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Biomedical subjects

G Hommel

Publications and source records attributed to G Hommel.

At least 19 recordsLinked to original sources

Hyperviscosity syndrome in patients with ovarian carcinoma.

BACKGROUND: In patients with ovarian carcinoma, an hematocrit-independent hyperviscosity syndrome is often present. The syndrome is characterized by normal or low hematocrit and hemoglobin concentration, an elevated platelet count, and an increase in clotting factor turnover. Because deep vein thrombosis (DVT) often complicates the course of ovarian carcinoma, the aim of this study was to investigate the possible association of hyperviscosity syndrome with the development of DVT. METHODS: Rheologic estimations of the blood included red blood cell (RBC) aggregation (stasis and low shear), plasma viscosity (pv), blood cell count, and fibrinogen, which were performed before primary surgery and the beginning of perioperative heparin thrombosis prophylaxis on 63 of 65 patients with Stage I-IV ovarian malignancy (according to the staging criteria of the International Federation of Gynecology and Obstetrics). Two patients who had had DVT 5-6 weeks in advance of the study were excluded from rheologic calculations. Thrombosis screening by impedance plethysmography was performed the day before primary major surgery; postoperatively on Days 1, 3, 5, 7, and 10; before each of 6 cycles of chemotherapy (once every 3 weeks); and thereafter once every 3 months during follow-up. All blood tests were also performed on 72 healthy women and 29 patients with benign ovarian tumor the day prior to surgery. RESULTS: All ovarian carcinoma patients, including 7 patients with tumors of low malignant potential, were eligible for surgery, and all except those with Stage IV disease (n = 12) were macroscopically tumor free after surgery. Before surgery, RBC aggregation, pv, and platelet and fibrinogen concentrations were significantly higher (P < 0.05) in cancer patients than in either of the control groups, whereas hemoglobin (hb) and hematocrit (hct) were significantly lower in cancer patients than in healthy women (P < 0.001). Platelet, leukocyte, and fibrinogen concentrations were significantly correlated to disease stage, whereas pv, RBC aggregation, hb, and hct were not. The preoperative pv was significantly higher in patients who later developed DVT (n = 17; 1.46+/-0.13 mPas; P = 0.01) than in those who did not (1.34+/-0.14 mPas). Of all estimated preoperative variables, only pv was a significant risk factor for postoperative and subsequent DVT (RR: 29.84; 95% CI: 1.076-827.16; P = 0.04). CONCLUSIONS: Our results confirm the presence of a hematocrit- and stage-independent hyperviscosity syndrome in untreated ovarian carcinoma patients. In addition, a high preoperative plasma viscosity was a significant risk factor for the development of DVT in the postoperative period and even thereafter.

Adult

Prospective evaluation of parathyroid graft function after total parathyroidectomy and heterotopic autotransplantation in renal hyperparathyroidism by bilateral determination of intact parathormone in cubital venous blood.

The value of gradients for intact parathyroid hormone (PTH) in the assessment of graft function after total parathyroidectomy/autotransplantation for renal hyperparathyroidism was evaluated in a prospective follow-up study. Altogether 99 patients who underwent operation from August 1, 1987 to December 31, 1996 were prospectively investigated and reexamined postoperatively, including analyses of serum calcium, alkaline phosphatase, and intact PTH in the antecubital venous blood of both arms. The postoperative course is known for all patients. Of the 99 patients included in the study, 95 underwent one to nine reexaminations (median three) over follow-up periods of 1 month to 5 years (median 24 months). Reproducible PTH gradients were established during follow-up. Ninety percent of the calculated gradients were < or = 20. Intermittent postoperative hypocalcemia, due to calcium deficiency of the skeleton in renal osteopathy, led to an increase in PTH secretion and gradients. Increasing gradients > 20 during follow-up make graft-dependent recurrence probable. The presence of a gradient of approximately 1 in bilaterally elevated PTH levels may be an indication of hyperfunctioning parathyroid tissue in the neck or mediastinum. The combined assessment of the course of gradients for intact PTH, hormone levels in both arms, and serum calcium permits an objective evaluation of parathyroid graft function.

Calcium

Psychosocial adjustment of children with spina bifida.

It was the aim of the present prospective study to investigate the influence of age, sex, intellectual function, and school type as well as of hydrocephalus, the level of lesion, and of the degree of handicap on the psychosocial adjustment of children with spina bifida. Seventy-five patients with spina bifida, aged 6 to 16 years were assessed concerning their psychosocial adjustment and their intellectual function by use of standardized instruments. The findings were compared with those of nondisabled controls, matched for age and sex. Children with spina bifida showed a tendency to be at an increased risk for psychosocial maladjustment. Influencing factors were age, sex, and the degree of handicap. Twelve- to 16-year-old boys and girls displayed significant adjustment problems in specific areas in comparison with their controls. There was a tendency for children with spina bifida to be attending inappropriate school types according to their intellectual abilities. Perhaps the most striking finding of our study was that children with spina bifida who attended a school for disabled children, even though it might be an IQ-appropriate setting, had a higher rate of psychosocial maladjustment than the disabled children in mainstream schools.

Adolescent

Indium-111-pentetreotide in Graves' disease.

UNLABELLED: Thyroidal and orbital lymphocytic infiltration in Graves' disease, as well as identification of somatostatin receptors on lymphocytes, has provided a rationale for receptor imaging with the radiolabeled somatostatin analog pentetreotide. Recently, we demonstrated that in contrast to controls, Graves' patients showed markedly increased orbital accumulation of pentetreotide. Longitudinal and follow-up data are presented here. METHODS: In 20 (16 hyperthyroid) Graves' patients with active eye disease, planar (thyroid) and SPECT (orbit) images were performed 4 and 24 hr after injection of 111In-pentetreotide (222 MBq) before and 3 mo after starting antithyroid and combined steroid and orbital radiotherapy. RESULTS: Thyroidal uptake decreased during methimazole treatment (4 hr postinjection, median: hyperthyroid 989 counts/pixel/MBq injected activity, euthyroid 253 counts, p = 0.001; 24 hr, 437 versus 95 counts/pixel/MBq, p = 0.005). Fourteen patients (70%) responded to steroid and radiotherapy. The pentetreotide orbit-to-brain ratio decreased markedly after completion of therapy (4 hr: 25 before versus 6.2 after therapy, p = 0.0003; 24 hr: 9.6 versus 2.7, p = 0.003). A high pretreatment ratio correlated with a response to therapy (p = 0.001: in 14 of 16 patients with a ratio > 10, 4 hr postinjection, ophthalmopathy improved; positive predictive value: 90%; median activity score before 6 versus 2 after therapy, p = 0.0001) in contrast to none of the four cases with a ratio less than 10 (score 5 versus 4, p = 0.08). CONCLUSION: Pentetreotide scans may be regarded as a semiobjective tool in the evaluation of Graves' disease, both at initial stages as well as during treatment.

Anti-Inflammatory Agents

Expression and prognostic value of the CD44 splicing variants v5 and v6 in gastric cancer.

In the present study, the expression and prognostic role of the CD44 splicing variants v5 and v6 were immunohistochemically investigated in 418 curatively resected gastric carcinomas. CD44v5 was expressed in 65.3 per cent (n = 273) and CD44v6 in 77.0 per cent (n = 322) of the tumours. Whereas the expression of CD44v5 was correlated with advanced pT categories, with lymph node involvement, and with the presence of blood and lymphatic vessel invasion, such a correlation could not be found for the variant v6. As shown by univariate analysis, patients with CD44v5-positive tumours had a significantly shorter overall survival than patients with CD44v5-negative tumours (P = 0.049). In contrast, expression of CD44v6 had no impact on prognosis (P = 0.574). In a multivariate analysis including the prognostic parameters pT category and pN category, as well as blood and lymphatic vessel invasion, the prognostic impact of CD44v5 expression could not, however, be maintained. Although in the present study the expression of CD44v5 was correlated with a more aggressive tumour type, these data suggest that neither CD44v5 nor CD44v6 can predict survival in patients with gastric cancer, nor is their expression a suitable tool for identifying subgroups of patients who may be at higher risk.

Adult

[Prospective observational study of surgical therapy of renal hyperparathyroidism].

A prospective long-term follow-up study in patients who had had surgical therapy for renal hyperparathyroidism was launched to investigate the results of surgical treatment and to evaluate possible correlations between preoperative laboratory values and the course of symptoms. From August 1987 to December 1995, 79 patients underwent surgery for renal hyperparathyroidism. It was the first neck exploration for 72 patients. Total parathyroidectomy with autotransplantation to a forearm was our preferred procedure (n = 67). The postoperative course of all patients is know. We carried out one to nine reexaminations (median 4) in 74 of 79 patients. The follow-up period ranged from 1 month to 5 years with a median of 18 months. After the operation transient hypocalcaemia occurred in 84.4% of patients. Postoperative hypocalcaemia correlated negatively with the preoperative levels of alkaline phosphatase and intact parathyroid hormone. Within the first month after surgery 60% of the preoperatively affected patients completely recovered from pruritus, whereas the skeletal syndrome took longer to disappear. One year after surgery 75% of the patients with pruritus and 79% of those with skeletal syndrome had became asymptomatic. After total parathyroidectomy with autotransplantation, patients with preoperatively elevated concentrations of alkaline phosphatase (> 200 U/I) experienced faster relief from joint pain than patients with preoperatively normal concentrations (P = 0.0297). To date 4.5% of the patients developed recurrent hyperparathyroidism after total parathyroidectomy with autotransplantation. Morbidity of surgery for renal hyperparathyroidism is influenced by patients' risk factors. Postoperative hypocalcaemia correlates negatively with the grade of renal osteopathy at the time of operation. Preoperative concentrations of alkaline phosphatase influence the rapidity of the relief from joint pain.

Adult

Diabetic microangiopathy and urinary glycosaminoglycans.

Alterations in the metabolism of glycosaminoglycans (GAG) may play a role in the pathogenesis of diabetic-associated microangiopathy. Consequently, the relationship between diabetic nephropathy and retinopathy and urinary GAG distribution was assessed in 96 IDDM patients in comparison to 103 healthy controls. GAG concentration in 24h urine samples was determined by precipitation with cetylpyridinium chloride and potassium acetate in ethanol followed by a colorimetric test with carbazole. A marked difference (P = 0.0008) in urinary GAG excretion between patients (24.3 +/- 1.5 mg/24 h, mean +/- SEM) and controls (16.2 +/- 0.75 mg/24 h) could be detected. In patients with IDDM of longer duration, GAG excretion was increased (< or = 10 yr: 20.8 +/- 2.1 vs > 10 yr: 27.4 +/- 2.1 mg/24 h; P = 0.03). Furthermore, IDDM patients with class 4 nephropathy and retinopathy exhibited a markedly higher GAG excretion compared to those without nephropathy (33.1 +/- 3.0 vs 22.6 +/- 1.7 mg/24 h, P = 0.005) or retinopathy (29.7 +/- 2.8 vs 21.2 +/- 1.7 mg/24 h, P = 0.009). An increased urinary GAG concentration was detected in IDDM patients with albuminuria (> 300 mg/24 h: 29.9 +/- 3.3 vs < 30 mg/24 h: 23.0 +/- 1.7 mg/24 h; P = 0.048), proteinuria (> 0.5 g/24 h: 30.3 +/- 3.7 vs < 0.05 g/24 h: 22.7 +/- 1.6 mg/24 h) and in patients with augmented serum creatinine in comparison to those with normal values (> 0.12 mg/L: 34.9 +/- 2.3 vs < 0.12 mg/L: 22.4 +/- 1.6 mg/24 h; P = 0.01). The results demonstrate a close relationship renal GAG excretion and the presence of microangiopathy in IDDM patients.

Adolescent

Randomized, double blind, placebo-controlled trial of low dose iodide in endemic goiter.

Iodine (I) is essential for normal thyroid function, and the majority of subjects tolerate a wide range of dietary levels. However, a subset of individuals upon exposure to normal or elevated levels of I develop thyroid dysfunction and autoimmunity. In this double blind trial, we evaluated efficacy and tolerability of low dose I in adults with euthyroid, diffuse, endemic goiter. Sixty-two subjects were randomly assigned I (0.2 mg/day) or placebo for 12 months. After termination of therapy, both groups were followed for a further 6 months. Thyroid sonography and determinations of thyroid-related hormones, urinary I excretion per 24 h, and thyroid antibodies were carried out at baseline and at 3, 6, 9, 12, 15, and 18 months. Markedly elevated urinary I values were found during therapy in subjects receiving I (32 at baseline vs. 213 micrograms/24 h at 12 months; P = 0.0001) compared to placebo (34 and 33 micrograms/24 h, respectively; P < 0.0001 vs. I). I substantially reduced thyroid volume (29 vs. 18 mL at 12 months; -38%; P = 0.0001), and at 18 months, the therapeutic effect was sustained. In the placebo group, no significant changes were observed. High microsomal and thyroglobulin autoantibody titers were present in 3 of 31 (9.7%) subjects receiving I, and I-induced hypo- and hyperthyroidism developed in 2 and 1, respectively. Fine needle biopsy revealed marked lymphocytic infiltration in all 3 cases. After withdrawal of I, thyroid dysfunctions spontaneously remitted, and antibody titers as well as lymphocytic infiltration decreased markedly. Follow-up of these 3 subjects for an additional 2 yr showed normalization of antibody titers in 2. Thus, among subjects with endemic goiter, low dose I successfully normalized thyroid volume and body I supplementation; nevertheless, reversible I-induced thyroid dysfunctions and autoimmunity were observed in nearly 10% of the subjects.

Adult

Blood coagulation and thrombosis in patients with ovarian malignancy.

Ovarian cancer cells appear to be capable of both thrombin formation and induction of fibrin degradation which may be essential prerequisites for the development of deep vein thrombosis (DVT) as well as the spread of malignancy. To study further this coagulation-cancer interaction in 60 patients with untreated ovarian cancer of FIGO stage I-IV the incidence of DVT was recorded pre-operatively, post-operatively on day 1, 3, 5, 7, 10, before each of six cycles of Cisplatinum/ Epirubicin/Cyclophosphamide chemotherapy, during follow-up and in the post-operative period of second look surgery. In addition, blood coagulation tests results were determined prospectively. Two patients were excluded from these calculations due to previous DVT 5 to 6 weeks before the diagnosis of ovarian cancer but all patients were eligible for surgery and randomized to receive either daily low molecular weight heparin (LMWH) (n = 28) or unfractionated heparin (UFH) (n = 32) for perioperative thrombosis prophylaxis until the 7th post-operative day. According to the FIGO stage, patients were equally distributed in the 2 heparin treatment groups. The predictive value of pre-operative coagulation test results, clinical parameters, and type of heparin used were tested in univariate and multivariate analysis for development of post-operative DVT and overall patients survival. Impedance plethysmography for DVT screening was used. The presence of DVT was then confirmed by phlebography. Only D-dimer and fibrinogen levels were correlated significantly with the FIGO stage while antithrombin, protein C, and plasminogen activator inhibitor activity were not. The incidence of DVT was 6.7% (4/60) up to the 7th and 8.3% (5/60) between the 8th and 29th post-operative day. DVT occurred in 10.6% (5/47) during chemotherapy. Pre-operative coagulation test results, the type of heparin used, and clinical parameters were not significant risk factors for post-operative DVT development in univariate analysis. The D-dimer and fibrinogen levels were significant risk factors for reduced overall survival in univariate analysis but only the FIGO stage was an independent predictor (in multivariate analysis). After a median follow up of 26.5 months (min. 8 months, max. 41 months), 21.4% of LMWH treated and 37.5% of UFH-treated patients died of cancer (p = 0.26). Pre-operative test results were neither predictive for DVT nor the outcome of cancer but patients showed an improved though not statistically significant overall survival after LMWH treatment.

Aged

Prognostic value of E-cadherin expression in 413 gastric carcinomas.

E-cadherin is a Ca(2+)-dependent intercellular adhesion molecule known to exert an invasion-suppressor function. In the present study, E-cadherin expression was immunohistochemically investigated in a retrospective series of 413 RO-resected gastric carcinomas using the monoclonal antibody (MAb) 5H9. Of these cases, 108 tumors revealed a preserved E-cadherin expression similar to that of normal gastric mucosa. In 95 tumors, E-cadherin expression was moderately reduced and in 86 tumors highly reduced. In 124 tumors, no or only a very weak dotted expression could be detected. There was a significant correlation between the degree of E-cadherin expression and the grade of tumor differentiation, as well as with histological type according to the Laurén and the WHO classifications. In contrast, no correlation could be demonstrated between E-cadherin expression and the prognostic parameters depth of invasion, lymph node involvement and vascular invasion. As shown by univariate Cox regression analysis, patients with E-cadherin-positive tumors had significantly better 3-and 5-year survival rates than patients with E-cadherin-negative tumors. This prognostic impact remained present in a multivariate Cox regression analysis, including the prognostic parameters pT category, pN category and vascular invasion.

Adult

Immunohistochemical study on the prognostic value of MIB-1 in gastric carcinoma.

The prognostic significance of tumour cell proliferation was investigated in a series of 418 gastric carcinomas using the monoclonal antibody MIB-1. Owing to strong intratumoural heterogeneity of MIB-1 expression three different proliferation indices (PIs) were determined in all carcinomas: (1) PImax in areas of maximal tumour cell proliferation, (2) PIrand in areas randomly distributed over the whole tumour. (3) PIfront in areas exclusively located at the tumour invasion front. There was a strong intertumoral heterogeneity with PImax ranging from 4.9% to 92.2%, PIrand ranging from 3.4% to 81.4% and PIfront ranging from 4.2% to 87.1%. The mean values were 51.3% +/- 19.7 for PImax, 34.2% +/- 18.3 for PIrand and 37.2% +/- 19.5 for PIfront. Whereas no statistically significant correlation could be found between proliferative activity and the clinicopathological parameters depth of invasion, lymph node involvement or grade of tumour differentiation, there was a positive correlation between a high proliferation index at the tumour invasion front (PIfront) and the presence of blood or lymphatic vessel invasion. No significant correlation could be demonstrated between the different proliferation indices and survival, even when different subgroups of patients were analysed separately. The present results suggest that the immunohistochemical evaluation of the proliferation activity has no predictive value for the prognosis of gastric cancer patients or the identification of subgroups of patients who may be at higher risk.

Adult

Randomized trial of intravenous immunoglobulins versus prednisolone in Graves' ophthalmopathy.

Glucocorticoids are usually given for management of Graves' ophthalmopathy (GO), but they may cause side effects. By comparison, intravenous administration of immunoglobulins resulted in clinical improvement and decreased antibody titres in a large number of autoimmune diseases. Therefore, a randomized trial was done, in which 19 patients with active GO were treated with a 20-week course of oral prednisolone (P, starting dose 100 mg/day), and 21 received 1 g immunoglobulin/kg body weight for 2 consecutive days every 3 weeks. The immunoglobulin course was repeated six times. Before and at the end (20 weeks) of immunomodulating therapy, ophthalmological investigation and quantitative magnetic resonance (MR) imaging were performed. A successful outcome was observed in 12 (63%) P- and in 13 (62%) immunoglobulin-treated patients. Overall, there were no marked differences in degree of improvement between the two groups. Responders to treatment in both groups showed improvements in proptosis (median from 24.5 to 21.5 mm; P < 0.005), visual acuity (from 0.6 to 0.85; P < 0.001), intraocular pressure (from 25 to 20 mmHg; P < 0.0001), lid aperture (from 14 to 12 mm: P < 0.01) and a decrease in eye muscle area (inferior, from 44 to 33 mm2; medial, from 43 to 34 mm2; both P < 0.0005). Among the immunoglobulin-treated patients, there was a marked decrease of thyroid antibody titres. Side effects were more frequent and severe during P than during immunoglobulin therapy. Thus, with respect to the above mentioned objective parameters, P and immunoglobulin appeared to be equally effective in treatment of active GO.

Administration, Oral

Blood coagulation during adjuvant epirubicin/cyclophosphamide chemotherapy in patients with primary operable breast cancer.

PURPOSE: Influences of adjuvant epirubicin/cyclophosphamide (EC) chemotherapy on blood coagulation were investigated in patients with operable breast cancer and the incidence of thromboembolic events was recorded. PATIENTS AND METHODS: In 50 consecutive node-positive breast cancer patients, serial coagulation studies (fibrinogen method of Clauss, antithrombin III, protein C amidolytic methods, D dimer enzyme-linked immunoadsorbent assay [ELISA] techniques, and plasminogen activator inhibitor [PAI] activity u-PA inhibition test) and impedance plethysmography (IPG) for screening of deep vein thrombosis (DVT) were performed preoperatively and postoperatively, before each of six cycles of adjuvant chemotherapy (60 mg/m2 epirubicin and 600 mg/m2 cyclophosphamide) and 3 months thereafter. Seventy-two healthy women served as controls. RESULTS: During chemotherapy, the phlebographically proven DVT incidence was 10% (n = 2 after second cycle; n = 3 after third cycle). Preoperative levels of D-dimer, fibrinogen, and the PAI activity were significantly higher than in healthy women and only mean levels of the D-dimer were significantly higher in patients with DVT compared with patients without DVT. Postoperatively, only D-dimer and fibrinogen levels significantly increased, while in the course of chemotherapy, these levels were significantly decreased. Mean D-dimer levels and PAI increased steadily in patients with DVT. Preoperatively and during chemotherapy, levels of antithrombin III and protein C were within the normal range. Only one patient with DVT had decreased protein C levels throughout chemotherapy. CONCLUSION: Monitoring with sophisticated coagulation tests during adjuvant EC chemotherapy for breast cancer does not identify patients at higher risk for DVT development. Preoperatively, in patients with later DVT, an imbalance of hemostasis is already present; thus, thrombosis might predominantly be initiated by malignancy-induced hypercoagulability and secondarily by the influence of EC chemotherapy. Prospective randomized trials must determine whether prophylactic anticoagulation during EC chemotherapy reduces the incidence of DVT.

Adult

The relationship of p53 expression to the prognosis of 418 patients with gastric carcinoma.

BACKGROUND: Mutations of the p53 gene belong to the most common genetic alterations in human cancer that have been implicated in tumorigenesis and tumor progression. Although p53 expression appears to be correlated with prognosis in patients with breast cancer and some other types of cancer, its prognostic role in gastric cancer is still uncertain. In the present study, therefore, the prognostic impact of p53 expression was evaluated in 418 patients with curatively resected gastric carcinomas without residual tumor (RO-resection). METHODS: Tumor sections of 418 RO-resected gastric carcinomas were stained with the monoclonal antibody DO-1 after microwave processing. p53 expression was statistically compared with clinico-pathologic features and postoperative survival. RESULTS: p53 expression was detected in 57.5% of all tumors, with strong inter- and intratumor heterogeneity. No immunoreactivity was observed in the normal mucosa adjacent to the tumor. Statistically, no significant correlation between p53 overexpression and depth of invasion, lymph node involvement, or grade of tumor differentiation was detected. The correlations with blood vessel invasion (P = 0.049) and lymphatic vessel invasion (P = 0.047) were of marginal significance. Survival analysis revealed no significant impact of p53 expression on survival, the 5-year survival rates were 40.6% +/- 7.8% for patients with p53 positive tumors and 49.2% +/- 8.9% for patients with p53 negative tumors (P = 0.43). Furthermore, no correlation with survival was found when four different levels of p53 expression were analyzed (P = 0.51). p53 expression had no influence on survival, in either the lymph node positive or negative groups. CONCLUSIONS: The data suggest that the immunohistochemical detection of p53 expression is at present not a predictor of outcome of patients with gastric cancer or to identify subgroups of patients who may be at higher risk.

Adult

A rapid algorithm and a computer program for multiple test procedures using logical structures of hypotheses.

It is demonstrated how improvements of general multiple test procedures can be obtained using information about the logical structures among the hypotheses. Based on a procedure of Bergmann and Hommel (B. Bergmann and G. Hommel, Improvements of general multiple test procedures for redundant systems of hypotheses, in Multiple Hypothesenprüfung--Multiple Hypotheses Testing, Eds. P. Bauer, G. Hommel and E. Sonnemann, pp. 100-115 (Springer-Verlag, Berlin, 1988)), a computer program was written by Bernhard (G. Bernhard, Computerunterstützte Durchführung von multiplen Testprozeduren--Algorithmen und Powervergleich, Doctoral thesis (Mainz, 1992)) using this information. It is applicable for a general class of systems of hypotheses which can be expressed in a linear way. By means of a simulation study it is shown that the proposed procedure is often substantially more powerful than other usual multiple test procedures.

Algorithms

Azathioprine combined with prednisolone or monotherapy with prednisolone in active Crohn's disease.

BACKGROUND: The role of azathioprine (AZA) in the treatment of active Crohn's disease (CD) is still controversial. This study examined whether AZA combined with standard prednisolone therapy improved the therapeutic outcome compared with monotherapy with prednisolone. METHODS: Forty-two patients with a Crohn's Disease Activity Index (CDAI) of > 150 were randomized into two groups. Both received 60 mg of prednisolone daily in a tapering regimen to a maintenance dose of 10 mg. In addition, group 1 received 2.5 mg AZA/kg body wt and group 2 received a placebo over the whole study period of 4 months. RESULTS: At the end of the trial, 16 of 21 patients (76%) in group 1 were in remission (CDAI < 150), compared with 8 of 21 (38%) in group 2 (P = 0.03). The CDAI in group 1 dropped from 290 +/- 97 (SD) to 72 +/- 84 and from 285 +/- 110 to 155 +/- 105 in group 2. The differences between activity indices in groups 1 and 2 became statistically significant after 8 weeks. The average prednisolone dose per day was 20.9 mg in group 1 and 26.7 mg in group 2 (P = 0.02). No major side effects were observed in this study. CONCLUSION: The combination of prednisolone and AZA was superior to the treatment with prednisolone alone in active CD. Patients receiving AZA showed remission more frequently, more quickly, and with lower doses of prednisolone.

Adolescent

Tumor-cell dissociation at the invasion front: a new prognostic parameter in gastric cancer patients.

Tumor-cell dissociation (TCD) is a well-known feature at the invasion front of malignant tumors, but little attention has so far been paid to its biological significance. Therefore, the aim of the present study was to score the degree of TCD at the invasion front (TCD 0-3) in a retrospective series of 445 gastric cancer patients and to compare its prognostic significance with the parameters T-stage, tumor size, grade of tumor differentiation, lymph-node involvement and vascular invasion. We could show that highly significant differences (p less than 0.0001, log-rank test) existed between the 5-year survival rates of patients with different degrees of TCD (TCD 0: 92.3%; TCD 1: 62.1%; TCD 2: 41.2%. TCD 3:38.5%) and that these differences were independent of T-stage 2, tumor size and grade of tumor differentiation. Univariate Cox regression analysis showed that in intestinal-type carcinomas, T-stage (Chi-square: 45.2) followed by blood vessel and lymphatic vessel invasion (Chi-square: 43.6 and 40.0) had the highest prognostic value, whereas TCD (Chi-square: 31.5) revealed a prognostic value quite similar to that of lymph-node involvement (Chi-square: 35.1). This prognostic relevance was still present in multivariate Cox regression analysis, showing that the determination of TCD provided an increase in prognostic information which significantly (P = 0.026) exceeded the information obtained by the combination of T-stage and lymph-node involvement. Our data suggest that TCD is a new prognostic parameter, especially in those gastric carcinomas in which lymph-node involvement or vascular invasion are not present.

Adult