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2.
Dermatol Ther ; 34(6): e15125, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34490707

RESUMO

Management of chronic/recurrent erythema nodosum leprosum (ENL) is challenging. The majority of these patients become steroid-dependent and suffer from the adverse effects of long-term corticosteroid use. Minocycline has shown promising results in a small series of chronic/recurrent ENL patients. The aim of this study was to compare the efficacy and safety of minocycline and clofazimine in patients with chronic/recurrent ENL. In this prospective randomized clinical trial, 60 participants with chronic/recurrent ENL were randomized (1:1) to receive either minocycline 100 mg once daily or clofazimine 100 mg thrice daily for 12 weeks along with prednisolone according to WHO protocol and followed up for 6 months. The outcome measures were mean time for initial control of ENL, proportion of patients having a recurrence of ENL, mean time for recurrence after initial control, additional prednisolone requirement, and frequency of adverse events. Initial control of ENL was achieved earlier in the minocycline group as compared to the clofazimine group (2.97 ± 1.9 weeks vs. 4 ± 1.96 weeks, respectively; p-0.048). The number of participants having ENL flares/recurrences during the study period was comparable in both groups (71.4% in clofazimine vs. 55.2% in minocycline group; p-0.2). The participants in the minocycline group remained in remission for a longer duration after initial control of ENL as compared to the clofazimine group (p-0.001). Mean additional prednisolone dose required for control of ENL flares/recurrences was also comparable in both groups (p-0.09). The minocycline group had fewer side effects than the clofazimine group (p-0.047). Minocycline led to a rapid and sustained improvement of ENL episodes with fewer adverse events showing a superior efficacy to clofazimine.


Assuntos
Eritema Nodoso , Hanseníase Virchowiana , Clofazimina/efeitos adversos , Eritema Nodoso/diagnóstico , Eritema Nodoso/tratamento farmacológico , Humanos , Hansenostáticos/efeitos adversos , Hanseníase Virchowiana/diagnóstico , Hanseníase Virchowiana/tratamento farmacológico , Minociclina/efeitos adversos , Estudos Prospectivos
3.
Arq. ciências saúde UNIPAR ; 25(1): 79-85, jan-abr. 2021.
Artigo em Português | LILACS | ID: biblio-1151426

RESUMO

Introdução: O diagnóstico da hanseníase possui números significativos que causam preocupação à saúde pública. Os casos de resistência medicamentosa nessa doença se iniciaram em meados dos anos 60 e diante do problema, a Organização Mundial da Saúde instituiu em 1981 a poliquimioterapia, associação dos antibióticos rifampicina, dapsona e clofazimina, tratamento atual de escolha. A resistência aos fármacos na hanseníase é reportada pela literatura, desvelando um obstáculo à sua eliminação. Apresentamos nessa revisão os principais aspectos da resistência medicamentosa no tratamento para hanseníase e seus impactos. Metodologia: Revisão sistemática sobre os aspectos da resistência medicamentosa utilizando a pesquisa exploratória como metodologia de abordagem. Foram pesquisados os termos resistência medicamentosa, hanseníase, recidiva, alterações genéticas e os operadores booleanos "and" e "or" na busca. Resultados e discussão: A dificuldade de tomar a medicação corretamente foi um dos principais fatores que acarretaram resistência do bacilo Mycobacterium leprae aos fármacos. Homens de países norte e sul-americanos e asiáticos foram os mais atingidos por episódios de resistência. A resistência medicamentosa é uma das principais causas de recidivas em hanseníase. O principal fármaco causador de resistência medicamentosa descrito nos trabalhos foi a dapsona (46,6%) e a maioria das alterações genéticas encontradas estão no gene rpoB; 23,2% dos registros relatados foram de resistência secundária aos fármacos e, também, sete casos de resistência múltipla a esses medicamentos. Conclusão: Os principais aspectos da resistência medicamentosa na hanseníase são os equívocos ao ingerir os medicamentos e as alterações genéticas na bactéria. Os impactos causados estão na dificuldade de refazer o tratamento, a possibilidade de nova transmissão e o aparecimento de sintomas mais graves.


Introduction: The diagnosis of leprosy has significant numbers causing public health concern. Reports of drug resistance in this disease begun in the mid-1960s and due to this problem, the World Health Organization instituted a multidrug therapy with rifampicin, dapsone, and clofazimine antibiotic association in 1981, which is currently the first-choice treatment for leprosy. Cases of drug resistance have been reported in literature, revealing an obstacle to the eradication of the disease. This paper has the purpose of presenting the key aspects and impacts of drug resistance in the treatment for leprosy. Methods: Systematic review of the drug resistance aspects using exploratory research as an approach methodology. The authors searched the terms drug resistance, leprosy, recurrence, genetic alterations, and the Boolean operators "and" and "or" between them. Results and discussion: The difficulty in taking the medication correctly was one of the key factors that led to drug resistance for Mycobacterium leprae. Men from North and South American, as well as from Asian countries, were the most affected by episodes of resistance. Drug resistance is one of the main causes of leprosy recurrences. Dapsone was the most frequently identified drug resistance in the studies (46.6%), while most of the genetic alterations were found in the rpoB gene; 23.2% of the cases were from secondary resistance episodes, and seven cases of multiple resistance were reported. Conclusion: The misconceptions when taking the treatment and the Mycobacterium leprae genetic alterations have been described as the key aspects of drugs resistance in leprosy and the impacts caused are the difficulty in redoing the treatment, the possibility of new transmission, and the appearance of more severe symptoms.


Assuntos
Resistência a Medicamentos/efeitos dos fármacos , Farmacorresistência Bacteriana/efeitos dos fármacos , Mycobacterium leprae/efeitos dos fármacos , Rifampina/efeitos adversos , Bactérias/genética , Preparações Farmacêuticas , Clofazimina/efeitos adversos , Fluoroquinolonas/efeitos adversos , Dapsona/efeitos adversos , Quimioterapia Combinada/efeitos adversos , Hanseníase/tratamento farmacológico , Antibacterianos/efeitos adversos
4.
Int J Clin Pharmacol Ther ; 58(9): 518-522, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32589131

RESUMO

A wide variety of drugs and substances have the potential to damage the respiratory system by different mechanisms. Clofazimine is an anti-leprosy drug that is normally only prescribed for a few years. It has a very long half-life, and crystalline deposition of the drug in various tissues has been documented. But up to now, no fatalities due to pulmonary damage have been described. We report the case of a patient who took clofazimine for almost 27 years as off-label treatment for Melkersson-Rosenthal syndrome. He suffered from progressive dyspnea, productive cough, and occasional hemoptysis. X-ray and CT of the thoracic organs revealed extensive multilocular, compact, tumor-like infiltrates with central necrosis in both lungs. Pulmonary function tests showed restrictive impairment and manifest hypoxemia. Histology of lung biopsies revealed intense interstitial accumulation of histiocytes and marked deposition of crystalline foreign material. The patient died from progressive respiratory failure. Autopsy revealed crystalline deposition and a histiocytic reaction in many other parenchymal organs. Conclusion: Pulmonary parenchymal deposition of drug crystals is a rare mechanism of drug-induced pulmonary diseases. Long-standing, off-label use of clofazimine may cause severe destruction of the lungs and can be fatal.


Assuntos
Clofazimina/efeitos adversos , Síndrome de Melkersson-Rosenthal , Insuficiência Respiratória , Biópsia , Evolução Fatal , Hemoptise , Humanos , Masculino , Síndrome de Melkersson-Rosenthal/induzido quimicamente , Síndrome de Melkersson-Rosenthal/tratamento farmacológico
5.
J Infect Dis ; 222(6): 1027-1036, 2020 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-32310272

RESUMO

BACKGROUND: Persistent and relapsing babesiosis caused by Babesia microti often occurs in immunocompromised patients, and has been associated with resistance to antimicrobial agents such as atovaquone. Given the rising incidence of babesiosis in the United States, novel drugs are urgently needed. In the current study, we tested whether clofazimine (CFZ), an antibiotic used to treat leprosy and drug-resistant tuberculosis, is effective against B. microti. METHODS: Mice with severe combined immunodeficiency were infected with 107B. microti-infected erythrocytes. Parasites were detected by means of microscopic examination of Giemsa-stained blood smears or nested polymerase chain reaction. CFZ was administered orally. RESULTS: Uninterrupted monotherapy with CFZ curtailed the rise of parasitemia and achieved radical cure. B. microti parasites and B. microti DNA were cleared by days 10 and 50 of therapy, respectively. A 7-day administration of CFZ delayed the rise of parasitemia by 22 days. This rise was caused by B. microti isolates that did not carry mutations in the cytochrome b gene. Accordingly, a 14-day administration of CFZ was sufficient to resolve high-grade parasitemia caused by atovaquone-resistant B. microti parasites. CONCLUSIONS: Clofazimine is effective against B. microti infection in the immunocompromised host. Additional preclinical studies are required to identify the minimal dose and dosage of CFZ for babesiosis.


Assuntos
Babesia microti/efeitos dos fármacos , Babesiose/tratamento farmacológico , Babesiose/parasitologia , Clofazimina/uso terapêutico , Hospedeiro Imunocomprometido , Hansenostáticos/uso terapêutico , Sequência de Aminoácidos , Animais , Babesia microti/genética , Babesia microti/imunologia , Babesiose/imunologia , Clofazimina/administração & dosagem , Clofazimina/efeitos adversos , Citocromos b/química , Citocromos b/genética , DNA de Protozoário , Modelos Animais de Doenças , Avaliação Pré-Clínica de Medicamentos , Resistência a Medicamentos , Eritrócitos/parasitologia , Hansenostáticos/administração & dosagem , Hansenostáticos/efeitos adversos , Camundongos , Parasitemia/parasitologia , Resultado do Tratamento
7.
Am J Trop Med Hyg ; 100(1): 24-30, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30298809

RESUMO

A subset of multibacillary (MB) leprosy patients manifest with clinical "nonresponsiveness" to the fixed-duration, World Health Organization multidrug therapy MB regimen (WHO-MDT-MBR). The aim of this retrospective study was to assess the effectiveness and safety of alternate anti-leprosy therapy (ALT) in such patients. This is an analysis of patients' records, registered in the leprosy clinic of our institute over a period of 6 years (2010-2015). The criteria for inadequate response/nonresponsiveness to treatment were as follows: 1) persistent/new lesions after completing ≥ 12 months of WHO-MDT-MBR (isolated reactions were ruled out histopathologically) and 2) persistent positive/increasing value of the morphological index (MI) and a 2 log increase in the bacteriological index (BI) after ≥ 12 months of WHO-MDT-MBR. Such cases were treated with ALT consisting of minocycline, clofazimine, and ofloxacin (24 months). Of 556 patients registered during the study period, 40.3% (224) were slit-skin smear (SSS) positive and 59.7% (332) were SSS negative. Of all, 35 patients (6.3%) satisfied the criteria for clinical nonresponsiveness. Of 224 SSS-positive patients, these 35 patients amounted to 15.6%. The mean BI and MI of these patients after completion of ≥ 12 months of WHO-MDT-MBR were 5.3 ± 0.6 and 14 ± 6.8%, respectively. After 6 months of treatment with ALT, MI became negative (0) in all these patients. After completion of ALT, the mean BI and MI became 1.7 ± 0.7 and 0%, respectively (P < 0.0001). There were 16 patients with corticosteroid-dependent recurrent/chronic erythema nodosum leprosum, who had excellent response with significant reduction in the number of reactional episodes and mean dose of prednisolone required (P < 0.0001). No serious adverse effects were noted. We conclude that ALT is safe and effective in the management of MB leprosy patients who are nonresponsive to 12 months of WHO-MDT-MBR.


Assuntos
Gerenciamento Clínico , Hansenostáticos/uso terapêutico , Hanseníase Multibacilar/tratamento farmacológico , Mycobacterium leprae/efeitos dos fármacos , Adulto , Clofazimina/efeitos adversos , Clofazimina/uso terapêutico , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Índia , Masculino , Registros Médicos , Pessoa de Meia-Idade , Minociclina/efeitos adversos , Minociclina/uso terapêutico , Estudos Retrospectivos , Centros de Atenção Terciária , Organização Mundial da Saúde , Adulto Jovem
8.
Trials ; 19(1): 456, 2018 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-30139372

RESUMO

BACKGROUND: Cryptosporidium infection and diarrhea (cryptosporidiosis) is a life-threatening infection in persons with HIV and also in children of 6-18 months of age in the developing world. To date, only nitazoxanide is licensed for treatment of cryptosporidiosis, and only in persons after the first year of life and with healthy immune systems. Clofazimine (CFZ: Lamprene®), an established drug that has been used for leprosy for more than 50 years, recently has been described as effective against Cryptosporidium in vitro and in mouse infections. The efficacy and pharmacokinetics of CFZ in vivo, in HIV-infected patients with cryptosporidial diarrhea are not known. METHODS: CRYPTOFAZ includes a randomized, double-blind, placebo-controlled study of the safety, tolerability and Cryptosporidium inhibitory activity of orally administered CFZ in subjects with HIV infection and chronic diarrhea with Cryptosporidium. An additional open label aspect of the study will compare the pharmacokinetics (PK) of orally administered CFZ in HIV-infected individuals with and without Cryptosporidium-associated diarrhea. The study will recruit a total of 66 subjects. Study participants will be given either CFZ or a placebo for 5 days while in hospital and will be followed up after discharge. Cryptosporidium will be diagnosed by quantitative PCR as the definitive test and by stool ELISA, which will also be used to quantify the shedding of Cryptosporidium in stool. PK will be studied on plasma and stool samples. Primary endpoints include reduction in the number of Cryptosporidium shed in stools over a 5-day period and compared to placebo recipients and the PK of CFZ in plasma assessed by area under the curve, peak plasma concentration, and half-life (T ½) determined after the last dose. DISCUSSION: This study provides an opportunity to explore a possible treatment option for HIV-infected patients with cryptosporidial diarrhea, who, as of now in Malawi and most of sub-Saharan Africa, do not have a definitive treatment apart from supportive care. The strength of this study lies in it being a randomized, double-blind, placebo-controlled trial. If shown to be effective and safe, the findings will also lay a foundation for a future study of the use of CFZ in children 6-18 months of age. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03341767 . Registered on 14 November 2017.


Assuntos
Infecções Oportunistas Relacionadas com a AIDS/tratamento farmacológico , Antiprotozoários/farmacocinética , Clofazimina/farmacocinética , Criptosporidiose/tratamento farmacológico , Diarreia/tratamento farmacológico , Infecções Oportunistas Relacionadas com a AIDS/diagnóstico , Infecções Oportunistas Relacionadas com a AIDS/parasitologia , Administração Oral , Adolescente , Adulto , Idoso , Antiprotozoários/administração & dosagem , Antiprotozoários/efeitos adversos , Antiprotozoários/sangue , Área Sob a Curva , Clofazimina/administração & dosagem , Clofazimina/efeitos adversos , Clofazimina/sangue , Criptosporidiose/diagnóstico , Criptosporidiose/parasitologia , Diarreia/diagnóstico , Diarreia/parasitologia , Método Duplo-Cego , Feminino , Meia-Vida , Humanos , Malaui , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Adulto Jovem
9.
An Bras Dermatol ; 93(3): 377-384, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29924240

RESUMO

BACKGROUND: The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs. OBJECTIVE: Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT). PATIENTS AND METHODS: After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial. RESULTS: Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported. STUDY LIMITATIONS: Loss of some monthly laboratory sample collection. CONCLUSIONS: There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients.


Assuntos
Clofazimina/efeitos adversos , Dapsona/efeitos adversos , Hansenostáticos/efeitos adversos , Hanseníase/tratamento farmacológico , Rifampina/efeitos adversos , Adolescente , Adulto , Anemia/sangue , Anemia/induzido quimicamente , Brasil , Criança , Clofazimina/administração & dosagem , Dapsona/administração & dosagem , Quimioterapia Combinada/efeitos adversos , Feminino , Hemoglobinas/análise , Humanos , Hansenostáticos/administração & dosagem , Hanseníase/sangue , Hanseníase/complicações , Masculino , Pessoa de Meia-Idade , Rifampina/administração & dosagem , Fatores de Risco , Resultado do Tratamento , Adulto Jovem
10.
An. bras. dermatol ; 93(3): 377-384, May-June 2018. tab, graf
Artigo em Inglês | LILACS | ID: biblio-949891

RESUMO

Abstract: BACKGROUND: The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs. OBJECTIVE: Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT). Patients and methods: After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial. RESULTS: Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported. STUDY LIMITATIONS: Loss of some monthly laboratory sample collection. CONCLUSIONS: There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients.


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Adulto Jovem , Rifampina/efeitos adversos , Clofazimina/efeitos adversos , Dapsona/efeitos adversos , Hansenostáticos/efeitos adversos , Rifampina/administração & dosagem , Brasil , Hemoglobinas/análise , Fatores de Risco , Resultado do Tratamento , Clofazimina/administração & dosagem , Dapsona/administração & dosagem , Quimioterapia Combinada/efeitos adversos , Anemia/induzido quimicamente , Anemia/sangue , Hansenostáticos/administração & dosagem , Hanseníase/complicações , Hanseníase/tratamento farmacológico , Hanseníase/sangue
12.
J Dtsch Dermatol Ges ; 15(8): 801-827, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28763601

RESUMO

Leprosy is a chronic infectious disease caused by Mycobacterium (M.) leprae. Worldwide, 210,758 new cases were diagnosed in 2015. The highest incidence is found in India, Brazil, and Indonesia. While the exact route of transmission remains unknown, nasal droplet infection is thought to be most likely. The pathogen primarily affects the skin and peripheral nervous system. The disease course is determined by individual host immunity. Clinically, multibacillary lepromatous variants are distinguished from paucibacillary tuberculoid forms. Apart from the various characteristic skin lesions, the condition is marked by damage to the peripheral nervous system. Advanced disease is characterized by disfiguring mutilations. Current treatment options are based on WHO recommendations. Early treatment frequently results in complete remission without sequelae. While paucibacillary forms are treated with rifampicin and dapsone for at least six months, multibacillary leprosy is treated for at least twelve months, additionally requiring clofazimine. Leprosy reactions during therapy may considerably aggravate the disease course. Besides individual treatment, WHO-supported preventive measures and strategies play a key role in endemic areas.


Assuntos
Hansenostáticos/uso terapêutico , Hanseníase Virchowiana/diagnóstico , Hanseníase Virchowiana/tratamento farmacológico , Hanseníase Tuberculoide/diagnóstico , Hanseníase Tuberculoide/tratamento farmacológico , Doenças Negligenciadas , Adulto , Idoso , Criança , Clofazimina/efeitos adversos , Clofazimina/uso terapêutico , Estudos Transversais , Dapsona/efeitos adversos , Dapsona/uso terapêutico , Progressão da Doença , Esquema de Medicação , Feminino , Fidelidade a Diretrizes , Humanos , Imunidade Celular/efeitos dos fármacos , Hanseníase Dimorfa/diagnóstico , Hanseníase Dimorfa/tratamento farmacológico , Hanseníase Dimorfa/epidemiologia , Hanseníase Dimorfa/imunologia , Hanseníase Virchowiana/epidemiologia , Hanseníase Virchowiana/imunologia , Hanseníase Tuberculoide/epidemiologia , Hanseníase Tuberculoide/imunologia , Assistência de Longa Duração , Masculino , Rifampina/efeitos adversos , Rifampina/uso terapêutico
13.
Int J Antimicrob Agents ; 49(5): 554-557, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28336312

RESUMO

Recently, multidrug-resistant tuberculosis (MDR-TB) has become a therapeutic challenge. In addition to drug resistance, drug adverse events, intravenous delivery, cost and availability of some antibiotics in low-income countries have led to a look back to old drugs, especially those efficient against closely related organisms such as Mycobacterium leprae. Here we review the available drugs that respect the conditions above and could be upgraded to first-line therapy for treating MDR-TB and extensively drug-resistant tuberculosis (XDR-TB).


Assuntos
Antituberculosos/uso terapêutico , Sinergismo Farmacológico , Tuberculose Extensivamente Resistente a Medicamentos/tratamento farmacológico , Mycobacterium tuberculosis/efeitos dos fármacos , Antituberculosos/efeitos adversos , Claritromicina/efeitos adversos , Claritromicina/uso terapêutico , Clofazimina/efeitos adversos , Clofazimina/uso terapêutico , Farmacorresistência Bacteriana Múltipla , Tuberculose Extensivamente Resistente a Medicamentos/microbiologia , Humanos , Minociclina/efeitos adversos , Minociclina/uso terapêutico , Fenotiazinas/efeitos adversos , Fenotiazinas/uso terapêutico , Sulfonamidas/efeitos adversos , Sulfonamidas/uso terapêutico
14.
Dermatol Ther ; 30(1)2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27549245

RESUMO

Leprosy is a chronic disease which primarily affects the skin, mucous membranes and peripheral nerves due to Mycobacterium leprae. It is now infrequent in Europe and is rarely reported during pregnancy. Leprosy can be exacerbated during pregnancy, and without treatment it can permanently damage the skin, nerves, limbs and eyes. Therefore, it is important to treat leprosy during pregnancy. This article describes a patient with multibacillary lepromatous leprosy who was treated with multidrug therapy during pregnancy and breastfeeding. The patient delivered a healthy baby girl without perinatal complications, and the infant's growth and development were normal during the 1-year follow-up period. Multidrug therapy consisting of dapsone, rifampicine, and clofazimine is highly effective for people with leprosy and considered safe, both for the mother and the child. Antileprosy drugs are excreted into human milk but there is no report of adverse effects except for skin discoloration of the infant due to clofazimine. Multidrug therapy for leprosy patients should be continued unchanged during pregnancy and breastfeeding.


Assuntos
Aleitamento Materno , Clofazimina/uso terapêutico , Dapsona/uso terapêutico , Hansenostáticos/uso terapêutico , Hanseníase Virchowiana/tratamento farmacológico , Hanseníase Multibacilar/tratamento farmacológico , Complicações Neoplásicas na Gravidez/tratamento farmacológico , Rifampina/uso terapêutico , Adulto , Clofazimina/efeitos adversos , Dapsona/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Hansenostáticos/efeitos adversos , Hanseníase Virchowiana/diagnóstico , Hanseníase Virchowiana/microbiologia , Hanseníase Multibacilar/diagnóstico , Hanseníase Multibacilar/microbiologia , Gravidez , Complicações Neoplásicas na Gravidez/diagnóstico , Complicações Neoplásicas na Gravidez/microbiologia , Rifampina/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
15.
Rev. chil. dermatol ; 33(2): 62-64, 2017. ilus
Artigo em Espanhol | LILACS | ID: biblio-964927

RESUMO

La lepra es una infección crónica, granulomatosa, producida por Mycobacterium leprae, que afecta piel y nervios periféricos. Se describen dos tipos de reacciones leprosas: tipo I y tipo II, las que corresponden a cuadros agudos que exacerban la enfermedad. Estas leproreacciones pueden ocurrir antes, durante o después del tratamiento. Se presenta el caso de un paciente masculino que acude a consultar con lesiones cutáneas y resultado de biopsia de piel con diagnóstico de lepra. Se inicia tratamiento multidroga OMS-MB1. Posteriormente presenta una leproreacción tipo I, por lo que se le realiza tratamiento con prednisona.


Leprosy is a chronic granulomatous infection of the skin and peripheral nervous system produced by Mycobacterium leprae. Two types of acute leprosy reactions have been described: type I and type II. These reactions can occur before, during or after treatment. We present the case of an adult male patient presenting with skin lesions and skin biopsy diagnostic for leprosy. A multidrug WHO-MB 1 treatment was initiated, after which he presents with type I lepra reaction requiring corticosteroids.


Assuntos
Humanos , Masculino , Pessoa de Meia-Idade , Hanseníase Virchowiana/diagnóstico , Hanseníase Virchowiana/tratamento farmacológico , Clofazimina/efeitos adversos , Quimioterapia Combinada/efeitos adversos , Eritema Nodoso/induzido quimicamente , Rifampina/efeitos adversos , Biópsia , Dapsona/efeitos adversos , Hanseníase Multibacilar/patologia , Hansenostáticos/efeitos adversos
16.
Int J Dermatol ; 54(11): 1325-32, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26094723

RESUMO

BACKGROUND: Type 2 lepra reaction (T2R) is a difficult-to-manage condition in leprosy, and an effective and safe steroid-sparing agent is needed for its management. The World Health Organization proposes clofazimine and recommends pentoxifylline for T2R. Our study was done to compare the effectiveness and safety of clofazimine and pentoxifylline therapy in patients with T2R. METHODS: Twenty patients with T2R were randomized equally. Group A received pentoxifylline 400 mg t.d.s, group B received clofazimine 100 mg t.d.s. for 12 weeks. Both groups received prednisolone 40 mg o.d., tapered over 12 weeks. The effectiveness parameters were days needed for resolution of cutaneous and systemic manifestations, relapses, cutaneous score, systemic score, and average daily prednisolone intake. Safety parameters were spontaneously appearing adverse events and laboratory parameter changes. RESULTS: The cutaneous scores in the clofazimine (P < 0.001) and pentoxifylline groups (P < 0.001) showed a progressive decline in subsequent follow-ups. Individual follow-ups were significantly lower than baseline in both groups (P < 0.05). Systemic scores fared similarly. There were no significant intergroup changes. Average daily prednisolone intake progressively decreased in group B (P < 0.001). Cutaneous and systemic manifestations took a comparable time to resolve. Both drugs were safe. CONCLUSION: Pentoxifylline effectively reduces initial severity; clofazimine provides sustained improvement but acts slowly.


Assuntos
Artrite Reativa/microbiologia , Clofazimina/uso terapêutico , Hansenostáticos/uso terapêutico , Hanseníase/tratamento farmacológico , Pentoxifilina/uso terapêutico , Inibidores de Fosfodiesterase/uso terapêutico , Adulto , Clofazimina/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Inflamação/microbiologia , Hansenostáticos/efeitos adversos , Hanseníase/complicações , Masculino , Pessoa de Meia-Idade , Neuralgia/microbiologia , Pentoxifilina/efeitos adversos , Inibidores de Fosfodiesterase/efeitos adversos , Resultado do Tratamento , Adulto Jovem
18.
BMJ Open ; 4(1): e004143, 2014 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-24384902

RESUMO

OBJECTIVES: Given the spread of multidrug-resistant tuberculosis (MDR-TB), new therapies are urgently needed, including the repurposing of existing drugs. We aimed to assess key considerations for the clinical and programmatic use of clofazimine (Cfz), a riminophenazine with antimycobacterial activity currently used to treat leprosy. DESIGN: Fixed and random effects meta-analysis of cohort studies and systematic review. SETTING: Electronic and manual searches were combined. INCLUSION CRITERIA: Observational studies on treatment of multidrug-resistant and extremely drug-resistant tuberculosis with Cfz or a Cfz-containing regimen, and published guidance and documents relating to cost and availability were eligible. RESULTS: 5 observational studies enrolled 861 patients, of which 602 received Cfz. The pooled proportion of adverse drug reactions requiring discontinuation of Cfz treatment was 0.1% (95% CI (0.0 to 0.6%)), and the median frequency of all adverse events was 5.1%. Cfz showed in vitro efficacy against Mycobacterium tuberculosis, and Cfz-containing regimens may have had a useful role in the treatment of patients with drug-resistant strains and who had limited alternative treatment options. However, Cfz uptake remains insufficient to meet global needs; there is only one internationally quality-assured manufacturer, which produces a limited quantity of the drug prioritised for treatment of leprosy, the only indication for which the drug is registered. CONCLUSIONS: While the data were limited, Cfz was associated with a risk for adverse drug reactions comparable to that of first-line TB treatment, which could be reasonably managed under programmatic conditions. However, low market availability and high cost are important barriers to access to Cfz for patients with MDR-TB.


Assuntos
Clofazimina/uso terapêutico , Tuberculose Extensivamente Resistente a Medicamentos/tratamento farmacológico , Hansenostáticos/uso terapêutico , Clofazimina/efeitos adversos , Estudos de Coortes , Humanos , Hansenostáticos/efeitos adversos , Guias de Prática Clínica como Assunto , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico
19.
An Bras Dermatol ; 88(2): 205-10, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23739719

RESUMO

BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations. OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients. METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundação Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. RESULTS: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days. CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies had shown, no treatment was stopped due to side effects. Nevertheless, patient follow-up and studies with bigger samples are necessary to guarantee the efficacy and safety of the alternative regimen as a second-line scheme in multi-drug therapy.


Assuntos
Clofazimina/efeitos adversos , Hansenostáticos/administração & dosagem , Hanseníase Multibacilar/tratamento farmacológico , Minociclina/efeitos adversos , Ofloxacino/efeitos adversos , Adolescente , Adulto , Brasil , Clofazimina/administração & dosagem , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Minociclina/administração & dosagem , Ofloxacino/administração & dosagem , Estatísticas não Paramétricas , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
20.
Indian J Pharmacol ; 45(2): 197-8, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23716903

RESUMO

Clofazimine-induced crystal-storing histiocytosis is a rare but well-recognized condition reported in literature. In addition to common reddish discoloration of the skin, clofazimine produces gastrointestinal disorder, sometimes severe abdominal pain. Also, the pathologic and radiologic findings can produce diagnostic difficulties if the pathological changes caused by it are not known. The authors report a case in a patient of leprosy to emphasize the importance of history, radiologic, and pathologic findings in small intestine. Clofazimine crystals are red in the frozen section and display bright-red birefringence. With the knowledge of this rare condition caused by clofazimine, appropriate management to avoid an unnecessary laparotomy is possible.


Assuntos
Dor Abdominal/induzido quimicamente , Clofazimina/efeitos adversos , Gastroenteropatias/induzido quimicamente , Histiocitose/induzido quimicamente , Hansenostáticos/efeitos adversos , Hanseníase/tratamento farmacológico , Humanos , Masculino , Adulto Jovem
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