Infusionstherapie und Transfusionsmedizin最新文献

Background: Shortly after the gel test was introduced into routine immunohaematology, an increased percentage of patients were reported to show a positive auto-control in the indirect antiglobulin test (IAT) of uncertain significance as the direct antiglobulin test (DAT) in the tube technique was negative.

Materials and methods: In our study 13,280 randomized patient blood samples were screened and additional investigations carried out including an analysis of patient histories in the 97 blood samples that were auto-control positive in the gel test.

Results: In 87.4%, a re-testing with polyspecific antiglobulin serum (83.2% with anti-IgG) showed positive results in contrast to only 52.9% re-tested by the tube test. Neither nonspecificity nor cold agglutinins were significant. None of the patients examined showed any signs of haemolysis except for one with pernicious anaemia. We concluded that the increased number of positive auto-controls and DATs is due to the greater sensitivity of the gel test and thus the detection of minute quantities of specific cell-bound IgG molecules, i.e. warm auto-antibodies or drug-induced antibodies.

Conclusion: Prior to transfusion, a positive result should be confirmed by a tube DAT. If this test is negative and there is no history of a previous transfusion or of haemolysis, the transfusion should not be delayed by carrying out further time-consuming investigations.

Objective: We tested the effect of anti Rhesus D [anti Rh(D)]-specific IgG in heavily pretreated patients with idiopathic thrombocytopenic purpura (ITP).

Design: Retrospective single case studies.

Setting: Clinical department of hematology.

Patients: 6 consecutive patients with heavily pretreated therapy-refractory ITP.

Interventions: 5 patients received one cycle of Anti Rh(D) in doses between 1,200 and 6,000 micrograms in 1 patient 2 consecutive cycles were applied. Treatment effect, durability, and side effects were monitored.

Results: Patients after splenectomy and/or immunosuppressive therapy did not respond. Response was short-lived in 2 other patients, one long-term remission could be achieved. Responders showed slight decreases in hemoglobin indicating mild hemolysis. Other major side effects were not observed and the therapy was well tolerated.

Conclusions: Our results suggest that therapy with Anti Rh(D) is safe and comparably inexpensive. No clear dose/effect correlation was found in our investigation. Only patients with platelet sequestration into the spleen might respond to Anti Rh(D) therapy.

Objective: In a pilot study blood donors were screened on HDL, LDL, and total cholesterol. The practicability and significance of such a screening in a blood bank should be tested.

Design: For this purpose, current methods to determine HDL, LDL, and total cholesterol were adapted on microtiter plates and validated. In a period of about 4 weeks all blood donors were tested for the three cholesterol parameters.

Setting: Red Cross blood bank in Baden-Baden, Germany with about 150,000 donations per year.

Participants: The HDL, LDL, and total cholesterol results of 10,006 blood donors could be evaluated.

Interventions: None.

Results: The mean total cholesterol was 192 +/- 36 mg/dl, the mean HDL cholesterol 56 +/- 15 mg/dl, and a mean LDL cholesterol of 123 +/- 39 mg/dl was found. The known age-dependency of the measured cholesterol fractions could be confirmed in our blood donor population. According to the current recommendations, more than 20% of the tested blood donors need a therapy.

Conclusions: The study shows that the screening of blood donors for increased total cholesterol for prevention of coronary heart disease could be done with a minimum of costs.

Background: In former years transmission of infectious diseases by blood products was repeatedly observed. To trace these incriminated batches of blood products proved to be nearly impossible.

Methods: This publication describes the documentation of different batches of blood products. In the simpliest case the batch numbers of blood products can be stored in files using forms. Besides this documentation of batches can be aided by EDP using databases and barcodes. A test for the correct and complete input of data is given.

Results: The registration of batches of commercially available blood products as well as blood preserves is possible. Incriminated batches can be traced back.

Conclusions: Besides donor selection, control of the manufacturing process and the use of inactivation procedures for viruses the documentation of batches substantially contributes to the safety of plasma derivatives. With the applied techniques documentation is easily achieved.

Objective: Since plateletpheresis is being used increasingly, it is important to regard quality control to check health risks for donors and to exclude these.

Design: Controlled randomised prospective open comparative study.

Setting: Department of Transfusion Medicine of a University Clinic.

Participants: 112 platelet donors were examined.

Interventions: Prior to and after plateletpheresis platelet reactivity was determined. The platelet concentrates in the two groups of 56 donors each were produced using either the cell separator 'CS-3000' and the collecting chamber PLT 30TM with the Omnix system (group I) or the cell separator 'AS-104' (group II).

Results: In group I five donors showed a pathologically increased platelet reactivity (p = 0.1297) after plateletpheresis. In group II there were 10 donors with a pathologically increased platelet reactivity (p = 0.0046) after plateletpheresis. The mean concentration of platelets was reduced by separation using the CS-3000 Omnix from 238 +/- 49 x 10(3)/microliters to 172 +/- 32 x 10(3)/microliters (68 +/- 27 x 10(3)/microliters) and from 243 +/- 53 x 10(3)/microliters to 180 +/- 31 x 10(3)/microliters (63 +/- 33 x 10(3)/microliters) using the AS-104. In the first case the platelet yield was 3.9 x 10(11) platelets/concentrate, in the latter case it was 2.9 x 10(11) platelets/concentrate. The 'CS-3000 Omnix' is significantly more effective in separating (58.4 +/- 15.5%) than the 'AS-104' with 44.2 +/- 7.2% (p < 0.0001).

Conclusions: Since both donor groups were comparable regarding all factors recorded--especially the cardiovascular risk factors--the separation process could be responsible for the different traumatisation of platelets.

Background: The aim of the present study was to compare 2 anti-HCV ELISA tests with respect to sensitivity and specificity in detecting Hepatitis C antigen.

Materials and methods: A 3rd-generation anti-HCV ELISA (Wellcozyme anti-HCV VK45) was compared with a 2nd-generation anti-HCV ELISA (Ortho HCV 2.0) in various serum panels: A) anti-HCV ELISA-positive samples of blood donations (n = 536), B) non-A, non-B hepatitis patients (n = 188), C) multi-transfused patients (n = 79), D) hemodialysis patients (n = 473), and E) random blood donors (n = 1,080).

Results: Of 248 cDNA polymerase chain reaction (cDNA-PCR) positive samples in panels A, B, and C, ELISA-VK45 detected 247 (99.6%) and Ortho-2 248 (100%). The cDNA-PCR-positive sample missed by ELISA-VK45 showed isolated anti-C33c reactivity in a 2nd-generation recombinant immunoblot (RIBA-2). Of 281 RIBA-2-positive samples, ELISA-VK45 detected 274 (97.5%) and Ortho-2 279 (99.3%). ELISA-VK45-negative, RIBA-2-positive samples showed combined anti-C100/5-1-1 reactivity in RIBA-2 in 6/7 cases and anti-C22 and C33c reactivity in one. Ortho-2-negative, RIBA-2-positive samples showed combined anti-C100/5-1-1 reactivity in RIBA-2 in 2/2 cases. The specificities of ELISA-VK45 and Ortho-2 were not significantly different in 1,080 blood donors.

Conclusion: It is concluded that the ELISA-VK45 lacks sensitivity because a cDNA-PCR-confirmed positive sample was missed in the assay. The specificity of both ELISAs was comparable.

Objective: To prevent dangers to health resulting from the application of drugs, the legislator requires the central registration and evaluation of all drug risks, especially of side effects and reciprocal effects. Since 1988 pharmaceutical enterprises have had to denominate a qualified person ('Stufenplanbeauftragter') who is responsible for the fulfilment of obligatory reporting. In case of complaints or side effects he has to take suitable measures according to a special plan ('Stufenplan').

Data sources: The basis of this survey are the legal requirements for drugs ('Arzneimittelgesetz') and supplementary regulations which define the duties of the 'Stufenplanbeauftragter'.

Results: Blood components are subject to the legal requirements ('Arzneimittelgesetz') without reservations. Therefore the corresponding regulations have to be applied without modification in institutes for transfusion medicine. In this article the tasks of the 'Stufenplanbeauftragter' are summarized and practical experience of a university institute for transfusion medicine is presented.

Conclusions: In connection with the transmission of viral infectious diseases it became evident that the 'Stufenplanbeauftragter' is very important for the initiation of effective measures in case of serious side effects. The security of blood components could be improved by the realization of the corresponding legal requirements in the institutes for transfusion medicine.

Objective: The strategies for combining two screening tests for HIV infections in blood or plasma donors are formulated in biometric terms and analyzed with respect to their value, i.e. their validity, cost and effectiveness.

Design: Biometrical modeling using assumptions on the validity of the single tests, the conditional correlations between them, as well as on the cost of testing and the consequences of false-negative or false-positive test results.

Results: If the test combination is defined as positive whenever at least one of the single tests is positive, then this rule (the 'believe the positive' rule, BTP), due to its lower specificity, has extremely low positive predictive values. In case of high prevalence rates of the infection (e.g. 1:1,000), the BTP rule leads to lower total cost than single testing, unless the latter has very high sensitivity (e.g. 99%). For smaller prevalence rates (< 1:50,000), which are more typical of the selected group of blood or plasma donors, combination testing is of little value because the extra cost of detecting one additional infection (compared with single testing) may reach several 100 million DM.

Conclusion: The cost for detecting additional cases of HIV infection by using combination instead of single testing in HIV screening is so high that this decision requires a public consensus.

Background: Cryopreservation is the only available method for the long-time maintenance of blood cells. The present study was designed to prove: (i) the reliability of multiparameter flow cytometry (MFC) for estimation of CD34+ cells in frozen-thawed cell suspensions and (ii) the acceptability of a new teflon container for the cryopreservation of hematopoietic progenitor cells.

Materials and methods: Each of 15 ABO-compatible buffy coats (BC) were pooled, and mononuclear cells (MNC) were then separated with the Fresenius AS 104 device (n = 10). MNC harvested by apheresis were then divided into 2 portions and transferred pairwise into either the new Fresenius or into Gambro cryopreservation containers. Paired samples were frozen at controlled rates (9% DMSO final concentration) and stored at -196 degrees C in liquid nitrogen for 2 weeks. Leukocyte, MNC and differential blood counts and proportions of CD3+, CD4+, CD8+, CD14+ and CD34+ cells were assessed from the pooled BC, the apheresis products, and the frozen-thawed samples. Methyl cellulose culture assays as well as trypan blue viability staining were also carried out.

Results: The mean content of the divided apheresis products was 4.9 x 10(9) leukocytes with 86% MNC, 6.89 x 10(6) CD34+ cells, 2.1 x 10(5) granulocyte-macrophage colony-forming units (CFU-GM) and 7.1 x 10(5) erythroid burst-forming units (BFU-E). As expected, there were virtually no granulocytes after freezing in both types of container. The corresponding mean cell content was as follows: 6.3 x 10(6) CD34+ cells, 2.5 x 10(5) CFU-GM, and 8.1 x 10(5) BFU-E in Fresenius containers, and 6.1 x 10(6) CD34+ cells, 1.3 x 10(5) CFU-GM, and 7.7 x 10(5) BFU-E in Gambro containers. The mean MNC viability of the samples frozen in Fresenius was 81.5% and 82.7% in the Gambro containers. MFC was found to compare with stained smear differentials. CD34+ cell counts correlated with CFU-GM (0.69, p = 0.03) and BFU-E (0.63, p = 0.02) colony formation.

Conclusions: The study reported here revealed no significant differences between the 2 types of storage containers. The new Fresenius teflon container could thus be recommended for cryopreservation of hematopoietic progenitor cells. MFC provided reliable data on CD34+ cell content and leukocyte subset composition of the frozen-thawed cell suspension.

Background: Storage of blood affects all blood components. Polymorphonuclear neutrophils (PMNs) are considered the main culprits of the storage lesion. Their prestorage removal improves the quality of blood components. Therefore, they are considered of no use in blood transfusion. However, their reduction may remove important antibacterial defense mechanisms.

Methods: The phagocytic activity of PMNs in whole blood was therefore determined together with additional, sequential changes of granula-specific and cytosolic constituents which they release. Blood from 12 volunteer donors was analyzed for plasma Na+ and K+, pH, LDH, lysozyme, PMN elastase, leukocytes, neutrophils, and neutrophil phagocytosis with Phagotest.

Results: Leukocytes decreased from (5.0 +/- 1.4) x 10(3) to (3.3 +/- 1.3) x 10(3) cells/microliter (mean +/- SD), most of them being PMNs. Their phagocytic capacity when rewarmed did not change significantly during the first 24 h of storage, after 3 days it came to a halt. At the same time an increasing fall in plasma sodium and pH became apparent, while plasma potassium, LDH, lysozyme, and elastase all rose by 427%, 235%, 87% respectively 1,479% at day 11. Together with these marker enzymes an armamentarium of antibiotic proteins, other proteolytic enzymes, and immunoregulatory molecules is released.

Conclusion: At present, it seems that the bactericidal activity in blood, due to the removal of phagocytic PMNs, does not outweight the clinical benefits of an improved component preparation where storage lesions are minimized and a number of transfusion-associated adverse reactions are avoided.