[Therapy of overactive bladder with propiverine ER: results of a non-interventional study with a propiverine retard formulation and comparison to clinical studies]. / Therapie der überaktiven Blase mit Propiverin ER : Ergebnisse einer nichtinterventionellen Studie mit einer Propiverin-Retardformulierung und Vergleich zur klinischen Studie.

BACKGROUND: The aim of this non-interventional study was to evaluate the efficacy and tolerability of propiverine ER under real life conditions. PATIENTS AND METHODS: The treatment of 5,565 patients with urge urinary incontinence, urgency or mixed urinary incontinence was documented over a 12-week period. Incontinence episodes, voiding frequency and voided volume were recorded at 3 visits (admission, after 4 and 12 weeks). Additionally the tolerability was evaluated at visits 2 and 3. RESULTS: The average incontinence episodes/24 h decreased during therapy from 4.23 to 2.89. The frequency of micturitions/24 h decreased by 5.50. The voided volume improved by 69 ml. Approximately 92 % of investigators and patients assessed the efficacy similarly with "very good" and "good". Dry mouth was the most frequent adverse drug reaction and decreased from 16.5 % after 4 weeks to 13.6 % after 12 weeks of treatment. CONCLUSION: The efficacy and tolerability of propiverine ER were confirmed under real life conditions.

Using flavoxate as primary medication for patients suffering from urge symptomatology.

A drug utilization observation study collected data on a total of 1800 patients given flavoxate (Spasuret 200) over 2 weeks for urge incontinence. Efficacy and tolerance parameters were determined. A subgroup of 618 patients without urinary tract infections or benign prostatic hyperplasia were treated with flavoxate only. The subgroup (n = 618) showed a reduction of dysuria (37%), nocturia (53%), and both daytime (61%) and nighttime urge (69%). Bladder volume at first urge sensation increased by 55.1+/-58.8 ml (36%), which was comparable to data from the entire group (1800 patients). In 89.2% of all patients the residual urine volume was stable or decreased. Undesirable side effects occurred in 1.8% of cases. Both groups showed better results with flavoxate four times daily (800 mg), compared to three times daily (600 mg). Flavoxate is effective and well tolerated and causes no additional problems due to residual urine or side effects.

Multi-center European evaluation of HIV testing on serum and saliva samples.

OBJECTIVE: to evaluate the reliability of HIV antibody testing on saliva. DESIGN: matched serum and saliva samples were collected from both seronegative (n = 344) and seropositive (n = 125) individuals in five European countries. Duplicate saliva samples collected with Omni-Sal devices provided by Saliva Diagnostic System (SDS) were pooled before analysis. METHODS: all samples were analyzed by Recombinant HIV1 EIA Cambridge Bioscience and 2nd generation Abbott HIV 1&2 1A80. EIA procedures were adapted for saliva testing by modification of sample dilution and/or cut-off calculation. All saliva recording positive and/or doubtful EIA results were further analyzed by Western blot as a confirmatory method. RESULTS: EIA results obtained from sera analysis from both seropositives and seronegatives allowed for calculation of the tests' sensitivity (HIV1 Biotech: 99.2%-100%; Abbott: 100%) and specificity (both tests 100%). In the series of 125 saliva samples collected from seropositives, the EIA results were as follows: with Biotech (3 negative, 3 in the grey-zone and 119 reactive) and with Abbott (1 negative, 1 in the grey-zone and 123 reactive). One saliva sample found negative by both EIA tests, although fulfilling HIV1 WB criteria of positivity, was collected from an HIV2 infected person. Out of 125 saliva samples collected from seropositives, 121 produced positive Western Blot profiles, 4 were indeterminate and 1 was found negative whereas 125/125 sera were found positive. CONCLUSION: the reliability of HIV testing of saliva is dependent on the sensitivity of EIA tests and on the criteria used for the interpretation of Western blot tests as well. Although saliva testing offers numerous advantages for epidemiological purposes, it should not be recommended for diagnosis.

Purging of peripheral blood stem cells yields BCR-ABL-negative autografts in patients with BCR-ABL-positive acute lymphoblastic leukemia.

Remission marrow from patients with BCR-ABL+ acute lymphoblastic leukemia (ALL) achieving clinical remission (CR) after induction or consolidation chemotherapy according to the German multicenter adult ALL (GMALL) protocol showed high titers of residual BCR-ABL+ cells. Therefore, we initiated a pilot study to monitor circulating BCR-ABL+ cells and to collect, purge, and autograft peripheral blood stem cells (PBSC) in these patients. After GMALL 05/93 high-risk phase II of induction chemotherapy (high-dose AraC 3 g/m2 x 8 does and mitoxantrone 10 mg/m2 x 3 doses), patients received 5-10 micrograms/kg subcutaneous recombinant human granulocyte colony-stimulating factor (rhG-CSF) daily. Mobilized CD34+ cells peaked between 20 and 26 days after starting chemotherapy at 4.8-75.6 (median 10.8) x 10(4)/mL peripheral blood (PB) (n = 5). Patients treated with additional chemotherapy cycles failed to mobilize adequate numbers of CD34+ cells. PB stem cells (PBSC) were purged using a cocktail of CD10, CD19, and AB4 monoclonal antibodies (mAbs) coupled to immunomagnetic beads (IMB). The median recoveries of total nucleated cells (TNC) and CD34+ cells after mAb/IMB purging were 84 and 81%. The peak numbers of CD34+ cells collected in a single leukapheresis were median 8.6 x 10(6)/kg pre- and 5.2 x 10(6)/kg postpurge (n = 4). The absolute prepurge CD19+ cells were as low as median 2.7 (range 1.4-19) x 10(6) per leukapheresis. Residual BCR-ABL+ cells in unpurged leukapheresis products were assessed by limiting-log10-dilution nested reverse-transcriptase polymerase chain reaction (RT-PCR) as one in 10(5) to one in 10(6) normal cells and were consistently undetectable in all purged PBSC autografts. We conclude that sufficient numbers of CD34+ cells for PBSCT can be collected after phase II but not at later stages of the GMALL 05/93 high risk protocol; PBSC grafts are 3 log less contaminated with residual BCR-ABL+ cells compared to an historical series of 13 autologous BM grafts; and purging of PBSC with mAb/IMB is feasible with minor loss of CD34+ cells and abolished BCR-ABL signals in the grafts.

[Development of HLA antibodies in thrombocyte substitution with cell separator products]. / Entwicklung von HLA-Antikörpern unter Thrombozytensubstitution mit Zellseparator-Produkten.

In a retrospective study we investigated the development of HLA antibodies in patients who received platelet concentrates from cell separators. 118 hematological/oncological patients from the Frankfurt University Clinics were investigated. They received between 4 and 66 platelet concentrates for the duration of 30 months. All patients had a negative antibody screening on admission. 31% developed either transient (15%) or permanent (16%) lymphocytotoxic antibodies. The increasing number of platelet transfusions did not correlate with the development of HLA antibodies, but the appearance of these antibodies seemed to be dependent on the disease. Permanent antibodies appeared in 8% of patients with acute leukemia, whereas 38% of patients suffering from CL, lymphoma, MDS and myeloma produced antibodies. Some patients (18) received granulocyte transfusions as well. It is striking that 11% of these patients developed permanent and 28% transient HLA antibodies. There exist no data about recent transfusions or previous pregnancies. To lower the rate of sensitization in patients with diseases such as CL, lymphoma, MDS and myeloma, it should be discussed whether leukocyte-depleted platelet concentrates should be given to these patients.

Anti-A in factor VIII concentrate: a cause of severe hemolysis in a patient with acquired factor VIII:C antibodies.

The authors report a case of acute macrohematuria in a patient with spontaneously acquired antibodies against factor VIII:C. Severe hemolysis was observed under factor VIII concentrate therapy. In 4 batches of the factor VIII concentrate high titers up to 1:512 of 'immune' anti-A were found. Clotting factor preparations used for replacement therapy, therefore, should be investigated for iso-antibodies, at least in situations where an intensive infusion therapy is required.