Effects of conjugated equine estrogens or raloxifene on lipid profile, coagulation and fibrinolysis factors in postmenopausal women.

OBJECTIVES: To compare the effect of conjugated equine estrogens (CEE) and raloxifene on lipid profile and hemostasis. MATERIALS AND METHODS: A double-blind, randomized and parallel study was performed with 90 healthy postmenopausal women, aged 54 +/- 5 years, divided into three groups and submitted to daily therapy with either CEE 0.625 mg, raloxifene 60 mg or placebo for 4 months. The lipid profile, coagulation and fibrinolytic factors were analyzed. RESULTS: CEE increased the levels of high density lipoprotein cholesterol (HDL-C) from 49.0 to 56.8 mg/dl (p < 0.001), very low density lipoprotein cholesterol (VLDL-C) from 17.2 to 22.3 mg/dl (p < 0.001), and triglycerides from 86.0 to 111.7 mg/dl (p < 0.001), and decreased the levels of low density lipoprotein cholesterol (LDL-C) from 121.0 to 106.5 mg/dl (p < 0.001). The only significant effect of raloxifene was an increase in the levels of HDL-C from 46.0 to 47.8 mg/dl (p = 0.019). There was no significant reduction in LDL-C, from 115.5 to 110.2 mg/dl (p = 0.06), VLDL-C, from 21.7 to 20.0 mg/dl (p = 0.201), and triglycerides, from 108 to 100 mg/dl (p = 0.201). CEE decreased the levels of fibrinogen, from 370.5 to 326.8 g/l (p = 0.039) and the levels of antithrombin III, from 99.5 to 93.2% (p < 0.001). Raloxifene decreased the levels of fibrinogen, from 354.7 to 302.0 g/l (p = 0.009) and the levels of antithrombin III, from 102.4 to 98.5% (p = 0.039). CEE increased levels of protein C from 103.7 to 115.3 mg/l (p < 0.001) and raloxifene did not change the levels of protein C (107.9 to 105.1 mg/l; p = 0.158). CEE decreased the antigen levels of tissue plasminogen activator (t-PA) from 8.8 to 6.8 U/ml (p < 0.001), and of plasminogen activator inhibitor (PAI-1) from 30.8 to 21.6 U/ml (p < 0.010), whereas raloxifene had no significant effect on either t-PA, from 9.6 to 9.2 U/ml (p = 0.235) or PAI-1 antigen levels, from 32.1 to 30.4 U/ml (p = 0.538). CONCLUSION Both CEE and raloxifene exert significant effects on the lipid and coagulation profile. CEE had a more significant effect on fibrinolysis than raloxifene. These effects may have a significant impact on the cardiovascular risk that needs to be confirmed in larger studies.     

Effects of androgen treatment in impotent men with normal and low levels of free testosterone

The relation between sexual function and serum free testosterone (fT) levels, which represent the active fraction of circulating testosterone, was evaluated. Two groups of impotent male subjects with mild hypogonadism were treated with oral testosterone undecanoate (TU); these men presented with tT/luteinizing hormone (LH) ratio and tT levels at the lower limits of normal. The first group had serum fT below 6.6 ng/ml, considered the lower normal value, according to our laboratory method, whereas the second group had normal fT limits. Administration of TU improved sexual function only in impotent men with low fT levels, but not in subjects with normal fT levels, even though the tT levels and the tT/LH ratio of the two groups were not significantly different. The results of our study suggest the presence of a minimun serum fT threshold, lying near the lower normal range, which determines the male sexual function. Moreover, serum fT levels were a more sensitive index than tT for identifying impotent men who can be successfully treated with androgens.     

Homocysteine-Lowering Therapy and Early Progression of Transplant Vasculopathy: A Prospective, Randomized, IVUS-Based Study

Although observational studies suggest that hyperhomocysteinemia may be a risk factor for coronary allograft vasculopathy (CAV), prospective data on homocysteine-lowering interventions and CAV development are lacking. We, therefore, randomized 44 de novo heart transplant (HT) recipients to 15 mg/day of 5-methyl-tetrahydrofolate (n=22), or standard therapy (control group, n=22) to investigate the effect of homocysteine lowering on the change in coronary intimal hyperplasia during the first 12 months after transplant, as detected by intra-vascular ultrasound (IVUS). Although 12 months after HT, homocysteinemia was lower in folate-treated patients (p<0.001), coronary intimal area increased similarly in the two groups (p>0.4). Conversely, hypercholesterolemia and cytomegalovirus infection were both associated with increased intimal hyperplasia (p<0.04), independently from folate intake. Sub-group analysis revealed that folate therapy reduced intimal hyperplasia in patients with hyperhomocysteinemia before randomization (n=19; p=0.02), but increased intimal hyperplasia in patients with normal homocysteine plasma concentrations (p=0.02). This bimodal effect of folate therapy persisted significantly after adjusting for cytomegalovirus infection and hypercholesterolemia. Despite effective in prevent hyperhomocysteinemia after heart transplantation, folate therapy does not seem to affect early CAV onset. However, sub-group analysis suggests that folate therapy may delay CAV development only in patients with baseline hyperhomocysteinemia, while may favor CAV progression in recipients with normal baseline homocysteinemia.     

Proximal gastric vagotomy. A comparative study between the standard technique and the extended technique associated with denervation of the greater curvature

Forty-six patients in the postoperative period of proximal gastric vagotomy (PGV) for duodenal ulcer (DU) were studied comparatively to verify whether the dividing of the gastroepiploic nerves (Rosati's maneuver) can reduce or not the occurrence of recurrent ulcer as it was proposed. Twenty-one patients who underwent PGV associated with Rosati's maneuver (PGV-R) were compared to 25 after standard PGV (PGV-S), according to several criteria: (1) clinical evaluation; (2) pre and postoperative basal and pentagastrin-stimulated gastric acidity; (3) postoperative basal and pentagastrin-stimulated serum pepsinogen; (4) postoperative basal and sham feeding-stimulated serum gastrin; (5) postoperative endoscopy; (6) endoscopic Congo red test. Both groups were similar (P greater than 0.05) as to age, sex, levels of preoperative gastric acidity and had a 24.4 month average follow-up (12 to 58 months). There has been no significant difference between the techniques studied as to clinical, secretory, morphological or hormonal gastric tests, although PGV-R proved more effective in reducing basal gastric acidity than PGV-S (P less than 0.05). We concluded that Rosati's maneuver does not improve the results obtained with PGV, although it provided greater reduction of basal gastric acidity than PGV-S.     

Ultrasound in tropical pyomyositis

Tropical pyomyositis is an infection of muscles mainly presenting in black people, occurring in the trunk and limbs. At Hoima Hospital, Uganda, 58 patients (30 men and 28 women) with a mean age of 21 years have been investigated by ultrasound; a total of 81 lesions were present. Two different characteristic images were found; abscess was present in 65 cases while 16 patients showed a diffuse infiltration among the muscular fibers. These two different images correspond to the two stages of histologic and clinical progression described by other authors. Ultrasound is useful to demonstrate the progression of pyomyositis and to determine when and where to drain any abscess.     

LEMMA: A Language for Easy Medical Models Analysis

The quality of health care systems and processes is becoming a prominent problem and more and more efforts are devoted to define methodologies and tools to measure and assure quality of care. New methods are required to optimize health care processes to guarantee high quality standards within (limited) available resources. Resource optimizations able to preserve the quality of treatments require good models of medical processes. This paper presents LEMMA, a new notation to model medical processes. LEMMA provides physicians with intuitive graphical elements to design their models. At the same time a high level timed Petri net corresponding to the designed model is built automatically. In this way, LEMMA models are ascribed formal semantics and can be executed and analyzed automatically. The dual language approach followed in this paper allows physicians to gain all the benefits of formal methods without being proficient in them. Medical users manage simple graphical elements, while Petri nets ensure formality and validation capabilities. In this way LEMMA mixes formal and informal notations, overcoming the problems of both the approaches. The definition of the notation has been supported by the development of an environment to design LEMMA models. The environment, besides letting us experiment with the notation, has been employed to define and analyze real case studies.     

Primary gastric non-Hodgkin's lymphoma in a population-based registry.

BACKGROUND. The incidence of primary gastric non-Hodgkin's lymphoma (NHL) appears to have increased worldwide in recent years, and this seems to be confirmed by large-sample population studies. METHODS AND RESULTS. We derived our data from the Lombardy Cancer Registry, which provides the incidence of cancer in the province of Varese, Northern Italy. From 1978 to 1987 we identified 3261 cases of gastric neoplasms, 119 of which were gastric NHL: 32 (1.87%) from 1978 to 1982, and 87 (5.32%) from 1983 to 1987. The difference in the age and sex standardized incidence trend between these two time periods was statistically significant (p < 0.001). The overall survival rate of the 112 evaluable patients was 54% at 5 years and 45% at 10 years. A multivariate analysis was performed. Age (p < 0.0005), clinical stage (p < 0.04) and therapy (p < 0.0005) were found to be significant prognostic factors for survival. CONCLUSIONS. This study stresses the utility of prospective randomized clinical trials that could indicate the optimal management of patients with primary gastric lymphoma.     

Users' awareness of factors associated with complications during pill use

This study compared the frequency of factors and diseases that contribute to the risks of oral contraceptive use among current users and non-users of oral contraception in order to evaluate the users' awareness of factors associated with complications during oral contraceptive use. Data from 5317 current users and 8863 non-users in the state of São Paulo, Brazil, were collected using questionnaires requesting information on the following variables: use of oral contraceptives, age, weight, smoking status, and the presence or history of hypertension, diabetes, cardiopathies, painful varicose veins, and epilepsy. Half of the users had some risk factors, and 17.4% were at high risk of complications from oral contraceptive use. Risk factors and diseases which appeared to be poorly known by the population as increasing the risk of oral contraceptive use were smoking, hypertension and painful varicose veins. Only a small percentage of the population appeared to know that these diseases and factors could increase the risk of health problems during oral contraceptive use. The results suggest a lack of information among users and providers on factors which are associated with an increased risk of health problems during use of oral contraceptives.

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Resumen Este estudio comparó la frecuencia de factores y enfermedades que contribuyen al riesgo de los anticonceptivos orales (AO) entre usuarias y no usuarias corrientes de anticonceptivos orales a fin de evaluar el grado de conocimiento entre las usuarias de los factores asociados con complicaciones durante el uso de AO. Se recopilaron datos de 5317 usuarias y 8863 no usuarias corrientes del Estado de S@o Paulo, Brasil, utilizando cuestionarios en los que se solicitabe información acerca de las siguientes variables: uso de AO, edad, peso, fumadora/no fumadora y la presencia o historia de hipertensión, diabetes, cardiopatías, várices dolorosas y epilepsia. La mitad de las usuarias tenían algunos factores de riesgo y el 17,4% de ellas corrían un alto riesgo de complicaciones por el uso de anticonceptivos orales. Los factores de riesgo y enfermedades que parecían ser poco conocidos por la población como tendientes a aumentar el riesgo del uso de anticonceptivos orales eran el fumar, la hipertensión y las várices dolorosas. Sólo un pequeño porcentaje de la población parecía saber que estas enfermedades y factores podían aumentar el riesgo de problemas de salud durante el uso de anticonceptivos orales. Los resultados sugieren una falta de información de las usuarias y proveedores con respecto a factores que están asociados con un riesgo mayor de problemas de salud durante el uso de anticonceptivos orales.

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Resumé Pour évaluer dans quelle mesure les utilisatrices et non utilisatrices de contraceptifs oraux sont sensibilisées aux facteurs associés à des complications, cette étude a comparé la fréquence des facteurs et des maladies qui contribuent au risque que présente l'utilisation de ces contraceptifs. Dans l'Etat de Sao Paulo (Brésil), des données ont été recueillies auprès de 5317 utilisatrices et 8863 non utilisatrices, au moyen de questionnaires demandant des renseignements concernant les variables suivantes: utilisation de contraceptifs oraux, âge, poids, tabagisme, présence ou antécédents d'hypertension, diabète, cardiopathies, varices douloureuses et épilepsie. La moitié des utilisatrices présentaient certains facteurs de risque et 17,4% des facteurs de risque élevé de complications résultant de l'utilisation de contraceptifs oraux. Les facteurs de risque et les maladies dont la population semblait mal connaître l'effet d'augmentation des risques qu'entrîne l'ingestion de contraceptifs oraux étaient le tabagisme, l'hypertension et les varices douloureuses. Un faible pourcentage seulement de la population paraissait savoir que ces maladies et facteurs pouvaient accroître les risques de problèmes de santé durant l'utilisation des contraceptifs oraux. Les résultats suggèrent que les utilisatrices et les pourvoyeurs des services de contraception ne sont pas suffisamment informés des facteurs associés à un risque accru de problèmes de santé durant l'utilisation des contraceptifs oraux.