate， one-year and two-year overall survival rate， and adverse effects. The secondary outcomes were the proportion of plasma cells in bone marrow， hemoglobin， β2-microglobulin， lactate dehydrogenase， serum creatinine， blood urea nitrogen， bone pain score， and KPS functional status score （KPS score） before and after treatment. ResultsIn terms of clinical efficacy， there was no statistically significant difference （P＞0.05） in the overall response rate ［the observation group 69.57%（16/23） vs the control group 70.37% （19/27）］ and deep remission rate ［the observation group 56.52% （13/23） vs the control group 55.56% （15/27）］ between groups after the treatment. The one-year overall survival rates of the observation group and the control group were 90.9% and 92.4%， and the two-year overall survival rates were 81.8% and 80.9% respectively， with no statistically significant differences between groups （P＞0.05）. During the treatment， no renal function injury occurred in both groups. The incidence of peripheral nerve injury in the observation group was 8.70%， which was lower than 48.15% in the control group （P＜0.01）. After the treatment， the proportion of myeloma plasma cells， β2-microglobulin， serum creatinine level， and bone pain score decreased， while the hemoglobin level and KPS score increased in both groups （P＜0.05 or P＜0.01）. Compared between groups after treatment， the bone pain score of the observation group was lower than that of the control group， while the KPS score was higher than that of the control group （P＜0.05）. ConclusionThe clinical efficacy of cinobufagin tablets combined with TD in the treatment of NDMM is equivalent to bortezomib/dexamethasone-containing regimen， but the former is more helpful in relieving the pain and improving the quality of life， and has better safety.
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Aim To investigate the absorption of thalidomide in inflammatory bowel disease(IBD)SD rats compared with healthy rats to provide a basis for the safety and efficacy of thalidomide in clinical practice. Method The IBD rat model was induced by the 2, 4, 6-trinitrobenzene sulfonic acid, by which the rats were continuously intervened for six days. The general state and disease activity index of the rats were recorded every day. The rats in IBD group after modeling and control group were administered with thalidomide at a dose of 10 mg·kg-1. The blood sample of the rats was collected at different time points. After a comprehensive evaluation of morphological and histopathological results, the samples of rats with IBD were determined by proven high performance liquid chromatography-mass spectrometry,and the pharmacokinetic parameters were calculated and compared with the healthy rats. Results The body weight of rats in IBD group was obviously lower than that in control group and the disease activity index, score of colonic macroscopic morphous and histopathology were obviously higher than those in control group. The success rate of modeling was 62.5%. The pharmacokinetic results showed that the Cmax(P<0.05)and AUC(P<0.01)of the IBD group both increased by 2 to 3 times, but there was no significant difference in t1/2,Tmax,MRT and other parameters. Conclusions The rate and extent of oral thalidomide absorption of rats in the model of inflammatory bowel disease significantly increase compared to those of healthy rats, which may provide new considerations for clinical practice of thalidomide in the treatment of IBD.
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Abstract Background: Atopic dermatitis (AD) is children's most frequent chronic inflammatory skin disease. In most patients, this condition is controlled with topical treatments; however, some patients with severe AD do not respond to these treatments, requiring systemic therapy. There is insufficient information about the ideal dose, time of use, clinical response, and safety of systemic therapy in children with severe AD. This study described the clinical characteristics of patients with severe AD who required systemic treatment, drugs used, their clinical course, adverse effects, and associated complications. Methods: We conducted a retrospective review of the records of pediatric patients with severe AD treated in the Dermatology Clinic, Instituto Nacional de Pediatría (2000 to 2018), who required systemic treatment for more than 3 months. Results: We included 21 patients. The mean age at disease onset was 3.31 years. The drugs used were methotrexate (57.1%), thalidomide (38%), prednisone (42.8%), azathioprine (19%), mycophenolate mofetil (9.5%), cyclosporine (4.7%), and systemic steroids as bridging therapy (42.8%). Adverse effects were mild and were observed in two patients (9.5%) treated with methotrexate and mycophenolate mofetil. Conclusions: Methotrexate was the most frequently used drug in > 50% of the patients, and most patients attained remission. Cyclosporine, azathioprine, and mycophenolate mofetil were also effective. Side effects were mild and infrequent. Comparative studies of systemic treatments for severe AD in the pediatric population are necessary.
Resumen Introducción: La dermatitis atópica (DA) es la enfermedad inflamatoria crónica de la piel más común en niños. En la mayoría de los pacientes la enfermedad se controla con tratamientos tópicos; sin embargo, algunos pacientes con DA grave no responden a estos tratamientos, por lo que requieren de terapia sistémica. Existe poca información acerca de la dosis ideal, tiempo de uso, respuesta clínica y seguridad del tratamiento sistémico en niños con DA grave. Se realizó este estudio para describir las características clínicas de pacientes con DA grave que requirieron un tratamiento sistémico, los medicamentos utilizados, la evolución clínica, los efectos secundarios y las complicaciones asociadas. Métodos: Se llevó a cabo una revisión retrospectiva de los expedientes de pacientes pediátricos con DA grave atendidos en el Servicio de Dermatología, Instituto Nacional de Pediatría (2000 a 2018), que hayan requerido tratamiento sistémico por más de 3 meses. Resultados: Se incluyeron 21 pacientes. La media de edad de inicio de la enfermedad fue de 3.31 años. Los fármacos utilizados fueron metotrexato (57.1%), talidomida (38%), prednisona (42.8%), azatioprina (19%), mofetil micofenolato (9.5%), ciclosporina (4.7%) y esteroides sistémicos como terapia puente (42.8%). Se observaron efectos secundarios leves en dos pacientes (9.5%) tratados con metotrexato y mofetil micofenolato. Conclusiones: El metotrexato fue el medicamento utilizado en más del 50% de los pacientes con remisión en la mayoría de ellos. La ciclosporina, azatioprina y mofetil micofenolato también fueron efectivos. Los efectos secundarios fueron leves y poco frecuentes. Es necesario realizar estudios comparativos de tratamientos sistémicos para DA grave en la población pediátrica.
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Recurrent erythema nodosum leprosum (ENL) is a type 2 leprosy reaction, which often poses a challenge for the treating physician. Patient may be non-ambulatory due to systemic symptoms like fever, body aches, joint pains, and painful skin lesions. Moreover, drugs like corticosteroids and thalidomide in refractory cases pose an increased risk of deep vein thrombosis (DVT). We have described a case who developed DVT in due course of the treatment.
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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.
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Humanos , Masculino , Femenino , Servicios Farmacéuticos , Talidomida/uso terapéutico , Lepra/tratamiento farmacológico , Centros de Salud , Estudios TransversalesRESUMEN
RESUMEN Fundamento: Aunque la estomatitis aftosa recurrente no tiene una etiología bien definida porque es una enfermedad multicausal, se ha reconocido que las interacciones o el debilitamiento del sistema inmunitario, contribuyen principalmente a la magnitud del proceso patológico. Las propuestas de tratamiento en pacientes inmunocomprometidos son diversas y por lo general se centran en alteraciones inmunológicas específicas. Objetivo: Evaluar el efecto clínico de los tratamientos propuestos para la estomatitis aftosa recurrente en pacientes inmunocomprometidos. Metodología: La búsqueda se realizó en las bases de datos PubMed/Medline y Cochrane. Se incluyeron ensayos clínicos que tuviesen entre sus variables de respuesta principales: Cicatrización de la úlcera aftosa, tiempo de cicatrización, de recurrencia e intensidad del dolor y entre las variables secundarias: Los efectos adversos y los síntomas. La extracción de datos se realizó de manera independiente por los autores. Se aplicó la metodología por la colaboración Cochrane para evaluar el riesgo de sesgo en cada uno de los estudios. Resultados: Se incluyeron 11 ensayos clínicos (8 controlados) publicados entre 1995 y 2020 y que aportan resultados de la eficacia de varias intervenciones terapéuticas: talidomida (4), irsogladine (2), rebamipida (1), láser de diodo (1), cápsulas de Omega-3 (1), vitamina B 12 (1), Complejo B (1). Seis de estos estudios incluyeron pacientes con la forma menor de estomatitis aftosa recurrente. El periodo de seguimiento estuvo entre los 14 y 360 días. Conclusiones: La talidomida puede ser eficaz en el alivio de los síntomas, la cicatrización y remisión de las lesiones, el diodo de láser y vitamina B12 en la disminución de la intensidad del dolor.
ABSTRACT Background: Although recurrent aphthous stomatitis does not have a well-defined etiology due to it is a multicausal disease, it has been recognized that the interactions or the weakening of the immune system, contribute mainly to the magnitude of the process pathological. Treatment proposals in immune compromised patients are diverse and they usually focus on specific immunological alterations. Objective: To evaluate the clinical effect of the proposed treatments for recurrent aphthous stomatitis in immunocompromised patients. Methodology: The search was performed in the PubMed/Medline and Cochrane databases. Clinical trials were included that could have among their main response variables: Aphthous ulcer healing, healing time, recurrence and pain intensity and among the secondary variables: Adverse effects and symptoms. data extraction was done independently by the authors. The methodology was applied by Cochrane collaboration to assess the risk of bias in each of the studies. Results: 11 clinical trials (8 controlled) published between 1995 and 2020 and that provided the results of the efficacy of various therapeutic interventions: thalidomide (4), irsogladine (2), rebamipide (1), diode laser (1), Omega-3 capsules (1), vitamin B 12 (1), Complex B (1). Six of these studies included patients with the minor form of stomatitis recurrent aphthous. The follow-up period was between 14 and 360 days. Conclusions: Thalidomide may be effective in relieving symptoms, healing and remission of the lesions, the laser diode and vitamin B12 in the decrease of the intensity of the pain.