RESUMO
BACKGROUND & AIMS: Levosulpiride is a benzamide derivate D(2) dopamine antagonist with prokinetic activity that can accelerate gastric emptying and reduce discomfort in response to gastric distention. The aim of the study is to compare the clinical efficacy of levosulpiride and cisapride in patients with dysmotility-like functional dyspepsia. METHODS: In a exploratory pilot study performed as a multicenter, randomized, double-masked trial, the effects of 8 weeks of treatment with either levosulpiride, 25 mg, 3 times daily (n = 69) or cisapride, 10 mg, 3 times daily (n = 71) were compared. Individual symptoms (pain/discomfort, fullness, bloating, early satiety, and nausea/vomiting), global symptom score, effect on health-related quality of life (HRQoL), and anxiety-state and anxiety-trait were evaluated. Adverse events also were recorded. RESULTS: Both levosulpiride and cisapride improved dyspeptic symptoms and decreased total symptom score (79.9% and 71.3%, respectively); no significant statistical difference between treatments was found (P = 0.07 for total symptom score). HRQoL improved similarly after both treatments, whereas no change was observed in anxiety. Medication-related adverse effects were present in 13 of 69 patients (18.8%) in the levosulpiride group and 8 of 71 patients (11.3%) in the cisapride group. Significantly more (P = 0.03) patients treated with cisapride had to abandon the trial because of side effects. CONCLUSIONS: Levosulpiride is at least as effective as cisapride in the treatment of dysmotility-like functional dyspepsia.
Assuntos
Cisaprida/administração & dosagem , Dispepsia/tratamento farmacológico , Transtornos da Motilidade Esofágica/tratamento farmacológico , Sulpirida/análogos & derivados , Sulpirida/administração & dosagem , Administração Oral , Adolescente , Adulto , Idoso , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Dispepsia/complicações , Dispepsia/diagnóstico , Transtornos da Motilidade Esofágica/complicações , Transtornos da Motilidade Esofágica/diagnóstico , Esofagoscopia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Probabilidade , Valores de Referência , Medição de Risco , Índice de Gravidade de Doença , Estatísticas não Paramétricas , Resultado do TratamentoRESUMO
Hepatitis B virus (HBV) DNA may persist in the liver in the absence of serum HBV-DNA after a self-limited acute hepatitis B. This may also occur in patients with chronic hepatitis C virus (HCV) infection but its prevalence and its impact on liver histology is unknown. HBV-DNA was tested by polymerase chain reaction (PCR) and by in situ hybridisation in liver biopsies from 98 patients with chronic hepatitis C who were hepatitis B surface antigen negative and serum HBV-DNA negative by PCR. HBV-DNA resulted positive in the liver of 37/98 (37.7%) patients without serum HBV-DNA. To test whether these patients had serum HBV-DNA levels under the detection limit of the PCR assay used in this study (50 copies/ml), PCR products in which HBV-DNA was undetectable after visualization of agarose gels were analysed by dot-blot hybridisation. With this method, HBV-DNA was positive in serum of 12/37 patients with liver HBV-DNA. Thus, 25/98 (25.5%) patients have HBV-DNA detectable only in liver. This was confirmed by in situ hybridisation, the percentage of infected hepatocytes ranging from 0.1% to 12%. In patients in whom the HCV infection was shorter than 20 years, HBV infected patients had higher (P = 0.01) fibrosis score (1.64 +/- 1.21) than HBV negative cases (0.53 +/- 0.66). In conclusion, a significant proportion of patients with chronic HCV infection have HBV-DNA in the liver in the absence of viral DNA in serum. The impact of this finding on liver histology deserves further research.
Assuntos
DNA Viral/análise , DNA Viral/sangue , Vírus da Hepatite B/isolamento & purificação , Hepatite B/complicações , Hepatite B/virologia , Hepatite C Crônica/complicações , Fígado/virologia , Adulto , Sequência de Bases , Biópsia , DNA Viral/química , Feminino , Antígenos de Superfície da Hepatite B/sangue , Vírus da Hepatite B/genética , Hepatócitos/virologia , Humanos , Hibridização In Situ , Fígado/patologia , Cirrose Hepática/patologia , Cirrose Hepática/virologia , Masculino , Pessoa de Meia-Idade , Dados de Sequência Molecular , Reação em Cadeia da Polimerase , Estudos Prospectivos , Alinhamento de Sequência , Análise de Sequência de DNARESUMO
BACKGROUND: There are patients in whom the etiology of long-standing abnormal results of liver-function tests is unknown (ALF-EU) after exclusion of all known causes of liver diseases. We analyzed the presence of hepatitis C virus (HCV) RNA in liver-biopsy specimens from 100 patients who were negative for anti-HCV antibodies and for serum HCV RNA and who had ALF-EU. METHODS: HCV RNA status was tested by reverse-transcription polymerase chain reaction (RT-PCR) and by in situ hybridization, in liver and peripheral-blood mononuclear cells (PBMCs). RESULTS: HCV RNA was detected in liver-biopsy specimens from 57 of 100 patients negative for anti-HCV antibodies and for serum HCV RNA (i.e., who had occult HCV infection). HCV RNA of negative polarity was found in the liver of 48 (84.2%) of these 57 patients with occult HCV infection. Nucleotide-sequence analysis confirmed the specificity of detection of HCV RNA and that patients were infected with the HCV 1b genotype. Of these 57 patients with intrahepatic HCV RNA, 40 (70%) had viral RNA in their PBMCs. With regard to liver histology, patients with occult HCV infection were more likely to have necroinflammatory activity (P=.017) and fibrosis (P=.022) than were patients without intrahepatic HCV RNA. CONCLUSIONS: Patients with ALF-EU may have intrahepatic HCV RNA in the absence of anti-HCV antibodies and of serum HCV RNA.