Transition from ziprasidone im to oral formulation in agitated patients with acute exacerbation of schizophrenia: an open trial.

INTRODUCTION: A transition from IM to oral formulation of an antipsychotic agent is often required during the long-term management of schizophrenia. This multicenter trial evaluates the IM/oral sequential administration of ziprasidone in agitated subjects with an exacerbation of schizophrenia. METHODS: Adult patients requiring IM therapy for schizophrenic symptoms were assigned to IM ziprasidone 10 mg for 3 days, followed by oral ziprasidone (initial dose: 80 mg/day) for 8 weeks. The primary efficacy outcomes were the change in the total PANSS and in the CGI-S scores vs. baseline values. RESULTS: In total, 150 patients were included in the study. A decline in the PANSS and CGI-S scores was observed throughout the study (p < 0.0001 vs. baseline): these reductions became significant at the point of transition from IM to oral formulation (p < 0.0001 vs. baseline). DISCUSSION: Even with the limitations of any non-comparative study, these results suggest that the IM/oral sequential administration of ziprasidone is an effective and well tolerated therapeutic option in the management of acute exacerbations of schizophrenia in agitated patients.

Multichannel intraluminal impedance to detect relationship between gastroesophageal reflux and apnoea of prematurity.

BACKGROUND: The association between gastroesophageal reflux and apnoea of prematurity is still controversial. Available data are biased by the heterogeneity of the infants enrolled as regard to some confounding factors and by the use of the traditional pH monitoring that is unable to detect non acid reflux events which might be prevalent in infants receiving frequent milk feeding. Multichannel intraluminal impedance has been recently introduced as a pH-independent method to investigate the bolus transport in hollow organs. OBJECTIVE: To assess if combined multichannel intraluminal impedance-pH study could be useful to detect an association between gastroesophageal reflux and apnoea of prematurity. METHODS: We prospectively evaluated a group of premature infants with apnoea of prematurity in absence of any confounding factors (ventilatory support, treatment with caffeine, permanent nasogastric tube, post-natal age older than 30 days) by simultaneous recording of 24-h multichannel intraluminal impedance-pH and cardiorespiratory monitoring. A temporal relationship between an apnoea and a reflux event was considered if both commenced within 20s of each other. RESULTS: Six premature infants [three male; median gestational age 31 weeks (range 27-36); birth weight 1335g (range 1200-2350); age at study 17 days (range 7-28)] were studied. A total of 405 reflux events [306 (76%) weakly acid and 99 acid reflux] and 142 apnoeas were detected. The frequency of apnoeas occurring during the reflux events period was significantly greater than the one calculated for reflux-free period [0.42/min (0.00-1.28) versus 0.016/min (0.003-0.028); p<0.05]. The sub-analysis based on chemical composition and duration of refluxate showed that the frequency of apnoeas associated with weakly acid reflux events was significantly greater than the one calculated for reflux-free period [0.416/min (0.00-1.30) versus 0.016/min (0.003-0.028), respectively; p<0.05] and that the frequency of apnoeas occurring during reflux events longer than 30s was significantly higher than those occurring during shorter reflux events (22% versus 11%; p<0.004). CONCLUSION: Our data show that weakly acidic reflux events are more prevalent than acid reflux events in premature infants, confirming the need for the use of multichannel intraluminal impedance-pH monitoring for diagnosis of gastroesophageal reflux in those patients. Gastroesophageal reflux and apnoea of prematurity are both common occurrences and, in our experience, may be temporally related especially as regard to weakly acid refluxate and reflux events longer than 30s.

Fourier transform infrared and differential scanning calorimetric studies of a surface-active material from rabbit lung.

A surface-active material with a chemical composition consistent with lung surfactant and with the ability to lower surface tension on a Wilhelmy balance to about 6 mN/m, has been isolated from rabbit pulmonary lavage. The thermotropic properties have been characterized with the techniques of Fourier transform infrared spectroscopy (FT-IR) and Differential Scanning Calorimetry (DSC). FT-IR melting curves were constructed from the temperature-dependence of the lipid CH2 symmetric stretching vibrational frequencies near 2850 cm-1. A broad gel-liquid crystal phase transition with an onset temperature of about 22 degrees C, and a completion temperature of about 38 degrees C was observed, with slight sample-to-sample variations in temperatures. A similar completion temperature was noted in DSC endotherms. Ca2+ (5-10 mM) increased the onset temperature of the lipid-melting event, and induced an ordering of surfactant and of its lipid extract at all temperatures studied. The effect on the lipids was suggestive of a Ca2+-induced phase separation caused by ion binding to phosphatidylglycerol and other acidic components. Evidence for a direct interaction between Ca2+ and the phosphate groups was suggested through small Ca2+-induced shifts in the 1090 cm-1 symmetric PO2 stretching frequency. Removal of most of the protein component from a 10:1 (lipid/protein, w/w) sample caused an ordering of the resultant lipid fractions. In contrast, removal of most of the protein component from a 20:1 sample resulted in no change in lipid order or thermotropic behavior. These observations are discussed in light of the roles played both by Ca2+ and protein in the spreading of surfactant. The power of FT-IR to acquire useful structural information from complex biological tissues is demonstrated.

Gastric electrical activity and gastric emptying in term and preterm newborns.

The aims of this study were to evaluate the gastric electrical activity and gastric emptying in preterm and term newborns and to assess the development of gastric motility by comparing newborns of different gestational ages. The cutaneous electrogastrography and the ultrasonographic study of the gastric emptying were performed before and after milk formula in three groups of infants: 12 preterm newborns with a gestational age of 28-32 weeks, 11 preterm newborns with a gestational age of 32-36 weeks, and 10 full-term newborns with a gestational age of 36-40 weeks. All recording sessions were performed 1 week after infants had reached full enteral feeding. The percentage of normal slow waves was similar in the three groups but it was not predominant compared to tachygastria in the earliest premature infants (59.3% (12.7-92.3) vs. 29.6% (3.7-78.8); P < 0.05). In addition, a progressive increase in the normal slow wave percentage (59.3% (17.4-87.4), 60.9% (38.1-89.7), 77.8% (66.4-84.8); P < 0.05) was observed as gestation advanced. As regards gastric emptying parameters, the antral area was greater and T(1/2) was longer in the preterm newborns of 28-32 weeks than preterm newborns of 32-36 weeks and full-term newborns (fasting antral area: 0.96 cm2 (0.6-1.5), 0.63 cm2 (0.4-1.2), 0.55 cm2 (0.1-0.9) respectively, P < 0.05; T(1/2): 83.4 min (76.0-108.5), 70 min (57.5-89.5) and 71.8 min (54.9-81.2), respectively P < 0.05). The comparisons of gastric emptying curves made among the three groups showed a reduced antral dilatation in preterm newborns of 28-32 weeks compared to full-term newborns at 30 and 60 min after a meal. In conclusion, although enteral feeding is important for the development process of gastrointestinal motility, gastric electrical activity and gastric emptying show an intrinsic maturation depending on the gestational age.

Rapid in vitro tests of surfactant film formation: advantages of the Exerowa black film method.

Based on our research, the natural configuration of surfactant from birth through adulthood takes the form of intraalveolar bubbles. Thus, bubble film analysis would seem to be the specific in vitro testing method for lung surfactant. In the present study we report a battery of five in vitro tests for assessing structural and functional properties of surfactant bubbles and bubble films from hydrophobic extracts, namely, the therapeutic surfactants Survanta (SU) and Infasurf (IN) (full strength and diluted to 3 mg phospholipid/mL) and from aqueous extracts from rabbit lung lavage at 3 mg phospholipid/mL (SAM). Each substrate was assessed by: 1) Shake test: stable bubbles from SU, IN, and SAM (50/50, v/v in 95% ethanol) covered the peripheral surfaces, indicating positive response; bubble production by IN and SAM always exceeded SU; 2) Click test: bubble clicking began immediately in all preparations except for undiluted SU, in which the onset of clicking was delayed more than 40 sec; 3) Pattle's stability test: diameters of SU, IN, and SAM bubbles were unchanged for more than 20 min in aerated solution, indicating stable very low surface tension; 4) bubble generation by gas dispersion from a single capillary: full-strength concentration of SU and IN produced relatively large bubbles-bubble rate (number/min) and size were comparable; all SU bubbles rupture in < 25 min, whereas IN bubbles were stable for > 30 min; and 5) Exerowa black film method: in contrast with each of the preceding methods for studying intact bubbles, the Exerowa method focuses on the contact between bubble films and permits direct observation of film formation and determination of film structure. Stable black films were formed spontaneously by both IN (full strength and diluted) and SAM. Conversely, SU (full strength) formed no black films but stable rheological films. Diluted SU films ruptured in 50% of trials. Since methods 1, 2, and 3 were nondiscriminatory and method 4 produced unphysiologically large bubbles for most mammals, we concluded that the black film method of Exerowa is the most discriminating of the tests studied here. It provides a unique visual record of foam film formation and stability and clearly defines differences relative to both the nature and concentration of the preparations.

Temperature affects mechanics and stability during initial inflation-deflation of mature fetal lung.

Volume-pressure (VP) curves of initial aeration of mature (0.94-0.97 term) rabbit fetuses were compared in three groups, respectively, at 37 degrees C, with maximal inflation pressure of 25 cm H2O (P25); 22 degrees C, P25; and 22 degrees C, P30. Anesthetized fetuses were delivered through uterotomy; chest was opened; trachea of fetal pulmonary liquid (FPL)-filled lungs cannulated; and lungs inflated-deflated in 5 cm H2O, 2 min steps under continuous microscopic observation. As distending pressure was increased, FPL moved peripherally with airways inflation by free gas and with saccular recruitment by free gas and bubbles. Saccular aeration continued during initial reduction of P from Pmax. At end-deflation, air was retained in saccules virtually exclusively as bubbles. Airways inflation required less P at 37 degrees C, though airways volume (V) was the same at both temperatures. Opening P was lower, and saccular aeration was larger and more rapid at 37 degrees C. The apparently higher distensibility at 37 degrees C was most likely due to temperature effects on fluid dynamics rather than on tissue elasticity. Maximal V attained during early P reduction in all groups, was total lung capacity (TLC) at 37 degrees C and less than TLC at 22 degrees C. Air retention at end-deflation, with films of near-zero surface tension, was greatest at 37 degrees C and least at 22 degrees C, P25. Lung stability, greater at 37 degrees C than at 22 degrees C, was best discriminated when V at P0 was taken into account.(ABSTRACT TRUNCATED AT 250 WORDS)

Fluid dynamics during initial aeration of mature fetal lung and effect of temperature.

Air volume-pressure (VP) curves were recorded simultaneously on pairs of mature rabbit fetuses from the same litter with one member of the pair at 37 degrees C and the other at 22 degrees C. Intrasaccular bubbles, formed primarily during inflation, were assessed for stability and surface tension (gamma). Average air flow rates (dV/dt) were calculated from the VP data. In separate experiments, liquid VP curves were recorded at 37 degrees and 22 degrees C: maximal liquid V was matched to maximal air V at 37 degrees and 22 degrees C, respectively. Fetal pulmonary liquid (FPL) viscosity (eta) and density (rho) were determined by standard methods. Both the effect of temperature on lung mechanics as reported previously, and the reliability of the rabbit model were confirmed in the paired fetuses. Analysis of fluid dynamics revealed that of the six parameters relevant to initial inflation-deflation of FPL-filled lungs, liquid rho, distensibility (recoil), and gamma were not altered significantly by temperature increase from 22 degrees to 37 degrees C. Enhanced lung mechanics at 37 degrees C (including enhanced inflation at lower P, higher maximal V, increased production of intrasaccular bubbles, and higher V at end-deflation) was primarily due to lowering of FPL eta at the higher temperature which appears to have an effect by augmenting bulk liquid flow and liquid drainage. Lower eta increases bulk flow through airways directly. Consequent recruitment and distention of these conducting units effectively increases radius (r) and further enhances flow. (The ultimate "brake" to airways flow at both temperatures is counter P from gamma at air/liquid menisci.).(ABSTRACT TRUNCATED AT 250 WORDS)

Intranasal surfactant aerosol therapy for otitis media with effusion.

OBJECTIVE: To determine the effect of surfactant alone and with other medications delivered intranasally as a metered dose inhaler (MDI) aerosol on the resolution of experimentally induced otitis media with effusion (OME). BACKGROUND: Eustachian tube dysfunction is a primary factor in the pathogenesis of OME. Intranasal surfactant via MDI has been shown in this laboratory to reduce passive opening pressure of the eustachian tube in normal gerbils and mice. STUDY DESIGN: OME was developed in 35 gerbils by transtympanic injection of 10 microg lipopolysaccharide from Klebsiella pneumoniae. Pretreatment otomicroscopy and tympanometry were performed to exclude pre-existing middle ear disease, and postinfection evaluations were performed on alternate days for a period of 30 days. Five animals received no treatment (control group); four were treated with propellant only (placebo); seven received surfactant alone; eight received surfactant and betamethasone; and six received surfactant with phenylephrine. All medications were sprayed intranasally as an aerosolized MDI and administered daily from postinfection day 2 onward. RESULTS: OME resolved after 16.0 +/- 0.44 days (mean + SD) in controls. There was no difference seen in the placebo or the surfactant with phenylephrine groups. Treatment with surfactant yielded resolution in 10.57 +/- 0.37 days; this was reduced to 8.57 +/- 0.37 days with surfactant plus betamethasone. These differences are statistically significant. There was no recurrence of OME in any group. CONCLUSION: This study demonstrates that using an aerosolized MDI surfactant with and without betamethasone decreases the duration of OME in this in vivo gerbil model.

Dosage regimens of intranasal aerosolized surfactant on otitis media with effusion in an animal model.

OBJECTIVE: To determine optimal dosage regimens of intranasal metered dose aerosolized surfactant with and without other medications in the treatment of otitis media with effusion (OME). STUDY DESIGN: Resolution of experimental OME in gerbils was determined based on otomicroscopy and tympanometry. Experimental intranasal drugs were: surfactant, surfactant with betamethasone, surfactant with phenylephrine, and a normal saline solution placebo. Medications were administered once or twice daily via a metered dose inhaler. RESULTS: For twice-daily dosing, mean days to OME resolution were 8.5 for the aerosolized surfactant, 6.3 for the surfactant with betamethasone, 18.7 for the surfactant with phenylephrine, and 16 each for control and placebo. Resolution with the once-daily dosage was longer for all conditions. Results were comparable using tympanometry. CONCLUSION: OME resolved faster than the natural course when treated with intranasal surfactant with and without steroids. Twice-daily dosing was statistically superior. SIGNIFICANCE: This study reiterates the effectiveness of OME treatment with an aerosolized synthetic surfactant with and without steroids and establishes a superior twice-daily dosage schedule.

[Merkel cell tumor. A clinical case]. / Il tumore a cellule di Merkel. Caso clinico.

Merkel's tumor cells represent a rare neuroendocrine neoplasia type which belong to an apudomi group but it's different due to the absence of the biogen amine and hormone polypeptide production. The authors report a rare case of Merkel's tumor cells clinically evident with a great neoformation under the left axilla but already represents at the moment of discovery a notable diffusion with repetition as in hepatic and suprarenal gland. Pointing out not only clinic case having arrived at their observance but also it's important to take note of this particular neoplasia and to suspect it in case of doubt interpretation of clinical tumor.

[Blood lead levels during pregnancy in th the newborn period. Study of the population of Bari]. / Livelli ematici di piombo in gravidanza e in età neonatale. Studio della popolazione di Bari.

Blood lead levels during pregnancy and in neonates immediately after birth have been evaluated, showing higher values in mothers compared to neonates (5.81 +/- 3.05 vs 4.87 +/- 3.60 micrograms/100 ml) and a positive correlation between maternal and neonatal levels (r = 0.82). On the basis of the results derived from the population examined, it has been observed that 6% of newborns have blood lead levels higher than 10 micrograms/100 ml a value recently identified by the Centers for Disease Control (CDC, Atlanta, USA) as a limit for toxicity in children. Moreover, neonatal Pb levels were higher than those found in infants from 6 to 12 months (4.87 +/- 3.60 vs 2.24 +/- 0.54 micrograms/100 ml). During the first week of life there is a steady decrease of blood lead levels, together with increasing renal lead excretion. This study was carried out at the "Dipartimento di Biomedicina dell'Età Evolutiva" University of Bari, southern Italy.

Development of melanoma throughout two close pregnancies. Case report.

Primary melanoma is the most malignant and the least frequent of all cutaneous tumors. Its incidence in pregnancy varies from 0.1 to 2.8/1000. Up to today, impact of pregnancy on melanoma's course is still a much debated question in the literature. Some earlier reports suggested a particularly serious prognosis for melanoma associated with pregnancy, while more recent studies show that pregnancy may influence relapses without significantly altering survival. This paper reports the case of a woman affected by melanoma, whose clinical conditions became more and more serious during her second pregnancy and the following puerperal period. The progressive impairment of her clinical condition has suggested a correlation between the two close pregnancies and the unfavourable course of her disease.

[Assessment of the effects of alfuzosin on miction with dynamic echography]. / Valutazione degli effetti dell'alfuzosina sulla minzione mediante ecografia dinamica.

Alfuzosina has a specific antagonist effect on the alfa-1-adrenergic post-junctional receptor posed at urethral laeve musculature, prostatic capsule and vesical trgonum. It's and ideal drug the symptoms of the difficult urinary flow typical of the benign prostatic hypertrophia (IPB) and of some patologies of vesical collum to attenuate. With this work we want to demonstrate the anatomic alterations of vesical collum and prostatic urethra by means of dynamic recording mictional phase with transrectal scan carried out before and after treatment. In this study, 30 patients were divided into three groups of 10 in relation to the pathology: overtone of vesical collum, little benign prostatic ipertrophia and great benign prostatic ipertrophia have included. The patients of each group have also been divided in undergroups of five (selected with the method of double-blind) of which the first treated with alfuzosina 7.5 mg/die for 30 days and the second with placebo. Considering the limits of this study, the analysis of the results have permitted to conclude that the drug has determined a subjective improvement in all patients except those with great IPB, while the objective valuation, reached comparing scan dynamic pictures before and after treatment, has made it possible to visualize an improvement on the opening of the vesical collum and the prostatic urethra after therapy with great variations of the size of che mictional funnel and same prostatic urethra. The alfuzosina is efficacious, in the cases under examination, except the third group were the compression on the urethra was of an elevated degree.

[Our experience with the orthotopic continent colonic neobladder]. / La nostra esperienza sulla neovescica colica ortotopica continente.

In the last years particular surgery operations became refined for the techniques and therapeutics progresses also developed in this field. This has allowed with major security to accomplish engagemently reconstruction operations after removal of the bladder, especially for cases of neoplastic pathology, to offer the patients a more normal quality of life avoiding urinary derivations that should change the performance of "EGO". After the operations of radical cystoprostatovesciculectomy different methods have been presented for the construction of heterotopical and orthotopical neobladder; among these the continent colic orthotopical neovesica of Goldwassern which uses the detubulization right colon, in our opinion could offer best functional and clinic results in virtue of easier execution and to use of minor number of intestinal segments. Moreover, for the peculiar characteristics of colic segment, allow to make a wide tank at low pression with perfect diurnal and nocturnal continence. We have, therefore, presenting the results of our experience regarding 12 cases of continent colic orthotopical neovesica, by Goldwasser, with a follow-up of 1-6 years which have comforted us with the results predicted. Although other techniques may offer similar results we believe that the Goldwasser method is still valid for all the above reasons.

[Fetal hydrops caused by cardiac failure in utero: description of 2 cases and pathogenetic considerations]. / Idrope fetale da scompenso cardiaco in utero: descrizione di due casi e considerazioni pathogenetiche.

Two cases of congestive heart failure in utero with fetal hydrops are reported. The diagnosis was made during pregnancy by means of echography. Cardiac failure, derived from supraventricular tachycardia not associated with structural anomalies of the heart, was observed in one of the patients. By digoxin administration and vagal stimulation the rhythm reverted to sinus, one hour after birth. In the second case fetal echography showed a fetus with serious bradycardia (45/min.) and ascites. On the bases of a median located and symmetric liver and of a complex heart malformation a diagnosis of "isomeric syndrome" was supposed. One hour after vaginal delivery, the newborn dead and autopsy confirmed a left isomeric syndrome with polisplenia and complex congenital cardiopathy (left ventricle and mitral hypoplasy, double outlet right ventricle, pulmonary stenosis, anomalous systemic and pulmonary venous return).

[Atopic manifestations, growth and nutritional data in newborns at high risk for allergy fed serum protein hydrolysate: 2-year follow-up]. / Manifestazioni atopiche, accrescimento e dati nutrizionali in neonati ad alto rischio per atopia allattati con idrolisato di sieroproteine: due anni di follow-up.

Authors have studied, in high risk for atopy newborns, with a follow-up of two years, the effect of feeding whey hydrolysate, evaluating the incidence of atopic manifestations, the growth pattern and different biochemical nutritional parameters, comparing the results to those observed in breast fed newborns. No significative differences have been shown suggesting that whey protein hydrolysate could be a good alternative to breast milk, when this is not available.

Delayed closure of ductus arteriosus in term newborns with congenital hypothyroidism: effect of L-thyroxine therapy.

Congenital hypothyroidism is associated with increased incidence of congenital defects (15.6%), frequently involving the heart (5.8%). Only few studies have evaluated the association between congenital hypothyroidism and patent ductus arteriosus. We report on two term newborns affected by thyroid agenesis and patent ductus arteriosus that closed after starting L-thyroxine substitutive therapy. This association suggests a close relation between hypothyroidism and patent ductus arteriosus. Hypothyroidism should be considered in term infants with patent ductus arteriosus because thyroid hormone production is among the prerequisites for postnatal ductal closure.

Early low-dose hydrocortisone in very preterm infants: a randomized, placebo-controlled trial.

BACKGROUND: Several reports indicate a decreased cortisol response to adrenocorticotropic hormone in preterm infants developing chronic lung disease and in preterm infants with refractory hypotension. Low-dose hydrocortisone (HC) may allow for beneficial effects. OBJECTIVE: Our aim was to assess whether HC is able to increase survival without chronic lung disease. METHODS: We performed a double-blind, randomized, placebo-controlled trial. Fifty mechanically ventilated infants (birth weight: 500-1,249 g) were randomized to receive treatment (HC 0.5 mg/kg/12 h for 9 days, then HC 0.5 mg/kg/24 h for 3 days) or placebo. Major outcome was survival without oxygen dependence at 36 weeks of postconceptional age (O(2)-free survival). RESULTS: The basic characteristics were similar between the two groups. O(2)-free survival was higher in the HC group (64 vs. 32%). The advantage was particularly evident among infants without antenatal steroids. The mortality rate was 16% in the HC group versus 40% in the control group (difference not significant). Hypotension after recruitment was reduced by HC (0 vs. 30%). The incidence of gastrointestinal perforation and other adverse effects was similar between the two groups. CONCLUSIONS: HC prophylaxis improved O(2)-free survival and early cardiocirculatory function in our population, without important short-term effects. The neurodevelopmental outcome will be assessed at 2 years.