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1.
J Behav Ther Exp Psychiatry ; 84: 101955, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38428361

RESUMO

BACKGROUND AND OBJECTIVES: Previous theoretical and empirical work has pointed to the important role of the body in emotion generation and emotion regulation. In the present study, we wanted to investigate if the performance of certain body postures and movement could facilitate cognitive restructuring of dysfunctional cognitive attitudes more effectively than traditional, verbal-only methods. METHODS: In total, 130 participants were randomized to one of two groups. One group was subjected to cognitive restructuring (i.e., restructure only group; CR-only), verbally exploring a dysfunctional attitude from a curious, strong, and courageous perspective. The other group received the same verbal instructions but in addition to this, was asked to perform different bodily exercises (i.e., motor-enhanced restructuring group; M-CR) supposed to enhance experience of the different perspectives from which cognitive restructuring was employed. RESULTS: Results confirmed the primary hypothesis, showing that the M-CR-group showed a larger decline in belief in dysfunctional attitudes compared with the CR-only group (F = 4.2, p = 0.041, d = 0.25). No differences on secondary outcomes were observed between the two groups. LIMITATIONS: Future research should explore the effects of motor-enhanced CR both more long-term (e.g., durability over weeks) and in clinical samples (e.g., anxiety and depression). CONCLUSION: Should the findings be replicated in clinical samples, it is encouraging that simple bodily exercises can enhance the effect of one of the most central skills of cognitive therapy.


Assuntos
Terapia Cognitivo-Comportamental , Postura , Adolescente , Adulto , Feminino , Humanos , Masculino , Adulto Jovem , Atitude , Terapia Cognitivo-Comportamental/métodos , Movimento/fisiologia , Postura/fisiologia
2.
Vasa ; 33(4): 219-25, 2004 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-15623197

RESUMO

BACKGROUND: Risk of subsequent deep vein thrombosis (DVT) following superficial vein thrombosis (SVT) is not fully appreciated. Mechanisms, time relations and risk factors for DVT arising upon earlier SVT remain unclear. The aim of this study was to analyze time relations between local symptoms of lower limb superficial vein thrombosis, duplex findings and onset of deep vein thrombosis during clinically evident course of SVT. PATIENTS AND METHODS: 46 patients with early (onset less than 72 hours prior to inclusion) clinical diagnosis of SVT, confirmed ultrasonographically were included in this prospective, multicenter study. Progress of pain, erythema and swelling in relation to subsequent ultrasound changes in size and localization of thrombus at 0, 7, 14 and 21 day of study has been recorded. RESULTS: Local symptoms subsided completely during 3 weeks. At that time thrombus disappeared completely only in 26% of cases, in remaining cases decreased in size from average 117.5 mm to 43.0 mm. Thrombus regression was similar to venous blood outflow direction--proximal to femoral area. Thrombus propagation was observed following regression of local symptoms of SVT. 4 cases of DVT (8.7%) were diagnosed at 2-11 days. CONCLUSIONS: Local, clinically detectable symptoms of SVT regress incomparably quicker than thrombus in affected veins. Risk of further thrombus propagation extends well beyond the period of intensive local symptoms of SVT. Regression of thrombus in femoral area requires significantly more time than in popliteal or calf segment. Thrombus propagation is directed with blood flow towards femoral segment.


Assuntos
Medição de Risco/métodos , Índice de Gravidade de Doença , Trombose Venosa/classificação , Trombose Venosa/diagnóstico por imagem , Adulto , Idoso , República Tcheca/epidemiologia , Progressão da Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polônia/epidemiologia , Fatores de Risco , Distribuição por Sexo , Ultrassonografia , Trombose Venosa/epidemiologia
3.
Eur J Vasc Endovasc Surg ; 28(5): 473-8, 2004 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-15465367

RESUMO

OBJECTIVE: o analyse the effect of superficial and perforating veins surgery on deep vein incompetence. METHODS: During a six-month period between 2000 and 2001 24 patients (32 limbs) with chronic venous insufficiency (CVI) were treated. They were selected because they had varicose veins and proximal deep vein incompetence with photoplethysmography (PPG) venous refilling time (VRT) <15 s with a below knee tourniquet, and a femoral or popliteal vein reflux time (RT) >1.5 s on duplex ultrasound. The group was divided according to aetiology into 21 legs with primary (Ep) and 11 with secondary CVI (Es). All patients underwent removal of varices with stripping of the saphenous veins, if appropriate. In 21 cases subfascial endoscopic perforating vein surgery (SEPS) was performed to ligate incompetent perforating veins. RESULTS: The average VRT for the entire group increased from 9.8 s before to 15 s after operation (p<0.001, paired t test). In the Ep group the average VRT increased from 11 to 18 s (p<0.001, paired t test), in Es group from 7.5 to 10 s (p>0.001, paired t test). Duplex ultrasonography before surgery showed femoral vein incompetence in 28 and the popliteal incompetence in 26 cases. The average femoral vein RT was 1.9 s before and 1.4 s after surgery (p<0.001, paired t test). The femoral RT in the Ep group decreased from 1.9 to 1.3 s (p<0.001, paired t test) and in the Es group from 1.9 to 1.6 s (N.S.). In the popliteal vein, RT was 1.8 s before, and 1.3 s after surgery (p<0.001, paired t test). The RT in the Ep group shortened from 1.8 to 1.1 s (p<0.001 paired t test) and in the Es group from 1.9 to 1.5 s (N.S.). CONCLUSION: Surgical treatment of varicose veins and of calf perforators results in reduced deep vein reflux. The improvement is most marked in cases of primary venous insufficiency.


Assuntos
Varizes/cirurgia , Procedimentos Cirúrgicos Vasculares/métodos , Insuficiência Venosa/cirurgia , Endoscopia , Feminino , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Pletismografia , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Varizes/complicações , Varizes/fisiopatologia , Insuficiência Venosa/complicações , Insuficiência Venosa/diagnóstico , Insuficiência Venosa/fisiopatologia
5.
Ann Oncol ; 13(8): 1225-35, 2002 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-12181246

RESUMO

BACKGROUND: Docetaxel has yielded promising response rates as a component of doxorubicin-based combination schedules in patients with metastatic breast cancer, including docetaxel/doxorubicin and docetaxel/doxorubicin/cyclophosphamide (AC). This randomized two-stage phase II study was conducted to evaluate sequential treatment with docetaxel and AC as first-line treatment in patients with recurrent or metastatic breast cancer previously untreated with chemotherapy for metastatic disease. PATIENTS AND METHODS: Thirty-three patients were randomized to either docetaxel (100 mg/m(2)) on day 1 of a 21-day cycle for three cycles followed by AC (60/600 mg/m(2)) on day 1 of a 21-day cycle for three cycles (n = 17) or vice-versa (n = 16), without prophylactic granulocyte colony-stimulating factor support. In addition, we compared pre-treatment serum sErbB1 and sErbB2 protein concentrations with that of an age- and menopausal status-matched group of healthy women, and examined changes in serum sErbB1 and sErbB2 protein concentrations in these two treatment schedules. Data from each one of the two arms of the trial (docetaxel then AC, or AC and then docetaxel) were analyzed separately. RESULTS: Enrollment was suspended after the first-stage of accrual, based on statistical design. Confirmed objective response rates after six cycles of treatment were 35% [95% confidence interval (CI) 14% to 62%] with docetaxel then AC and 38% (95% CI 15% to 65%) with AC then docetaxel. Dose reductions were frequent and mostly due to grade 4 neutropenia. Median survival time was 2.5 years in the docetaxel then AC group, and 1.1 years in the AC then docetaxel group. Serum sErbB1 concentrations were not significantly different between the study patients and healthy women, and did not change significantly after three and six cycles of treatment. In contrast, serum sErbB2 concentrations were significantly higher in the study patients compared with healthy women and tended to decrease after three and six cycles of treatment. CONCLUSIONS: Response rates at the end of six cycles of treatment, which led to termination of accrual after the first stage using either the sequence of docetaxel first or docetaxel after AC chemotherapy, were lower than anticipated. However, median survival times and median progression-free survival times are similar to those reported in other studies. These data further suggest that additional studies to assess whether serum sErbB2 concentrations are useful predictors of responsiveness to chemotherapy are warranted.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Paclitaxel/análogos & derivados , Taxoides , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/patologia , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/tratamento farmacológico , Carcinoma Ductal de Mama/patologia , Carcinoma Lobular/tratamento farmacológico , Carcinoma Lobular/patologia , Estudos de Casos e Controles , Ciclofosfamida/administração & dosagem , Progressão da Doença , Docetaxel , Doxorrubicina/administração & dosagem , Receptores ErbB/sangue , Feminino , Humanos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/patologia , Paclitaxel/administração & dosagem , Receptor ErbB-2/sangue , Indução de Remissão , Taxa de Sobrevida
6.
Leukemia ; 15(8): 1171-5, 2001 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-11480558

RESUMO

In an earlier study of previously untreated patients with chronic lymphocytic leukemia (CLL), we used a concomitant combination of chlorambucil and 2-chlorodeoxyadenosine and reported overall (OR) and complete (CR) remission rates of 80% and 20%, respectively. After a median follow-up of 5 years, more than 80% of the responders have had a relapse. In the current phase II study of 27 previously untreated patients with CLL, we used a sequential combination of six cycles of intravenous cyclophosphamide (1 g/m2) plus oral prednisone (100 mg/m2 per day for 5 days) followed by two to six cycles of 2-chlorodeoxyadenosine (5 mg/m2 per day for 5 days). The OR and CR rates were 96% and 33%, respectively. After a median follow-up of 29 months, 35% of the responders have had a relapse. Progression-free survival was significantly better in CR patients than in those with partial remission. However, minimal residual disease was phenotypically detected in four of the nine CR patients. Despite the fact that the current OR and CR rates are superior to those seen in a historical cohort treated with a concomitant schedule, a longer follow-up period is needed to assess the durability of these remissions, and a controlled trial is necessary to estimate the impact on overall survival and toxicity.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Adulto , Idoso , Cladribina/administração & dosagem , Ciclofosfamida/administração & dosagem , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Leucemia Linfocítica Crônica de Células B/mortalidade , Leucemia Linfocítica Crônica de Células B/patologia , Masculino , Pessoa de Meia-Idade , Prednisona/administração & dosagem , Indução de Remissão
7.
Int J Occup Med Environ Health ; 14(1): 35-41, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11428254

RESUMO

Good practice in health, environment and safety management in enterprise (GP HESME) is a process that aims at continuous improvement in health, environment and safety performance, involving all stakeholders within and outside the enterprise. This WHO program is supported by other international organizations, and the declaration of Ministers of Health and Ministers of Environment adopted in 1999. The basic issues of the GP HESME concept are presented as well as its prerequisites, benefits and participants. The key partners in GP HESME are employers and their organizations, representatives of employees, governmental agencies, local authorities, financial and insurance institutions, occupational health services, environmental and social services, associations of professionals, research and training institutions. The HESME system is intended to function at different levels: international, national, local community, and enterprise settings. The lists of expected benefits for each group of stakeholders are discussed. Evaluation of GP HESME is based on the criteria and indicators, the most important of them are briefly presented.


Assuntos
Política de Saúde , Serviços de Saúde do Trabalhador/normas , Gestão da Segurança/normas , Gestão da Qualidade Total , Europa (Continente) , Humanos , Cooperação Internacional , Política , Indicadores de Qualidade em Assistência à Saúde
8.
Med Sci Monit ; 7(2): 316-24, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11257743

RESUMO

Intimal hyperplasia is extensively studied in order to improve arterial reconstruction outcome. The mechanisms leading to stenosis or restenosis may vary according to the technique used for arterial reconstruction. Lesions are mostly made of an accumulation of smooth muscle cells and fibroblasts, with only sparse inflammatory cells. The accumulated material reduces the graft lumen and ultimately induces thrombosis. Intimal hyperplasia with smooth muscle cell and matrix accumulation is the prominent feature in all these situations with evidences of intense cell proliferation and cell death. The purpose of this review is to present the biology of intimal hyperplastic response based on the recently published data. Experiments in the rabbits have shown that the vein wall thickening is mainly regulated by the tangential wall stress which is applied transversely to the vein wall as a blood pressure. Experiments in the rat carotid artery balloon injury suggested that heparin could be used as a treatment to prevent intimal hyperplasia. Treatments for preventing restenosis after angioplasty or stenoses development in bypasses have been disappointing clinical evaluation suffers from insufficient prospective randomized studies. Intimal hyperplasia is the major cause of failure after arterial reconstruction. The biology of intimal hyperplasia is complex, and treatment disappointing. Some types of hyperplasia may need to be preserved in order to prevent functional atrophy and aneurysmal dilatation of vein grafts.


Assuntos
Túnica Íntima/fisiologia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Divisão Celular , Humanos , Músculo Liso Vascular/citologia
9.
Pol Merkur Lekarski ; 11(66): 491-4, 2001 Dec.
Artigo em Polonês | MEDLINE | ID: mdl-11899845

RESUMO

The aim of our study was to evaluate the frequency of C. pneumoniae infection in abdominal aortic aneurysm (AAA) patients by measuring C. pneumoniae specific serum IgG, IgM and IgA levels and the activation of their immune system by measuring the concentrations of IL-10, IL-12, IFN-gamma and TNF-alpha in patients' serum. Microimmunofluorescence method was applied to evaluate the level of anti-C. pneumoniae IgG, IgA and IgM. The concentrations of cytokines were evaluated using ELISA method. Serologic markers of persistent C. pneumoniae infection have been detected in 25/28 (89.3%) patients and in 6/20 (30%) healthy controls. In 40% (10/25) of patients with serologic markers of persistent C. pneumoniae infection high titers of specific IgG and IgA indicated active infection--reinfection or exacerbation of chronic infection. Mean concentrations of IL-10, IL-12, IFN-gamma and TNF-alpha indicated lack of protection against intracellular pathogens. Since all patients in this group were diagnosed as having symptomatic AAA, we suggest that active infection can exacerbate inflammation in the AAA wall and accelerate progression of the disease. In our opinion patients with active C. pneumoniae infection may be candidates to the antimicrobial treatment.


Assuntos
Aneurisma da Aorta Abdominal/imunologia , Aneurisma da Aorta Abdominal/microbiologia , Infecções por Chlamydophila/imunologia , Chlamydophila pneumoniae , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/sangue , Aneurisma da Aorta Abdominal/patologia , Estudos de Casos e Controles , Infecções por Chlamydophila/sangue , Infecções por Chlamydophila/microbiologia , Infecções por Chlamydophila/patologia , Chlamydophila pneumoniae/imunologia , Ensaio de Imunoadsorção Enzimática , Feminino , Fluorimunoensaio , Humanos , Imunoglobulina A/sangue , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Interferon gama/sangue , Interleucina-10/sangue , Interleucina-12/sangue , Masculino , Pessoa de Meia-Idade , Fator de Necrose Tumoral alfa
10.
Ginekol Pol ; 72(11): 862-6, 2001 Nov.
Artigo em Polonês | MEDLINE | ID: mdl-11848026

RESUMO

OBJECTIVES: The results of treatment of 74 patients with vesicovaginal fistulas are presented. MATERIALS AND METHODS: The clinical analysis have been performed in 74 women aged from 24 to 70 years (on average 53.4), who had to be treated for vesicovaginal fistulas in the Department of Urology of Lublin University School of Medicine between 1966-1999. RESULTS: The most common cause of vesicovaginal fistulas was gynaecological surgery. Patients who-underwent the operation 96, 9% were cured (after 1st operation 84, 8%). 8 cases were cured by using conservative therapy.


Assuntos
Procedimentos Cirúrgicos em Ginecologia , Fístula Vesicovaginal/etiologia , Fístula Vesicovaginal/cirurgia , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento
11.
Ginekol Pol ; 72(11): 867-70, 2001 Nov.
Artigo em Polonês | MEDLINE | ID: mdl-11848027

RESUMO

Our observations of 14 women with vesico-uterine fistulas as a result of caesarean section complications were presented. The patients were treated between 1965-1999 in urology clinic in Lublin. The case were diagnosed on the basis of medical history, radiological investigations and cystoscopy. In 3 cases hysterectomy was performed, in the rest of cases uterus was preserved and after the first operation complete recovery was observed.


Assuntos
Cesárea/efeitos adversos , Fístula , Fístula da Bexiga Urinária , Doenças Uterinas , Adulto , Feminino , Fístula/diagnóstico , Fístula/etiologia , Fístula/cirurgia , Humanos , Reoperação , Fatores de Risco , Fatores de Tempo , Fístula da Bexiga Urinária/diagnóstico , Fístula da Bexiga Urinária/etiologia , Fístula da Bexiga Urinária/cirurgia , Doenças Uterinas/diagnóstico , Doenças Uterinas/etiologia , Doenças Uterinas/cirurgia
12.
Artigo em Inglês | MEDLINE | ID: mdl-11977305

RESUMO

The aim of this study was to analyze the scientific protocol of 21 patients operated due to abdominal aortic aneurysm. Arterial hypertension was the common feature for the whole group. Typical microscopic changes for true aortic aneurysm in all histopathological findings were approved. A different in size thrombus was always present inside the aortic sac. In every case atherosclerotic lesions were recognized in the aneurysm wall. In some samples the multiple inflammatory infiltration consisting of mononuclear cells were observed. Simultaneously an intensive angiogenesis process was seen.


Assuntos
Aorta Abdominal/patologia , Aneurisma da Aorta Abdominal/patologia , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/etiologia , Calcinose/patologia , Doenças Cardiovasculares/complicações , Colesterol/análise , Colágeno/análise , Endotélio Vascular/patologia , Fibrose , Humanos , Pessoa de Meia-Idade
13.
Ginekol Pol ; 71(9): 1094-8, 2000 Sep.
Artigo em Polonês | MEDLINE | ID: mdl-11082982

RESUMO

Twenty patients, aged 54.4 +/- 12.6 years, suffering from genuine stress urinary incontinence underwent intravaginal slingplasty. The mechanical support for the urethra provided prolen mesh tape. The aim of the study was the assessment of clinical efficacy of newly introduced method of the treatment of genuine stress urinary incontinence. The diagnosis of urinary incontinence was based on patients' history, Gaudenz questionnaire and the results of urodynamic investigation. The mean time of surgical procedure was 20 minutes. The follow-up which was done after 1.5 to 7 months from the operation revealed that all patients remained continent. Among complications related to the procedure were 2 cases of cystotomy, 1 case of retropubic haematoma and 2 cases of urinary retention. None complication required invasive treatment and influenced the end results of the therapy.


Assuntos
Polipropilenos/uso terapêutico , Implantação de Prótese , Incontinência Urinária por Estresse/cirurgia , Adulto , Idoso , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Inquéritos e Questionários , Resultado do Tratamento , Vagina
14.
Med Wieku Rozwoj ; 4(2): 197-205, 2000.
Artigo em Polonês | MEDLINE | ID: mdl-11013873

RESUMO

The aim of the study was the definition of standard approach to a newborn with gastroschisis. The rules of treatment introduced in 1992 enabled the closure of the abdominal wall primarily in all newborns and made it possible to decrease the mortality considerably. This was achieved despite the fact that we usually did not have influence on time and method of delivery or quality of transportation to our department. In the Department of Pediatric Surgery of Institute Mother and Child, in the years 1992-1997, twenty three newborns with gastroschisis were admitted. The standard approach in all patients was the following: insertion of the catheters to the small bowel through the appenddicocaecostomy and to the large bowel through the rectum, intraoperative irrigation of the meconium (mucosolvan), forceful stretching of the abdominal wall, returning of extraabdominal viscera under control of central venous pressure or middle airway pressure (anesthesiologic control). In the postoperative period all patients routinely had controlled ventilation, administration of analgesic drugs, catecholamines, antibiotics and total parenteral nutrition. Intestinal catheters were gradually removed every day for irrigations of all levels. Oral nutrition was started after the return of effective peristalsis. From 23 treated newborns 16 are alive. 7 children died, 4 of them were resuscitated before operation because of severe general condition. Two patients died because of sepsis in the second month of life, one because of SIDS (sudden infant death syndrome) in the third week of life. Sixteen children are followed up. The development of all children is normal.


Assuntos
Gastrosquise/terapia , Músculos Abdominais/cirurgia , Cateterismo , Seguimentos , Humanos , Recém-Nascido , Nutrição Parenteral , Cuidados Pós-Operatórios , Irrigação Terapêutica/métodos , Resultado do Tratamento
15.
Clin Cancer Res ; 6(9): 3486-92, 2000 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-10999733

RESUMO

There continues to be a need for new systemic approaches for the treatment of advanced pancreatic cancer. The purpose of this study was to compare the antitumor activity of the somatostatin analogue octreotide to 5-fluorouracil chemotherapy in a Phase III setting. Eighty-four patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 and limited tumor volume were randomized to receive octreotide 200 microg three times daily or 5-fluorouracil with or without leucovorin. After the first 12 patients had been randomized to octreotide, we increased the dose in the remaining patients to 500 microg three times daily. This change was based on early reports in other studies, suggesting that our original dose may not have been effective and that higher doses of octreotide were well tolerated. A planned interim analysis performed after 84 patients were enrolled demonstrated inferior time to progression and survival for the patients randomized to octreotide. Further accrual to the octreotide arm of this protocol was therefore terminated. Octreotide in doses of 200-500 microg three times daily does not delay progression or extend survival in patients with advanced pancreatic cancer compared with treatment with 5-fluorouracil with or without leucovorin.


Assuntos
Antimetabólitos Antineoplásicos/uso terapêutico , Antineoplásicos Hormonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Ductal Pancreático/tratamento farmacológico , Fluoruracila/uso terapêutico , Octreotida/uso terapêutico , Neoplasias Pancreáticas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antimetabólitos Antineoplásicos/administração & dosagem , Antimetabólitos Antineoplásicos/efeitos adversos , Antineoplásicos Hormonais/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Progressão da Doença , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Humanos , Leucovorina/administração & dosagem , Leucovorina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Octreotida/efeitos adversos , Taxa de Sobrevida
16.
J Clin Oncol ; 18(6): 1239-45, 2000 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-10715293

RESUMO

PURPOSE: Randomized studies have suggested that sucralfate is effective in mitigating diarrhea during pelvic radiation therapy (RT). This North Central Cancer Treatment Group study was undertaken to confirm the antidiarrheal effect of sucralfate. Several other measures of bowel function were also assessed. PATIENTS AND METHODS: Patients receiving pelvic RT to a minimum of 45 Gy at 1.7 to 2.1 Gy/d were eligible for the study. Patients were assigned randomly, in double-blind fashion, to receive sucralfate (1.5 g orally every 6 hours) or an identical looking placebo during pelvic RT. RESULTS: One hundred twenty-three patients were randomly assigned and found assessable. Overall, there was no significant difference in patient characteristics between those receiving sucralfate and those receiving placebo. Moderate or worse diarrhea was observed in 53% of patients receiving sucralfate versus 41% of those receiving placebo. Compared with patients receiving placebo, more sucralfate-treated patients reported fecal incontinence (16% v 34%, respectively; P =. 04) and need for protective clothing (8% v 23%, respectively; P =. 04). The incidence and severity of nausea were worse among those taking sucralfate (P =.03). Analysis of patient-reported symptoms 10 to 12 months after RT showed a nonsignificant trend toward more problems in patients taking sucralfate than in those taking placebo (average, 2.3 v 1.9 problems, respectively; P =.34). CONCLUSION: Sucralfate did not decrease pelvic RT-related bowel toxicity by any of the end points measured and seems to have aggravated some gastrointestinal symptoms.


Assuntos
Antidiarreicos/uso terapêutico , Diarreia/prevenção & controle , Neoplasias Pélvicas/radioterapia , Sucralfato/uso terapêutico , Adulto , Diarreia/etiologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Radioterapia/efeitos adversos , Estatísticas não Paramétricas
17.
J Clin Oncol ; 17(6): 1884-90, 1999 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-10561229

RESUMO

PURPOSE: A prospective randomized phase III clinical trial was conducted to assess whether the addition of tamoxifen (TAM) to the three-agent regimen of cisplatin (CDDP), dacarbazine (DTIC), and carmustine (BCNU) significantly increased the progression-free survival and overall survival of patients with advanced malignant melanoma. PATIENTS AND METHODS: Patients with advanced malignant melanoma were treated with CDDP + DTIC + BCNU (CDB) with or without TAM. The dose schedule was CDDP 25 mg/m(2) given intravenously (IV) for 30 to 45 minutes in 500 mL of dextrose and (1/2) normal saline (NS) on days 1 to 3 of a 3-week cycle; DTIC 220 mg/m(2) IV for 1 hour in 500 mL of dextrose and (1/2) NaCl on days 1 to 3 of a 3-week cycle; BCNU 150 mg/m(2) IV for 2 to 3 hours in 750 to 1,000 mL of dextrose and 5% water on day 1 of every odd 3-week cycle; and TAM 20 mg taken orally every morning. RESULTS: There were 184 eligible patients enrolled. These patients were observed until death or for a minimum of 1.3 years. At last contact, 12 were still alive. The median time to progression was 3.4 months on the CDB arm and 3.1 months on the CDB + TAM arm. The median survival time was 6.8 months with CDB and 6.9 months with CDB + TAM. Progression-free survival (P =.429) and overall survival (P =.545) were not found to differ by treatment. CONCLUSION: The addition of TAM to this three-agent regimen of CDB was not found to provide a meaningful clinical advantage in the treatment of patients with advanced malignant melanoma.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias Oculares/tratamento farmacológico , Melanoma/tratamento farmacológico , Neoplasias Cutâneas/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Carmustina/administração & dosagem , Cisplatino/administração & dosagem , Dacarbazina/administração & dosagem , Intervalo Livre de Doença , Neoplasias Oculares/mortalidade , Feminino , Humanos , Masculino , Melanoma/mortalidade , Pessoa de Meia-Idade , Estudos Prospectivos , Neoplasias Cutâneas/mortalidade , Taxa de Sobrevida , Tamoxifeno/administração & dosagem , Resultado do Tratamento
18.
Am J Clin Oncol ; 22(5): 509-16, 1999 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-10521069

RESUMO

The objective was to determine the safety and efficacy of adding a maximally tolerated dose of 2-chlorodeoxyadenosine (2-CdA) to standard chlorambucil (CLB) therapy in previously untreated B-cell chronic lymphocytic leukemia (CLL). Thirty patients with CLL (median age, 64 years) received two courses of 2-CdA given intravenously (2 mg/m2 daily for 7 days) added to biweekly administration of CLB at 30 mg/m2 given orally. The diagnosis of CLL, treatment indications, and response criteria were according to the National Cancer Institute established guidelines. Sixteen patients (53%) had advanced-stage disease, and four (13%) had trisomy 12 abnormality. The overall remission rate was 80%, including 20% complete remission (CR), 30% nodular partial remission (nPR), and 30% partial remission (PR). Minimal residual disease was detected phenotypically in two of five patients with CR and in eight of nine with nPR. Overall, CR, nPR, and PR rates were not influenced significantly by the presence of cytogenetic abnormalities or advanced clinical stage. With a median follow-up of 33 months, 58% of patients who had a response had relapse. Median time to progression in all 30 patients was 30 months, and time to progression and progression-free survival were not significantly different for the different response groups, clinical stages, or cytogenetic groups. Severe neutropenia and thrombocytopenia occurred in 33% and 7% of patients, respectively. Only two patients had documented bacterial infections, and four had herpetic infections. Concurrent combination chemotherapy with abbreviated doses of 2-CdA and standard-dose CLB is feasible and safe in previously untreated CLL. Antitumor activity may be superior to that of CLB alone given in conventional doses. Whether a different schedule of combining these two agents would result in improved outcome is being investigated.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Clorambucila/administração & dosagem , Cladribina/administração & dosagem , Progressão da Doença , Feminino , Humanos , Leucemia Linfocítica Crônica de Células B/mortalidade , Leucemia Linfocítica Crônica de Células B/patologia , Masculino , Neoplasia Residual/patologia , Análise de Sobrevida , Estados Unidos/epidemiologia
19.
Am J Clin Oncol ; 22(5): 517-22, 1999 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-10521070

RESUMO

Paclitaxel is an antimicrotubule agent that interferes with cell division. It has demonstrated promising single-agent activity against non-small-cell lung cancer. The purpose of this study was to evaluate the therapeutic effectiveness of paclitaxel in previously untreated patients with extensive stage small-cell lung cancer (SCLC). The study was designed as a two-stage phase II trial. All patients who entered received paclitaxel by intravenous infusion at a dose of 250 mg/m2 during 24 hours. Granulocyte colony stimulating factor was also provided to ameliorate neutropenia. Cycles were repeated at 21-day intervals. Patients who achieved a complete response received a maximum of 10 cycles of treatment, whereas those who achieved a partial response/regression continued treatment until progression or undue toxicity developed. Patients who progressed or maintained stable disease for six cycles were crossed over to cisplatin and etoposide. Forty-three patients entered the study and all were evaluable for analysis. Responses were observed in 23 (53%) of the patients. There was no significant difference in the response rates in patients with measurable or evaluable disease (13/23 versus 10/20, p = 0.76). At the time of analysis, 39 patients had progressed with a median time to progression of 95 days, and 39 patients had died with a median survival of 278 days. The 1-year achieved survival rate was 24%. Significant neutropenia (absolute neutrophil count <1,000/microl) occurred in 24 (56%) of the patients, but only 2 patients experienced severe infection (grade > or = 3), and there were no septic deaths. The results indicate that paclitaxel is active against SCLC. Myelosuppression was the main side effect in this patient population. Response duration was short (median = 3.4 months), which suggests that paclitaxel is not sufficient as a single agent. Further studies of paclitaxel in combination with other agents against SCLC are currently in progress within the North Central Cancer Treatment Group and other cancer treatment groups. Key Words: Paclitaxel-G-CSF-Small-cell lung cancer-North Central Cancer Treatment Group.


Assuntos
Antineoplásicos Fitogênicos/uso terapêutico , Carcinoma de Células Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Paclitaxel/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma de Células Pequenas/mortalidade , Progressão da Doença , Feminino , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Neutropenia/induzido quimicamente , Neutropenia/prevenção & controle , Taxa de Sobrevida , Estados Unidos/epidemiologia
20.
Am J Clin Oncol ; 22(3): 258-61, 1999 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-10362332

RESUMO

Mucositis is a prominent dose-limiting toxicity associated with 5-FU-based chemotherapy. On the basis of preliminary data suggesting that the amino acid glutamine could alleviate this problem, the authors developed this trial. Patients scheduled to receive their first 5-FU-based chemotherapy regimen were selected for study. Following stratification, patients were randomized, in a double-blind manner, to receive oral glutamine or a placebo preparation in a prophylactic manner. Patients in both groups were given oral cryotherapy before chemotherapy and were evaluated for mucositis by standard physicians' evaluation and by a self-report instrument. Sixty-six patients were randomized to receive glutamine and 68 to receive the placebo preparation. There were no significant differences or substantial trends in the mucositis scores between the two study arms as measured by either the physicians or the patients. It was concluded that the dose and schedule of glutamine used in this clinical trial does not alleviate 5-FU-induced mucositis.


Assuntos
Antimetabólitos Antineoplásicos/efeitos adversos , Fluoruracila/efeitos adversos , Glutamina/uso terapêutico , Estomatite/induzido quimicamente , Estomatite/prevenção & controle , Administração Oral , Administração Tópica , Idoso , Antimetabólitos Antineoplásicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Feminino , Fluoruracila/administração & dosagem , Glutamina/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Antissépticos Bucais
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