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T Scholten

Publications and source records attributed to T Scholten.

At least 19 recordsLinked to original sources
PubMed2005

On-demand therapy with pantoprazole 20 mg as effective long-term management of reflux disease in patients with mild GERD: the ORION trial.

AIMS: To compare safety and efficacy of on-demand pantoprazole 20 mg/40 mg versus placebo in the long-term management of patients with mild gastroesophageal reflux disease (GERD) after heartburn relief. METHODS: A total of 634 patients with endoscopically confirmed GERD grade 0/I and heartburn were included. During the acute phase, patients were treated with pantoprazole 20 mg once daily for 4 weeks. Those patients relieved from heartburn entered the long-term phase, and were randomly assigned to either treatment group pantoprazole 20 mg, 40 mg or placebo. Over 6 months, patients took study medication on demand (antacids as rescue medication) and discontinued the drug once symptoms abated. RESULTS: After 4 weeks a total of 87.1%/90.0% of patients were free of heartburn (ITT/PP), and entered the subsequent long-term phase. The perceived average daily symptom load (placebo: 3.93, pantoprazole 20 mg: 2.91, pantoprazole 40 mg: 2.71, ITT) and the number of antacid tablets taken (average number, placebo: 0.68, pantoprazole 20 mg: 0.45, pantoprazole 40 mg: 0.33, ITT) were significantly higher in the placebo than in both pantoprazole groups (p<0.0001), with no statistically significant difference between the two pantoprazole groups. The discontinuation rate due to insufficient control of heartburn was significantly lower in both pantoprazole groups compared to placebo (placebo: 10.9, pantoprazole 20 mg: 2.8, pantoprazole 40 mg: 0.9, ITT). CONCLUSIONS: Our findings favor on-demand treatment with pantoprazole 20 mg for the long-term management of heartburn in patients with uncomplicated GERD (grade 0/I) with superiority to placebo.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2003

Once-daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD-related symptoms.

AIM: To compare the efficacy of pantoprazole and esomeprazole for the treatment of gastro-oesophageal reflux disease- (GERD-) related symptoms. METHODS: In this multicentre, randomized, double-blind study 217 patients [intention-to-treat (ITT) population] diagnosed with endoscopically proven GERD grade B/C received pantoprazole (40 mg once daily (o.d.), n = 112] or esomeprazole (40 mg o.d/, n = 105) for 4 weeks. Patients recorded GERD-related symptoms (daytime and night-time) using diaries (daily), and/or by telephone interviews (every third day) and completed the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The area under the time curve (AUC) for the sum score of GERD-related symptoms (symptom load of each patient during the treatment) and the time to reach adequate relief from GERD-related symptoms were calculated. RESULTS: Patients reported first adequate relief from daytime GERD-related symptoms after a mean of 3.7 (pantoprazole) and 5.9 days (esomeprazole) (P = 0.034); the values for the night-time were 1.7 and 3.5 days, respectively (P = 0.012, ITT). The AUCs for the single symptoms and the sum scores were comparable. CONCLUSIONS: Treatment with pantoprazole resulted in significantly faster first-time relief from daytime and night-time GERD-related symptoms than esomeprazole. Pantoprazole and esomeprazole were similar with respect to reduction of load of GERD-related symptoms.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2001

Performance of the score systems Acute Physiology and Chronic Health Evaluation II and III at an interdisciplinary intensive care unit, after customization.

BACKGROUND: Mortality predictions calculated using scoring scales are often not accurate in populations other than those in which the scales were developed because of differences in case-mix. The present study investigates the effect of first-level customization, using a logistic regression technique, on discrimination and calibration of the Acute Physiology and Chronic Health Evaluation (APACHE) II and III scales. METHOD: Probabilities of hospital death for patients were estimated by applying APACHE II and III and comparing these with observed outcomes. Using the split sample technique, a customized model to predict outcome was developed by logistic regression. The overall goodness-of-fit of the original and the customized models was assessed. RESULTS: Of 3383 consecutive intensive care unit (ICU) admissions over 3 years, 2795 patients could be analyzed, and were split randomly into development and validation samples. The discriminative powers of APACHE II and III were unchanged by customization (areas under the receiver operating characteristic [ROC] curve 0.82 and 0.85, respectively). Hosmer-Lemeshow goodness-of-fit tests showed good calibration for APACHE II, but insufficient calibration for APACHE III. Customization improved calibration for both models, with a good fit for APACHE III as well. However, fit was different for various subgroups. CONCLUSIONS: The overall goodness-of-fit of APACHE III mortality prediction was improved significantly by customization, but uniformity of fit in different subgroups was not achieved. Therefore, application of the customized model provides no advantage, because differences in case-mix still limit comparisons of quality of care.

APACHE↗
PubMed2000

Comparison of acute physiology and chronic health evaluations II and III and simplified acute physiology score II: a prospective cohort study evaluating these methods to predict outcome in a German interdisciplinary intensive care unit.

OBJECTIVE: To evaluate the ability of three scoring systems to predict hospital mortality in adult patients of an interdisciplinary intensive care unit in Germany. DESIGN: A prospective cohort study. SETTING: A mixed medical and surgical intensive care unit at a teaching hospital in Germany. PATIENTS: From a total of 3,108 patients, 2,795 patients (89.9%) for Acute Physiology and Chronic Health Evaluation (APACHE) II and 2,661 patients (85.6%) for APACHE III and Simplified Acute Physiology Score (SAPS) II could be enrolled to the study because of defined exclusion criteria. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Probabilities of hospital death for patients were estimated by applying APACHE II and III and SAPS II and compared with observed outcomes. The overall goodness-of-fit of the three models was assessed. Hospital death rates were equivalent to those predicted by APACHE II but higher than those predicted by APACHE III and SAPS II. Calibration was good for APACHE II. For the other systems, it was insufficient, but better for SAPS II than for APACHE III. The overall correct classification rate, applying a decision criterion of 50%, was 84% for APACHE II and 85% for APACHE III and SAPS II. The areas under the receiver operating characteristic curve were 0.832 for APACHE II and 0.846 for APACHE III and SAPS II. Risk estimates for surgical and medical admissions differed between the three systems. For all systems, risk predictions for diagnostic categories did not fit uniformly across the spectrum of disease categories. CONCLUSIONS: Our data more closely resemble those of the APACHE II database, demonstrating a higher degree of overall goodness-of-fit of APACHE II than APACHE III and SAPS II. Although discrimination was slightly better for the two new systems, calibration was good with a close fit for APACHE II only. Hospital mortality was higher than predicted for both new models but was underestimated to a greater degree by APACHE III. Both score systems demonstrated a considerable variation across the spectrum of diagnostic categories, which also differed between the two models.

APACHE↗
PubMed2000

Multicenter phase II study of oral idarubicin in treated and untreated patients with B-chronic lymphocytic leukemia.

Idarubicin is the first anthracycline that can be administered orally facilitating antineoplastic chemotherapy at an improved quality of life. In different studies idarubicin has proved clinical effectiveness in patients with advanced low grade non Hodgkin's lymphoma. We performed a phase II study in 19 patients with untreated and pretreated B-CLL of Binet stage A-C. Idarubucin was administered orally at a dose of 15 mg/m2 over 3 days every 4 weeks. Of 19 evaluable patients (m:f, 16:3, median age 64 years, range 41-80 years) 7 were previously untreated while 12 patients had received prior therapy with fludarabine, chlorambucil or similar non-anthracycline containing regimens. 12 pts had Binet stage C, 5 Binet stage B and 2 Binet stage A. Five patients achieved a partial remission (26%), 5 patients had stable disease (26%) and 9 patients showed progressive disease (47%), resulting in an overall response of 26% (5/19). There was no correlation of response rate with Binet stages or previous treatment regimens. Treatment associated side effects consisted predominantly of mild nausea and vomiting (26%) as well as minor infections (21%) and diarrhoea (16%). These data demonstrate that oral idarubicin as a single agent is well tolerated but of limited effectiveness in B-CLL. Further studies are needed to assess different doses and schedules of oral idarubucin and to test it in combination with other chemotherapeutic agents.

Administration, Oral↗
PubMed1999

[Intensive care medicine for elderly patients: how applicable are the APACHE III and III score systems?].

OBJECTIVE: Scores like APACHE (Acute Physiology And Chronic Health Evaluation) were evaluated for unselected intensive care unit (ICU) admissions. Can they also be used for risk stratification and quality assurance in selected subgroups like elderly patients? METHODS: Over a 3-year period data of all admissions of a 12 bed interdisciplinary ICU were collected. APACHE II and III scores and probabilities of hospital deaths were compared with observed outcomes. The discriminatory power was evaluated by calculating the areas under the receiver operating characteristic (ROC) curves. Calibration was analyzed with standardized mortality ratios (SMR) and the Hosmer-Lemeshow goodness-of-fit statistic. RESULTS: Of 3382 admissions due to exclusion criteria, 2795 patients were analyzed, 1396 (49.9%) of these were > or = 65 years, mean age 75 (65-99) years. 62.5% were non-operative, 37.5% postoperative admissions, 35% after emergency operations. ICU mortality was 11.7%, hospital mortality 25.1%. The areas under the ROC curves were 0.77 for APACHE II and 0.79 for APACHE III (whole collective 0.83 and 0.85, respectively). The SMR was 1.17 for APACHE II and 1.23 for APACHE III compared with 1.06 and 1.22 for all patients, respectively. Calibration for elderly patients was insufficient for APACHE II (Hosmer-Lemeshow chi-square = 19, p < 0.025) as well as for APACHE III (chi-square = 41, p < 0.001), while it was good for all patients for APACHE II (chi-square = 12, p > 0.1) but not so for APACHE III (chi-square = 48, p < 0.001). CONCLUSIONS: APACHE II and III both show good discrimination for elderly patients although a little inferior than for all patients. Both scores can be used for risk stratification of elderly ICU patients. Mortality prognosis is not sufficient for geriatric patients although APACHE II calibrates well for all. Application of these scores for quality assurance in selected subgroups like elderly patients cannot be recommended based on these data.

APACHE↗
PubMed1997

How accurate is the assessment of thyroid volume by palpation? A prospective study of 316 patients.

Goitre is the cardinal symptom of most thyroid diseases and treatment is often influenced by the evaluation of thyroid size. Quantitative palpation of the thyroid gland could offer a quick and easy initial examination method for discovering most thyroid diseases. However, this clinical technique is frequently underestimated and its accuracy is not evaluated. Therefore, we examined the question whether thyroid volume can be determined with sufficient precision by manual palpation. 316 patients with suspected thyroid diseases were selected at random at our hospital and prospectively studied. Thyroid volume of each patient was assessed by palpation followed by ultrasonically scanning. The examinations were performed by two physicians: an endocrinologist (A) and a resident (B) who had undergone a structured palpation training. Ultrasonic scanning of 99 thyroid glands revealed a high level of agreement (r2 = 0.87) between both physicians. Examiner A evaluated 111 patients by palpation and ultrasonic scanning. The mean volume determined by ultrasound was 35.9 ml (SD = 27.1 ml) with a range of 4-152 ml. This correlated well with the results of palpation (r2 = 0.872). Examiner B evaluated 215 patients. These ultrasonically determined volumes had a mean value of 37.3 ml (SD = 24.2 ml; range 4-145 ml) and correlated well with the results obtained by palpation (r2 = 0.856). A total of 53 patients were examined by both physicians. The interobservers' comparison of the palpation results yielded an excellent correspondence (r2 = 0.893). We conclude that the manual palpation technique yields sufficiently precise quantitative results for clinical purposes and can be taught. Clinical assessment of thyroid size on a routine basis should result in better diagnostic strategies for thyroid diseases and in cost savings.

Adolescent↗
PubMed1996

[The milk-alkali syndrome--a rare differential diagnosis for hypercalcemia].

HISTORY AND CLINICAL FINDINGS: A 54-year-old man was hospitalised because hypercalcaemia and associated renal failure were suspected. He had a history suggesting gastric ulcer, with nonspecific back and shoulder pain and spontaneously passed kidney stone. On admission the patient reported reduction in physical fitness, fatigue, headache and nausea without vomiting. Physical examination was unremarkable except for pain on pressure over the thoracic and lumbar vertebrae. INVESTIGATIONS: Hypercalcaemia of 3.9 mmol/l was found while parathormone was low. Serum creatinine concentration was 2.8 mg/dl. Malignancy was excluded after extensive tests. A florid gastric ulcer was demonstrated, together with Helicobacter pylori infection. Computed tomography revealed stippled calcifications in the kidneys. TREATMENT AND COURSE: Renal function markedly improved, the hypercalcaemia disappeared and the parathormone level rose within four days of the administration of sodium chloride (2.51 daily of a 0.9% solution) and of furosemide (40 mg daily). Repeat questioning of the patient revealed that because of stomach pains he had for four years been taking up to 6 g calcium carbonate daily in the form of a prescription-free antacid. He was thereupon treated for a milk-alkali syndrome. Calcium concentration became normal, while renal function has remained slightly impaired a year later. The ulcer has healed without recurrence on eradication of the Helicobacter pylori infection with amoxicillin and omeprazole. CONCLUSIONS: The danger of some "over the counter" prescription-free medications should not be underestimated and patients should be routinely questioned about them. Absorbable antacids should no longer be taken in the treatment of peptic complaints now that effective antacids, H2-receptor antagonists and proton-pump inhibitors have become available.

Antacids↗
PubMed1992

[Malignant fibrous histiocytoma of the aorta].

Upper gastrointestinal bleeding occurred in a 64-year-old woman who was being treated with 1,000 mg acetylsalicylic acid and three times 5,000 IU heparin daily previous to a planned embolectomy because of occlusion of a lower leg artery. Radiology demonstrated multiple areas of osteolysis of the left thorax which were interpreted as recurrence of carcinoma of the breast, treated by mastectomy and radiotherapy 15 years previously. Acute renal failure, recurring severe back and abdominal pain, paraplegia of both legs and finally death from circulatory failure were explained as having been caused by multiple embolisation in the course of arteriosclerosis or a paraneoplastic increase in clotting activity. Autopsy revealed complete occlusion of the descending thoracic aorta by a malignant fibrous histiocytoma which had been the site of multiple emboli of thrombotic material and tumour tissue to spleen, kidneys, liver, intestinal segments, spinal cord and the artery to the left lower leg. Adrenal metastasis and osteolysis of the ribs were due to the histiocytoma and not the previously known carcinoma of the breast.

Aorta, Thoracic↗
PubMed1992

Treatment results of the thioether lipid ilmofosine in patients with malignant tumours.

In a multicentre study patients with liver metastases stratified to the histology of the primary tumour were investigated. A total of 102 patients with colorectal adenocarcinoma, non-small-cell lung cancer, pancreatic cancer, primary liver carcinoma and malignant melanoma were treated with the thioether lipid ilmofosine. The drug was administered orally as a tablet at a dosage of 150-300 mg/day (75 mg/tablet). The tolerability of ilmofosine was poor. There was a dose-limiting gastrointestinal toxicity with nausea, vomiting and loss of appetite (WHO grade II-IV) in 67% of patients. During the period of therapy (1-29 weeks, 8.5 weeks mean) no complete remission and no partial response were observed. We thus conclude that treatment with oral ilmofosine is not effective in patients with liver metastases due to various malignancies.

Adenocarcinoma↗
PubMed1991

[Eosinophilia-myalgia syndrome].

The following is an outline of one typical case of chronic eosinophilia-myalgia syndrome (EMS). In 1987 a 62-year-old woman began taking L-tryptophan, 1.5 g nightly, due to sleeping difficulty. During the months preceding the appearance of EMS she continued to take L-tryptophan, derived from the biosynthetic production of the Japanese manufacturer "Showa Denko". She has suffered increasingly from severe myalgia and a proximal muscle weakness since July of 1989. In November, 1989 her white blood cell count measured 12.1 X 10(9)/l with 3.6 X 10(9) eosinophil cells/l. The bone marrow exhibited an increased granulopoesis and an extreme increase in the amount of eosinophil cells. The muscle biopsy specimen indicated an inflammation with perivascular distribution. The eosinophil cell count of the blood was quickly normalized via the introduction of prednisone over a short period. In the absence of further immunosuppressive therapy a slow improvement can be seen in the myalgia and in her general condition. Since the beginning of 1990 there has been a slow development of hyperpigmented scleroderma-like skin changes with distal distribution.

Biopsy↗
PubMed1991

Pentastomiasis in Canada.

We report a case of human pentastomiasis in a 28-year-old man who emigrated to Canada from Nigeria in 1982 and died as a result of a motor vehicle accident in 1989. At autopsy, in addition to trauma, numerous small cystic nodules (3 to 9 mm in diameter) were discovered in the liver, pleura, lungs, and mesentery and under the intestinal and parietal peritoneum. The parasites were diagnosed as well-preserved, encysted Armillifer armillatus nymphs. Neither degenerative nor inflammatory granulomatous reactions were observed in the adjacent tissue. To our knowledge, this is the first reported case of human infection with encysted nymphs of A armillatus and the eighth reported case of pentastomiasis in North America.

Adult↗
PubMed1985

[Healing rates following omeprazole and ranitidine treatment of gastric ulcer. Results of a German multicenter study].

The effectiveness of omeprazole (20 mg orally each morning) or ranitidine (150 mg orally twice daily) in the treatment of gastric ulcer was compared in 184 out-patient in a randomized, endoscopically controlled multi-centre double-blind ("double dummy") trial. Healing rates with omeprazole after two, four and eight weeks were 43, 81 and 95%, respectively, those with ranitidine were 45, 80 and 90%, a statistically not significant difference. Independently of medication, small ulcers (less than 8 mm diameter) healed more quickly than larger ones. Ulcers in the body of the stomach responded poorest to both drugs. Smoking had no statistically significant effect on healing rate. Omeprazole and ranitidine had similarly favourable effects on symptoms. Neither side effects nor changes in biochemical parameters could be ascribed to omeprazole. Both drugs had equivalent effects on the healing of gastric ulcers in the stated dosages.

Adult↗
PubMed1985

Famotidine versus ranitidine for the short-term treatment of duodenal ulcer.

One-hundred and eight-three patients with endoscopically proven duodenal ulcers, enrolled in this prospective, double-blind study, were randomly allocated to receive famotidine 40 mg once at night, 20 mg twice daily, 40 mg twice daily, or ranitidine 150 mg twice daily for 2-8 weeks. Pretreatment characteristics between the four groups were similar. After 4 weeks of treatment, among the famotidine-treated patients, 38 of 42 (90.5%) healed with the 40 mg once nightly regimen, 35 of 42 (83.3%) with 20 mg twice daily, and 37 of 41 (90.2%) with 40 mg twice daily. In the ranitidine group 40 of 43 patients (93.0%) healed. After 8 weeks of treatment, the respective data were: 97.6, 95.2, 100 and 93.0%. Different results between the famotidine groups and the ranitidine group were not statistically significant. All treatments were well tolerated and severe adverse events were rare. Famotidine 40 mg given once at night appears to be as safe and effective as conventional therapy with ranitidine, indicating the importance of overnight gastric acidity in the pathogenesis of duodenal ulcer disease.

Adolescent↗
PubMed1985

[Famotidine versus ranitidine in the acute treatment of duodenal ulcer. A multicenter comparative study in Germany].

185 patients with endoscopically proven duodenal ulcers were randomly allocated to treatment with either famotidine 40 mg nocte, 20 mg bid, 40 mg bid or ranitidine 150 mg bid for 2-8 weeks in a prospective double-blind study. The four groups were similar with regard to age, sex, duration of ulcer disease, smoking habits etc. After 2 weeks treatment 28/42 patients (66.7%) healed on famotidine 40 mg nocte, 24/42 patients (57.1%) on famotidine 20 mg bid, 26/41 patients (63.4%) on famotidine 40 mg bid and 28/43 patients (65,1%) on ranitidine 150 mg bid. The corresponding healing rates after 4 weeks were 90.5%, 83.3%, 90.2% and 93%, respectively. After 8 weeks more than 93% of the patients had healed ulcers. At each time there was no statistical difference between the different famotidine regimens and the ranitidine group. All treatments were well tolerated and severe adverse events were rare. Famotidine 40 mg at night, therefore, appears to be as good as conventional ranitidine.

Adolescent↗
PubMed1985

[Secretin and bicarbonate secretion in probands and ulcer patients following bolus administration of hydrochloric acid into the duodenum].

Various amounts of hydrochloric acid (50, 100 and 200 ml) of two different concentrations (70- and 140 mmol/l) were rapidly instilled into the duodenum of eight healthy subjects and five duodenal ulcer patients. Secretin, gastrin and bicarbonate output were measured. Secretin release and bicarbonate secretion are dependent on acid load and not on acid concentration. There is a linear correlation between the amount of acid instilled into the duodenum and pancreatic bicarbonate output. After duodenal acidification duodenal ulcer patients released equal amounts of secretin and secreted as much bicarbonate as healthy subjects.

Adult↗