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Biomedical subjects

M Pritsch

Publications and source records attributed to M Pritsch.

At least 19 recordsLinked to original sources
PubMed2001

Frequency and predictors of osteoporotic fractures after cardiac or liver transplantation: a follow-up study.

BACKGROUND: Osteoporosis and related fractures are a major complication after organ transplantation. The aim of this study was to find out the frequency and predictors of osteoporotic fractures after cardiac or liver transplantation. METHODS: 235 consecutive patients who had a cardiac transplant (n=105; 88 men, 17 women) or a liver transplant (130; 75 men, 55 women) were followed. Vertebral fractures were assessed by a standardised analysis of spinal radiographs before and annually after transplantation. Clinical and non-vertebral fracture data were noted from hospital records. FINDINGS: In the first and second years after transplantation, the proportion of patients (Kaplan-Meier estimates) who had at least one vertebral fracture was slightly higher in the cardiac group (first year 21%, second year 27%) than in the liver group (first year 14%, second year 21%). In the third and fourth years, one third of patients from both groups had had one or more vertebral fractures. Non-vertebral fractures occurred in nine patients (7%) after liver transplantation and avascular necrosis of the hip head in three patients (3%) after cardiac transplantation. In both groups, no dose-dependent effect of immunosuppressive therapy on fracture development could be identified. Independent predictors assessed by multivariate analysis were age (hazard ratio [95% CI] increase of 5 years, 1.71 [1.1-2.7]) and lumbar bone-mineral density (decrease of 1 SD t score, 1.97 [1.2-3.2]) in cardiac transplantation patients, and vertebral fractures before transplantation (6.07 [1.7-21.7]) in the liver group. INTERPRETATION: The high frequency of osteoporotic fractures in the 2 years after transplantation and the limitations of reliable fracture-risk predictions, show the need to investigate preventive therapies.

Adult↗
PubMed2001

[The effects of psychotherapy on Crohn's disease patients--results of a randomized multicenter study].

In a prospective multicenter study of Crohn disease patients, the influence of psychotherapy on the course of the disease and on psychosocial variables (anxiety, depression, life satisfaction and data of the PSKB) was studied. Psychodynamic oriented psychotherapy was provided in addition to a standardized medical treatment and took place during the first year of the two-year observation period. 108 of 488 patients were recruited and randomly assigned to the psychotherapy and the control group. 84 patients completed the somatic and 81 the psychosocial follow up. 23% of the control group and 30% of the psychotherapy group showed episode-free courses, 29% and 17% respectively underwent surgery (worst outcome group). The ranking and comparisons of the disease course showed no significant difference (p = 0.125) between psychotherapy and control group. The psychosocial variables also showed no differences between these groups. Subjectively, the patients report favourable effects to psychotherapy.

Adolescent↗
PubMed2000

[Basic principles of clinical therapeutic studies--what, how and why?].

Treatment evaluation is one of the most important tasks in medical research. Detailed standards have been developed during the last decades. The efficacy/effectiveness of treatments can only be assessed in comparison to control groups. To guarantee the internal validity of these comparisons, the groups have to be comparable at the beginning of the study. This can be achieved by randomized allocation of patients to treatment. Furthermore, as far as possible patient and physician should be blinded to treatment in order to avoid subjective influences on treatment results. Groups should still be comparable when analysing the trial, thus an analysis according to the principle of intention-to-treat ("as randomized") should be performed. These indispensable principles for design, conduct and analysis of clinical trials are widely accepted and contribute to reliable and credible results.

Humans↗
PubMed2000

[Monitoring clinical studies. Development, measures and consequences].

BACKGROUND: Clinical trials play an important role in developing and establishing new therapeutic and diagnostic procedures. In the planning and execution of these trials procedures and measures which allow for continual observation, description and evaluation of the study progress are to be taken into account. This is due to ethical, scientific and economic considerations. Together these procedures and measures are termed "monitoring". Repeated evaluation of the main study question is one particular monitoring measure. Results from this sequential procedure may lead to an early termination of patient recruitment. In the last 3 decades methods for interim analyses were developed which take into account the increased chance of errors when evaluating repeatedly the same question. By adjustment they guarantee a prespecified level of significance in the end result of the trial. Even though statistical significance may be evident in an interim analysis, this has not always to result in early termination of the trial. The decision to end a trial early must include other considerations than the mere evaluation of the main study question. In particular, consequences of the decision such as credibility and transferability of the trial result to subsequent therapeutic routine application are to be discussed.

Clinical Trials as Topic↗
PubMed1999

[Monitoring of clinical trials. Methodology, interim analyses, and end results].

BACKGROUND: Clinical trials play an important role in developing and establishing new therapeutic and diagnostic procedures. In the planning and execution of these trials procedures and measures which allow for continual observation, description and evaluation of the study progress are to be taken into account. This is due to ethical, scientific and economic considerations. Together these procedures and measures are termed "monitoring". Repeated evaluation of the main study question is one particular monitoring measure. Results from this sequential procedure may lead to an early termination of patient recruitment. In the last 3 decades methods for interim analyses were developed which take into account the increased chance of errors when evaluating repeatedly the same question. By adjustment they guarantee a prespecified level of significance in the end result of the trial. Even though statistical significance may be evident in an interim analysis, this has not always to result in early termination of the trial. The decision to end a trial early must include other considerations than the mere evaluation of the main study question. In particular, consequences of the decision such as credibility and transferability of the trial result to subsequent therapeutic routine application are to be discussed.

Clinical Trials as Topic↗
PubMed1999

[Basic principles of clinical trials--what, how, and why?].

Treatment evaluation is one of the most important tasks in medical research. Detailed standards have been developed during the last decades. The efficacy/effectiveness of treatments can only be assessed in comparison to control groups. To guarantee the internal validity of these comparisons, the groups have to be comparable at the beginning of the study. This can be achieved by randomized allocation of patients to treatment. Furthermore, as far as possible patient and physician should be blinded to treatment in order to avoid subjective influences on treatment results. Groups should still be comparable when analysing the trial, thus an analysis according to the principle of intention-to-treat ("as randomized") should be performed. These indispensable principles for design, conduct and analysis of clinical trials are widely accepted and contribute to reliable and credible results.

Clinical Trials as Topic↗
PubMed1999

Primary reconstruction of traumatic bony defects using allografts.

We retrospectively reviewed 207 patients suffering from traumatic bone defect who had been treated at our institution between 1973 and 1993. Three types of traumatic bone defects were identified: I, minor; II, major cortical; III, major articular. Each type was further subdivided into: A, open injury; B, closed injury. The proposed treatment modality of each type was included within each classification. Types II and III posed the greatest difficulties in management. However, massive bone allografts can be successfully used in these situations, even in the early phases of treatment, but only given specific prerequisites.

Accidental Falls↗
PubMed1999

Twenty-five years of clinical experience with bone banking in Israel.

BACKGROUND: Bone banking and the clinical use of banked tissue are the most common forms of allopreservation and transplantation in modern medicine. OBJECTIVES: This article reviews 25 years (1973-98) of experience in bone banking in Israel. METHODS: A nationwide survey on the clinical application of the banked musculoskeletal tissues during 1996 was conducted by means of a written questionnaire sent to all orthopedic departments in Israel. RESULTS: The response rate to the questionnaire was 84%. A total of 257 cases were allocated bone allografts: the majority comprised 225 spongy bones, 26 were massive bone allografts and 6 were soft tissue allografts. CONCLUSION: Improvement of quality control and quality assurance of the banked tissues, together with development of skills in the use of osteoinductive and osteoconductive materials, cast the future of musculoskeletal tissue banking.

Bone Banks↗
PubMed1998

Effect of psychotherapy on the course of Crohn's disease. Results of the German prospective multicenter psychotherapy treatment study on Crohn's disease. German Study Group on Psychosocial Intervention in Crohn's Disease.

BACKGROUND: Our aim was to study the influence of psychotherapy in addition to a standardized corticosteroid treatment on the somatic and psychosocial course of Crohn's disease. METHODS: In a prospective, randomized multicenter study 108 of 488 patients received either drug treatment or, in the intervention group, additionally psychotherapy in the first half of the 2-year follow-up period. RESULTS: Eighty-four patients (77.8%) completed the somatic and 81 (75%) the psychosocial follow-up. Twenty-three per cent of the control group and 30% of the psychotherapy group showed episode-free courses; 29% and 17%, respectively, underwent surgery due to failure of drug treatment. The main analysis, which was based on subranking by number, duration, and severity of relapses, failed to show significant differences between the two groups (P = 0.125). The same result was obtained for the psychosocial status after 1 year in the main target criteria depression, anxiety, psychosocio-communicative status, and quality of life. CONCLUSIONS: The confirmatory analysis did not prove significantly better courses after additional psychotherapy. There was a tendency towards fewer operations.

Adolescent↗
PubMed1998

Results of interleukin-2-based treatment in advanced melanoma: a case record-based analysis of 631 patients.

PURPOSE: In patients with stage IV melanoma, durable responses have been reported with treatment regimens that involve high-dose interleukin-2 (IL-2). We analyze long-term results of 631 melanoma patients from 12 institutions who had received IL-2 alone, in combination with interferon alfa 2a or 2b (IFNalpha), or with cytotoxic drugs. METHODS: Case records that contained pretreatment parameters, response data, and updated survival information were collected. After univariate analysis, the multivariate evaluation of the impact of pretreatment parameters on response and survival was performed by logistic regression and Cox's regression, respectively. RESULTS: Patients were divided into four groups according to treatment: IL-2 alone (n=117), IL-2 and chemotherapy (n=49), IL-2 and IFNalpha (n=153), and IL-2, chemotherapy, and IFNalpha (n=312). The median survival of all patients was 10.5 months and the 2- and 5-year survival rates were 19.9% and 10.4%, respectively. Independent prognostic factors for response and survival were entirely different, treatment group being the only significant factor for response, and serum lactate dehydrogenase (LDH), metastatic site, and performance predicting survival. The addition of IFNalpha to IL-2 was associated with prolonged survival, but the effect of additional chemotherapy was less obvious. CONCLUSION: Serum LDH, metastatic site, and performance status are useful stratification factors for randomized trials in metastatic melanoma. The improved long-term survival rates observed in melanoma patients treated with IL-2/IFNalpha-containing regimens are notable in contrast to the reported 5-year survival rates of 2% to 6% achieved with chemotherapy, but because selection bias cannot be ruled out, the impact of IL-2, as well as all other components of the treatment regimens, on survival needs to be confirmed in prospective randomized trials.

Adult↗
PubMed1997

Monteggia and equivalent lesions. A study of 41 cases.

Forty-one patients who suffered from a Monteggia fracture and were treated between 1984 and 1993 were reviewed retrospectively using a new motion score of the elbow joint. There were 14 children and 27 adults of whom 34 were available for review. The results in children were significantly better than those of the adults. Among the adults, the final results of the patients who had a Bado Type 1 equivalent injury were significantly worse than those of the other groups, especially when associated with a fracture of the radial head. The type of fracture, open or closed, the presence of a fracture of the olecranon, and the energy level of the trauma did not have any significant prognostic value. Good correlation was shown between the new motion score and the Figgie elbow score. The Bado Type 1 equivalent injuries should be considered as a special subgroup of the Monteggia lesion, necessitating extra attention in treatment and rehabilitation, and a close followup of the patient.

Adolescent↗
PubMed1996

Prognostic factors for response and survival in patients with metastatic melanoma receiving immunotherapy.

Sixty-five patients with advanced melanoma treated in phase II trials with interferon-alpha and high dose interleukin-2 were analysed for pretreatment prognostic parameters. Three levels of response were used: objective remission [three complete response (CR)/14 partial response (PR)], stable disease and progression. Elevated lactate dehydrogenase (LDH), impaired performance status and high tumor load were associated with poor response. Multivariate analysis considering two levels of response [CR/PR vs stable disease (SD)/progressive disease (PD)] did not reveal any model with more than one significant factor. Considering survival, LDH was also a strong factor. Additional prognostic factors here were performance status, metastatic sites, alkaline phosphatase and tumor load. A Cox regression analysis revealed LDH, performance status and metastatic sites as independent factors. The prognostic values of these parameters will have to be confirmed in a larger patient cohort. Using the landmark method, it was estimated whether the response obtained after two cycles of treatment predicted survival. Patients with PD at this time had a median further survival of 6 months, SD of 27 months, and PR/CR of more than 31 months. This observation may help making decisions at this time.

Dose-Response Relationship, Drug↗
PubMed1994

Pharmacokinetics and pharmacodynamics of lisinopril in advanced renal failure. Consequence of dose adjustment.

To prevent drug accumulation and adverse effects the dose of hydrophilic angiotensin-converting enzyme (ACE) inhibitors, e.g. lisinopril, must be reduced in patients with renal failure. To obtain a rational basis for dose recommendations, we undertook a prospective clinical trial. After 15 days of lisinopril treatment pharmacokinetic and pharmacodynamic parameters were determined in patients with advanced renal failure (n = 8; endogenous creatinine clearance [CLCR]: 18 ml.min-1.1.73 m-2) and in healthy subjects with normal renal function (n = 16; CLCR: 107 ml.min-1.1.73 m-2). The volunteers received 10 mg lisinopril once daily, the daily dose in patients (1.1-2.2 mg) was adjusted to the individual CLCR according to the method of Dettli [13]. After 15 days of lisinopril treatment the mean maximal serum concentration (Cmax) in patients was lower than in volunteers (30.7 vs 40.7 ng.ml-1, while the mean area under the concentration-time curve (AUC0-24 h) was higher (525 vs 473 ng.h-1.ml-1). ACE activity on day 15 was almost completely inhibited in both groups. Plasma renin activity, angiotensin I and angiotensin II levels documented marked inhibition of converting enzyme in volunteers and patients. Furthermore, average mean arterial blood pressure in patients decreased by 5 mmHg and proteinuria from 3.9-2.7 g per 24 h after 15 days of treatment with the reduced dose of lisinopril. Adjustment of the dose of lisinopril prevents significant accumulation of the drug in patients with advanced renal failure during chronic therapy. Mean serum levels did not exceed this in subjects with normal renal function receiving a standard dose.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1993

Evaluation of serum neural cell adhesion molecule as a new tumor marker in small cell lung cancer.

BACKGROUND: Small cell lung cancer (SCLC) is distinguished from other histologic types of lung cancer by possessing a variety of neuroendocrine properties. Neuron-specific enolase (NSE) is the most frequently elevated tumor marker for patients with SCLC at diagnosis. To assess the value of neural cell adhesion molecules (NCAM), another possible tumor marker for small cell lung cancer, NCAM was evaluated in the sera of patients with histologically confirmed SCLC in two prospective multicenter trials. METHODS: The study includes 221 patients with SCLC, normal human blood donors (n = 34), patients with benign lung disease (n = 53), and patients with non-small cell lung cancer (n = 28). NCAM was determined by means of an enzyme immunoassay, NSE by a radioimmunoassay. RESULTS: The data show the following: (1) 51% (113 of 221) of all patients with SCLC had NCAM levels higher than 20 U/ml, 34% (75 of 221) had NSE levels higher than 25 ng/ml; (2) levels of both markers significantly differ between limited and extensive disease patients; (3) patients with pathologic NCAM and NSE levels have significantly shorter survival times; (4) a positive correlation between pretreatment NSE and NCAM levels was found (n = 221, r = 0.60); and (5) a correlation between serum marker levels and clinical status was found in follow-up studies of 19 patients. CONCLUSIONS: From these data, it is concluded that NCAM is, along with NSE, a potential tumor marker for SCLC.

Adult↗
PubMed1993

Adhesions of distal tibiofibular syndesmosis. A cause of chronic ankle pain after fracture.

Ankle pain after uncomplicated ankle fractures poses a diagnostic and therapeutic challenge, especially in joints that exhibit insignificant radiographic changes. Ankle joint arthroscopy has become an important diagnostic and therapeutic tool for such cases. Adhesion of the distal tibiofibular syndesmosis, as yet an undescribed entity, was found to be the cause of chronic ankle pain in 11 of 19 patients suffering from chronic ankle pain after an uncomplicated fracture of the ankle. Symptoms resolved after arthroscopic resection of the adhesions in all 11 patients. Arthroscopy has an important role in diagnosis and management of unexplained ankle pain after a seemingly uncomplicated fracture.

Adult↗