Prospective comparison of flecainide versus sotalol for immediate cardioversion of atrial fibrillation.

This study sought to compare the efficacy and safety of intravenous flecainide and sotalol for immediate cardioversion of atrial fibrillation. We performed a prospective, randomized, single-blind, multicenter trial, including 106 hemodynamically stable patients with atrial fibrillation, stratified according to duration of the arrhythmia. Exclusion criteria included severely reduced left ventricular systolic function, recent antiarrhythmic therapy, and hypokalemia. Patients were randomly assigned to receive either intravenous flecainide or intravenous sotalol. Trial medication was given at a dose of 1.5 mg/kg body weight (maximum 150 mg). Overall, 28 of 54 patients (52%) given flecainide and 12 of 52 patients (23%) given sotalol converted to sinus rhythm during the first 2 hours after start of the infusion (p = 0.003). Multivariate analysis confirmed that treatment allocation to flecainide, an arrhythmia duration of < or = 24 hours, higher plasma magnesium level at baseline, higher age for men, and lower age for women independently increases the probability of conversion. The frequency of adverse effects was not significantly different in the 2 treatment groups.

[Preoperative autologous blood collection under erythropoietin stimulation. Preliminary results in patient selection, erythropoietin dosage and administration]. / Präoperative autologe Blutkollektion unter Erythropoietinstimulation. Vorläufige Ergebnisse in Patientenauswahl, Erythropoietin-Dosis und Administration.

In a randomised study we have evaluated the influence of erythropoietin (EPO) on the yield of autologous blood in elective surgery (total hip replacement). The study was performed placebo controlled in 82 patients: 25 patients received 200 IE EPO/kg 2 x/week i.v. over 3 weeks (group C), 30 patients 100 IE EPO in the same schedule (group B), and 27 patients received placebo (group A). All patients were treated with 3 x 250 mg Fe-sulfate p.o. during the study time. The number of collected blood conserves was not significantly different in these groups (5.4 in group C, 5.06 in group B, 4.8 in group A), but there was a significant difference in patients with a diminished hemoglobin (Hb < 14 g/dl): 5.2 in group C, 4.9 in group B, and 3.6 in group A. Patients with a normal hemoglobin level showed a significantly higher preoperative hemoglobin in group C against group A. We conclude that the application of EPO is suggestive in patients with a diminished hemoglobin, but also in patients with normal hemoglobin the blood picture at the time of surgery is higher in EPO treated patients.

[MCA and CA 15-3 in the follow-up of patients with breast cancer]. / MCA und CA 15-3 in der Verlaufskontrolle bei Patientinnen mit Mammakarzinom.

After surgery and radiotherapy circulating serum levels of the tumour markers MCA and Ca 15-3 were evaluated in 226 clinically disease-free breast cancer patients. 15 of them presented with local recurrences and/or distant metastases after a follow-up period of twelve months. Six patients belonged to the group of 180 with both markers negative, two belonged to the 32 patients with only one marker positive, and seven to the group of 14 with both markers positive. After twelve months the probability of disease-free survival (calculated by the method of Kaplan-Meier) is 96% in patients with negative tumour markers and only 51.4% in patients with both markers positive (p less than 0.001). After 16 months these values are 96% versus 25.7% with the same statistical significance. The value of tumour marker examinations in the regular follow-up of patients with breast cancer lies in the early detection of tumour activity and therefore in a better chance of response to subsequent treatment. The diagnostic sensitivity of MCA was 75.5%, and for Ca 15-3 70.24%.

[CA-5000 (Sysmex). A contribution to the complete automation in blood coagulation analysis]. / CA-5000 (Sysmex). Ein Beitrag zur Vollmechanisierung in der Gerinnungsanalytik.

The Sysmex CA-5000 is a completely automated analysis device for the determination of various coagulation tests. The measurement is based on the scattered light measurement in the 90 degree angle. The apparatus is characterized by simple operation, great flexibility in the selection of reagents and by excellent precision. The comparability with globular coagulometry is described.

Evaluation of a new alpha-amylase assay using 4.6-ethylidene-(G7)-1-4-nitrophenyl-(G1)-alpha-D-maltoheptaoside as substrate.

The determination of alpha-amylase activity using an ethylidene-blocked 4-nitrophenyl-maltoheptaoside (EPS) has been evaluated in five laboratories on eight different analysers at 25 degrees C, 30 degrees C and 37 degrees C. The protecting ethylidene group inhibits hydrolysis at the non-reducing end of the substrate molecule by the auxiliary enzyme, alpha-glucosidase. The combined reagent is therefore stable for at least 10 days at 2-8 degrees C. HEPES is used, because the molar absorbance of 4-nitrophenol is independent of temperature in the presence of this buffer. Compared with the method using unprotected substrate 4-nitrophenyl-alpha-D-maltoheptaoside (4NP-G7), the present method is equal or better with respect to the imprecision, linearity and interlaboratory transferability of results in human and control sera. Since the protected and unprotected substrates differ in their turnover rate, the new assay yields activities which differ from those of the 4-nitrophenyl-alpha-D-maltoheptaoside method. Based on the homogeneous results obtained in method comparisons between EPS and 4-nitrophenyl-alpha-D-maltoheptaoside, and in order to maintain the 4-nitrophenyl-alpha-D-maltoheptaoside reference values, a conversion factor was derived to eliminate the above differences: activityEPS x 2.50 = activity4NP-G7. The temperature and instrument independence of this relationship was demonstrated in a total of 720 human sera and plasmas.

Reference ranges for alpha-amylase in serum and urine with 4,6-ethylidene-(G7)-1-4-nitrophenyl-(G1)-alpha,D-maltoheptaoside as substrate.

Reference ranges for alpha-amylase in serum, spontaneously voided urine, and 24 h urine were determined, using 4,6-ethylidene-(G7)-1-4-nitrophenyl-(Gl)-alpha,D-maltoheptaoside as the substrate (EPS method), at 25, 30, and 37 degrees C. The measured values were evaluated with and without the use of a factor which converts the results of the alpha-amylase EPS method into values comparable to those obtained with the alpha-amylase PNP method (substrate: 4-nitrophenyl-alpha,D-maltoheptaoside); comparison with the established reference ranges of the PNP method was therefore possible. The values for urine sometimes deviated markedly from the PNP reference ranges, but the values for serum showed close agreement. With the use of the conversion factor, the following reference ranges are proposed for the new alpha-amylase method: Serum (186 males and 131 females): up to 120 U/l (25 degrees C), up to 160 U/l (30 degrees C), and up to 220 U/l (37 degrees C). Spontaneously voided urine: up to 600 U/l (n = 323, 25 degrees C), up to 800 U/l (n = 373, 30 degrees C), and up to 1000 U/l (n = 373, 37 degrees C). 24 h urine: up to 450 U/24 h (n = 90, 25 degrees C), up to 650 U/24 h (n = 129, 30 degrees C), and up to 900 U/24 h (n = 129, 37 degrees C).

Diagnostic value of elastase-alpha 1-proteinase inhibitor in cerebrospinal fluid.

In this report we introduce CSF Elastase-alpha 1-Proteinase inhibitor as a valuable indicator for differentiating bacterial meningitis from aseptic meningitis and other neurological disorders. All patients (n = 26) with bacterial meningitis had increased CSF concentrations of E-alpha 1-PI above the range of normal (range of reference values: 0.0-2.3 micrograms/l, n = 79; bacterial meningitis: 30-3490 micrograms/l, n = 26). Concentrations of E-alpha 1-PI in bacterial meningitis were significantly elevated when compared with those in aseptic meningitis (0.0-194 micrograms/l, n = 37), polyneuropathy (0-23 micrograms/l, n = 24) and cerebrovascular attack (0-23.2 micrograms/l, n = 17).

Evaluation of a colorimetric test for the determination of alpha-amylase with p-nitrophenylheptaoside as substrate.

A continuous method for the determination of alpha-amylase activity with a defined substrate has been published by Rauscher et al. in Berichte der Osterreichischen Gesellschaft für Klinische Chemie 4, 150 (1981). It offers the following advantages: good practicability, easy adaptation to analysers and short incubation time. Twenty-one laboratories took part in a multicentric study on this method, working with different instruments and manual procedures at three temperatures. Additionally, all laboratories participated in a laboratory improvement program, in order to discriminate systematic from accidental errors. Data on imprecision, linearity, interferences and comparability of the method have been presented at a workshop. The resulting coefficients of variation for imprecision in series as well as from day to day were 0.6-6.3% and 1.3-7.7%, respectively. No interferences from bilirubin, glucose, maltose and 37 selected drugs were found. The results from the described method correlate well with those from an UV-test (substrate: maltoheptaose); compared with other methods, however, the expected systematic deviations were observed. Reference values for 25, 30 and 37 degrees C are indicated in this report.

[Non-secreting myeloma. Case report with immunohistologic and electron microscopic studies]. / Das nicht-sezernierende Myelom. Ein Fallbericht mit immunhistologischen und elektronenmikroskopischen Untersuchungen.

Immunological, immunofluorescence and electromicroscopic studies were performed in a case of atypical myeloma. The 77-year-old patient presented with skeletal pain, multiple osteolytic lesions and bone marrow infiltration by atypical plasma cells. Monoclonal light chains kappa were confined to the plasma cells, as shown by immunofluorescence. No monoclonal immunoglobulin or fragments were detected in plasma or concentrated urine, even by highly sensitive immunological methods. The concentration of the immunoglobulins G, A and M in the plasma was markedly reduced. The plasma cells contained very little sarcoplasmatic reticulum. The simultaneous occurrence of monoclonal light chains kappa in the plasma cells and the absence of monoclonal immunoglobulins or fragments in plasma and urine suggest a non-secretory myeloma.

[Routine serum digoxin determination on hospital admission (author's transl)]. / Digoxinscreening bei Spitalsaufnahme.

The purpose of the present study was the collection of data concerning digitalis treatment of patients outside hospital. The investigation was carried out on 200 patients over 60 years of age, consecutively admitted to a 750-bed general hospital (35% ot a medical ward, 65% to other specialities). An ECG and serum creatinine and digoxin determinations were performed on the day of admission and a careful history taken of the drugs administered before admission. 30 patients reported the use of digoxin or other digitalis drugs, whilst another 48 patients reported taking cardiac drugs in general. The prevalence of digoxin levels exceeding 2 ng/ml was 11.5% in the group of patients known to have taken digitalis preparations, 18% among the 92 patients with positive serum digoxin levels and highest (30%) in the subgroup admitted due to cardiac failure. In patients with digoxin levels above 2 ng/ml the prevalence of elevated serum creatinine values (greater than 1.2 mg%) was markedly increased. Among patients with normal serum creatinine levels the mean age of patients with digoxin levels above 2 ng/ml was significantly higher than of those with digoxin levels below 2 ng/ml. A clear correlation between digoxin levels and ECG changes was not demonstrable; simultaneous administration of diuretics promotes the appearance of electrocardiographic signs of digitalis toxicity.

Determination of renal clearances of amylase/creatinine with chromogenic and enzymatic methods.

Urinary amylase was estimated by chromogenic (amylochrome Roche) as well as enzymatic methods (SKI and Beckman: substrate starch and substrate maltotetraose respectively). Random and timed urines (24 hour collections) were analysed. Clearances of amylase gave different results dependent upon the amylase-test used and the glomerular filtration rate. Correlation between chromogenic and enzymatic methods (starch as substrate) was poor. The ratio of amylase and creatinine clearance was used to test different methods. Reference values for this ratio for the amylochrome method (N = 106) were 2.85 +/- 0.99% and for the Beckman-DS method (N = 60) 2.82 +/- 0.87%.

[Determination of alpha-amylase by an enzymatic kinetic method on the ABA-100 (author's transl)]. / Bestimmung von alpha-Amylase mit enzymatisch-kinetischer Methode auf dem ABA-100.

The enzymatic method of H. W. Schiwara (1972) Z. Klim. Chem. Klin. Biochem. 10,12--16 (reagents by Smith Kline Instruments), using the enzymatic reaction sequence alpha-amylase -- alpha-glucosidase -- hexokinase/glucose 6-phosphate dehydrogenase for the determination of alpha-amylase was evaluated on the ABA-100. The coefficient of variation for control sera and human pooled serum was 0.9--4.2% within series, and 1.4--6.6% day to day. Reference values for a healthy population (212 blood donors) in sera were 13--79 U/1 (+/- 2 SD), mean 46 U/1. In catch urines the values did not show a normal distribution; the minimal and maximal range for men was 58--385 U/1, for women 7--318 U/1. The kinetic curve of the enzymatic test was measured and the influence of glucose and linearity studied. In comparison with the enzymatic test, the chromogenic method Amlyochrom Roche was tested on the sera and urine of patients. The coefficient of correlation in sera was r = 0.975, in urine r = 0.965.

[Sucrosuria following an oral sucrose load (author's transl)]. / Saccharosurie nach oraler Saccharosebelastung.

44 male and 103 female subjects were given an oral load of 1 g or 2 sucrose/kg body weight. Glucose, fructose and sucrose were determined in capillary blood and urine samples before and after sucrose ingestion. Sucrose was detected in the blood only in 10 cases, but was present in the urine in each subject (max. 1132 mg sucrose/100 ml). Urinary excretion of sucrose is considered to be a physiological phenomenon since none of the subjects had any metabolic disorder.

[A simple and quick method for measuring low blood-glucose concentrations (author's transl)]. / Eine schnelle und einfache Methode zur Bestimmung niedriger Blutglucose-Konzentrationen.

A new method of measuring glucose concentrations (Reflotest-Hypoglycemie) was tested on 141 serum samples and 119 capillary blood samples and compared with the hexokinase-glucose-6-phosphate dehydrogenase method. The Reflotest (reflectance meter) compared well with the reference test. Comparison of results with three sera measured by the method in six different laboratories indicated the accuracy of the test. Endogenous bilirubin, uric acid, and haematocrit values did not influence the result. The test is therefore suitable for quantitative measurements.

[Studies on the accuracy and precision of total serum cholesterol in regional interlaboratory trials (author's transl)]. / Uber die Zuverlässigkeit der Bestimmung des Gesamtcholesterins im Rahmen regionaler Rundversuche

The between-run precision of the Liebermann-Burchard reaction modified by Watson was, in our laboratory, 2-3%, the within-run coefficient of variation was 1-2%. The between-run precision of the enzymatic test was 3-4%, the within-run coefficient of variation was 3%. The regression analysis of 92 serum specimens from patients was y = -17.31 + 1.04 chi, the coefficient of regression was r = 0.996. Interlaboratory trials of serum cholesterol were studied in the normal and pathological range. Lyophilized samples of serum prepared commercially and from fresh specimens from patients were analysed by the method of Liebermann-Burchard as well as by the enzymatic procedure. Acceptable results estimated by Liebermann-Burchard were obtained in the different laboratories after using a common standard of cholesterol. The coefficient of variation of the enzymatic test in the interlaboratory trial was higher in comparison to the Liebermann-Burchard reaction. Methodological difficulties of the Liebermann-Burchard reaction are discussed and compared with the specific, enzymatic assay.

[Quality control of coagulation tests (author's transl)]. / Ein Beitrag zur Qualitätskontrolle von Gerinnungsuntersuchungen

The results of quality control of coagulation tests from intralaboratory control programmes are reported and compared with interlaboratory surveys. The test programme includes the following assays: the thromboplastin time (Quick), the partial thromboplastin time and the thrombotest. It can be seen from the results of the thromboplastin time that reliable figures were obtained from intralaboratory quality control examinations only (CV=7% to 13%). In comparison to these results great differences were found in interlaboratory surveys (CV=15% to 30%). The result of interlaboratory surveys of the thrombotest demonstrated a CV of 15% to 20%. The intralaboratory quality control of the partial thromboplastin time showed satisfactory reliability (CV=7.4%). Satisfactory conformity of results was obtained between different laboratories only by using common reagents (CV=8.7%). Possible factors responsible for deviations in laboratory examinations are discussed and proposals for improvement in the realibility of coagulation tests are made.