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1.
Eur Heart J ; 23(17): 1351-9, 2002 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-12191746

RESUMO

AIMS: The BRIE trial is a registry evaluating the safety and performance of (90)Sr delivered locally (Beta-Cath TM system of Novoste) to de-novo and restenotic lesions in patients with up to two discrete lesions in different vessels. METHODS AND RESULTS: In total, 149 patients (175 lesions) were enrolled; 62 treated with balloons and 113 with stents. The restenosis rate, the minimal luminal diameter and the late loss were determined in three regions of interest: (a) in a subsegment of 5mm containing the original minimal luminal diameter pre-intervention termed target segment; (b) the irradiated segment, 28 mm in length, and (c) the entire analysed segment, 42 mm in length, termed the vessel segment. Binary restenosis was 9.9% for the target segment, 28.9% for the irradiated segment, and 33.6% for the vessel segment. These angiographic results include 5.3% total occlusions. Excluding total occlusions binary restenosis was 4.9%, 25% and 29.9%, respectively. At 1 year the incidence of major adverse cardiac events placed in a hierarchical ranking were: death 2%, myocardial infarction 10.1%, CABG 2%, and target vessel revascularization 20.1%. The event-free survival rate was 65.8%. Non-appropriate coverage of the injured segment by the radioactive source termed geographical miss affected 67.9% of the vessels, and increased edge restenosis significantly (16.3% vs 4.3%, P=0.004). It accounted for 40% of the treatment failures. CONCLUSION: The results of this registry reflect the learning process of the practitioner. The full therapeutic potential of this new technology is reflected by the restenosis rate at the site of the target segment. It can only be unravelled once the incidence of late vessel occlusion and geographical miss has been eliminated by the prolonged use of thienopyridine, the appropriate training of the operator applying this new treatment for restenosis prevention, and the use of longer sources.


Assuntos
Braquiterapia/métodos , Doença da Artéria Coronariana/radioterapia , Reestenose Coronária/prevenção & controle , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão , Braquiterapia/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Radioisótopos de Estrôncio/uso terapêutico , Análise de Sobrevida , Resultado do Tratamento , Radioisótopos de Ítrio/uso terapêutico
2.
J Am Coll Cardiol ; 33(2): 358-65, 1999 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-9973015

RESUMO

OBJECTIVES: We studied the effects of rate and some cardioactive drugs on the atrial surface electrocardiogram (ECG). BACKGROUND: In atrioventricular block, atrial surface ECG is unmasked. The effect of rate alone permits detection of the effect of other exogenous stimulations such as drugs in the presence of rate alterations. METHODS: High fidelity, high gain ECG leads I, II and III were recorded from 51 patients with heart block. Durations of P and Ta waves and the total PTa interval were measured from nonconducted atrial events. RESULTS: No relationship was found between sinus cycle length and PTa, P or Ta in 31 patients. In 20 patients, progressively decreasing the atrial pacing cycle length from 853 ms to 381 ms resulted in a linear reduction of the PTa interval from 444 to 291 ms (rho = 0.76, slope = 0.24). This was largely due to shortening of Ta. A linear rate correction formula was derived: corrected PTa = PTa - 0.24 (PP - 1000). Atropine (0.02 mg/kg) shortened the PP interval (p < 0.001) and the PTa interval (p < 0.01). Propranolol (0.1 mg/kg) prolonged the PP interval (p < 0.001) but did not alter the PTa interval. Neither disopyramide (2.0 mg/kg) nor flecainide acetate (2.0 mg/kg) altered the PP interval, but both prolonged the PTa interval (p < 0.001). This was largely due to P wave lengthening after flecainide (p < 0.001) and to Ta prolongation after disopyramide (p < 0.001). CONCLUSIONS: In heart block, PTa, P and Ta waves can be measured reliably. The effects of pacing and some antiarrhythmic drugs on the atrial myocardium are similar to those known at the ventricular level.


Assuntos
Antiarrítmicos/uso terapêutico , Estimulação Cardíaca Artificial , Eletrocardiografia , Átrios do Coração/fisiopatologia , Bloqueio Cardíaco/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antiarrítmicos/administração & dosagem , Atropina/administração & dosagem , Atropina/uso terapêutico , Disopiramida/administração & dosagem , Disopiramida/uso terapêutico , Eletrocardiografia/efeitos dos fármacos , Feminino , Flecainida/administração & dosagem , Flecainida/uso terapêutico , Átrios do Coração/efeitos dos fármacos , Bloqueio Cardíaco/fisiopatologia , Frequência Cardíaca/efeitos dos fármacos , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Propranolol/administração & dosagem , Propranolol/uso terapêutico , Reprodutibilidade dos Testes
3.
Cathet Cardiovasc Diagn ; 43(4): 403-7, 1998 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-9554765

RESUMO

This randomised trial compared the Micro Stent I and the Palmaz-Schatz stent for the elective treatment of short (<8 mm long), new-onset coronary stenoses. The primary endpoints were restenosis rate and minimal luminal diameter at 6 mo angiographic follow-up. The secondary endpoints were angiographic and procedural success of stenting and a composite clinical endpoint at 6 mo (death, myocardial infarction, and target site revascularisation). A total of 93 patients were randomised. Clinical and angiographic characteristics of the two groups were comparable. Angiographic success of stenting was 96% in both groups, and there were no complications so that the procedural success was also 96% in both groups. The restenosis rate was 29% for Micro Stent I and 27% for the Palmaz-Schatz stent (P = NS). The minimal luminal diameter at 6 mo was 1.75 +/- 0.72 mm in the Micro Stent I group and 1.84 +/- 0.59 in the Palmaz-Schatz group (P = NS). At 6 mo, a clinical endpoint was reached by 21% of the patients in the Micro Stent I group and by 11% in the Palmaz-Schatz group (P = NS). In conclusion, the elective treatment of short coronary stenosis with the Micro Stent I or the Palmaz-Schatz stent resulted in similar early and late outcomes. In particular, the late angiographic results were very similar.


Assuntos
Doença das Coronárias/terapia , Stents , Idoso , Cateterismo , Angiografia Coronária , Doença das Coronárias/diagnóstico por imagem , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Resultado do Tratamento
6.
Arch Mal Coeur Vaiss ; 90(9): 1223-9, 1997 Sep.
Artigo em Francês | MEDLINE | ID: mdl-9488768

RESUMO

Two hundred AVE (Arterial Vascular Engineering) microstents measuring 4 to 30 mm were implanted in 140 patients aged 62 +/- 10 years with Class II to IV angina of the Canadian Cardiovascular Society Classification. The indications were: de novo lesions (30%), suboptimal angioplasty results (54%), acute occlusion (8%) or restenosis (8%). The stents of 3.0 to 4.0 mm diameter were implanted in the left main coronary artery (1%) the left anterior descending artery (20%), the left circumflex artery (19%), the right coronary artery (44%) or a venous bypass graft (7%) after intravenous injection of 15,000 IU of heparin. Daily treatment with aspirin 100 mg and ticlopidine 500 mg was instituted from the day of the procedure. The success rate was 98.5% with only 3 technical failures. The minimal luminal diameter and percentage stenosis ranged from 0.80 +/- 0.2 mm and 74 +/- 13% before to 2.66 +/- 0.38 mm and 15 +/- 7% after the procedure in vessels with an average reference diameter of 3.05 +/- 0.35 mm. There were 3% of stent-related immediate clinical complications. In February 1996, 97 patients had survived 6 months. With a 97% follow-up rate, the clinical event rate was 18%. The angiographic follow-up rate was 70% and the restenosis rate was 27%. The authors conclude that the AVE microstents are easy to implant and provide excellent immediate angiographic results with a low complication rate.


Assuntos
Angioplastia Coronária com Balão , Angiografia Coronária , Isquemia Miocárdica/terapia , Stents , Idoso , Anticoagulantes/administração & dosagem , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/mortalidade , Inibidores da Agregação Plaquetária/administração & dosagem , Recidiva , Reoperação , Stents/efeitos adversos , Resultado do Tratamento
7.
Am Heart J ; 132(2 Pt 1): 263-8, 1996 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-8701885

RESUMO

This study compared the clinical and angiographic outcome, during a 6-month follow-up period, of 84 patients with new-onset lesions of the right coronary artery randomized to either Wiktor stent implantation (42 patients) or conventional balloon angioplasty (42 patients). At hospital discharge, three patients in each group (7%, p = not significant [NS]) reached a clinical end point. At 6 months, these proportions were 24% (10 patients with stents) and 29% (12 patients with angioplasty) (p = NS). There were no incidents of death or myocardial infarction. Despite a larger minimal luminal diameter after stenting (2.87 mm [95% confidence interval; 2.66 to 2.96 mm] vs 2.37 mm [2.23 to 2.61 mm for angioplasty] [p = 0.001]), no difference was observed at 6 months of follow-up (1.75 mm [1.43 to 2.18 mm] vs 1.74 mm [1.45 to 2.03 mm] [p = NS], respectively). Accordingly, angiographic restenosis rates were 47.5% (19 of 40 patients with stents) and 35% (14 of 40 patients with angioplasty) (p = NS). Elective stenting with the Wiktor stent and conventional balloon angioplasty are safe and immediately effective therapeutic options for symptomatic, obstructive right coronary artery disease. At 6 months of follow-up, clinical and angiographic outcome did not differ. The role of Wiktor stent placement in primary restenosis prevention remains to be determined for lesions of the right coronary artery.


Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Stents , Constrição Patológica , Angiografia Coronária , Humanos , Recidiva , Resultado do Tratamento
8.
Am Heart J ; 130(6): 1164-7, 1995 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-7484764

RESUMO

This observational single-center trial examines the safety and efficacy of unplanned endoluminal stenting for the treatment of a suboptimal angiographic result (defined as a residual stenosis after angioplasty of 40% to 50% without delayed runoff as estimated by visual assessment) after conventional coronary angioplasty in native, new-onset, coronary artery stenoses. Between October 1991 and April 1994, 101 patients with suboptimal results after coronary angioplasty in new-onset lesions were treated by endoluminal Wiktor (41 patients) and Palmaz-Schatz (60 patients) stent implantation. Stenting was a technical and angiographic success in all cases. In-hospital complications were subacute closure (2%) and vascular complications at puncture site necessitating surgery (12%) or blood transfusion (3%). No myocardial infarction occurred, nor was any urgent bypass surgery performed. At follow-up restenosis was detected in 16 (20%, 80% angiographic follow-up rate) patients requiring repeat angioplasty (8%) and elective bypass grafting (4%). Myocardial infarction was not documented. However, one patient died suddenly at 5 months of follow-up. The unplanned use of intracoronary stents is a safe and effective therapeutic option for the treatment of a suboptimal angiographic result after conventional angioplasty in new-onset lesions. This approach guarantees a high immediate angiographic success but implies a considerable incidence of vascular complications at puncture site.


Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/cirurgia , Stents , Idoso , Constrição Patológica , Angiografia Coronária , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Tratamento
9.
J Interv Cardiol ; 8(6 Suppl): 752-5, 1995 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-10159765

RESUMO

This is a review on prospective randomized comparisons of PTCA and stents in the treatment of de novo native coronary artery lesions. BENESTENT and STRESS, two multicentric studies, used the articulated Palmaz-Schatz stent. In Lausanne, a single center trial limited to right coronary artery lesions, was conducted using the Wiktor stent. During the in-hospital phase. BENESTENT and STRESS showed the composite clinical end point to be less in the stent than in the PTCA groups (p < 0.05). In Lausanne, there was no difference between groups. The incidence of subacute closure was similar with both treatments in three trials. Angiographically, both postprocedural minimal luminal diameter (MLD) and percentage stenosis were larger in the stent group (P < 0.05). At 6 months, in both BENESTENT and STRESS, a composite clinical end point was reached by less stent patients than PTCA patients, with a reduced need for repeat nonsurgical reintervention by stenting. However, in Lausanne, there was no difference between stent and PTCA groups. At 6 months in both BENESTENT and STRESS, a persistent lower MLD, a larger percentage of stenosis, and a higher incidence of angiographic restenosis were found in the PTCA groups (P < 0.05). In Lausanne, no differences in MLD, percentage stenosis and angiographic restenosis were found between groups. Effective stenting of de novo lesions does improve immediate results compared to conventional balloon PTCA. The long-term outcome of stenting with Palmaz-Scharz stents is also improved compared to PTCA.


Assuntos
Angioplastia Coronária com Balão , Doença das Coronárias/terapia , Stents , Doença das Coronárias/cirurgia , Humanos , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva
10.
Arch Mal Coeur Vaiss ; 88(7): 987-91, 1995 Jul.
Artigo em Francês | MEDLINE | ID: mdl-7487330

RESUMO

Between March 1991 and June 1994, the authors treated restenosis (> or = 50%) of coronary endoprostheses in 17 men aged 39 to 72 years by balloon angioplasty. The stents had been implanted for de novo stenosis in 14 patients, restenosis in 1 patient and for acute occlusion in 2 patients. The vessels treated were the left anterior descending artery (1 case), the left circumflex artery (2 cases), the right coronary artery (7 cases) and venous bypass grafts (7 cases). The endoprostheses used were 5 Wallstents in 4 patients, 13 Wiktor stents in 11 patients and 2 Palmaz-Schatz in 2 patients. Clinically, the patients with restenosis presented with class II angina (6 patients), class III (8 patients) and class IV (3 patients) of the Canadian Cardiovascular Society Classification. Conventional balloon angioplasty was performed 17 months (range: 3 to 87 months) after stent implantation and resulted in immediate clinical and angiographic success (residual stenosis < or = 50% on quantitative analysis) in all patients. In particular, there were no dissections. The minimal lumenal diameter (MLD) and percentage stenosis changed from 1.04 mm (range: 0.87 to 1.20) and 72% (range: 68 to 76) respectively before stent implantation to 2.83 mm (range: 2.46 to 3.20) and 23% (range: 20 to 27) after stent implantation. Restenosis resulted in a MLD and percentage stenosis of 0.89 mm (range: 0.77 to 1.01) and 73% (range: 69 to 78) respectively. After angioplasty of the stent, they returned to 2.68 mm (range: 2.29 to 3.06) and 27% (range: 23 to 30) respectively. The patients were not anticoagulated after angioplasty.(ABSTRACT TRUNCATED AT 250 WORDS)


Assuntos
Angioplastia Coronária com Balão , Prótese Vascular , Doença das Coronárias/terapia , Stents/efeitos adversos , Adulto , Idoso , Angiografia Coronária , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Falha de Prótese , Recidiva
11.
Arch Intern Med ; 154(4): 441-9, 1994 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-8117177

RESUMO

BACKGROUND: Few studies have been performed to compare fenofibrate, a second-generation fibrate, and simvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. This study was aimed to compare the efficacy of both drugs in reducing atherogenic risk factors in type IIa or IIb hyperlipidemia. METHODS: Sixty-three patients entered this single-center, double-blind, crossover trial. Sixty patients (32 with type IIa and 28 with type IIb hyperlipidemia) were randomized to treatment for 3 months with a single daily 200-mg dose of micronized fenofibrate or 20 mg of simvastatin and then changed to the alternative treatment for a further 3-month period. RESULTS: After the first treatment period, in both types IIa and IIb, fenofibrate and simvastatin produced similar significant reductions in levels of total cholesterol and low-density lipoprotein cholesterol; high-density lipoprotein cholesterol levels were increased with both drugs in type IIb. Only fenofibrate decreased total triglyceride levels in type IIb, Lp(a) lipoprotein levels in patients with high baseline values, and fibrinogen. After the second period of treatment, in both types IIa and IIb, switching from fenofibrate to simvastatin resulted in a further reduction in total cholesterol and low-density lipoprotein cholesterol levels. The difference in the response of the two treatments on levels of total triglycerides, Lp(a) lipoprotein, and fibrinogen was confirmed after changing over to the alternative treatment. This short-term study showed few adverse effects for both drugs. CONCLUSIONS: Fenofibrate and simvastatin provide similar variations on total cholesterol and low-density lipoprotein cholesterol levels after a 3-month treatment period, with simvastatin having the capacity to decrease these measures further when administered after fenofibrate. However, fenofibrate exhibits a significant effect on other established risk factors, such as total triglyceride, fibrinogen, and Lp(a) lipoprotein levels, and accordingly has a broader spectrum of activity than simvastatin.


Assuntos
Anticolesterolemiantes/uso terapêutico , Fenofibrato/uso terapêutico , Hipercolesterolemia/tratamento farmacológico , Lovastatina/análogos & derivados , Adolescente , Adulto , Idoso , Anticolesterolemiantes/efeitos adversos , LDL-Colesterol/sangue , Método Duplo-Cego , Feminino , Fenofibrato/efeitos adversos , Humanos , Hipercolesterolemia/sangue , Hipertrigliceridemia/sangue , Hipertrigliceridemia/tratamento farmacológico , Lovastatina/efeitos adversos , Lovastatina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Prognóstico , Sinvastatina , Triglicerídeos/sangue
12.
Cardiovasc Res ; 26(10): 939-43, 1992 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-1486587

RESUMO

OBJECTIVE: The aim was to assess the effects of therapeutic doses of intravenous adenosine on human atrial and ventricular repolarisation. METHODS: The effects of 6 mg and 12 mg bolus doses of adenosine on the atrial and ventricular monophasic action potentials were studied using the contact catheter technique in 19 patients undergoing routine diagnostic electrophysiology studies. The effect on atrial repolarisation was studied before and after beta blockade in a subgroup of patients. RESULTS: The duration of the monophasic action potential to 90% repolarisation (MAPD90) was measured in all cases. After 6 mg of adenosine the atrial MAPD90 shortened from 227(SD 29) ms to 188(25) ms (p < 0.005); after 12 mg it shortened from 221(31) ms to 168(32) ms (p < 0.001). The maximum shortening was unaltered by propranolol 0.15 mg.kg-1. The ventricular MAPD90 showed no significant change after 12 mg, at 240(32) ms v 234(33) ms. CONCLUSIONS: Therapeutic doses of adenosine shorten the atrial but not the ventricular monophasic action potential duration. The effect is dose dependent and not abolished by beta blockade.


Assuntos
Potenciais de Ação/efeitos dos fármacos , Adenosina/administração & dosagem , Coração/efeitos dos fármacos , Adenosina/farmacologia , Fibrilação Atrial/induzido quimicamente , Relação Dose-Resposta a Droga , Esquema de Medicação , Átrios do Coração/efeitos dos fármacos , Ventrículos do Coração/efeitos dos fármacos , Humanos , Injeções Intravenosas , Propranolol/farmacologia
13.
Br Heart J ; 67(1): 67-71, 1992 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-1739530

RESUMO

OBJECTIVE: To assess the effects of low energy ablation of the substrate for atrial flutter. DESIGN: Initial retrospective analysis of patients undergoing low energy ablation of the atrioventricular node for refractory atrial flutter (group 1) was followed by a prospective assessment of low energy ablation in the posterio-inferior right atrium for the same condition (group 2). SETTING: Tertiary referral centre for management of cardiac arrhythmias. PATIENTS: Seven men (aged 50-67 years) with refractory atrial flutter. INTERVENTIONS: Multiple (3-10) low energy DC shocks with a cumulative energy of 100-245 J in the region of the atrioventricular node in group 1 and 12-15 low energy DC shocks (cumulative energy 110-235 J) guided by the anatomical landmarks of the triangle of Koch and applied directly to the atrial wall. MAIN OUTCOME MEASURE: Freedom from recurrence of atrial flutter. RESULTS: In group 1 despite initial complete atrioventricular block in three patients, atrioventricular conduction had resumed in all by one month. All four, however, were in sinus rhythm at follow up six to 13 months later. Two of the three patients in group 2 were free of atrial flutter at follow up three to four months after ablation. CONCLUSION: Ablation of the atrial flutter substrate with low energy DC shocks is feasible. Precise electrophysiological mapping is not necessary.


Assuntos
Flutter Atrial/cirurgia , Eletrocoagulação/métodos , Idoso , Nó Atrioventricular/cirurgia , Fascículo Atrioventricular/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
14.
Int J Tissue React ; 13(5): 243-8, 1991.
Artigo em Inglês | MEDLINE | ID: mdl-1806546

RESUMO

Thirty-six healthy men aged 20-31 years took part in a randomized, double-blind, double-dummy, parallel-group study to compare the effects of repeated doses of piroxicam-beta-cyclodextrin, piroxicam and placebo on faecal blood loss and the endoscopic appearances of gastric and duodenal mucosa. After an initial endoscopy, subjects received on day 0 autologous erythrocytes labelled with 51Cr. Complete daily faecal collections were then made from days 6 to 12. From days 13 to 40, subjects received daily by mouth either piroxicam-beta-cyclodextrin (containing 20 mg piroxicam), piroxicam 20 mg, or placebo. Complete faecal collections were made daily from days 13 to 41; blood samples for red-cell 51Cr activity were taken weekly. Endoscopy was repeated 16-20 h after the last dose of medication. Faecal blood loss was calculated from 51Cr activity of blood and faeces. Compliance with medication was confirmed by blood sampling on days 20, 27 and 34. General tolerability of the medication was good, although 1 subject was withdrawn from piroxicam-beta-cyclodextrin and 1 from piroxicam treatment because of abdominal pain. There were no clinically significant changes in haematology, biochemistry or urinalysis results in any subject. Endoscopic appearances deteriorated moderately in 3 subjects receiving piroxicam and 3 receiving piroxicam-beta-cyclodextrin, but did not deteriorate in any subject receiving placebo. There was a trend for cumulative blood loss to be higher for piroxicam than for the other treatments in the last 12 days of dosing.(ABSTRACT TRUNCATED AT 250 WORDS)


Assuntos
Ciclodextrinas/farmacologia , Sistema Digestório/efeitos dos fármacos , Mucosa Gástrica/efeitos dos fármacos , Hemorragia Gastrointestinal/etiologia , Piroxicam/farmacologia , beta-Ciclodextrinas , Administração Oral , Adulto , Radioisótopos de Cromo/análise , Radioisótopos de Cromo/sangue , Ciclodextrinas/administração & dosagem , Ciclodextrinas/efeitos adversos , Sistema Digestório/patologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Combinação de Medicamentos , Endoscopia , Eritrócitos/química , Fezes/química , Mucosa Gástrica/patologia , Humanos , Masculino , Piroxicam/administração & dosagem , Piroxicam/efeitos adversos
15.
Postgrad Med J ; 66(778): 622-6, 1990 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-2217030

RESUMO

Forty-five healthy men aged 21-34 years took part in a double-blind, parallel-group, placebo-controlled study of the effects of 28 days' treatment with lornoxicam 4 mg twice daily or indomethacin 50 mg twice daily on faecal blood loss and the endoscopic appearances of gastric and duodenal mucosa. After an initial endoscopic examination, subjects received, intravenously, on day 0, autologous erythrocytes labelled with 51Cr. Complete daily faecal collections were then made from days 6-12, 20-26 and 34-40. The drug treatments or placebo were given from days 13-41. Faecal blood loss was calculated from 51Cr-specific activity of blood and faeces. Endoscopy was repeated 4-8 hours after the last dose of medication; mucosal appearance was graded on a 5-point scale. Lornoxicam caused no more adverse events than placebo; indomethacin caused more indigestion and central nervous system effects, and one subject in this group was withdrawn from the study. Median total blood losses during the pre-treatment and the second and fourth weeks of treatment were respectively 3.33, 3.95 and 5.71 ml for lornoxicam, 2.87, 7.04 and 7.75 ml for indomethacin, and 4.55, 3.64 and 4.13 ml for placebo. Differences between treatments were not statistically significant (P = 0.081 for second week of treatment, P = 0.383 for fourth week of treatment; Kruskal-Wallis test). The effect of chlortenoxicam on faecal blood loss in this study was thus intermediate between placebo and indomethacin, but within- and between-subject variability was such that the differences were not statistically significant. Endoscopic findings were normal in most subjects before and after all treatments, but indomethacin was associated with a slightly greater deterioration in endoscopic score and was the only treatment associated with Grade 3 appearance (in a single patient) in post-treatment endoscopy.


Assuntos
Anti-Inflamatórios não Esteroides/efeitos adversos , Duodeno/efeitos dos fármacos , Mucosa Gástrica/efeitos dos fármacos , Indometacina/efeitos adversos , Sangue Oculto , Piroxicam/análogos & derivados , Adulto , Método Duplo-Cego , Duodenoscopia , Gastroscopia , Humanos , Masculino , Piroxicam/efeitos adversos
16.
Lung ; 168 Suppl: 737-40, 1990.
Artigo em Inglês | MEDLINE | ID: mdl-2117186

RESUMO

The effect of an immunostimulating drug, OM-85 BV, was demonstrated on recurrent infection rates in 265 elderly patients with a defined state of chronic bronchitis, during a 6-month, double-blind, placebo-controlled trial. Patients receiving OM-85 BV presented less infections (p = 0.005) and a significantly reduced intake of antibiotics (p = 0.02) as compared to those receiving a placebo and the antibiotic intake was significantly reduced (p = 0.02).


Assuntos
Adjuvantes Imunológicos/administração & dosagem , Bactérias , Bronquite/terapia , Extratos Celulares , Infecções Respiratórias/terapia , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Bronquite/imunologia , Doença Crônica , Método Duplo-Cego , Feminino , Humanos , Tolerância Imunológica/efeitos dos fármacos , Masculino , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecções Respiratórias/imunologia
17.
Curr Med Res Opin ; 11(8): 501-9, 1989.
Artigo em Inglês | MEDLINE | ID: mdl-2805771

RESUMO

In a double-blind study, the pharmacodynamic effects of single and repeated doses of two formulations of trazodone were compared in 14 healthy young volunteers (6 men and 8 women). They received either 100 mg trazodone conventional capsules or 150 mg controlled-release tablets daily at 08.00 hours for two 7-day periods separated by a 'wash-out' period of 2 weeks. Blood pressure standing and lying, critical flicker fusion frequency and manual dexterity were measured on Days 1 and 7 of each session before and at intervals up to 8 hours after the dose. Manual dexterity was tested by measuring the time taken to drop 50 airgun pellets down a narrow tube. A daily pre-dose blood sample was also taken for measurement of trazodone to check compliance and to confirm that steady state had been achieved. Steady state plasma concentrations were reached by Day 2 of repeated dosing on both treatments. There was a trend towards shorter duration of the expected depressant effect of trazodone on critical flicker fusion frequency and manual dexterity on Day 7 for both treatments, which was significantly different between treatments for manual dexterity (p less than 0.001): for the controlled-release tablet, manual dexterity performance was better on Day 7 than on Day 1 at all times after dosing, whereas for the conventional capsule manual dexterity was worse on Day 7 than on Day 1 until 4 and 8 hours after dosing, when performance was better than on Day 1. In this study, both formulations of trazodone caused the expected negative effects on psychomotor function. Further studies would be required to confirm the apparent advantage of the controlled-release tablet in the test of manual dexterity.


Assuntos
Trazodona/farmacocinética , Adulto , Análise de Variância , Preparações de Ação Retardada , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Masculino , Trazodona/administração & dosagem , Trazodona/efeitos adversos
18.
Eur Heart J ; 9(5): 489-97, 1988 May.
Artigo em Inglês | MEDLINE | ID: mdl-3402464

RESUMO

DPI201-106 is a new positive inotropic agent. The cardiac electrophysiology of 16 patients was studied before and during DPI 201-106 administration (loading dose of intravenous DPI 201-106, 1.8 mg kg-1 h-1 administered over 10 min, followed by a maintenance dose of 0.2 mg kg-1 h-1). DPI 201-106 had no effect on the sinus node. The AH interval during fixed-rate atrial pacing became prolonged during DPI 201-106 infusion. There was a significant prolongation of the QT interval [QT (corrected), 417 +/- 22 to 502 +/- 35 ms, P less than 0.05; QT (atrial pacing at 600 ms), 374 +/- 17 to 419 +/- 23 ms, P less than 0.05; QT (ventricular pacing at 600 ms), 409 +/- 37 to 449 +/- 30 ms, P less than 0.05]. The ventricular effective refractory period significantly prolonged during DPI 201-106 administration (242 +/- 21 to 287 +/- 56 ms, P less than 0.05), but the supernormal-period duration decreased. The atrial effective refractory period was shortened in four patients and prolonged in one (261 +/- 67 to 240 +/- 53 ms, NS). The corrected atrial repolarization time (PTac) shortened significantly during DPI 210-106 infusion (479 +/- 26 to 445 +/- 22 ms at 20 min of the maintenance dose, P less than 0.05). Atrial fibrillation was initiated in five patients during DPI infusion, but no ventricular arrhythmia was provoked. These findings suggest that DPI 201-106 has novel differential electrophysiological effects on atria and ventricles.


Assuntos
Eletrocardiografia , Coração/efeitos dos fármacos , Contração Miocárdica/efeitos dos fármacos , Piperazinas/farmacologia , Adolescente , Adulto , Idoso , Eletrofisiologia , Feminino , Coração/fisiopatologia , Bloqueio Cardíaco/fisiopatologia , Sistema de Condução Cardíaco/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Piperazinas/sangue , Período Refratário Eletrofisiológico/efeitos dos fármacos , Estimulação Química
19.
Am J Cardiol ; 61(9): 28E-30E, 1988 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-2831702

RESUMO

The hemodynamic response of isosorbide-5-mononitrate (IS-5-MN) to the addition of the widely used therapy of diuretic drugs and the maximally tolerated dose of enalapril for heart failure was assessed in 8 patients with congestive heart failure (CHF) (New York Heart Association class II and III). The diuretic therapy was furosemide, 40 to 80 mg/day, with or without amiloride, 5 to 10 mg/day. The dose of enalapril was 5 to 20 mg/day. Four hours after the administration of the morning dose of enalapril, a Swan-Ganz catheter was positioned in the pulmonary artery. Patients received increasing doses of IS-5-MN to produce a satisfactory decrease in pulmonary capillary wedge pressure. Two of the first 3 patients studied had a large reduction in blood pressure when given 10 mg of IS-5-MN. Subsequent patients were therefore given an initial dose of 5 mg, the total dose being 5 to 20 mg over 2 hours. Results at baseline and 1 hour after the final dose of IS-5-MN are expressed as mean +/- standard deviation. Both pulmonary artery systolic and diastolic pressures decreased significantly (p less than 0.05) by 12.2 +/- 8.9/4.2 +/- 5.2 mm Hg, from 47.2 +/- 16.0/21.6 +/- 6.0 mm Hg to 35.0 +/- 15.2/17.4 +/- 9.3 mm Hg. Pulmonary capillary wedge pressure decreased by 8.6 +/- 4.4 mm Hg, from 22.1 +/- 5.4 to 13.6 +/- 7.5 mm Hg (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)


Assuntos
Diuréticos/administração & dosagem , Enalapril/administração & dosagem , Insuficiência Cardíaca/tratamento farmacológico , Dinitrato de Isossorbida/análogos & derivados , Idoso , Pressão Sanguínea/efeitos dos fármacos , Débito Cardíaco/efeitos dos fármacos , Doença Crônica , Quimioterapia Combinada , Feminino , Insuficiência Cardíaca/fisiopatologia , Frequência Cardíaca/efeitos dos fármacos , Humanos , Dinitrato de Isossorbida/administração & dosagem , Dinitrato de Isossorbida/uso terapêutico , Masculino , Pessoa de Meia-Idade , Pressão Propulsora Pulmonar/efeitos dos fármacos
20.
Arch Fr Pediatr ; 43(8): 621-4, 1986 Oct.
Artigo em Francês | MEDLINE | ID: mdl-3813785

RESUMO

A prospective study was carried out among 190 low birthweight neonates (less than 2,500 g) in order to assess their ratio of total body fat by 2 adiposity indices: Weight/Height3 (W/H3) at birth and Weight/Height2 (W/H2) subsequently. Adequate for gestational age (AGA) girls with weight indices (W/H3) above the 10th percentile (AGA/I+) had a lower height than AGA/I- girls on the 6th (p less than 0.01) and 9th (p less than 0.05) months of corrected chronological ages. Mean weight and height of small for gestational age (SGA) neonates with weight indices (W/H3) lower than the 10th percentile (SGA/I-) were similar to the SGA/I+ as soon as 3 months of corrected chronological age. SGA/I+ infants experienced a progressive increase in low weight indices (W/H2) until 15-18 months without significant differences with SGA/I- at 3, 6, 9 months of corrected chronological age. Meanwhile, low indices (W/H2) were more frequently observed in SGA/I- at 15-18 months. Thus the early characteristics in weight indices disclose a lower ratio of body fat in SGA infants than in normal children, at least up to age 15-18 months.


Assuntos
Peso Corporal , Recém-Nascido de Baixo Peso/crescimento & desenvolvimento , Tecido Adiposo/fisiologia , Estatura , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Masculino , Estudos Prospectivos , Fatores de Tempo
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