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1.
Int J Clin Pharmacol Ther ; 49(11): 637-47, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22011688

RESUMO

INTRODUCTION: Flupirtine, a nonopioid analgesic without antipyretic or antiphlogistic properties, constitutes a unique class within the group of WHO-I analgesics. First approved in Germany on a national level in 1989, this selective neuronal potassium channel opener evolved rapidly into one of the most preferred analgesics for the treatment of musculoskeletal pain in some European countries. However, its use outside Europe was limited due to a discrepancy between the empirical application of the drug and supporting evidence. As a consequence, the German Pain Society commissioned an independent research institute to perform a pooled re-analysis of all available data from randomized controlled trials (including some trial not yet published). METHODS: A retrospective pooled analysis of the individual patient data from 8 randomized controlled Phase III - IV clinical trials was carried out which included patients with sub-acute and chronic musculoskeletal pain. The efficacy and tolerability of flupirtine at dosages of 100 - 400 mg/d were compared to placebo and/or active comparators. Data were pooled by treatment and by subject. The primary endpoint was the average change in pain intensity for the overall maintenance period. RESULTS: A total of 1,046 patients was evaluated for efficacy and 1,095 patients for safety. Based on 3,337 pain assessments, treatment with flupirtine and active comparators resulted in significant reductions in pain intensity compared to baseline beginning from Day 4 (flupirtine) and Day 5 (comparators) and continuing up to the end of the study period as well as during the overall maintenance period (all p < 0.001). Flupirtine prooved to be non-inferior to the active comparators (p < 0.001) but showed a superior tolerability profile with a significantly lower number of patients reporting treatment emergent adverse events (28.6 vs. 39.1%, p < 0.001) and a significantly lower percentage of patients who prematurely discontinued study medication due to these adverse events (7.1 vs. 11.7%, p = 0.013). LIMITATIONS: The limitations in the study were confined to those inherent in the retrospective and pooled analysis design. CONCLUSION: On the basis of this pooled analysis of individual data from 8 controlled clinical trials involving patients suffering from sub-acute/chronic musculoskeletal pain, the efficacy of flupirtine was superior to placebo across its effective and approved dosage range. Flupirtine was at least as active as the active comparators and showed a superior tolerability profile with a significantly lower treatment discontinuation rate.


Assuntos
Aminopiridinas/uso terapêutico , Analgésicos/uso terapêutico , Dor Crônica/tratamento farmacológico , Dor Musculoesquelética/tratamento farmacológico , Aminopiridinas/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
2.
Neurology ; 52(7): 1507-10, 1999 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-10227648

RESUMO

Sumatriptan is a highly effective treatment for migraine in adults but its efficacy in children has not been determined. Fourteen children with migraine (6.4 to 9.8 years of age; seven girls, six with aura) participated in a randomized double-blind placebo-controlled crossover study to evaluate the efficacy of sumatriptan nasal spray. After sumatriptan, 12 of 14 (versus 6 of 14 after placebo) reported a decrease in pain intensity (p = 0.031); complete headache relief was obtained in 9 of 14 after sumatriptan versus 2 of 14 after placebo (p = 0.016). Migraine-associated symptoms were also significantly reduced by sumatriptan.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Sumatriptana/administração & dosagem , Sumatriptana/uso terapêutico , Administração Intranasal , Criança , Método Duplo-Cego , Feminino , Humanos , Masculino
3.
Epilepsy Res ; 46(1): 63-7, 2001 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-11395290

RESUMO

Physical maturation is one of the essential developmental processes during childhood and adolescence, which can be adversely affected by a number of internal and external factors. An important side effect associated with the long-term use of some antiepileptic drugs is change in body weight, followed by an increased risk for subsequent maturational problems in pediatric epilepsy patients. To evaluate the effect of lamotrigine on body growth in children and adolescents with epilepsy, weight, height and body mass index (BMI) values of 103 pediatric epilepsy patients (m/f ratio: 53/50) treated with lamotrigine monotherapy were prospectively evaluated for a period of 18.7+/-11.8 (range 6--71) months. Age at therapy introduction was 6.7+/-2.7 (range 1.6-16.4) years and daily lamotrigine dose was 7.4+/-2.2 (range 3.5--14.2) mg/kg body weight (BW). Standard deviation scores (S.D.S.) at therapy initiation versus follow-up were height -- S.D.S.: 0.07+/-0.42 versus 0.08+/-0.42 (P=n.s.); weight -- S.D.S.: -0.01+/-0.44 versus -0.01+/-0.43 (P=n.s.) and BMI -- S.D.S.: -0.24+/-0.47 versus -0.25+/-0.37 (P=n.s.). Lamotrigine long-term monotherapy was associated with normal body growth in pediatric and adolescent patients with epilepsy, regardless of patient age, gender or duration of therapy.


Assuntos
Anticonvulsivantes/uso terapêutico , Epilepsia/tratamento farmacológico , Epilepsia/fisiopatologia , Crescimento/fisiologia , Triazinas/uso terapêutico , Adolescente , Estatura , Índice de Massa Corporal , Peso Corporal , Criança , Pré-Escolar , Feminino , Seguimentos , Crescimento/efeitos dos fármacos , Humanos , Lactente , Lamotrigina , Masculino , Estudos Prospectivos , Valores de Referência
4.
Pediatr Neurol ; 19(5): 385-7, 1998 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-9880146

RESUMO

Most complications of sinusitis have a significant risk of severe morbidity and possibly mortality. Therefore a keen awareness of the subtle signs and symptoms of bacterial spread beyond the paranasal sinuses must be maintained. This increased awareness is especially important in mentally retarded and psychomotor handicapped children because they can develop a rapidly fatal course despite the absence of any warning signs.


Assuntos
Abscesso/diagnóstico por imagem , Abscesso/etiologia , Coma/complicações , Sinusite Frontal/complicações , Osteomielite/etiologia , Criança , Espaço Epidural , Sinusite Frontal/diagnóstico por imagem , Humanos , Masculino , Osteomielite/diagnóstico por imagem , Estado Vegetativo Persistente/complicações , Tomografia Computadorizada por Raios X
5.
Pediatr Neurol ; 15(4): 293-8, 1996 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-8972527

RESUMO

Conventional and quantitative aspects of electroencephalographic recordings obtained during a follow-up surveillance study in long-term survivors of acute lymphoblastic leukemia in childhood were investigated with respect to differences in central nervous system prophylaxis given during antileukemic therapy and compared with data derived from healthy controls. Central nervous system prophylaxis consisted either of cranial irradiation (18 Gray, group A, n = 8) or intermediate high-dose methotrexate (2000 mg/m2; group B, n = 5), each combined with intrathecal methotrexate. Conventional electroencephalographic analysis revealed comparable results in all three study groups. However, quantitative electroencephalography showed significantly increased absolute power scores for all frequency bands in both long-term survivor groups. Relative power estimates revealed a significant increase in delta/tau activities in both prophylaxis groups compared to healthy controls, which were countered by decreased percentage power scores in the alpha-range. Quantitative electroencephalographic comparisons between both central nervous system prophylaxis groups revealed only small differences in quantity, not quality, of the observed power disturbances with slightly higher deviations in irradiated long-term survivors than in nonirradiated ones. Topographical distributions of spectral band power were comparable between all three study groups without evidence for therapy-related topographical differences.


Assuntos
Eletroencefalografia/estatística & dados numéricos , Leucemia-Linfoma Linfoblástico de Células Precursoras/fisiopatologia , Processamento de Sinais Assistido por Computador , Adolescente , Adulto , Córtex Cerebral/efeitos dos fármacos , Córtex Cerebral/fisiopatologia , Córtex Cerebral/efeitos da radiação , Terapia Combinada , Irradiação Craniana , Relação Dose-Resposta a Droga , Eletroencefalografia/efeitos dos fármacos , Eletroencefalografia/efeitos da radiação , Feminino , Seguimentos , Humanos , Masculino , Metotrexato/administração & dosagem , Metotrexato/efeitos adversos , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Leucemia-Linfoma Linfoblástico de Células Precursoras/radioterapia
6.
J Int Med Res ; 39(1): 41-50, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21672306

RESUMO

Opioid-induced constipation (OIC) is a severe, persisting side-effect of opioid therapy. The Bowel Function Index (BFI(a), numerical analogue scale 0 - 100), calculated as the mean of three variables (ease of defaecation, feeling of incomplete bowel evacuation, and personal judgement of constipation) was developed to evaluate bowel function in opioid-treated patients with pain. This clinician-administered tool allows easy measurement of OIC from the patient's perspective. The purpose of this investigation was to define a reference range reflecting BFI values in non-constipated chronic pain patients who were recruited into a cross-sectional survey and asked for their perceptions of constipation. The BFI scores were assessed and compared with those of patients with confirmed OIC obtained from two previously published trials. Results were analysed and a reference range of BFI values of 0 - 28.8, into which 95% of non-constipated chronic pain patients fell, was defined. This permits discrimination between chronic pain patients with, or without, constipation.


Assuntos
Analgésicos Opioides/efeitos adversos , Constipação Intestinal/induzido quimicamente , Naloxona/efeitos adversos , Oxicodona/efeitos adversos , Dor/tratamento farmacológico , Projetos de Pesquisa , Doença Crônica , Constipação Intestinal/fisiopatologia , Constipação Intestinal/psicologia , Estudos Transversais , Defecação/efeitos dos fármacos , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Dor/fisiopatologia , Qualidade de Vida/psicologia , Valores de Referência , Inquéritos e Questionários
7.
Med Pediatr Oncol ; 29(2): 121-31, 1997 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-9180914

RESUMO

Monitoring of therapy-related late effects after acute lymphoblastic leukemia (ALL) therapy in childhood has become an increasingly important area in posttherapeutic patient surveillance. The usefulness of conventional electro-encephalographic (EEG) investigations as part of these attempts is controversially discussed. However, EEG recordings have become a popular approach for judgement on the functional integrity of the central nervous system in this subject group. The present report focuses on this problem and discusses the question whether and to what extent conventional EEG recordings were correlated with further measures of central nervous system (CNS) integrity and therapeutic differences. EEGs were recorded in 110 subjects, asymptomatic long-term survivors of ALL in childhood, during a large retrospective multicenter study evaluating CNS late sequelae following antileukemic therapy in Germany and Austria. EEG findings were correlated with demographic data, illness- and treatment-related parameters, as well as with data on the morphological, neurological and psychological status of the participating subjects. At the time of follow-up the EEG was abnormal in 47 cases (42.7%). The most frequent EEG abnormalities observed were disturbances of the background activity (n = 45, 95.8%), followed by hypersynchrone activities (n = 1.0, 21.3%) and interhemispheric differences/focal slowing (n = 6, 12.8%). With exception of age at diagnosis, none of the observed EEG abnormalities showed a correlation with any of the aforementioned illness- or treatment-related parameters. Eighty percent of the observed EEG abnormalities were found in children younger than 5 years at diagnosis. Children less than 2 years of age as well as those above 5 years at onset of disease showed a significantly reduced prevalence of EEG disturbances compared to subjects between 2 and 5 years at diagnosis. Neither the degree of illness nor therapy-specific differences showed any relationship to EEG outcome. There was no specific EEG finding for a specific morphological substrate, neurological or psychological deficiency and vice versa. Overall, there was no beneficial effect of routine EEG testing in children following therapy for ALL. According to our data, the evaluation of conventional EEG recordings of otherwise asymptomatic ALL long-term survivors is not a very helpful measure for predicting the degree of behavioral deficiencies, neurological disturbances, or morphological CNS abnormalities, which may be present or will develop in this special subject group.


Assuntos
Sistema Nervoso Central/fisiologia , Eletroencefalografia , Leucemia-Linfoma Linfoblástico de Células Precursoras/complicações , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Adolescente , Adulto , Sistema Nervoso Central/efeitos dos fármacos , Sistema Nervoso Central/efeitos da radiação , Doenças do Sistema Nervoso Central/etiologia , Criança , Pré-Escolar , Intervalo Livre de Doença , Feminino , Humanos , Lactente , Masculino , Leucemia-Linfoma Linfoblástico de Células Precursoras/psicologia , Estudos Retrospectivos
8.
Eur J Pediatr ; 156(9): 727-33, 1997 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-9296540

RESUMO

UNLABELLED: Monitoring of therapy-related late effects after acute lymphoblastic leukaemia (ALL) therapy in childhood has become an increasingly important field in posttherapeutic patient surveillance. The usefulness of neurophysiological investigations (e.g. EEG, evoked potentials (EP)) as part of these attempts is controversial. The present report focuses on this problem and the question whether and to what extent routinely performed EEG recordings and visual evoked potentials (VEP) were correlated with further measures of CNS integrity. EEGs and VEPs were recorded in 163 asymptomatic long-term survivors of ALL in childhood during a large retrospective multicentre study evaluating CNS late sequelae following antileukaemic therapy. Fifty-two ALL long-term survivors (4.5-10.6 years after end of therapy, median: 8.8 years), who had been treated according to BFM-81 SR-A (n = 30) or SR-B (n = 22) were selected for this analysis focusing on therapy-related CNS late effects. Therapy protocols differed with regard to the mode for CNS prophylaxis: SR-A, cranial irradiation with intrathecal methotrexate; SR-B, intrathecal and iv methotrexate. Neurophysiological findings were correlated with illness- and treatment-related parameters, as well as with data on the morphological, neurological and psychological status of the CNS. At the time of follow-up neurophysiological measures were abnormal in 28/52 cases (53.8%). Neither illness- nor therapy-specific differences in CNS prophylaxis showed any relationship to EEG/VEP outcome any relationship to EEG/VEP outcome in this reduced group of the whole study population. Children with EEG/VEP abnormalities showed a significantly higher incidence of structural CNS disturbances compared to those with inconspicuous neurophysiological recordings (60.9% vs 31.8%). However, in this special subject group there was no specific neurophysiological finding for a specific morphological substrate, neurological or psychological deficiency and vice versa. CONCLUSION: Routinely performed EEG/VEP investigations are not very helpful measures to predict the presence or degree of behavioural deficiencies, neurological disturbances, or morphological CNS abnormalities. Patients who received cranial irradiation or systemic methotrexate applications showed the same incidence of neurophysiological disturbances without evidence for specific neurotoxic correlates.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Córtex Cerebral/efeitos dos fármacos , Eletroencefalografia/efeitos dos fármacos , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Adolescente , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Asparaginase/administração & dosagem , Asparaginase/efeitos adversos , Córtex Cerebral/fisiopatologia , Criança , Pré-Escolar , Daunorrubicina/administração & dosagem , Daunorrubicina/efeitos adversos , Relação Dose-Resposta a Droga , Esquema de Medicação , Potenciais Evocados Visuais/efeitos dos fármacos , Potenciais Evocados Visuais/fisiologia , Feminino , Seguimentos , Humanos , Masculino , Metotrexato/administração & dosagem , Metotrexato/efeitos adversos , Leucemia-Linfoma Linfoblástico de Células Precursoras/fisiopatologia , Prednisona/administração & dosagem , Prednisona/efeitos adversos , Tempo de Reação/efeitos dos fármacos , Tempo de Reação/fisiologia , Vincristina/administração & dosagem , Vincristina/efeitos adversos
9.
Med Pediatr Oncol ; 28(6): 387-400, 1997 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-9143382

RESUMO

The effect of cranial irradiation on possible therapy-induced morphological central nervous system (CNS) side effects of children cured from acute lymphoblastic leukemia (ALL) is controversially discussed. In a retrospective multicenter study, 118 former ALL patients in first continuous remission were investigated using cranial computerised tomography (CCT) or magnetic resonance imaging (MRI) scans to evaluate CNS related impairments. Corresponding to the different kinds of CNS prophylaxis, the patient sample was divided: group A (n = 39) receiving intrathecal methotrexate (ITMTX) and systemical medium-high-dose methotrexate (SMHDMTX), group B (n = 41) cranial irradiated (in mean 16.8 Gy) and administering ITMTX and SMHDMTX, group C (n = 38) irradiated (in mean 17.1 Gy) and getting ITMTX. Pathologic scans showed atrophy, leukoencephalopathy, calcifications or grey matter changes. These findings were compared with the neuropsychological test results. Abnormal MRI or CCI scans were found in 61/118 patients (51.7%). Fifteen belonged to group A (38.5%), 23 to B (56.1%) and 23 to C (60.5%). Patients with definite CNS changes show reduced neuropsychological test results. The prevalence of brain alterations seems to appear twice increased after lengthening the posttherapeutic interval in irradiated patients as in nonirradiated patients. Irradiated patients as an age younger than 2 years at diagnosis may show a lower prevalence for developing CNS alterations. CNS alterations are not sex-related. Children treated with cranial irradiation in combination with SMHDMTX and/or ITMTX were at greater risk of developing morphological brain alterations than patients with chemotherapy alone. These alterations are partly correlated with reduced neuropsychological performances and seem to stay with a longer posttherapeutic interval.


Assuntos
Encéfalo/patologia , Encéfalo/efeitos da radiação , Leucemia-Linfoma Linfoblástico de Células Precursoras/diagnóstico por imagem , Leucemia-Linfoma Linfoblástico de Células Precursoras/radioterapia , Adolescente , Fatores Etários , Áustria , Encéfalo/irrigação sanguínea , Encéfalo/diagnóstico por imagem , Encefalopatias/etiologia , Criança , Pré-Escolar , Doenças Desmielinizantes/etiologia , Alemanha , Humanos , Lactente , Imageamento por Ressonância Magnética , Testes Neuropsicológicos , Leucemia-Linfoma Linfoblástico de Células Precursoras/patologia , Radioterapia/efeitos adversos , Dosagem Radioterapêutica , Estudos Retrospectivos , Tomografia Computadorizada por Raios X , Doenças Vasculares/etiologia
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