Incidence of tardive dyskinesia: a comparison of long-acting injectable and oral paliperidone clinical trial databases.

BACKGROUND: To assess the tardive dyskinesia (TD) rate in studies of once-monthly long-acting injectable (LAI) paliperidone palmitate (PP) and once-daily oral paliperidone extended release (Pali ER). METHODS: Completed schizophrenia and bipolar studies for PP and Pali ER (≥ 6 month duration with retrievable patient-level data) were included in this post hoc analysis. Schooler-Kane research criteria were applied using Abnormal Involuntary Movement Scale (AIMS) scores to categorise probable (qualifying AIMS scores persisting for ≥ 3 months) and persistent TD (score persisting ≥ 6 months). Spontaneously reported TD adverse events (AEs) were also summarised. Impact of exposure duration on dyskinesia (defined as AIMS total score ≥ 3) was assessed by summarising the monthly dyskinesia rate. RESULTS: In the schizophrenia studies, TD rates for PP (four studies, N = 1689) vs. Pali ER (five studies, N = 2054), were: spontaneously reported AE, 0.18% (PP) vs. 0.10% (Pali ER); probable TD, 0.12% (PP) vs. 0.19% (Pali ER) and persistent TD, 0.12% (PP) vs. 0.05% (Pali ER). In the only bipolar study identified [Pali ER (N = 614)], TD rate was zero (spontaneously reported AE reporting, probable and persistent TD assessments). Dyskinesia rate was higher within the first month of treatment with both PP (13.1%) and Pali ER (11.7%) and steadily decreased over time (months 6-7: PP: 5.4%; Pali ER: 6.4%). Mean exposure: PP, 279.6 days; Pali ER, 187.2 days. CONCLUSIONS: Risk of TD with paliperidone was low (< 0.2%), regardless of the formulation (oral or LAI), in this clinical trial dataset. Longer cumulative exposure does not appear to increase the risk of dyskinesias.

First evidence of oncologic neuropathic pain prevalence after screening 8615 cancer patients. Results of the On study.

BACKGROUND: Thirty percent to ninety percent of cancer patients suffer from pain, including neuropathic pain (NP), which results in great burden for cancer patients. Thus, it was of great interest to determine NP prevalence in cancer patients in Spain, to raise awareness of the condition, and aiming to improve management of cancer NP. PATIENTS AND METHODS: A 1-month follow-up prospective epidemiological multicenter study was conducted to assess prevalence and management of NP in Spanish oncologic units. The first 10 cancer patients at each unit diagnosed with NP by the validated Douleur Neuropathique 4 questionnaire (DN4) were recruited. RESULTS: Of 8615 screened patients, 2567 (30%) suffered from pain. From these, 33% had NP according to investigators and 19% according to DN4 test. Three hundred and sixty-six patients (mean age 62.6 years; 61.2% male) were recruited. Pain decrease at 1 month was greater in patients with metastases (P<0.01) and depended on treatment (P<0.05), with 'oxycodone' showing 50.4% pain relief. CONCLUSIONS: NP prevalence in cancer pain is 33%. DN4 reports only about half the cancer NP cases diagnosed by clinicians. Pharmaceutical treatment of cancer pain, including NP, has a greater effect in patients with metastases and seems to depend on the specific treatment used.

All-Optical flip-flop operation using a SOA and DFB laser diode optical feedback combination.

We report on the switching of an all-optical flip-flop consisting of a semiconductor optical amplifier (SOA) and a distributed feedback laser diode (DFB), bidirectionally coupled to each other. Both simulation and experimental results are presented. Switching times as low as 50ps, minimal required switch pulse energies below 1pJ and a repetition rate of 1.25GHz have been measured. Contrast ratios over 25dB have been obtained. The dependence on the pulse length and CW input power of the minimal required switch energy is investigated.

Evaluation of the oxygenation ratio as long-term prognostic marker after lung transplantation.

OBJECTIVE: We hypothesized that the arterial blood gas oxygen tension/fraction of inspired oxygen ratio (PaO2/FiO2) would prove to be useful as a mortality marker after lung transplantation (LT). The aims of this study were to define the prevalence of various ranges of PaO2/FiO2 during the first 24 hours after LT and to evaluate which measurement using the PaO2/FiO2 best correlates with mortality. METHODS: A retrospective study was performed that included all patients who underwent LT from 1997 to 2005. We collected PaO2/FiO2 ratios at 0, 12, and 24 hours after admission to the intensive care unit (ICU). We classified the 132 patients in 5 groups, based on PaO2/FiO2 (Group 1, PaO2/FiO2 <100; Group 2, PaO2/FiO2 100-199; Group 3, PaO2/FiO2 200-299; Group 4, PaO2/FiO2 300-399; Group 5, PaO2/FiO2 >or=400). The correlation between PaO2/FiO2 and mortality was studied using Cox regression. RESULTS: Cox regression analysis showed that PaO2/FiO2 at 0 and 12 hours after admission to the ICU were not useful mortality markers. However, the PaO2/FiO2 at 24 hours after admission to the ICU was a useful long-term prognostic marker. PaO2/FiO2 >100 (groups 2, 3, 4, and 5) at 24 hours was significantly associated with less mortality when a lower PaO2/FiO2 was the reference (hazard Ratio: 0.08, 0.02, 0.05, and 0.02, respectively). On multivariate analysis PaO2/FiO2 >or=100 (groups 2, 3, 4, and 5) at 24 hours was significantly associated with less mortality when a lower PaO2/FiO2 was the reference (hazard ratio: 0.07, 0.003, 0.01, and 0.005, respectively). CONCLUSIONS: A value of PaO2/FiO2 >100 mm Hg 24 hours after admission to the ICU is associated with a lower mortality.

[Pain caused by brachial plexus injury during coronary revascularization. Report of 3 cases]. / Dolor por lesión del plexo braquial tras cirugía de revascularización coronaria. A propósito de tres casos.

We report three cases of injury of the brachial plexus after coronary revascularization surgery. During the postoperative phase all patients presented plexopathy involving the left C8 and D1 roots. The symptoms were pain, paresthesia, and motor deficits. The proposed mechanisms for injury of the brachial plexus during cardiac surgery are: hyperabduction of the arm, direct traumatism produced by the needle during catheterization of the internal jugular vein, and traction and compression associated with sternal retraction. In the three patients we ruled out alterations during cannulation of the internal jugular vein and malposition of the arms. We think that in our cases the fundamental mechanism was an excessive and assymetrical opening of sternal and Favoloro's separators that were used in all cases during dissection of the left internal mammary artery. We conclude that injury of the brachial plexus can be minimized by reducing the opening of both separators and by placing Favaloro's separator in a lower position.

[Cerebrospinal fluid drainage and deep systemic hypothermia with total absence of circulation for spinal cord protection during surgery on the thoracic aorta]. / Drenaje de líquido cefalorraquídeo e hipotermia profunda sistémica con parada circulatoria total como método de protección medular durante la cirugía de aorta torácica.

A 53-yearold man with a dissecting aneurysm of Stanford's type-B or Crawford's type I measuring 8.5 cm in diameter underwent replacement of the distal descending aorta and the thoracic aorta using techniques for spinal cord protection involving deep hypothermia at 17 degrees C and lasting 38 minutes with total absence of circulation. A subarachnoid catheter was inserted at the lumbar level to monitor spinal fluid pressure as well as to provide drainage if pressure exceeded 10 mm Hg. During surgery 60 ml was drained, followed by 95 ml after surgery on the same day and 325, 262 and 169 ml on the following three days. No signs of neurological deficit were observed during the postoperative period. Clinical course was good until hypovolemic shock developed 27 days after the operation due to upper digestive tract bleeding caused by two duodenal ulcers that perforated the gastroduodenal artery. Emergency antrectomy and vagotomy were performed. The patient died from multiple organ failure. Spinal cord injury continues to be one of the most feared complications after excision of thoracic and thoracoabdominal aorta aneurysm. Currently, various ways of protecting the spinal cord are practiced, including drainage of cerebrospinal fluid, partial bypass of the femoral artery, intercostal artery reimplantation, drug therapy and local spinal and/or systemic hypothermia. These methods, together with shorter clamping time have achieved a reduction in the incidence of spinal cord injuries.

[Prolonged neurologic deficiency after accidental spinal anesthesia]. / Déficit neurológico prolongado tras anestesia espinal accidental.

A case of severe prolonged neurological deficit following inadvertent spinal anesthesia is presented. Intradural block occurred after a test dose of Bupivacaine and vasoconstrictor when inserting an epidural catheter for post-thoracotomy pain-relief treatment. The likely triggering and etiological factors responsible for the neurological damage after spinal anesthesia were studied and evaluated, mainly those toxic and traumatic. Special mention of the local anesthetics and sodium bisulfite used is made. Preventive measures for this sort of complication are suggested.

[Acute pancreatitis after resection of abdominal aortic aneurysm]. / Pancreatitis aguda tras la resección de un aneurisma de aorta abdominal.

The case of a patient who developed acute pancreatitis following resection of a ruptured aneurysm of the abdominal aorta is presented. During the first postoperative days the patient evolved satisfactorily except for specific abdominal symptoms. On the sixth day the patient suddenly presented tachycardia, hypotension, increase in abdominal distension and anemia for which emergency laparotomy was performed with signs of diffuse peritoneal steatonecrosis with an increase in the size and inflammation of the pancreas with necrotic and hemorrhagic zones being observed. The patient developed multiorganic failure and died at 18 days later. In this case, as in others described in the literature the beginning was uneventful. Only the determination of amylase and/or lipase, and the performance of abdominal CAT when these are increased, may be useful to obtain early diagnosis.

Longitudinal changes of insight in first episode psychosis and its relation to clinical symptoms, treatment adherence and global functioning: one-year follow-up from the Eiffel study.

OBJECTIVES: The Eiffel study is a longitudinal, naturalistic study of patients with first episode psychosis (FEP) designed to evaluate the predictive value of defective insight on treatment adherence and global functioning. METHODS: Five hundred seventy-seven patients with FEP were assessed at baseline and at a 1-year follow-up. They were compared in terms of sociodemographic factors, psychopathology, insight, treatment adherence and functional outcome. Longitudinal functionality was prospectively assessed with the clinical global impression (CGI) and global assessment of functioning (GAF) rating scales. RESULTS: At baseline, up to 50% of our sample presented with a lack of insight. Most clinical symptoms, including insight, improved over the follow-up period. Insight, education and social withdrawal significantly predicted CGI and GAF at follow-up. Insight and level of education were predictive of treatment adherence. CONCLUSIONS: Insight significantly predicted the general clinical course, treatment adherence and functional outcome in our FEP sample after 1 year. Only education additionally accounted for the longitudinal course. Since our results suggest that better insight improves treatment adherence and consequently clinical course and functional outcome, insight could be a specific target of treatment in early intervention programs.

[Treatment adherence in schizophrenia. A comparison between patient's, relative's and psychiatrist's opinions]. / Adherencia terapeutica en la esquizofrenia: una comparacion entre las opiniones de pacientes, familiares y psiquiatras.

INTRODUCTION: Patients with psychiatric illness typically have great difficulty following a medication regimen, but they also have the greatest potential for benefiting from adherence. Due to the lack of insight in schizophrenia, adherence to treatment is especially important. We try to analyze and compare the opinion on adherence and compliance of psychiatrists, patients with schizophrenia and relatives. METHOD: A direct, anonymous survey specifically designed for the project was administered to psychiatrists, patients and relatives from all over Spain through different associations of patients and family legally constituted in Spain. Analysis was done separately for variables corresponding to the three groups. RESULTS: The psychiatrists (n = 844) considered that 56.8 % of their evaluated patients (n = 7.439) were noncompliers in the past month, as opposed to 43.2% of these patients who were considered good compliers (3,215 patients). Ninety-five percent of the patients (n = 938) stated that they took their medication regularly, while 5 % answered no to this question. Eighty-two percent of relatives (n = 796) think that patients regularly take their medication, but 47% state that they sometimes forget to take it. CONCLUSIONS: Treatment adherence should be evaluated in clinical trials and in research on treatment of diseases, particularly in chronic mental diseases such as schizophrenia. It seems clear that only programs aimed at detection and resolution of the problems involved in treatment adherence will be able to improve the mid- and long-term prognosis of patients with schizophrenic disorders.

[Treatment of renal arteriovenous fistula by means of embolization using a fibrin sponge]. / Tratamiento de las fistulas arteriovenosas renales por medio de embolizacion con esponja de fibrina.

The selective embolization with fibrin sponge has controlled the persistent hematuria subsequent to a great renal arteriovenous post-operative fistula whereby the kidney recovered immediately after the embolization its normal functioning. A control arteriograph realized six weeks later showed the recanalization of the vessels, without any evidence of fistula. In another case, the renal massive hematuria after a percutaneous renal biopsy which produced a state of acute anemia was treated with the same method. The angiographic control showed the disappearance of the fistula, with a small ischemia zone distant from the embolized zone.