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Biomedical subjects

W Köpcke

Publications and source records attributed to W Köpcke.

At least 19 recordsLinked to original sources
PubMed1995

Validation of methods for the assessment of cataract progression in the Roche European-American Anticataract Trial (REACT)

The Roche European-American Anticataract Trial (REACT) will assess the effect of antioxidants on progression of cataract in humans. This report evaluates the methods used in REACT. Seventy three subjects (139 eyes) with cortical (C), posterior subcapsular (P), nuclear (N) or mixed cataract were seen twice within two weeks for eye examinations, assessments of visual function, lens photographs and CCD images. The degree of cataract and nuclear color (NC) were assessed with subjective (LOCS III) and objective (computerized, CASE 2000 CCD) methods. Repeat visit values were used to calculate intraclass correlation coefficients (r1) and 95% tolerance limits (TL). A clinically significant change (CSC) was defined as one step in LOCS III. The relative power of each method to detect cataract change and sample sizes needed to achieve statistically significant results were calculated. The r1 values for visual function tests ranged from 0.76 to 0.88; if these tests of visual function were used to detect a clinically significant change in cataract severity, sample sizes of 840 to 2707 per group would be needed. The r1 values for LOCS III were 0.88 to 0.97, and sample sizes ranged from 50 to 135 per group. The r1 values for the CCD were 0.93 to 0.98, and sample sizes ranged from 1 to 42 with poorer values relating to measurement of P. We conclude that the methods used in REACT are reproducible. The analytical algorithms in the image analysis programs did not permit differentiation between C and P opacification; therefore, P cataract is best measured with LOCS III. REACT sample sizes are adequate to detect a difference of 0.2 LOCS III units/year between the mean rates of cataract progression in two groups.

Adult↗
PubMed1991

Predictive value of serum procollagen-III-peptide for the survival of patients with cirrhosis.

The value of the aminoterminal procollagen-III-peptide (P-III-P) in predicting death or survival was evaluated in a group of 43 patients with proven postnecrotic or alcoholic cirrhosis. Patients were followed-up prospectively for 2 years. The prognostic value of P-III-P was compared with the Child classification, fasting and postprandial serum bile acids, and standard laboratory tests such as bilirubin, prothrombin index, pseudocholinesterase, albumin, GOT, GPT, gamma-GT, and clinical findings such as ascites, encephalopathy (assessed with the number connection test = NCT), and nutritional status. Between patients who died and those who survived the following 2 years, there were significant differences in the following parameters at the time of inclusion in the study: encephalopathy judged by NCT (p = 0.001), serum albumin (p = 0.0012), postprandial serum bile acids (p = 0.0024), fasting serum bile acids (p = 0.0025), pseudocholinesterase (p = 0.0044), GOT (p = 0.015), bilirubin (p = 0.016), and prothrombin index (p = 0.01). None of the other parameters investigated, including SP-III-P (p = 0.46), revealed any statistically significant differences between patients who died and survivors. The prognostic significance of laboratory tests and recorded clinical findings was evaluated, either alone or in combination with life-table analysis using the Cox model. SP-III-P, alone or in combination with other parameters, failed to improve prediction of mortality in patients with cirrhosis. In comparison to the Child classification (p = 0.0004) the combination of NCT and postprandial serum bile acids showed a similar ability (p = 0.0003) to predict patient survival.

Biomarkers↗
PubMed1991

Design and analysis of the HYPREN-trial: safety of enalapril and prazosin in the initial treatment phase of patients with congestive heart failure.

Since the introduction of angiotensin converting enzyme (ACE) inhibitors into the adjunctive treatment of patients with congestive heart failure, cases of severe hypotension, especially on the first day of treatment, have occasionally been reported. To assess the safety of the ACE inhibitor enalapril a multicenter, randomized, prazosin-controlled trial was designed that compared the incidence and severity of symptomatic hypotension on the first day of treatment. Trial medication was 2.5 mg enalapril or 0.5 prazosin. Subjects were 1210 inpatients with New York Heart Association (NYHA) functional class II and III. Patients who received enalapril experienced clinically and statistically significantly less symptomatic hypotension (5.2%) than the patients who received prazosin (12.9%). All patients recovered. It was concluded that treatment with enalapril was well tolerated and it is, therefore, unreasonable to restrict the initiation of treatment with enalapril to inpatients.

Aged↗
PubMed1990

Depressive syndromes in schizophrenic patients after discharge from hospital. ANI Study Group Berlin, Düsseldorf, Göttingen, Munich.

A total of 364 schizophrenic outpatients who were stabilized for 3 months on continuous neuroleptic therapy after discharge from the hospital were rated according to three different scales for depressive syndromes (Brief Psychiatric Rating Scale anxious depression factor, AMDP/depression, and the self-rating PD-S depression scale). Between 19.5% and 27.5% of the patients were rated as depressed, or 35.7%-42.8%, when mild depressive syndromes were included. There were low, but significant correlations between demographic or life-event data and depression scores on the self-rating scale, whereas fewer correlations were found on the observer ratings. No associations were found between social adjustment and depression. Moderate correlations were found between measures of the apathetic syndrome and depression ratings, while observer ratings showed higher correlations than the self-rating. High depression scores, especially in the observer ratings, correlated with scales for global psychopathological assessment (CGI, GAS). There were significant correlations between extrapyramidal rigidity and observer rating depression scores, whereas the total amount of neuroleptics given had no influence. These results are interpreted on the basis of hypotheses about depressive syndromes in schizophrenia.

Antipsychotic Agents↗
PubMed1990

[Biochemical aspects of the evaluation of fixed drug combinations].

Various disciplines have to contribute to the general problem of the evaluation of fixed dose combination drugs, as for instance (clinical) pharmacology, biometry, scientific drug regulations and public health officials. The EC guideline 75/318/EWG and its eludications as well as the German "Arzneimittelprüfrichtlinien" of Dec. 14, 1989 (as referred to in the "Arzneimittelgesetz" of 1986) required that such issues concerning fixed dosage combination drugs must be considered and taken into account. In this framework it is the responsibility of biometry to both to guarantee the use of a valid study design to assure interpretation of the results and to quantify the reliability of pharmacological and clinical considerations. The following paper is concerned with biometrical aspects of the combination drug problem. Basic considerations from a clinical or a pharmacological point of view with respect to the question of whether fixed combination drugs are reasonable or not are not discussed. To support the use of combinations of drugs, a central argument is the improvement of the benefit risk relation compared with that of an adequate monotherapy. Beyond this the fixed combination drugs require additional arguments regarding the enhencement of the safety or the simplicity of the therapy fixing the ratio. It follows that fixed combination drugs have to be supported twice, first with respect to the combination itself, and second with respect to the fixed mixing ratio of its components. The biometrical aspects of the assessment of the gains from (fixed) drug combinations are related to the kind of benefit/risk improvement that is expected. In the first section we discuss some possible types of benefit and risk.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1988

Prophylactic sclerotherapy before the first episode of variceal hemorrhage in patients with cirrhosis.

The value of sclerotherapy as prophylaxis against the first episode of variceal hemorrhage has not been established. Therefore, we randomly assigned 133 patients with cirrhosis of the liver (of alcoholic origin in 66 percent), esophageal varices, and no previous intestinal bleeding to either prophylactic sclerotherapy (n = 68) or no prophylaxis (n = 65). The groups were comparable in hepatic function, endoscopic findings, and the pathogenesis of cirrhosis. All patients who subsequently had a first episode of variceal hemorrhage received sclerotherapy whenever possible. During a median follow-up of 22 months, variceal hemorrhage occurred in 28 percent of the patients receiving sclerotherapy and 37 percent of the controls (P = 0.3). Thirty-five percent of the sclerotherapy group and 46 percent of the control group died. The survival curves (Kaplan-Meier) of both groups were similar (P = 0.2). However, among patients with alcoholic and moderately decompensated cirrhosis (Child-Pugh group B), survival was significantly higher in those receiving sclerotherapy, although the risk of bleeding was only marginally reduced by this procedure. We conclude that prophylactic sclerotherapy does not significantly reduce the risk of bleeding from esophageal varices, but that a subgroup of patients with esophageal varices and moderately decompensated alcoholic cirrhosis may benefit from prophylactic sclerotherapy because of factors not solely attributable to prevention of an initial episode of variceal bleeding.

Adolescent↗
PubMed1988

Essential thrombocythemia. Clinical characteristics and course of 61 cases.

Sixty-one patients with essential thrombocythemia (ET) were followed from 1974 through 1987 at the Medizinische Poliklinik. Fifty-one patients (84%) presented with thromboembolic complications, and eight patients (13%) with hemorrhages. In seven patients (12%), a thrombocytosis was detected accidentally. Disturbances of the microcirculation (67%), mainly of the fingers and toes (53%), were the most frequent thromboembolic symptoms. The mean age of all patients was 58 years (male patients, 61 years; female patients, 56 years). The average platelet count at diagnosis was 897,000/microliter. The average maximal platelet count was 1.231 X 10(6)/microliter (range, 500,000/microliter to 4 X 10(6)/microliter). Seventy-two percent had a moderate leukocytosis (average, 12,400/microliter), 34% a splenomegaly, 29% a hepatomegaly. Signs of hypermetabolism were infrequent, lactate dehydrogenase (LDH) and uric acid elevations, if present, were moderate. Bleeding time and viscosity were normal in most patients. Spontaneous platelet aggregation was increased in 81% of patients (n = 40). Platelet aggregation studies with the aggregation inducing substances adenosine diphosphonate (ADP), platelet activating factor (PAF), thrombin, collagen, and adrenalin showed hypoaggregation in most patients. Adrenalin-induced aggregation distinguished best between ET-patients and reactive thrombocytosis showing hypoaggregation in all ET-patients tested (n = 16) and in none of 22 controls. Bone marrow studies were performed in 57 patients. The histologic studies (done in 49 patients) were consistent with a chronic myeloproliferative disorder in all cases. In 41 cases (84%) the picture of a megakaryocytic myelosis was found, in 12 of these a granulocyte-rich form of megakaryocytic myelosis. Cytologic studies only (eight patients) did not differentiate ET well from reactive thrombocytosis. Platelet aggregation studies and bone marrow histology may be of help in the diagnosis of difficult cases of thrombocytosis. The Philadelphia status was negative in all cases studied (14 patients). Fourteen patients died. The causes of death were thromboembolic complications in probably 11 and acute leukemia in two patients. The probability of 10-year survival is 64% after a mean follow-up time of approximately 5 years. It appears that considering the average age of ET patients at diagnosis, life expectancy is close to normal.

Bone Marrow↗
PubMed1988

[Clinical characterization of essential thrombocythemia in comparison with other myeloproliferative diseases and reactive thrombocytoses].

60 patients with essential thrombocythemia (ET) have been retrospectively and prospectively followed from 1974 through 1987. The presenting signs and symptoms and the course of the disease were analyzed and compared to 10 patients with persisting reactive thrombocytosis selected from 6,000 patients with reactive thrombocytosis and to 50 patients with other myeloproliferative diseases. 54 ET-patients presented with complications, 46 with thrombembolic, 3 with hemorrhagic problems and 5 with thrombembolic and hemorrhagic problems. In 6 patients ET was detected accidentally. Disturbances of the microcirculation, mainly of the fingers and the toes, were the most frequent symptom. The average maximal platelet count was 1,207,000/microliter. The average platelet count at diagnosis was 880,000/microliter. 16 patients had an elevation of the serum creatinine at diagnosis, which deteriorated during the course of the disease. Bone marrow examinations were performed in 56 patients, histology in 48 patients, cytology in 29 patients. In contrast to the clinical diagnosis the histological diagnosis was in 4 cases each polycythemia vera and myeloproliferative syndrome without further specification. 12 patients died thus far. The causes of death were thrombembolic complications in 9, acute leukemia in 2 patients, in 1 patient the cause of death is not known. 10 years after diagnosis 61% of the patients are still alive. It appears that ET is a more important risk factor for the disturbances of the micro- and macrocirculation than has been recognized until now. ET is, if thrombembolic complications are avoided, a disease with a relatively benign course.

Aged↗
PubMed1988

[Prognostic parameters in liver cirrhosis, varicose bleeding and sclerosing therapy. Prospective comparison of a prognostic system with the Child classification obtained by discriminant analysis].

Prospective prognosis systems for predicting half-year death-rate after bleeding from oesophageal varices and sclerotherapy were tested on 129 patients. The receiver-operating-characteristic curves of three discriminant scores were compared with the Child-Pugh classification. It was found that the latter is still the best for prognosticating the course of the disease. A simplified discriminant score which contains as its only factors bilirubin and the Quick value does, however, give nearly as good information.

Adolescent↗
PubMed1987

[Prospective controlled study of therapy of chronic myeloid leukemia (CML)].

The current status of the prospective German multicenter study on the therapy of chronic myelogenous leukemia (CML) is reported. After three years 188 of the projected 300 patients have been randomized. The duration of the study will be 8 years. The clinical characteristics of the randomized patients correspond well to those reported in the literature. Risk factors are distributed equally in both arms. One problem is the relatively high drop-out rate of about 12% thus far. Survival curves for the two treatment arms will be presented, although at present the number of patients having reached the end of the chronic phase is too small to allow definitive evaluation.

Adult↗
PubMed1985

Long-term sclerotherapy of bleeding esophageal varices in patients with liver cirrhosis. An evaluation of mortality and rebleeding risk factors.

Ninety-six liver cirrhosis patients with bleeding esophageal varices receiving long-term sclerotherapy with the flexible endoscope were studied prospectively to analyze mortality and rebleeding risk factors. The difference in the 1-year survival rates of Child's groups A (100%) and B (82%) versus Child's C patients (38%) was highly significant (p less than 0.001). Multivariate analysis revealed that, as single factors, serum bilirubin, grade of ascites, and prothrombin time and, as a combination, the four variables bilirubin, ascites, aspartate aminotransferase, and age distinguished best between survivors and non-survivors during the first 6 months after inclusion in the study. For the separation of rebleeders and non-rebleeders during the first 2 months, prothrombin time and grade of ascites gave the best distinction. Thus, cirrhotics with variceal hemorrhage, ascites, jaundice, and a prolonged prothrombin time remain a high-risk group also with long-term sclerotherapy.

Adolescent↗
PubMed1984

[Long-term sclerosing therapy of bleeding esophageal varices. A prospective course study].

Longterm sclerotherapy by flexible endoscopy was done in 109 patients with acute bleeding from oesophageal varices in a prospective follow-up study. The severity of the liver disease was classified according to Child (Pugh's modification) at the beginning of treatment. Patients were followed-up for at least 12 months with a maximum of 44 months. The one-year survival rate for all patients was 67%. Child-A patients (100%) and child-B patients (84%) had a significantly better survival than Child-C patients (36%; P less than 0.001). The rate of haemorrhage per patient-month was significantly lower (P less than 0.001) in Child-A patients (0.4%) and Child-B patients (2.4%) than in Child-C patients (8.5%). After initial sclerosing of 8 weeks' duration the rate of recurrent haemorrhage was only 1.3% per patient-month. There was a significant difference (P less than 0.005) between Child-A patients (0.2%) and Child-B and -C patients (2%). The data show that Child-Pugh's classification permits a high prognostic accuracy in predicting results of sclerotherapy. Child-A and -B patients are suitable candidates for longterm sclerotherapy whereas Child-C patients show a clearly increased risk of recurrent bleeding during the early phase of treatment and have a markedly reduced survival rate.

Esophageal and Gastric Varices↗
PubMed1984

[Surgical treatment of cervix cancer. Treatment results and data on the postoperative course over a minimum of 5 years following uniform surgery and standardized histological examination of the histological material of 1092 patients at 4 university gynecology clinics].

Treatment results of 1092 patients with operated cervical carcinoma were evaluated and assessed on the basis of data supplied by four University Clinics of gynaecology. Surgical treatment and histological processing of all surgical specimens were uniform. Indication for postoperative radiation was determined differently at the individual clinics. The treatment results obtained can be compared with one another not on the basis of clinical stage assessment; the only criterion is the histologically proven extension of the tumour, ascertained via an examination of the surgically obtained specimen. With continuous tumour growth in accordance with stage Ib, the 5-year survival rate after surgery alone was 90.5%, after additional radiation 95.6%. In case of continuous tumour growth in accordance with stage II, the 5-year survival rate after operation alone was 79.5%, after operation and radiation 83.1%. The differences in the 5-year survival rates are statistically not significant. Taking into consideration a discontinuous metastatic tumour growth in the region of the parametric tissue, the 5-year survival rate after operation alone was 72.7%, after subsequent radiation 75%, in case of metastases in the region of the lymph nodes 77.8% and 60.5%, respectively. These differences in survival rates were not statistically verifiable. Furthermore, if individual tumour parameters were tested and statistical pairing was performed, it became evident that prognosis of patients with infaust tumour criteria could not be influenced by postoperative radiation.

Combined Modality Therapy↗
PubMed1983

[Morphological criteria in decreased patients who had undergone surgery for cervical cancer].

In 966 patients who had undergone surgery and who had been suffering from squamous cell carcinoma, tumour recurrence occurred in 16.8% of the cases. In almost 70% of these cases, recurrence was seen in the first two years following treatment. 15% of the patients died of the carcinoma. Compared with the patients who had stayed alive, post-mortem examination of the patients who had died of carcinoma revealed in 65.5% of the patients an immature squamous cell carcinoma, in 37.7% a dissociated tumour growth, in 21.7% penetration of the tumour into the lymph vessels, and in 62.1% penetration into the blood vessels. Macrometastases in the area of the regional lymphatic nodes were seen in 45.2%. In the surviving patients, the percentage of immature carcinomas was 47.4%, whereas dissociated tumour growth was seen in 18.7% and penetration into the lymph or blood vessels in 5.8 and 14.1% of the cases, respectively. Macrometastases in the area of the regional lymphatic nodes were seen in 11.8% of the cases. In woman patients with an early recurrence of tumour, or in women who had died of the carcinoma, mostly immature carcinomas, tumour penetration into vessels, and macrometastases in regional lymphatic nodes were observed.

Carcinoma, Squamous Cell↗
PubMed1983

Detoxification treatment for chronic schizophrenic patients: experimental results and data from a survey.

Blood detoxification as a treatment of schizophrenia has been studied intensively since 1977 by a number of research centers. Results of an open study on 10 chronic schizophrenic patients--two showing improvement--were less favorable than those reported in the initial publications. In order to possibly identify a subgroup of responders to this treatment, a survey was undertaken in which 95 centers were invited to participate. Of the 95 centers which originally treated schizophrenic patients with detoxification and which were asked to send data on these patients to the Registry of the European Dialysis and Transplant Association, 39 centers replied (35 from Europe and four from the United States). From the 100 patients reported on in Europe, 17 were reported to be very much improved and 22 to be improved. Of the patients from the United States, 86% were reported as improved. No subgroup of responders could be identified, and differences between centers concerning nosological subgroups, treatment methods, and results were so great that no real comparison was possible. Although data from this survey are not totally conclusive, in connection with the updated literature they do not encourage further research in this treatment of schizophrenia.

Adult↗