Clival SubduralHematoma after Drainage of Concomitant Intracranial and Spinal Cord Subdural Hematomas ­ Rare Case Report

Concomitant traumatic spinal cord and intracranial subdural hematomas associated with a retroclival hematoma are very uncommon. Their pathophysiology is not totally elucidated, but one hypothesis is the migration of the hematoma from the head to the spine. In the present case report, the authors describe the case of a 51-year-old man presenting with headache, nauseas and back pain after a head trauma who presented with intracranial and spinal cord subdural hematomas. Drainage was performed but, 1 week later, a retroclival subdural hematoma was diagnosed. The present paper discusses the pathophysiology, the clinical presentation, as well as the complications of concomitant traumatic spinal cord and intracranial subdural hematomas associated with a retroclival hematoma, and reviews this condition.

Decompressive Craniectomy for Viral Encephalitis: Two Case Reports

A decompressive craniectomy is a therapeuticmodality not commonly used in cases of refractory intracranial hypertension due to viral encephalitis. In this article the authors present two cases of patients with viral encephalitis that have undergone decompressive craniectomy to control intracranial pressure. Both evolved with Glasgow outcome score of 4. The main clinical data for the surgical decision are Glasgow coma scale and the pupils of the patient associated with the imaging tests showing a large necrotic area and perilesional edema. The evolution of the patients undergoing decompression was satisfactory in 92.3% of cases.

Azelastine and budesonide (nasal sprays): Effect of combination therapy monitored by acoustic rhinometry and clinical symptom score in the treatment of allergic rhinitis.

The aim of this study was to objectively evaluate the effects of intranasal therapy with azelastine (AZE), budesonide (BUD), and combined AZE plus BUD (AZE/BUD) using a nasal provocation test (NPT) and acoustic rhinometry in patients with allergic rhinitis. A randomized, single-blind, crossover study with three treatment sequences was used. Thirty patients with persistent AR received the three treatments using a nasal spray twice daily for 30 days and were evaluated by an NPT with histamine before and after each period of treatment. The treatment comparison, assessed by the nasal responsiveness to histamine, was monitored based on subjective (symptom score) and objective parameters (acoustic rhinometry). The minimal cross-area 2 (MCA2) was measured by acoustic rhinometry at 1, 4, 8, and 12 minutes after NPT for each histamine concentration administered (0.5, 1, 2, 4, and 6 mg/mL) up to at least a 20% reduction in the MCA2 from baseline (NPT20). The subjects were scored regarding nasal response encompassing histamine dose and time after histamine administration that caused nasal obstruction (NPT20 score) to assess the treatments' effects. Combination therapy produced a significant increase in baseline MCA2, viz., the improvement of nasal patency (p = 0.005). The symptoms score was significantly decreased after treatment with AZE (p = 0.03), BUD (p < 0.0001), and AZE/BUD (p < 0.0001), compared with pretreatment. The NPT20 score was significantly higher (p = 0.0009) after AZE/BUD, compared with AZE and BUD on their own. Thus, AZE therapy combined with BUD might provide more therapeutic benefits than the isolated drugs for improving nasal patency.

Contralateral extradural hematoma following decompressive craniectomy for acute subdural hematoma (the value of intracranial pressure monitoring): a case report.

INTRODUCTION: Decompressive surgery for acute subdural hematoma leading to contralateral extradural hematoma is an uncommon event with only few cases previously reported in the English medical literature. CASE PRESENTATION: The present study describes the case of a 39-year-old White Brazilian man who had a motorcycle accident; he underwent decompressive craniectomy for the treatment of acute subdural hematoma and evolved contralateral extradural hematoma following surgery. CONCLUSION: The present case highlights the importance of close monitoring of the intracranial pressure of severe traumatic brain injury, even after decompressive procedures, because of the possible development of contralateral extradural hematoma.

Automated determination of venlafaxine in human plasma by on-line SPE-LC-MS/MS. Application to a bioequivalence study.

A new automated SPE-LC-ESI-MS/MS method was developed and validated to quantify venlafaxine in human plasma using fluoxetine as an internal standard. The analytes were automatically extracted from plasma by C18 SPE cartridges, separated on a C8 RP column and analyzed by MS in the multiple reaction-monitoring (MRM) mode. The method has a chromatographic run time of 4.0 min and a linear calibration curve over the range of 0.25-200 ng/mL (r >0.997). The between-run precisions, based on the percent RSD for replicate quality controls (0.75; 80, and 200 ng/mL), were < 8.5% for all concentrations. The between-run accuracies, based on the percent relative error, were < 4.0%. This method was successfully employed in a bioequivalence study of two venlafaxine capsule formulations (test formulation from Eurofarma (Brazil) and Efexor XR, reference formulation, from Wyeth-Whitehall, Brazil) in 48 healthy volunteers of both sexes who received a single 150 mg dose of each formulation. More than 3000 samples were analyzed eliminating the analyst's exposure to hazardous organic solvents normally employed in off-line liquid-liquid extractions. The 90% confidence interval (CI) of the individual ratio geometric mean for Test/Reference was 91.6-103.4% for AUC(0-48 h) and 102.2-112.6% for C(max). Since both 90% CI for AUC(0-48 h) and C(max) were included in the 80-125% interval proposed by the US Food and Drug Administration (FDA) and the Brazilian National Health Surveillance Agency (ANVISA), the test formulation was considered bioequivalent to Efexor XR according to both the rate and extent of absorption.

Standardizing selection criteria in nasal medication studies.

UNLABELLED: Clinical studies on nasal topical medications require the standardization of 'nasosinusal normality' in order to establish control groups through a specific evaluation of the upper airways. AIM: to standardize the evaluation of candidates for control groups in clinical studies on nasal topical medications. MATERIAL AND METHODS: healthy male volunteers of 18 to 50 years of age, asymptomatic from the nasosinusal standpoint were subjected to a sequential and excluding assessment made up of clinical evaluation, immediate hypersensitivity skin test, saccharin test, flexible nasofibroscopy and nasal cytology. STUDY DESIGN: Cross-sectional contemporary cohort. RESULTS: Of the 33 people originally enrolled, 14 (42.4%) were excluded for clinical reasons. Of the 19 remaining, 2 (10.5%) had atopy diagnosed in the skin test and were excluded. 17 were tested with saccharin and presented normal mucociliary clearance. Evaluation by nasal endoscopy showed abnormality in 2 cases (11.8%) and these were excluded. The remaining 15 were submitted to nasal cytology, which proved normal, representing 45.5% of those initially included. CONCLUSION: The proposed protocol for sequential and excluding evaluation was effective in defining candidates for the establishment of control groups in clinical studies on nasal topical medications.

Bioequivalence of two enteric coated formulations of pantoprazole in healthy volunteers under fasting and fed conditions.

PURPOSE: To compare the bioavailability of two pantoprazole (CAS 102625-70-7) formulations (40 mg pantoprazole enteric coated tablets) under fasted and fed conditions as well as to evaluate the dissolution profile in biorelevant media. METHODS: The subjects received either 40 mg of the reference or of test formulation in fasting (n = 28) and fed (n=70) condition. The studies were conducted according to a single dose and randomized crossover design. Blood samples were collected up to 12 h after drug administration in fasting condition and up to 48 h in fed condition. Plasma concentrations of pantoprazole were determined by LC-MS/MS. Pharmacokinetic parameters were calculated from the observed plasma concentration-time profiles. Bioequivalence between the formulations in fasting and fed condition was assessed considering 90% confidence intervals for the ratio of means for lnCmax and lnAUC(0-t) within 0.8-1.25. Dissolution profiles were evaluated in biorelevant media [Fasting State Simulating Intestinal Fluid (FaSSIF) and Fed State Simulating Intestinal Fluid (FeSSIF)]. The sameness of the dissolution curves was assessed by f2 values between 50 and 100. RESULTS: Under fasting condition the 90% confidence interval for the ratio of means for the lnCmax, (0.94-1.03) and lnAUC(0-t) (0.89-0.99) was within the guideline range of bioequivalence (0.80-1.25). However, the data for lnCmax (0.51-0.76) and lnAUC(0-t) (0.68-0.90) under fed condition were not within the bioequivalence range. The postprandial study demonstrated a high intra-subject variability and in some subjects pantoprazole could not be detected for up to 24 h, although the dissolution profile of reference and test formulations presented a similar disposition in FaSSIF and FeSSIF as confirmed by the values of f2 higher than 50. CONCLUSION: The results demonstrated that the test formulation was bioequivalent to the reference in fasting condition but not in postprandial state. The dissolution profile in FaSSIF indicates that this biorelevant medium was more adequate to discriminate the in vivo disposition of pantoprazole than FeSSIF. Furthermore, the fed condition study had shown a pronounced influence of food in the absorption of pantoprazole after single oral dose administration.

Clinical toxicology study of an herbal medicinal extract of Paullinia cupana, Trichilia catigua, Ptychopetalum olacoides and Zingiber officinale (Catuama) in healthy volunteers.

In Brazil, a herbal medicinal extract named Catuama containing a mixture of Paullinia cupana (guarana; Sapindaceae), Trichilia catigua (catuaba; Meliaceae), Ptychopetalum olacoides (muirapuama; Olacaceae) and Zingiber officinale (ginger; Zingiberaceae) is used as a body stimulant, energetic, tonic and aphrodisiac. The present study investigated the chronic administration of 25 mL Catuama twice a day during 28 days for any toxic effect on healthy human volunteers of both sexes. No severe adverse reactions or haematological and biochemical changes were reported.

Lansoprazole quantification in human plasma by liquid chromatography-electrospray tandem mass spectrometry.

An analytical method based on liquid chromatography with positive ion electrospray ionization (ESI) coupled to tandem mass spectrometry detection was developed for the determination of lansoprazole in human plasma using omeprazole as the internal standard. The analyte and internal standard were extracted from the plasma samples by liquid-liquid extraction using diethyl-ether-dichloromethane (70:30; v/v) and chromatographed on a C(18) analytical column. The mobile phase consisted of acetonitrile-water (90:10; v/v)+10 mM formic acid. The method has a chromatographic total run time of 5 min and was linear within the range 2.5-2000 ng/ml. Detection was carried out on a Micromass triple quadrupole tandem mass spectrometer by Multiple Reaction Monitoring (MRM). The intra- and inter-run precision, calculated from quality control (QC) samples, was less than 3.4%. The accuracy as determined from QC samples was less than 9%. The method herein described was employed in a bioequivalence study of two capsule formulations of lansoprazole.

Estudo multicêntrico brasileiro de eficácia e tolerabilidade da associaçäo de anlodipino e enalapril em formulaçäo galênica única no tratamento da hipertensäo arterial leve a moderada / Brazilian multicente study the efficacy and tolerability the association in anlodipino and enalapril in galenic fomulation in treatment arterial hypertension mild-to-mderate

Comparar o emprego de uma formulaçäo galêmica única da associaçäo do antagonista de cálcio dihidropiridínico nlodipino com o inibidor da enzima de conversäo enalapril, em duas dosagens diferentes, com a utilizaçäo isilada de cada um dos componentes da associaçäo notratamento de pacientes hipertensos essenciais leves a moderados. Utilizou-se um estudo multicêntrico, duplo cego, randomizado e paralelo. Foi avaliada a eficácia anti-hipertensiva com medida da pressäo arterial no consultório e monitorizaçäo ambulatorial da pressäo arterial (MAPA), a tolerabilidade, a segurança clínica por exames clínico-aboratoriais, os efeitos nos metabolismos glicídico e lipídico e na morfometria e funçäo cardíada. Visando avaliar de forma objetiva e temporal o desenvolvimento eventual do adverso do edema de membros inferiores, foi determinado de modo seriado o volume das pernas dos pacientes pela técnicaque utiliza o princípio de Arquimedes. O estudo teve duraçäo de 24 semanas e foram incluídos 99 pacientes com pressäo darterial diastólica entre 90 e 115 mm Hg após três semanas de retirada da medicaçäo anti-hipertensiva. Os esquemas terapêuticos mostraram-se seguros e adquados ao tratamento. A associaçäo galênica de anlodipino e enalapril nas duas doses empregadas apresentou, pela medida da pressäo arterial no consultório e por MAPA, eficácia anti-hipertensiva semelhante ao emprego de anlodipino isolado e superior à observada com uso exlusivo do enalapril. Ressalta-se que a eficácia da associaçäo foi obtida com doses menores que as empregadas com cada droga isolada. As duas dosagens da associaçäo mostraram perfil de tolerabilidade superior ao do anlodipino ou do enalapril isolados, com reduçäo significativa da incidência de tosse e de edema de membros inferiores, que foi acompanhada de um menor aumento no volume da perna. O tratamento com a associaçäo näo modificou os parâmetros metabólicos e determinou reduçäo nos 1ndices da morfometria do ventrículo esquerdo. A formulaçäo galêmica de anlodipino e enalapril é segura, útil, de alta eficácia e de melhor tolerabilidade que o emprego de cada componente isolado no tratamento de pacientes com hipertensäo essencial leve `a moderada