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Biomedical subjects

J Hasford

Publications and source records attributed to J Hasford.

At least 19 recordsLinked to original sources
PubMed1992

24-hour blood pressure measurement in antihypertensive drug trials: data requirements and methods of analysis.

Non-invasive ambulatory blood pressure monitoring is an appropriate technique for the identification of the target population requiring antihypertensive treatment, since the systematic bias seen in casual clinic measurement is removed. The use of the technique in controlled clinical trials leads to a reduction in the sample size required to show a treatment difference in antihypertensive effect compared to sporadic single measurements, although in practice the number of recruited patients can considerably exceed the number of evaluable patients, due to poor compliance or incompleteness of data. In addition, the equality of observation essential in clinical trials cannot be controlled to the same degree as is possible with clinic measurements. Comparison of estimators of the overall characteristic blood pressure reveals that the 24-hour mean value produces an adequate estimator. A description of the individual blood pressure profile is obtained using smoothing procedures, the moving interval average providing a robust and simple approach. Clinically meaningful characteristics of the profile are difficult to define due to a dearth of information on prognostic importance of the features of the 24-hour blood pressure profile. Smoothed individual profiles can be combined to produce graphical descriptive treatment group summaries.

Antihypertensive Agents↗
PubMed1992

Compliance and the benefit/risk relationship of antihypertensive treatment.

Compliance is defined as a patient's behavior in terms of taking prescribed medication, following diets, or executing medically recommended lifestyle changes. Furthermore, compliance measures the extent to which a person's behavior coincides with medical or health advice. The measurement of compliance over time is still a problem. The recently developed medication monitors, however, enable precise documentation of the taking of pills out of the container over long time periods. Long-term compliance with antihypertensive treatments is, referring to the literature, about 50%. The causes of partial compliance are not yet well known. Partial compliance is often accompanied by reduced benefit, e.g., poor blood pressure control. There are even strong arguments that partial compliance increases the risks of treatment, especially with beta-blockers. Thus, the traditional physicians' nonperception of patients' partial compliance is no longer acceptable, as partial compliance has a negative impact on the benefit/risk ratio.

Antihypertensive Agents↗
PubMed1991

Plasmapheresis and subsequent pulse cyclophosphamide versus pulse cyclophosphamide alone in severe lupus: design of the LPSG trial. Lupus Plasmapheresis Study Group (LPSG).

A group of clinics are collaborating in the Lupus Plasmapheresis Study Group (LPSG) to investigate whether repeated plasmapheresis prior to pulse cyclophosphamide improves the therapeutical results in severe systemic lupus erythematosus (SLE). The underlying rationale is the hypothesis that plasmapheresis 1) eliminates pathogenic autoantibodies and immune complexes and 2) induces compensatory lymphocyte activation via feedback mechanisms between circulating antibodies and their respective clones ("antibody rebound"). It should be possible to utilize this enhanced activity for increased clonal deletion if pulse cyclophosphamide is applied shortly after plasmapheresis. Accordingly, in a randomized study, the LPSG will be comparing the repeated application of pulse cyclophosphamide alone with a treatment involving repeated plasmapheresis prior to the cyclophosphamide pulses in severe SLE. A third arm of the study will be gathering experience with a more intensified procedure. This overview summarizes the most important details of the planned study.

Combined Modality Therapy↗
PubMed1991

First dose hypotension with enalapril and prazosin in congestive heart failure.

Since the introduction of angiotensin converting enzyme 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 angiotensin converting enzyme inhibitor enalapril a multicenter, open, randomized, prazosin-controlled trial was designed comparing the incidence and severity of symptomatic hypotension on the first day of treatment. Trial medication was 2.5 mg enalapril or 0.5 mg prazosin. Subjects were 1210 inpatients with New York Heart Association functional class (I)/II and III who were not adequately compensated with digitalis and/or diuretics. In the group receiving enalapril, 3 patients (0.5%) experienced severe hypotension on day 1 and 28 patients (4.7%) moderate hypotension. In those given prazosin, 15 patients (2.6%) experienced severe hypotension and 60 patients (10.3%) moderate hypotension. The difference is statistically significant (P less than or equal to 0.000012). All patients recovered. It was concluded that treatment of patients suffering from congestive heart failure New York Heart Association functional class (I)/II or III with enalapril is comparably well tolerated.

Aged↗
PubMed1991

Evaluating quality-of-life measures for clinical trials in Germany.

In spite of an increased discussion of psychosocial outcomes of medical treatments, quality-of-life assessments in clinical trials conducted in Germany are rare. Barriers to the development of quality-of-life-related evaluation research include conceptual, methodologic, practical, and political issues. Each issue is characterized by specific problem areas and by current approaches to problem solving; both are affected by crosscultural considerations. This paper analyzes state-of-the-art in quality-of-life research in Germany with regard to four key issues and presents original work in a biometrical center as an example.

Clinical Protocols↗
PubMed1991

Medical students knowledge of HIV infection and AIDS. Members of the Association of University Teachers in General Practice.

To evaluate the knowledge on infection with the human immunodeficiency virus (HIV) a questionnaire survey was carried out in West German medical students attending general practice courses. Lecturers of 19 medical schools agreed to participate and 1665 completed questionnaires were returned. The analysis of students' answers showed some remarkable deficiencies. The data suggest that teaching of this subject in medical school may be insufficient. General practitioners could possibly contribute to reaching a higher level of knowledge.

Acquired Immunodeficiency Syndrome↗
PubMed1991

Efficacy and safety of ursodeoxycholic acid for dissolution of gallstone fragments: comparison with the combination of ursodeoxycholic acid and chenodeoxycholic acid.

A prospective, double-blind, randomized, single-center study was conducted to compare ursodeoxycholic acid alone with the combination of ursodeoxycholic acid and chenodeoxycholic acid for dissolution therapy of gallstone fragments after shock wave lithotripsy. Patients with single radiolucent gallstones up to 30 mm in diameter or up to three stones of similar total volume received either 750 mg ursodeoxycholic acid alone (group A, n = 138) or the combination of 500 mg ursodeoxycholic acid and 500 mg chenodeoxycholic acid (group B, n = 144) in a single bedtime dose. The bile acids were administered from 2 wk before electrohydraulic lithotripsy until 3 mo beyond complete disappearance of all fragments. Patient's characteristics, stones (group A, 82% single stones, maximum diameter 19 +/- 5 mm, mean +/- S.D.; group B, 82% single stones, 18 +/- 5 mm), lithotripsy treatment and follow-up period were not different between the two groups. Between the two groups, no statistically significant difference was found in the time required for complete clearance of the fragments (group A, median time = 15 mo; group B, median time = 13 mo; p = 0.7). At 12 mo after lithotripsy, the probability of complete clearance was 46% +/- 5% in group A and 49% +/- 5% in group B. Diarrhea occurred significantly more often in group B than in group A (p less than 0.001) and was the main reason for withdrawal of randomized medication. Severe adverse effects of the bile acids were not observed. It is concluded that monotherapy with ursodeoxycholic acid is as efficient as the combination of ursodeoxycholic acid and chenodeoxycholic acid for fragment dissolution after lithotripsy.(ABSTRACT TRUNCATED AT 250 WORDS)

Abdominal Pain↗
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

Low-dose aspirin versus anticoagulants for prevention of coronary graft occlusion.

The prevention of graft occlusion by aspirin (100 mg/day) or heparin followed by phenprocoumon was investigated in a randomized trial in 235 patients after aortocoronary bypass operation. Aspirin treatment started 24 hours before, and heparin 6 hours and phenprocoumon 2 days after surgery. The results of the vein graft angiography and the clinical outcome 3 months postoperatively did not differ: 22% of 218 vein graft distal anastomoses in the aspirin group and 20% of 272 in the anticoagulant group were occluded. At least 1 occluded distal anastomosis was present in 38% of 74 patients in the aspirin-treated group and in 39% of 86 in the anticoagulant group. Worst-case analysis of all randomized patients showed graft occlusions, cardiovascular complications or lost to follow-up in 42% of 122 aspirin-treated patients compared with 41% of 113 patients treated with anticoagulants. For grafts with endarterectomy the occlusion rate was lower in the aspirin (12% of 49) than in the anticoagulant (22% of 41) group (p less than or equal to 0.05). Increased perioperative blood loss in the aspirin group (1,211 +/- 814 ml in the first 48 hours vs 874 +/- 818 ml in the anticoagulant group [p less than or equal to 0.001]) without a higher reoperation rate indicates effective platelet inhibition with low-dose aspirin. Because occlusion rates were equal but high in these patients with advanced stage of coronary artery disease, a combination of low-dose aspirin and anticoagulation should be investigated to reduce graft occlusion rates further.

Aspirin↗
PubMed1989

Renal and hepatic tolerance of nonionic and ionic contrast media in intravenous digital subtraction angiography.

The liver and kidney tolerance of iopromide 370 in comparison to that of sodium meglumine diatrizoate 370 or iopamidol 370 in doses of 2 ml/kg body weight was examined in two controlled double-blind studies with intravenous digital subtraction angiography on the basis of enzyme assays in serum and urine. In patients with normal kidney function no changes were observed in the levels of the liver enzymes GPT, GOT, and gamma glutamyl transpeptidase (GGT) serum up to 72 hours after injection of iopromide or sodium meglumine diatrizoate. Among the kidney-specific enzymes, the excretion of GGT in urine increased after injection of iopromide and iopamidol. The maximum increase of GGT excretion was, however, statistically significantly lower in the group treated with iopromide than in the iopamidol group. Within 72 hours, the activities had been returned to the initial values in both groups.

Angiography↗
PubMed1988

[HIV testing in general practice].

In the third quarter of 1987 a questionnaire was sent to 350 consecutive patients of a general practice for the purpose of ascertaining patients' willingness to be tested (if desired, anonymously) without charge for antibodies against human immunodeficiency virus (HIV). They were asked, among other questions, about their reasons for or against wanting the test, previous blood transfusions, drug dependence, homo- or bisexuality, and sexual contact with heroin addicts. Nearly half the questionnaires (162 were completed and returned. Of the responding patients 60% voted for, 40% against the test. The large majority of those for it reported no previous risk factors but wanted to have what they assumed would be a negative test confirmed in writing. In addition to this questionnaire study all clinical and anamnestic indications for HIV testing were documented over a six-month period (16 cases). Two heroin addicts and a homosexual male had a positive anti-HIV test, while all others were negative.

Acquired Immunodeficiency Syndrome↗
PubMed1988

Magnesium pyridoxal 5-phosphate glutamate reduces hyperlipidaemia in patients with chronic renal insufficiency.

Chronic renal insufficiency is often accompanied by hyperlipidaemia and subsequent coronary heart disease. Two groups of 15 patients with serum creatinine greater than 2 mg/100 ml and serum cholesterol less than 250 mg/100 ml were given 3 x 50 mg magnesium pyridoxal 5-phosphate glutamate (MPPG) or placebo for 12 weeks in a double-blind, randomised study. Total cholesterol in the MPPG group (282.4 mg.100 ml-1) was lower than in the placebo group (354.3 mg.100 ml-1) after 12 weeks of treatment. Triglycerides in the MPPG group were 265.1 mg.100 ml-1 compared to 361.9 mg.100 ml-1. After 12 weeks on MPPG the LDL/HDL ratio of 3.56 was lower than in the placebo group-6.83. Side effects in the MPPG group were similar to those in the placebo group. Thus, MPPG was an effective antihyperlipidaemic agent in patients with renal insufficiency.

Adult↗
PubMed1987

Evaluation of the usefulness of dimethicone and/or senna extract in improving the visualization of abdominal organs.

Intestinal gas is the most common cause of technically unsatisfactory abdominal ultrasound scans. In the attempt to increase the visualization of abdominal organs, many investigators use antifoaming agents or laxatives. In the present, randomized, placebo-controlled, double-blind trial, a liquid dimethicone preparation and an extract of senna, alone and in combination, were tested as a means to improve scan quality. Response variables were defined on the basis of pancreas, aorta, and kidney visibility. There was no difference in the response variables of the three groups compared to placebo (P greater than 0.3-0.55). The results suggest that neither dimethicone nor senna improves the visibility of abdominal organs in ultrasound examination.

Abdomen↗
PubMed1987

Risk-benefit analyses of drugs: fundamental considerations and requirements from the point of view of the biometrician. Problems in the assessment of the combination of trimethoprim with sulfamethoxazole.

Risk-benefit analyses are a prerequisite for a rational decision about therapies, e.g. drugs. Ingredients of a risk-benefit analysis are: 1. quality and quantity of the benefit; 2. quality and quantity of the harm; 3. benefit and harm of the natural history of the disease; 4. benefit and harm of therapeutic alternatives; 5. commensurability of harm and benefit; 6. consideration of all types of adverse drug reactions together. The available evidence was not suitable for a sound risk-benefit analysis of the use of trimethoprim-sulfamethoxazole. However, there seems to be enough evidence to restrict the use of trimethoprim-sulfamethoxazole in diseases with a benign prognosis and/or when there are therapeutic alternatives with a smaller risk/benefit ratio. Reliable rules for risk-benefit analyses have to be developed and the necessary information has to be gained also in methodologically sound phase IV research.

Adult↗
PubMed1987

[Advantages and problems of multicenter therapy studies exemplified by a study of the treatment of metastasizing renal cell carcinoma with recombinant interferon-alpha-2c].

The advantages of multicenter trials are numerous: quicker recruitment of the necessary number of patients, clearer results which are more convincing and whose acceptance is higher, as the patient sample of multicenter trials is supposed to be representative. However, multicenter trials require strong efforts for quality assurance concerning admission, treatment and follow-up, thus a highly developed coordinating center is needed. Data on recruitment and protocol compliance, i.e. deviations from the study protocol, are presented for the study of the treatment of metastatic renal cell carcinoma and discussed with respect to their impact on the results of the study. 102 patients were randomized either for IFN alpha-2C or IFN alpha-2C plus medroxyprogesteroneacetate. 16% of the patients violated inclusion criteria and essential data were missing in 16% of the patients. Overall treatment results (remission rate of 5.6%, median survival time of 7 months) and the data on adverse events have been biased by lack of protocol compliance. However, the results concerning the lack of differences between treatments remain valid.

Carcinoma, Renal Cell↗
PubMed1979

[Digoxin concentrations in plasma and tissue. A postmortal investigation (author's transl)].

Postmortal tissue digoxin concentration and prefinal and postmortal plasma digoxin concentrations from 9 patients were determined using the 125J-digoxin radioimmunoassay. The concentration of digoxin in the myocardium of the left ventricle was 61.44 +/- 45.17 ng/g. In the right ventricle the concentration was 36.78 +/- 33.11 ng/g. Higher digoxin concentrations were found in the right atrium (34.93 +/- 21.86 ng/g) than in the left atrium (25.43 +/- 14.57 ng/g). In plasma samples taken after death approximately 62% higher digoxin concentrations were found than in samples of patients in prefinal state. Histological examination revealed positive correlation between in the high varying digoxin concentrations and the pathological conditions of the tissue structure.

Aged↗
PubMed1978

[Suicide with beta-methyldigoxin (author's transl)].

A 50-year-old woman committed suicide by taking an overdose of beta-methyldigoxin. The interval between swallowing the tablets and death was about 60 minutes. Plasma and tissue samples, taken 163 hours after death, were analysed for glycosides by radioimmunoassay. The plasma-glycoside level was 75.1 ng/ml, in the left ventricular myocardium it was 143.2 ng/g wet-weight. and in the right ventricular myocardium 159.7 ng/g wet-weight. The tissue-plasma ratio for the various parts of the heart varied from 0.8 to 2.1. Death occurred in the early distribution stage.

Digoxin↗