ABSTRACT
INTRODUCTION: Some experimental, Phase II clinical trials and the preliminary reports of the Cuban Phase III clinical trial indicate that alpha-IFN (IFN) may be useful in relapsing remitting (RR) multiple sclerosis (MS). The reports in Cuba showed that 70% of the MS patients have cognitive dysfunction. OBJECTIVE: To assess the efficacy of IFN-alpha2b recombinant in the cognitive dysfunction of RR MS. PATIENTS AND METHODS: 57 RR-MS clinical definite patients from the randomised, double blind, placebo controlled study of 225 patients with RR-MS and brain MRI confirmed. Patients were randomly assigned to receive intramuscular IFN-alpha2b (Heberon R) 10 million IU (high dose), 3 million IU (low dose) or placebo twice week for 2 years. Outcome results were blinding evaluated considering changes in the following tests: Luria, WAIS, Benton and PASAT-3. Adverse events and side effects were not evaluated to maintain physician blinding. RESULTS: The initial comparison of the groups did not show any differences among the placebo (n=20), low dose (n=18) and high dose (n=19) considering age (p=0.234), gender, ethnic group (p=0.012), years ill (p=0.787), EDSS (p=0.203) and rate of relapses (p=0.432). The Luria's Test showed an improved in the low dose group from 2.50 +/- 1.34 to 1.39 +/- 1.85 (p=0.029) and in the high dose group from 3.22 +/- 1.89 to 2.17 +/- 1.50 (p=0.006) vs placebo 2.85 +/- 1.66 to 2.90 +/- 1.97 (p=0.723). The results of the Benton's test demonstrated that the low dose group had an improved from 5.50 +/- 1.10 to 6.22 +/- 1.31 (p=0.047), in the high dose group from 4.87 +/- 1.85 to 5.78 +/- 1.35 (p=0.005) where as in the placebo group worse from 5.15 +/- 1.76 to 5.05 +/- 2.11 (p=0.893). The WAIS test showed the same results, the low dose group increased from 5.17 +/- 1.34 to 6.06 +/- 1.21 (p=0.022), the high dose group from 4.56 +/- 1.38 to 5.39 +/- 1.29 (p=0.007) and the placebo group worse from 5.25 +/- 1.25 to 5.05 +/- 1.57 (p=0.354). Finally, the PASAT-3 test increased in the IFNs groups: from 45.72 +/- 10.61 to 49.94 +/- 11.68 (p=0.015) in the low dose group, from 42.67 +/- 11.04 to 48.72 +/- 8.84 (p=0.03) in the high dose group, but in the placebo group worse from 44.55 +/- 10.86 to 41.95 +/- 13.74 (p=0.655). CONCLUSION: IFN-alpha improved the cognitive dysfunction in RR-MS patients. The higher dose is more beneficial.
Subject(s)
Cognition Disorders/drug therapy , Interferon-alpha/therapeutic use , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/physiopathology , Adult , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Cognition Disorders/diagnosis , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Interferon alpha-2 , Male , Multiple Sclerosis, Relapsing-Remitting/diagnosis , Neuropsychological Tests , Placebos , Recombinant Proteins , Treatment OutcomeABSTRACT
INTRODUCTION: Several reports of new cases of CNS demyelination or reactivation of MS after hepatitis B vaccination have raised the possibility of a causal relationship. Conversely, some authors have concluded that the risk of developing a demyelinating CNS event after a hepatitis B vaccination is unknown. PATIENTS AND METHODS: We have observed a 40 year old man, with diabetes mellitus (DM) type 1 and a previous history of recurrent acute demyelinating encephalomyelitis (rADEM). The patient had experienced three episodes of neurological dysfunction and he fulfilled the criteria for definite clinical MS but MRI showed demyelinating lesions in the pons and cerebellum without MRI criteria of MS. CSF analysis showed oligoclonal banding. The patient had been clinically stable during the last 6 years. Yearly MRI during this period had not shown any new disease activity. He was admitted in our MS Clinic due to dizziness, nausea, vomiting and diplopia, 6 weeks after the first of the two injections for hepatitis B vaccine after participating in the national programme of vaccination in DM type 1 patients. Clinical examination showed intranuclear ophtalmoplegia, visual loss in the left eye and worsening of the previous cerebellar and pyramidal signs. MRI showed an increase in the old lesions with high intensity signals on T2 weighted sequences with post gadolinium enhancement on T1 weighted sequences located in the brainstem and mesencephalon. The patient s diabetes mellitus deteriorated with ketoacidosis that needed increased doses of insulin. His condition worsened and he developed partial motor seizures. He improved 15 days later but he still had involvement of the cerebellar and pyramidal systems and occasional dizziness. CONCLUSIONS: As pointed out by some authors and in view of this observation, it would seem reasonable, as a precautionary measure, to avoid hepatitis B vaccination in patients with a personal or family history of symptoms suggestive of a demyelinating disease of the CNS.
Subject(s)
Brain/pathology , Encephalomyelitis, Acute Disseminated/diagnosis , Encephalomyelitis, Acute Disseminated/etiology , Hepatitis B Vaccines/adverse effects , Adult , Anti-Inflammatory Agents/therapeutic use , Azathioprine/therapeutic use , Diagnosis, Differential , Encephalomyelitis, Acute Disseminated/drug therapy , Hepatitis B/prevention & control , Humans , Immunosuppressive Agents/therapeutic use , Magnetic Resonance Imaging , Male , Multiple Sclerosis/diagnosis , Prednisone/therapeutic use , Recurrence , Vaccination/adverse effectsABSTRACT
En una investigación realizada en el bioterio de la Facultad de Ciencias Médicas de Cienfuegos en el período comprendido entre los meses de enero a mayo de 1997, se pudo demostrar el efecto que tiene la Caesalpinia lam en la Hiperplasia Benigna de Próstata inducida por enantato de testosterona (100 mg) en animales de experimentación, el árbol fue colectado en lazona de La Sierrita del municipio de Cumanayagua de esta provincia y certificada por especialistas del jardín botánico, posteriormente, se dividió la muestra de trabajo en cuatro grupos con ocho ratas cada uno de la línea sprague dowley categoría convencional,formándose dos grupos controles y dos para la aplicación del tratamiento a diferentes concentraciones; a partir de la investigación se obtuvieron datos obre el peso corporal del animal y los niveles de fosfatasa ácida antes y al finuir este. Los datos fueron procesados mediante computación y se comprobó que esta planta disminuye los valores de fosfatasa ácida en la hiperplasia benigna de próstata de impuesto el tratamiento médico y que tiene un efecto importante en la disminución del tamaño de la próstata y el índice prostático
