Fibrinogen/LDL apheresis as successful second-line treatment of sudden hearing loss: a retrospective study on 217 patients.

BACKGROUND: Sudden sensorineural hearing loss (SSHL) may be caused by a reduction of cochlear perfusion. Cholesterol and fibrinogen negatively influence rheological properties of blood thus leading to alteration of microcirculation. Fibrinogen/LDL apheresis improves cochlear blood flow by acutely decreasing plasma cholesterol and fibrinogen. METHODS: Remission rates of 217 patients with SSHL were analysed retrospectively after single apheresis. All patients had been treated otherwise before without any improvement of hearing. We investigated data in regard to frequency of hearing loss and time between onset of symptoms and apheresis. RESULTS: 15% of all patients had complete remissions, whereas partial remissions were seen in 46%. No change of hearing threshold was seen in 33%, 2% worsened. Remission rates decreased from 70% for a time of 2 weeks between onset of SSHL and apheresis to 63% and 21% for 6 weeks and 3 months. CONCLUSION: The present study shows that apheresis was followed by complete or partial remissions in 61% of patients even as second line therapy. The window for good therapeutic success is approximately 6 weeks.

[Fibrinogen/LDL apheresis for treatment of sudden hearing loss: an observational study on 152 patients]. / H.E.L.P.-Apherese bei der Behandlung des Hörsturzes: Eine Anwendungsbeobachtung an 152 Patienten.

Disturbances of cochlear microcirculation are among the most discussed causes of sudden sensorineural hearing loss. Increased levels of cholesterol and fibrinogen seem to act as risk factors for inner ear disorders. Fibrinogen/LDL apheresis greatly reduces the concentration of plasma fibrinogen thus leading to improved cochlear blood flow. In a retrospective case series remission rates of 152 patients suffering from sudden sensorineural hearing loss and resistant to former treatment were investigated after treatment with a single apheresis. Complete remission was reported in 11% of patients, partial remission in 43%. 37% had no change of hearing threshold and 2% reported a decrease in hearing. Rates of complete remissions decreased from 22% within the first 2 weeks after onset of hearing loss to 14% after 6 weeks. In the same period of time rates of partial remissions decreased from 33% to 13%. The present study shows that apheresis achieved complete or partial remission in 54% of patients even after unsuccessful treatment with another therapy and the therapeutic window lies by approximately 6 weeks.

[Evaluation of the sampling plan for a Salmonella monitoring program for slaughter pigs]. / Bewertung der Stichprobenplanung für ein Salmonellen-Monitoringprogramm bei Mastschweinen.

In the setting of the Salmonella monitoring programme of the Federal Republic of Germany the sampling plan does not take into account prevalences occuring in reality. Hence, in most farms the testing effort will increase. This particularly applies to pig farms up to 100 fatteners, for which the proportion of animals to be tested is too high. Besides, the threshold values determing the allocation to the three quality categories, less than 20%, 20-40%, and more than 40% Salmonella positive fatteners, are also chosen too high.

[Treatment of sudden hearing loss through Fibrinogen/LDL-apheresis. A prospective, randomized multicenter trial]. / Behandlung des Hörsturzes durch Fibrinogen-LDL-Apherese. Eine prospektive randomisierte Multizenterstudie.

INTRODUCTION: Sudden sensorineural hearing loss (SSHL) is thought to be of various origins. Disturbances of microcirculation, autoimmune pathology and viral infection are among the most likely causes. Acute reduction of plasma fibrinogen and serum LDL positively influences hemorheology and endothelial function and might thus be an effective therapy for SSHL. OBJECTIVE: To test the hypothesis that fibrinogen/LDL-apheresis is as effective or superior to conventional therapy with plasma expanders and prednisolone in the treatment of SSHL. DESIGN: controlled, prospective, randomized, multicenter trial. SETTING AND PATIENTS: 201 patients were recruited from 01/2000 to 6/2001 at the University Clinics of Munich, Berlin, Hamburg and Bochum. Inclusion criteria was sudden sensorineural hearing loss of unknown origin within 6 days of onset. INTERVENTIONS: Single fibrinogen/ LDL-apheresis infusion of prednisolone (250 mg, tapered by 25 mg daily), hydroxyethyl starch (500 ml, 6%) and pentoxifylin (400 mg/day). MAIN OUTCOMES: Improvement of pure tone thresholds 48 h after onset of therapy. RESULTS: Over all improvement of pure tone thresholds in the fibrinogen/ LDL-apheresis treated patients is slightly but not significantly better than in the standard therapy group. After 48 h, 50% speech perception in the fibrinogen/ LDL-apheresis group (21.6+/-20.1 dB) is significantly (p<0.034) better than in the standard group (29.3+/-29.4 dB). Patients with plasma fibrinogen levels of more than 295 mg/dl have a substantial and significantly (p<0.005) better improvement of speech perception (15.3+/-17.3 dB) than standard treated patients (6.1+/-10.4 dB). CONCLUSIONS: Fibrinogen/LDLapheresis is at least equally effective compared to prednisolone treatment in sudden hearing loss. Selected patients with plasma fibrinogen of more than 295 mg/dl improve significantly better when treated with fibrinogen/LDLapheresis.

[Sampling plan for the establishment of a serologic Salmonella surveillance for slaughter pigs with meat juice ELISA]. / Stichprobenplanung für die Etablierung eines serologischen Salmonellen-Monitoringprogramms bei Mastschweinen mittels Fleischsaft-ELISA.

The guidelines of the German Ministery of Food, Agriculture and Forestry outlining a Salmonella surveillance programme, "Leitlinien für ein Programm zur Reduzierung des Eintrags von Salmonellen durch Schlachtschweine in die Fleischgewinnung" (February 5th, 1998), provide a staggered spot-check size depending on the annual production of slaughtery pigs. A classification of farms into three quality categories (< 20%, 20-40%, and > 40%) is performed by salmonella antibody levels detected in meat samples using ELISA. Beside a fundamental inquiry into the salmonella status, the programme ought to lead to a decreased burden on slaughtery pigs and finally to a reduced salmonella entry into meat handling and processing companies. The spot-check plan is based on an unfavourable initial position and does not consider the real situation of salmonella load in pig fattening farms. For many farms the procedure will lead to an unjustified expenditure of examinations. In simple model calculations it is shown how a significant reduction of testing amount can be reached and statistical reliability is guaranteed, too. At the same time, we attempt to find a compromise between optimal spot check size and practicability. For reasons of free enterprise, an additional category would be desirable containing farms without any positive antibody titres in the samples. The results achieved so far indicate that a large number of German slaughter pig producers would fall into this category, without the necessity of a higher examination effort.

[Meat juice ELISA for determination of Salmonella incidence in slaughter pig herds in Bavaria]. / Fleischsaft-ELISA zur Beurteilung der Salmonellen-Inzidenz von Schlachtschweinen in Bayern.

Meat samples from diaphragm pillars were randomly taken from 3,048 pigs of 52 Bavarian herds after slaughtery. Meat-juice was collected and tested for salmonella antibodies in an indirect ELISA. The number of samples was calculated according to the annual production of slaughter pigs of a farm outlined in the "Leitlinien für ein Programm zur Reduzierung des Eintrags von Salmonellen durch Schlachtschweine in die Fleischgewinnung" from February 05th, 1998 (< 100 slaughter pigs: 45 samples, 100-200 slaughter pigs: 50 samples, > 200 slaughter pigs: 60 samples per year). Salmonella antibodies were detected in 48 carcasses (1.6%) of 12 farms (23.1%). However, 33 (68.8%) of these carcasses were originated from a single farm which had to be classified into category III (prevalence of > 40% in the samples). No bacteria could be isolated from this farm in a follow up examination. The 51 other farms (98%) were classified into category I (prevalence of < 20% in the samples). Farms with in/out-management showed a higher degree of reagents (2.1T%) than farms with continuous stabling (0.8T%). In a pig experimentally immunized with LPS-antigen preparations of Salmonella typhimurium it was shown that antibodies induced were nearly at the same level in all meat samples and even in selected organs (liver, kidney, parotis, mesenteric lymph nodes).

[Quality of life of hypertensive physicians with hypertension therapy. Randomized double-blind study of 237 female and male physicians with high blood pressure]. / Lebensqualität hypertensiver Arzte unter Hochdrucktherapie. Randomisierte Doppelblindstudie an 237 Arztinnen und Arzten mit Bluthochdruck.

In a group of 237 hypertensive male and female physicians, a placebo-controlled randomized double-blind, cross-over trial was performed to investigate the effects of the ACE inhibitor captopril on blood pressure and well-being. A thoroughly tested standardized measurement of well-being was employed. On the basis of the multivariate linear model, differences in the response to treatment (t-tests for cross-over differences) were investigated in terms of the seven parameters of well-being measured. In comparison with placebo, captopril (50 mg once daily) had a significant effect on five of the seven parameters. Thus, mood, general well-being, work performance, regeneration and quality of sleep all improved under treatment. It was also found that these improvements were not an immediate consequence of blood pressure reduction. The standardized evaluation employed here thus proved to be an informative additional evaluation criterion of antihypertensive therapy.

[Progressive left ventricular dilatation following anterior myocardial infarct as a determinant for the development of heart failure]. / Progrediente linksventrikuläre Dilatation nach Vorderwandinfarkt als Determinante für die Entwicklung einer Herzinsuffizienz.

35 consecutive patients were studied prospectively with respect to echocardiographic left ventricular size after anterior myocardial infarction. In 25 patients sufficient follow-up was possible. Another 57 patients and volunteers were examined to prove accuracy in comparison to angiocardiography and nuclear magnetic resonance imaging and reproducibility as well as to define normal values. While two-thirds of all patients did not develop left ventricular dilation, one-third showed marked dilation with left ventricular size being 41% above mean normal value. All patients who subsequently developed congestive heart failure or died were in this group. Two-thirds showed no left ventricular dilation and had an uneventful follow-up. Mean left ventricular dilation for all infarcts was 22% within 4 weeks and 26% within 6.3 months, but some patients showed marked left ventricular dilation beyond 4 weeks. We conclude that serial echocardiography is very useful for stratification of risk for CHF after myocardial infarction, and left ventricular dilation is a major risk factor for CHF.

Captopril in combination with hydrochlorothiazide: comparative efficacy vs perceived best therapy.

An open, randomized, multicentre, comparative trial on 2128 patients with mild-to-moderate hypertension, treated with so-called perceived best therapy or a combination of captopril plus hydrochlorothiazide (HCTZ), was conducted over a period of 10 weeks. Both regimens lead to significant blood pressure reductions within the initial 6 weeks, with a difference of 3 mmHg systolic and 2 mmHg diastolic in favour of the captopril plus HCTZ regimen as compared to the perceived best therapy. Both an increase in the daily dose of captopril in uncontrolled patients receiving initial treatment with captopril plus HCTZ and treatment with captopril plus HCTZ in uncontrolled patients receiving the perceived best therapy was followed by improved blood pressure control. There were more withdrawals mainly due to side effects and non-compliance in the captopril plus HCTZ group as compared to the perceived best therapy group. By contrast, there were fewer side effects and a tendency towards a more pronounced improvement of complaints and general well-being in the captopril plus HCTZ group. The study has yielded no clear evidence of an increased number of side effects known to be associated with captopril. Changes of the treatment regimen and dosages according to diastolic blood pressure during the study are difficult to achieve in a study of this type and size.

Prediction of annualized lactation yield from partial lactations.

Extension factors for annualized lactation yields [365 (total lactation yield)/-days between calvings] were computed by generating 747,904 partial lactations from complete lactation records of 105,379 Israeli-Holstein cows with one to three lactations. Factors included in the model were last test yield, days pregnant, days in milk, farm type, calving season, and days remaining in the lactation. Both linear and quadratic effects were assumed for the first three factors. Primiparous and multiparous cows were analyzed separately for milk, fat, and economically fat-corrected milk [.67 (milk) + 10 (fat)] yields. Adjusted coefficients of determination computed for this model were .04 higher for fat and .01 higher for milk and economically fat-corrected milk than for an alternate model in which remaining yield was predicted as a linear function of last test yield and remaining days in milk. Correlations between actual and predicted lactations for partial lactations of less than 4 mo in milk computed by the first model were .03 higher for fat but were nearly identical to those computed by the second model for milk. Although last test yields was the most important factor in predicting annualized yields, inclusion of other factors increased accuracy of annualized fat yield prediction.

[Misoprostol and cimetidine in the treatment of duodenal ulcer. A multicenter Swiss double-blind study]. / Misoprostol und Cimetidin bei der Behandlung des Ulcus duodeni. Eine multizentrische Schweizer Doppeltblindstudie.

The efficacy and tolerance of misoprostol a synthetic prostaglandin E1 analogue-and of cimetidine were evaluated in the treatment of duodenal ulcer following a double blind multicenter design. A group of Swiss gastroenterologists recruited 119 patients with endoscopically proven acute duodenal ulcer. They were enrolled and treated according to a uniform protocol either with misoprostol 4 X 50 micrograms daily, with misoprostol 4 X 200 micrograms daily or with cimetidine 4 X 300 mg daily. Patients who were healed after 4 or 8 weeks were followed during 6 months. Cumulative healing rates at 4 weeks in groups receiving misoprostol 200 micrograms, misoprostol 800 micrograms or cimetidine 1200 mg daily were 42%, 58% and 71% respectively. Patients treated with cimetidine showed a more rapid improvement of symptoms than patients treated with misoprostol. Symptomatic recurrences after ulcer healing occurred in almost 40% of the patients within 6 months, irrespective of the type of acute ulcer treatment. Risk factors for slowed healing and increased rate of recurrence were evaluated in the present study, and the results were compared with the results of two previous trials performed according to a similar protocol. Smoking appeared to slow healing and to favor relapses. Moderate consumption of alcohol appeared to decrease the relapse rate. In the present trial, ulcer size was associated with ulcer pain but not with ulcer healing.

Effects of days open on annualized milk yields in current and following lactations.

Length of open period affected annualized yield [(total lactation yield/calving interval) 365]. Yield was maximum with more days open for low, as opposed to high, peak production and for primiparous, as opposed to multiparous, cows. Interactions with days open were not found for mean herd production or cow production relative to the herd mean. Number of days open for maximum yield was similar for milk, fat, and economically fat-corrected milk [.67 kg milk + 10 kg fat]. Correction factors were derived by smoothed least square means of days open classes. Additive adjustment factors were more appropriate than multiplicative adjustment factors. Records adjusted for days open were not able to predict the following lactation yield significantly better than unadjusted records. Cumulative yield of current and following annualized lactations, including the contribution of the calf expressed in units of milk production, was greatest at 117 and 98 days open for primiparous and multiparous cows. For cows with high peak production maximum yield was with 12 to 14 fewer days open than for cows with moderate peak. Conception prior to 2 mo postpartum had an adverse effect on cumulative yield.