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J Balogh

Publications and source records attributed to J Balogh.

At least 19 recordsLinked to original sources
PubMed2002

Prophylaxis of radiation-associated mucositis in conventionally treated patients with head and neck cancer: a double-blind, phase III, randomized, controlled trial evaluating the clinical efficacy of an antimicrobial lozenge using a validated mucositis scoring system.

PURPOSE: Mucositis occurs in almost all patients treated with radiotherapy for head and neck cancer. The aim of this multicenter, double-blind, prospective, randomized trial was to evaluate the clinical efficacy of an economically viable antimicrobial lozenge (bacitracin, clotrimazole, and gentamicin [BcoG]) in the alleviation of radiation-induced mucositis in patients with head and neck cancer. PATIENTS AND METHODS: One hundred thirty-seven eligible patients were randomized to treatment with either antimicrobial lozenge (69 patients) or placebo lozenge (68 patients). The primary end point of the study was the time to development of severe mucositis from the start of radiotherapy. Secondary end points included severity and duration of mucositis, pain measurement, radiation therapy interruption, and quality of life. Mucositis was scored using a validated mucositis scoring system. RESULTS: Toxicity profiles were similar between the two arms of the study. The median time to development of severe mucositis from the start of radiotherapy was 3.61 weeks on BCoG and 3.96 weeks on placebo (P =.61). There were no statistically significant differences between the arms in the extent of severe mucositis as measured by physician, in oral toxicities as recorded by patients, or in radiotherapy delays. CONCLUSION: This study was conducted on the basis of a pilot study that demonstrated the BCoG lozenge to be tolerable and microbiologically efficacious. A validated mucositis scoring system was used. However, in this group of patients treated with conventional radiotherapy, the lozenge did not impact significantly on the severity of mucositis. Whether such a lozenge would be beneficial in treatment situations where rate of severe mucositis is higher (ie, in patients treated with unconventional fractionation or with concomitant chemotherapy) is unknown.

Administration, Oral↗
PubMed2002

Hearts from mice lacking desmin have a myopathy with impaired active force generation and unaltered wall compliance.

OBJECTIVE: Desmin intermediate filaments are key structures in the cytoskeleton of cardiac muscle. Since they are associated with Z-discs and intercalated discs, they may have a role in sarcomere alignment or force transmission. We have explored the mechanical function of the desmin filaments in the cardiac wall by comparing desmin-deficient (Des-/-) and wild-type (Des+/+) mice. METHODS: The Langendorff technique was used to examine the contractility of the whole heart. Rate of force generation, Ca(2+)-sensitivity and force per cross-sectional area were measured in skinned ventricle muscle preparations. RESULTS: Des-/- mice have a cardiomyopathy with increased heart weight. Diastolic pressure was increased at all filling volumes in the Des-/- group. Since passive wall stress (i.e. force per area) was unchanged, the alteration in diastolic pressure is a consequence of the thicker ventricle wall. Developed pressure, rate of pressure increase and developed wall stress were significantly reduced, suggesting that active force generation of the contractile apparatus is reduced in Des-/-. Concentrations of actin and myosin in the ventricle were unaltered. Measurements in skinned muscle preparations showed a lower active force development with unaltered Ca(2+)-sensitivity and rate of tension development. CONCLUSION: It is suggested that the intermediate filaments have a role in active force generation of cardiac muscle, possibly by supporting sarcomere alignment or force transmission. The desmin filaments do not contribute the passive elasticity of the ventricle wall. Des-/- mice provide a model for genetic cardiomyopathy where the main factor contributing to altered cardiac performance is a decrease in active force generation, possibly in combination with a loss of functional contractile units.

Actins↗
PubMed2001

Nontraumatic osteonecrosis after chemotherapy for testicular cancer: a systematic review.

Nontraumatic osteonecrosis is a well-documented late complication of chemotherapy for hematologic malignancies, with prolonged corticosteroid exposure implicated. Reports of this treatment complication in patients treated with chemotherapy for solid tumors are sparse. We reviewed our institutional experience and the published medical literature to explore an association between chemotherapy for testicular cancer and the occurrence of nontraumatic osteonecrosis. Two databases of men with testicular cancer were reviewed. Search of the medical literature included MEDLINE, CANCERLIT, and EMBASE. Two of 107 men with testicular cancer treated with chemotherapy at our center were identified with nontraumatic osteonecrosis. Literature review identified 14 reports describing patients with 39 solid tumors with osteonecrosis after chemotherapy. Of 38 adults, 28 had testicular cancer and 6 had breast cancer. All patients with testicular cancer had received cisplatin, vinblastine, and bleomycin, or bleomycin, etoposide, and cisplatin. Twenty-seven of 28 had received corticosteroids. Diagnosis was subacute in three and delayed a mean of 26 months (range, 12-47 months) in 26. The femoral head was involved in 26 patients, with bilateral involvement in 18. Crude incidence was 1.5% (95% CI, 0.9-2.1). Nontraumatic osteonecrosis is an infrequent but disabling late complication of cancer chemotherapy reported most commonly in adult patients with testicular cancer. Corticosteroid exposure makes this association plausible.

Adult↗
PubMed2001

[Analysis of antibiotic usage].

Economic analysis is founded on the assumption that resources are limited and that should be used in a way that maximizes the benefits gained. Pharmacoeconomics extends these assumptions to drug treatment. Therefore, a full pharmacoeconomic analysis must consider two or more alternative treatments and should be founded on measurement of incremental cost, incremental efficacy, and the value of successful outcome. Antibiotic policy based only on administrative restrictions is failed, instead of it disease formularies and infectologist consultation system are needed. Equally important are various programmes that encourage the cost-conscious use of the antibiotics chosen. Some of the methods evaluated in the literature include: streamlining from combination therapy to a single agent, early switching from parenteral to oral therapy, initiating treatment with oral agents, administering parenteral antibiotic at home from outset of therapy, and antibiotic streamlining programmes that are partnered with infectious disease physicians. The solution is the rational and adequate use of antibiotics, based on the modern theory and practice of antibiotic policy and infection control, that cannot be carried out without the activities of experts in this field.

Anti-Bacterial Agents↗
PubMed2001

[Therapeutic aspects of HIV/AIDS infected patients and evaluation of therapeutic protocols].

The first HIV-infected patients were treated in 1986, however, at that time medicines inhibiting HIV replication were not available. Solely the complications of AIDS and opportunistic infections could be treated. The HIV replication inhibition capacity of antiretroviral nucleoside and ribavirin were tested in Hungary in 1987, an early date even in international practice. The first nucleoside reverse transcriptase inhibitor (NRTI), azidothymidine, presently called zidovudine (ZDV), was introduced in 1989. By giving patients the appropriate dosage of this, the progression of the disease could be delayed by approximately 6 months to one year. In 1991, the application of two new NRTI was commenced, namely zalcitabine (DDC) and didanosine (DDI). These medicines were applied partly in case of ZDV intolerance and as a part of the sequential monotherapy. In 1994 and 1995 two new NRTI's were introduce, namely stavudine (d4T) and lamivudine (3 TC). At that same time, to obtain a more effective replication inhibition method, a double NRTI combination became part of the therapeutic protocol. The year 1996 resulted in significant changes. At the beginning of the year, two compounds belonging to two new therapeutic procedures. These are saquinavir (SQV) and delavirdine (DLV) belonging to the groups of protease inhibitors and non-nucleoside reverse transcriptase, respectively. The so-called virus cocktails and the effective active antiretroviral therapy (HAART) were applied and, later, to monitor the efficiency of the treatment, the opportunity was provided to measure the copy number of HIV-RNS. The treatment of the HIV disease entails a number of unanswered questions. The maximum result that can be achieved by using today's therapeutic methods is to prolong that particular phase of the HIV disease, which secures the patient a fairly good quality of life. The new combination of the antiretroviral compounds produced by the pharmaceutical industry provides better changes to prolong said period by years, sometimes decades. However, the real solutions to the problem are only theoretically known treatment procedures (gene therapy, cytokins) today.

Acquired Immunodeficiency Syndrome↗
PubMed1999

Accelerated radiotherapy with delayed concomitant boost in locally advanced squamous cell carcinoma of the head and neck.

PURPOSE: To determine the toxicity, maximum tolerated dose (MTD), and clinical effectiveness of a 5-week course of accelerated radiotherapy with delayed concomitant boost in locally advanced squamous cell carcinoma of the head and neck (SCCHN). METHODS AND MATERIALS: Thirty-five patients with untreated T3T4NM0 or TN2 (> 3 cm) N3M0 SCC of the oral cavity, oropharynx, hypopharynx, or larynx were entered in the study between January 1994 and October 1997. The initial target volume was treated with conventional daily fractions. A small field boost covering gross disease was added as a second daily fraction during the last 2 weeks of the 5-week schedule, using a minimum interfraction interval of 6 h. The study was initiated using 180-cGy fractions to deliver a total dose of 63 Gy over 33-35 days. A classical dose escalation strategy was planned to increase the delivered dose in steps using minimum cohorts of three patients, up to a maximum of 70 Gy in 200-cGy fractions. RESULTS: In the dose escalation study, 4 patients were entered at level 1 (63 Gy), 9 at level 2 (65 Gy), and 8 at level 3 (67 Gy). One patient was withdrawn at level 2 because of unstable angina, and 1 at level 3 because of uncontrolled diabetes. One patient at level 3 failed to complete treatment because of radiation toxicity. RTOG Grade 3 mucositis, dermatitis, or pharyngitis was documented in 1 (25%), 5 (63%), and 7 (100%) evaluable patients at levels 1, 2, and 3, respectively. Grade 4 reactions were documented in 1 patient at each level. One patient at level 3 died 5 weeks post-treatment of unknown causes. Two additional patients at level 3 died of progressive disease and RT toxicity. Sixty-five Gy (level 2) was chosen as the MTD. In the MTD study, 14 additional patients were entered at level 2, providing a total of 22 evaluable patients with a median follow-up of 21 months (range 12-41 months). Grade 3 mucositis, dermatitis, or pharyngitis were documented in 11 (50%), 8 (36%), and 6 (27%) patients, respectively. One patient developed Grade 4 mucositis. A complete response was recorded in 16 (77%). Three of 5 patients with uncontrolled disease and 3 of 3 patients with recurrent disease underwent salvage surgery with no postoperative complications. Radiotherapy controlled disease above the clavicles in 14 (68%). Ultimate locoregional control was achieved in 17 (77%). The disease-free, overall, and cause-specific survival of all patients entered at level 2 was 56%, 76%, and 80%, respectively, at 2 years. Late complications have been limited to 3 patients (trismus, chronic mucosal ulcer, and soft tissue necrosis). CONCLUSION: A 5-week course of accelerated radiotherapy with delayed concomitant boost can deliver 65 Gy with acceptable toxicity, encouraging rates of complete response, and locoregional control, and no compromise of salvage surgery in patients with locally advanced SCCHN. The regimen is worthy of further study in a Phase III trial.

Adult↗
PubMed1999

Diminished responses to IL-13 by human monocytes differentiated in vitro: role of the IL-13Ralpha1 chain and STAT6.

The primary IL-13 receptor complex on human monocytes is believed to be a heterodimer comprised of the IL-4R alpha chain and the IL-2R gamma chain (gamma(c))-like molecule, IL-13R alpha1. mRNA levels for IL-13R alpha1, but not IL-4R alpha, were markedly decreased in in vitro monocyte-derived macrophages (MDMac), and with increasing time of monocytes in culture correlated with the loss of IL-13 regulation of lipopolysaccharide-induced TNF-alpha production. Analysis of cell lines Daudi and THP-1 that differentially express gamma(c) and IL-13R alpha1 showed that IL-13 can activate STAT6 in IL-13R alpha1-positive THP-1 cells but not in gamma(c)-positive, IL-13R alpha1-negative Daudi cells. IL-13 activation of STAT6 was reduced in MDMac which was associated with diminished IL-13-induced expression of CD23 and MHC class II. However, with reduced IL-13R alpha1 expression and low nuclear STAT6 activity, some IL-13-induced responses were unaltered in magnitude in MDMac. In the absence of functional IL-13R alpha1 and gamma(c), IL-13 must signal through an alternative receptor complex on MDMac. Experiments with a blocking antibody to IL-4R alpha showed that this chain remains an essential component of the IL-13 receptor complex on MDMac.

Base Sequence↗
PubMed1999

Differential responses of human monocytes and macrophages to IL-4 and IL-13.

The primary interleukin-4 (IL-4) receptor complex on monocytes (type I IL-4 receptor) includes the 140-kDa alpha chain (IL-4R alpha) and the IL-2 receptor gamma chain, gamma(c), which heterodimerize for intracellular signaling, resulting in suppression of lipopolysaccharide (LPS)-inducible inflammatory mediator production. The activity of IL-13 on human monocytes is very similar to that of IL-4 because the predominant signaling chain (IL-4R alpha) is common to both receptors. In fact, IL-4R alpha with IL-13R alpha1 is designated both as an IL-13 receptor and the type II IL-4 receptor. When the anti-inflammatory activities of IL-4 and IL-13 were investigated on synovial fluid macrophages and compared with the responses by monocytes isolated from the patients at the same time as joint drainage, the response profiles differed with some responses similar in the two cell populations, others reduced on the inflammatory cells. Similar differences were recorded in the response profiles to IL-4 and IL-13 by monocytes and monocytes cultured for 7 days in macrophage colony-stimulating factor (M-CSF) or granulocyte-macrophage CSF (GM-CSF) (monocyte-derived macrophages, MDMac). MDMac have reduced gamma(c) mRNA levels and reduced expression of the functional 64-kDa gamma(c). There was a similar loss of IL-13R alpha1 mRNA on monocyte differentiation. In turn, there was a significant reduction in the ability of IL-4 and IL-13 to activate STAT6. These findings suggest that different functional responses to IL-4 and IL-13 by human monocytes and macrophages may result from reduced expression of gamma(c) and IL-13R alpha1.

Cell Differentiation↗
PubMed1998

The prognostic significance of tracheostomy in carcinoma of the larynx treated with radiotherapy and surgery for salvage.

PURPOSE: To determine retrospectively the prognostic significance of airway compromise necessitating tracheostomy in carcinoma of the larynx managed with radical radiotherapy and surgery for salvage (RRSS). METHODS AND MATERIALS: The charts of 270 patients managed with RRSS at the Toronto-Sunnybrook Regional Cancer Centre between June 1980 and December 1990 were reviewed. Airway compromise necessitating tracheostomy was documented in 26 patients prior to radiotherapy and 3 patients during radiotherapy. Of 29, 27 had T3T4 primaries. Patients have been followed for a median of 5 years. RESULTS: Patients managed without tracheostomy had a 2-year disease-free survival of 74% compared to 41% for those managed with tracheostomy. The adverse impact of airway compromise was more marked in patients with glottic primaries (78% vs. 32%, p = 0.0001) than those with supraglottic primaries (64% vs. 47%, p = 0.18). Tracheostomy was identified in univariate analysis, but not in multivariate analysis, as having a statistically significant impact on local control and local-regional control. Radiotherapy controlled disease above the clavicles in 185 of 267 (69%) evaluable patients. 83% of isolated local-regional failures underwent salvage surgery. Among those managed without tracheostomy, ultimate local-regional control (LRC) was achieved in 161 (94%) of 172 glottic primaries and 54 (81%) of 67 supraglottic primaries. Among those managed with tracheostomy, ultimate LRC was achieved in 9 (69%) of 13 glottic primaries and 12 (80%) of 15 supraglottic primaries. In a subset analysis of 76 patients with T3T4 primaries, there was no statistically significant difference in larynx preservation, disease-free survival, or cause-specific survival between those managed with and without tracheostomy. CONCLUSION: Airway compromise necessitating tracheostomy is an adverse prognostic factor in patients with carcinoma of the larynx. However, larynx preservation is possible in over 40% of those undergoing tracheostomy and radiotherapy with no compromise of cause-specific survival. The need for pretreatment tracheostomy should not rule out the possibility of RRSS.

Adult↗
PubMed1998

Gap-filling and end-of-sentence effects in real-time language processing: implications for modeling sentence comprehension in aphasia.

We present an on-line study showing different sources of lexical activation during sentence comprehension, distinguishing in this respect between reflexive syntactic and less temporarily constrained nonsyntactic sources. Specifically, we show that both the syntactic process of gap filling and a nonsyntactic end-of-sentence effect can be measurable in real time and can be temporally separated. The distinction between activation sources provides a new perspective on real-time sentence comprehension in aphasia and accounts for the disparate results reported in the literature.

Aged↗
PubMed1998

A randomized trial of standard versus partially hyperfractionated radiation with or without concurrent 5-fluorouracil in locally advanced cervical cancer.

The objective of this study was to determine whether the addition of concurrent 5-fluorouracil (5-FU) and/or a change in radiation fractionation improves pelvic control and survival or decreases complications in advanced cervical cancer, FIGO stages IB/IIA (>=5 cm) to IVA inclusive. After stratification by pelvic disease extent, 234 of a planned 292 patients were randomized to receive one of four possible treatments: (a) standard external beam pelvic irradiation (RT) 5000 cGy in 25 fractions versus (b) RT as in arm (a) with infusional IV 5-FU 1g/m2 daily in the first and last 4 days of RT, (c) partially hyperfractionated RT, 5280 cGy in 33 fractions, two fractions per day on the first and last 4 days of RT, or (d) arm (c) with the same FU. All were followed with a linear source of intracavitary RT to deliver 40 Gy. The median duration of follow-up for the 221 evaluable patients was 59 months. The 5-year Kaplan-Meier disease-free survival (DFS) in arm (a), (c), (d), and (b), respectively, were 45, 53, 58, and 61%. The differences in survival and pelvic control were not statistically significant. An exploratory subset analysis was performed within stratum 1 and stratum 2 to generate hypotheses for future studies. Only for the 99 patients in stratum 1 (IB/IIA or medial parametrial IIB disease) was the 5-year DFS significantly better (long rank P = 0.05) for standard RT and 5-FU. The DFS was 39% for arm (a), 76% for arm (b), 58% for arm (c), and 65% for arm (d). A multivariate analysis of patient, tumor, and treatment related prognostic factors identified only the use of 5-FU to account for the observed difference. The crude serious late bowel or bladder complication rate was 5.9%. Overall concurrent infusional 5-FU was not beneficial when added to standard RT in this study. The possible benefit for patients in stratum 1 requires exploration in a further randomized trial with appropriate accrual.

Adult↗
PubMed1997

Human bioequivalence study of a new nifedipine containing retard filmtablet after single and repeated administration.

A clinical pharmacokinetic bioequivalence study with two retard filmtablet preparations, both containing 20 mg of nifedipine (CAS 219829-25-4) was carried out. The investigated test preparation was Cordaflex 20 mg retard filmtablet. The pharmacokinetic parameters were determined after single and repeated administration in 15 and 16 healthy male volunteers, respectively, in open, randomised studies of cross-over design. Plasma levels of nifedipine were determined by HPLC with electrochemical detection using a robotic sample preparation technique. Statistical comparison of the pharmacokinetic parameters (AUC0-infinity, AUCss, tau tmax, Cmax, Css,min, Css,av, MRT, etc.) calculated from plasma concentration-time curves by ANOVAlog, confidence interval, Schuirman's, Westlake's, Anderson's and Wilcoxon's tests, furthermore the comparison of the clinical results did not show any significant difference between the two preparations. It is concluded that the two preparations are bioequivalent after repeated administration.

Adult↗
PubMed1997

Is selective neck dissection sufficient treatment for the N0/Np+ neck?

OBJECTIVE: The purpose of this study was to evaluate the therapeutic role of selective neck dissection performed electively in the N0 patient. METHOD: Fifty-four patients with squamous cell carcinoma of the oral cavity, pharynx, and larynx, without clinical evidence of lymph node metastases, underwent 72 selective neck dissections over a 6-year period. The preoperative tumour and patient data were recorded in all patients. Mean follow-up was 59 months. Outcome data pertaining to pathologic nodal status, tumour recurrence, and survival were recorded on all patients. RESULTS: Eighty-one percent of patients were histologically and clinically node negative. Seven percent of N0/Np0 patients failed in the neck compared to 50% of patients with occult nodal metastases (N0/Np+). Salvage treatment following nodal recurrence was successful in only one patient. CONCLUSION: Selective neck dissection does not compromise survival and may minimize surgical morbidity in the N0/Np+ population.

Adult↗
PubMed1996

Endometrial carcinoma--relative effectiveness of adjuvant irradiation vs therapy reserved for relapse.

Fifty-four patients with recurrent endometrial carcinoma were identified from a retrospective review of charts of 304 endometrial cancer patients seen between 1983 and 1989 at our center. A review was undertaken to identify the patterns of relapse, to determine the outcome of salvage treatment, to examine the factors predictive of effective salvage, and, if salvage is effective, to assess an alternative strategy to routine adjuvant postoperative pelvic radiotherapy. Forty percent of the entire recurrent population are long-term survivors. Of the 54 relapsing patients, primary therapy had been surgery alone in 32 and surgery and adjuvant radiotherapy (rt) in 22. Isolated pelvic recurrence was the predominate relapse site in those who had not received adjuvant pelvic RT as primary therapy (23 of 32 or 72%). Distant relapse predominated in those who received adjuvant RT (17 or 22 or 77%). Twenty-eight (54%) failed in the pelvis alone, and 26 (46%) had a component of distant failure. Of the 28 with isolated pelvic relapse, 16 had vaginal mucosal disease involvement only and 12 had disease in the parametrium and/or the pelvic sidewall. With a minimum follow-up for the survivors of 5 years, 21 of the 28 with isolated pelvic relapse received radical radiotherapy and 14 or 67% had maintained pelvic control until death or last follow-up. Eleven of 14 (79%) with disease confined to the mucosa had pelvic control, whereas only 3 of 7 (43%) with extramucosal disease were controlled. No patient experienced major treatment-related toxicity. Tumor size, anatomic extent of pelvic recurrence, RT dose, and disease-free interval were examined for prognostic significance for pelvic control and survival by univariate analysis. Only anatomic extent of pelvic recurrence showed a nonstatistically significant trend as a predictor for control with P = 0.08. In conclusion, a significant proportion of patients with disease recurrence confined to the pelvis can be rendered disease-free long-term with maintained pelvic control. A reexamination of the role of routine adjuvant pelvic RT is therefore undertaken in light of these data.

Aged↗
PubMed1996

[Comparative human pharmacokinetic studies of 20 mg nifedipine-containing Cordaflex and Adalat film coated retared tablets].

Comparative pharmacokinetic studies have been carried out with two 20 mg nifedipine active substance-containing retard film coated tablets, Cordaflex produced by EGIS Pharmaceuticals Co., Ltd. and Adalat of Bayer AG. The pharmacokinetic parameters and the relative bioavailability were determined in 15 and 16 healthy male volunteers, respectively after single and repeated administration in open, randomized cross over study. The plasma concentration of nifedipine was determined by HPLC-ED method, using laboratory robot for automated sample preparation. On the basis of graphical and statistical comparison of the pharmacokinetic parameters (AUC0-infinity, AUCss,0-tau, tmax, Cmax, Css,min, Css,av, MRT, etc.) calculated from the time-plasma concentration curve, moreover on the basis of clinical results, there was no significant difference between the two preparations. In conclusion, the relative bioavailability of Cordaflex and Adalat 20 mg retard tablets did not show significant difference after single and repeated administration.

Administration, Oral↗