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Prospective Manner (prospective + manner)
Selected AbstractsEfficacy of infliximab in pediatric Crohn's disease: A randomized multicenter open-label trial comparing scheduled to on demand maintenance therapyINFLAMMATORY BOWEL DISEASES, Issue 3 2009Frank M. Ruemmele MD Abstract Background: Infliximab (IFX) is efficacious in inducing remission in severe forms of pediatric Crohn's disease (CD). Adult studies indicate that IFX is also safe and well tolerated as maintenance therapy. The present study aimed to evaluate in a prospective manner the efficacy and safety of IFX as maintenance therapy of severe pediatric CD comparing scheduled and "on demand" treatment strategies. Methods: Forty children with CD (nonpenetrating, nonstricturing as well as penetrating forms, mean age: 13.9 ± 2.2 years) with a severe flare-up (Harvey,Bradshaw Index [HBI] ,5, erythrocyte sedimentation rate [ESR] >20 mm/h) despite well-conducted immunomodulator therapy (n = 36 azathioprine, n = 1 mercaptopurine, n = 3 methotrexate) combined with steroids were included in this randomized, multicenter, open-label study. Three IFX infusions (5 mg/kg) were administered at week (W)0/W2/W6. At W10, clinical remission (HBI <5) and steroid withdrawal were analyzed and IFX responders were randomized to maintenance therapy over 1 year: group A, scheduled every 2 months; group B, "on demand" on relapse. Results: In all, 34/40 children came into remission during IFX induction therapy (HBI: 6.7 ± 2.5 (WO) vs. 1.1 ± 1.5 (W10); P < 0.001). At the end of phase 2, 15/18 (83%) patients were in remission in group A compared to 8/13 (61%) children in group B (P < 0.01), with a mean HBI of 0.5 versus 3.2 points (group A versus B, P = 0.011). In group A, 3/13 (23.1%) children experienced a relapse compared to 11/12 (92%) children in group B. No severe adverse event occurred during this trial. Conclusions: IFX is well tolerated and safe as maintenance therapy for pediatric CD, with a clear advantage when used on a scheduled 2-month basis compared to an "on demand" basis. (Inflamm Bowel Dis 2009) [source] Is nerve stimulation needed during an ultrasound-guided lateral sagittal infraclavicular block?ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 4 2010Y. GÜRKAN Background: The objective of the study was to evaluate the influence of ultrasound (US) guidance alone vs. neurostimulation (NS) and US (NSUS) guidance techniques on block performance time and block success rate for the lateral sagittal infraclavicular block (LSIB). Methods: In a randomized and prospective manner, 110 adult patients scheduled for distal upper limb surgery were allocated to the US or the NSUS groups. In the US group, a local anesthetic (LA) was administered only with US guidance to produce a ,U'-shaped distribution around the axillary artery. In the NSUS group, LA was administered under US guidance only after electrolocation of one of the median, ulnar or radial nerve-type responses. A total of 30 ml of LA (10 ml of levobupivacaine 5 mg/ml and 20 ml of lidocaine 20 mg/ml) was administered in both groups. Sensory block was tested at 10 min intervals for 30 min. Successful block was defined as analgesia or anesthesia of all five nerves distal to the elbow. Results: Block success rate was 94.5% in both groups. Block performance time was significantly shorter in the US than the NSUS group (157 ± 50 vs. 230 ± 104 s) (P=0.000). Block onset time was similar in both groups (12.5 ± 4.8 in the US vs. 12.8 ± 5.4 min in the NSUS groups). There were two arterial punctures in the NSUS group. Conclusions: During LSIB performance US guidance alone produces block success rate identical to both US and NS guidance yet with a shorter block performance time. [source] Single vs. double stimulation during a lateral sagittal infraclavicular blockACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 10 2009E. AKY Background: The objective of this study was to evaluate the influence of single vs. dual control during an ultrasound-guided lateral sagittal infraclavicular block on the efficacy of sensory block and the time of block onset. Methods: In a prospective manner, 60 adult patients scheduled for distal upper limb surgery were randomly allocated to single (Group S) or double stimulation (Group D) groups. A local anesthetic (LA) mixture of 20 ml of levobupivacaine 5 mg/ml and 20 ml of lidocaine 20 mg/ml with 5 ,g/ml epinephrine (total 40 ml) was administered in both groups. In the Group S following a median, an ulnar or a radial nerve response, the entire LA was administered at a single site. In Group D 10 ml of LA was administered following the electrolocation of the musculocutaneous nerve and 30 ml LA was injected following median, ulnar or radial nerves. A successful block was defined as analgesia or anesthesia of all five nerves distal to the elbow. Sensory and motor blocks were tested at 5-min intervals for 30 min. Results: The block was successful in 27 patients in Group S and 28 patients in Group D. The time from starting the block until satisfactory anesthesia was significantly shorter in Group D than in Group S (19.3 vs. 23.2 min) (P<0.05). Total sensory scores were significantly higher in the double stimulation group at 20 and 30 min after the block performance (P<0.05). Conclusions: Although the block performance time was longer in the double stimulation group, block onset time and extent of anesthesia were more favorable in the double stimulation group. [source] Delayed immune-mediated adverse effects related to hyaluronic acid and acrylic hydrogel dermal fillers: clinical findings, long-term follow-up and review of the literatureJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 2 2008J Alijotas-Reig Abstract Introduction Implantation of dermal filler for cosmetic purposes is becoming increasingly common worldwide. It is thought that hyaluronic acid (HA) alone or combined with acrylic hydrogels (HA-AH) does not have severe nor persistent side-effects. However, recent evidence may show that major, local and/or systemic, immediate or delayed adverse effects may appear in relation with its use. Objective To evaluate the clinical complaints, laboratory data, treatment and follow-up of patients with delayed adverse effects related to HA and HA-AH implant fillers. Design Prospective, case-series study of patients filled with HA and HA-AH compounds. Setting The study has been done in a tertiary, teaching university hospital. Patients We report on a series of 25 patients, 15 of them in prospective manner, with severe, delayed side-effects related to HA-AH. Inclusion criteria have been drawn up. Patients with immediate side-effects were excluded. Patients were submitted to a clinical follow-up, battery of blood tests and thorax X-ray films. Besides, a review of the literature was made. We undertook a computed-assisted (MEDLINE), National Library of Medicine, Bethesda, MD, USA, search of the literature from 1996 up to December 2005. Main outcome Clinical evaluation of granulomas, skin manifestations and other local and systemic immune-mediated disorders possibly related to HA and HA-AH fillers or their cumulative interaction with previously administered fillers. Results Of 25 cases, 16 were filled with HA alone and 9 with a HA-AH compounds. Of 15 cases analysed and with long-term follow-up, 10 were filled with HA alone, and the remaining five were filled with a HA-AH. Time latency average up to beginning of symptoms was 13.7 months. Three of these 15 cases had been filled before with silicone and another one with Artecoll. Tender nodules were seen in 14 patients. Systemic manifestations appeared in three cases. Laboratory abnormalities were noted in all studied cases. After 16-month average follow-up, seven patients seem to be cured, and six have recurrent bouts. Two cases were lost during follow-up. Conclusion Although in some cases, these clinical complications might have been associated with previous fillers or with other unknown foreign bodies, we feel that, although infrequently, delayed and recurrent chronic inflammatory and granulomatous reactions may complicate HA and HA-AH implant fillers. [source] Cardiovascular and Pulmonary Effects of Hetastarch Plus Hypertonic Saline Solutions during Experimental Endotoxemia in Anesthetized HorsesJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 6 2006DACVIM, Lucas G. Pantaleon MV Background:Small volume resuscitation has been advocated as a beneficial therapy for endotoxemia in horses but this therapy has not been investigated in a prospective manner. The objective of this study was to determine the cardiopulmonary effects of small-volume resuscitation using hypertonic saline solution (HSS) plus Hetastarch (HES) during experimental endotoxemia in anesthetized horses. Hypothesis:Treatment of horses with induced endotoxemia using HES-HSS does not alter the response of various cardiopulmonary indices when compared to treatment with either small-or large-volume isotonic crystalloid solutions. Animals:Eighteen healthy horses were randomly assigned to 1 of 3 groups. Anesthesia was maintained with halothane. Endotoxemia was induced by administering 50 ,g/kg of Escherichia coli endotoxin IV. The horses were treated over 30 minutes with 15 mL/kg of balanced polyionic crystalloid solution (control), 60 mL/kg of balanced polyionic crystalloid solution (ISO), or 5 mL/kg of HSS followed by 10 mL/kg of HES (HSS-HES). Methods:Prospective randomized trial. Results:Cardiac output (CO) after endotoxin infusion increased significantly (P < .05) from baseline in all groups, whereas mean central venous pressure increased significantly (P < .05) in the ISO group only. Mean pulmonary artery pressure increased from baseline (P < .05) in horses treated with isotonic fluids and HSS-HES. There was no effect of treatment with HSS-HES on CO, systemic vascular resistance (SVR), mean arterial pressure, blood lactate concentrations, or arterial oxygenation. Conclusions and Clinical Importance: The use of HSS-HES failed to ameliorate the deleterious hemodynamic responses associated with endotoxemia in horses. The clinical value of this treatment in horses with endotoxemia remains unconfirmed. [source] Review article: interactions between genotype and response to therapy in inflammatory bowel diseasesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2006K. R. HERRLINGER Summary Background More than half of the patients with inflammatory bowel diseases are candidates for immunosuppressive therapy. However, even the most effective drugs used in inflammatory bowel disease are only successful in about two-thirds of patients. Adverse events limit their use in a further substantial proportion of patients. Recent research has focussed on the possibility of predicting a drugs' efficacy and/or toxicity by identifying polymorphic variants in the genes encoding enzymes involved in metabolic pathways. Aim To highlight recent advances and limitations in the field of pharmacogenetics in inflammatory bowel disease. Results Recent pharmacogenetic studies have mainly focussed on immunosuppressive agents including corticosteroids, azathioprine, methotrexate and infliximab. Several polymorphic genes encoding enzymes involved in the metabolism of these drugs have been identified including the inosine triphosphate pyrophosphatase in thiopurine therapy, the methylene tetrahydrofolate reductase in methotrexate therapy and polymorphisms in apoptosis genes in infliximab therapy. However, at the present time, genotyping for the variants of the thiopurine methyltransferase gene, an enzyme important for the metabolism of the thiopurine drugs, is the only useful test in clinical practice. Conclusions Although the field of pharmacogenetics in inflammatory bowel disease is promising most new targets have so far failed to translate into clinical practice. Future pharmaceutical trials should include pharmacogenetic research to test appropriate candidate genes in a prospective manner. [source] Comparison of activin A and cell-free fetal DNA levels in maternal plasma from patients at high risk for preeclampsiaPRENATAL DIAGNOSIS, Issue 13 2006Claude Henri Diesch Abstract Objectives We examined the concentration of activin A in a prospective manner before the clinical manifestation of preeclampsia and compared the data with those of cell-free fetal DNA in the maternal plasma. Methods The levels of activin A were analysed by enzyme-linked immunosorbent assay (ELISA) for pregnant women: (1) with preeclampsia (n = 34) in the third-trimester and normal controls (n = 44); and (2) at-risk of preeclampsia in the second-trimester (n = 15) as indicated by uterine artery Doppler and normal controls (n = 68). Correlation between activin A level and cell-free fetal DNA level was examined using the Spearman rank test. Results The level of plasma activin A was significantly higher in the preeclamptic samples (12.056 vs 7.068 ng/mL, p = 0.000). The increase in the activin A concentration was observed prior to the onset of preeclampsia (3.483 vs 1.324 ng/mL, p = 0.000). This increase in activin A correlated significantly with the increased level of cell-free fetal DNA, in the maternal circulation prior to the onset of preeclampsia (r = 0.977, p = 0.000). Conclusion Our data suggest that circulatory activin A could be an independent biomarker for the early identification and monitoring of preeclampsia. Copyright © 2006 John Wiley & Sons, Ltd. [source] Effect of Seven Different Modalities of Antihypertensive Therapy on Pulse Pressure in Patients with Newly Diagnosed Stage I HypertensionCARDIOVASCULAR THERAPEUTICS, Issue 1 2009Gokhan Alici In this study, we investigated the effect of different antihypertensive agents on pulse pressure (PP). The study was designed in a prospective manner and patients were sequentially allocated to one of the seven different therapy groups, according to the order of enrollment (every first patient to group I, every second patient to group II, and etc). Patients in group I received 10 mg of lisinopril, in group II 10/6.25 mg of lisinopril/hydrochlorothiazide, in group III 80 mg of valsartan, in group IV 80/6.25 mg of valsartan/hydrochlorothiazide, in group V 5 mg of amlodipine, in group VI 1.25 mg of indapamide, and finally those in group VII received 50 mg of atenolol. The reduction in PP was more significant in patients receiving lisinopril, lisinopril hydrochlorothiazide, valsartan, and valsartan hydrochlorothiazide, when compared with patients receiving indapamide, atenolol, and amlodipine (P < 0.05 for each group). Factors such as age, gender, and body mass index were not found to significantly influence the effectiveness of antihypertensive agents on PP. The reduction in PP was more apparent with lisinopril, lisinopril hydrochlorothiazide, valsartan, and valsartan hydrochlorothiazide in diabetic patients, when compared with those without diabetes (P < 0.001, P < 0.05). And also patients on therapy with 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitors had a greater reduction in PP with lisinopril, lisinopril hydrochlorothiazide, valsartan, and valsartan hydrochlorothiazide (P < 0.001, P < 0.05). [source] Lymph node metastases in the lower neckCLINICAL OTOLARYNGOLOGY, Issue 3 2003W. Giridharan Lymph node metastases in the lower neck Current knowledge suggests that lymph node metastases in the lower neck (supraclavicular fossa and posterior triangle) are associated with a poor survival. Very little systematic work has been published on this subject. This was a retrospective study carried out on a database where all patients were entered in a prospective manner over a 35-year period using a standard pro-forma. Data on 168 patients presenting with a lower neck node metastasis were retrieved. The main outcome measures were: association between variables and tumour-specific survival. Data were displayed in contingency tables and analysed by chi-square and categorical modelling. Recurrence and survival were plotted in a cause-specific manner using the Kaplan Meir method. Differences in curves were analysed using the log rank test. Multivariate analysis was carried out using Cox's proportional hazard model. The only association was between site and node level and histology. Head and neck tumours were associated with squamous histology (P = 0.0004) and supraclavicular nodes (P = 0.0047). Survival time was not significantly different when lower-neck lymph node metastasis from the head and neck was compared to non-head and neck metastasis: 5-year survival 30% and 10% respectively (P = 0.1363). Survival with posterior triangle metastases was significantly better than supraclavicular metastases (P = 0. 0059), confirmed on multivariate analysis. Laterality of metastasis had no effect on survival (P < 0.0001). There was no significant difference in survival between squamous and non-squamous metastases on Cox regression (P = not significant). There were 85 head and neck primaries including lymphomas, 53 infraclavicular primaries and 30 unknown primaries. There were 73 squamous cell carcinomas, 27 adenocarcinomas, 34 lymphomas, 28 undifferentiated tumours and six other tumours. Nearly half the primary tumours were below the clavicle. Survival was unaffected by laterality, primary site or histology, but was better for posterior triangle nodes. [source] | ||||||||||