[Bone banks : The state-of-the-art]. / Knochenbanken : State-of-the-Art.

Bone banks are responsible for the collection, production, testing, packaging, storage and delivery of osseous grafts. In compliance with legal and quality requirements, it is their main task to ensure the biological properties and the microbiological safety of the transplants as well. German legal requirements for bone banking are explained and current standards with respect to donor selection, laboratory tests and tissue processing, as well as labeling are discussed. Production and preparation procedures should include a validated microbiological inactivation method that largely preserves the biological properties of the tissue.

Comparative infectious serology testing of pre- and post-mortem blood samples from cornea donors.

Defined serological blood tests of deceased cornea donors are required to minimize the risk of viral infections of a transplant recipient as much as possible. Haemolysis, autolysis and bacterial contamination, may produce significant changes of post-mortem blood samples, which may lead to false serological test results. Pre- and post-mortem findings from the same cornea donors of the University Tissue Bank of the Charité in the years 2004-2009 (n = 487) were retrospectively analyzed and compared. The test results from pre-mortem blood samples were defined as the reference for the post-mortem blood test. Of 487 cornea donors, there were a total of 21 cases (4.3%) with discrepancies between serological test results from pre- and post-mortem blood samples. Of these, 7 values referred to the HBsAg-testing, 3 to the anti-HBs-, 1 to the anti-HBcIgG + IgM-, 1 to the anti-HCV-, 4 to the anti-HIV 1/2- and 5 to the TPLA-findings. False negative results within post-mortem serology occurred in 4 of 487 cases (0.8%). False positive results within the post-mortem blood samples occurred at a much more frequent rate, with 17 of 487 cases (3.5%). Discrepancies between serological pre- and post-mortem blood tests occur mainly due to the use of non-validated test systems. Therefore, it seems reasonable to test pre- and post-mortem blood samples serologically, whenever possible, at the same time, regardless of the sample age. Positive results, regardless of the sample type, should always be retested with validated confirmation tests (e.g. NAT), in order to differentiate between false and true positive results.

Influence of blood donation on levels of water-soluble vitamins.

Iron depletion is a well-known side effect of blood donation. Research evidence also suggests an increasing prevalence of vitamin deficiency in apparently healthy subjects, but there is little information regarding the relationship between blood donation and vitamin status. A total of 217 volunteers (80 first-time and 137 repeat blood donors) were consecutively enrolled in the study. All subjects completed self-administered medical history and food intake forms, which included questions regarding alcohol consumption and smoking as well as on vitamin supplement, iron and contraceptive use (females). Vitamin B6, folic acid, vitamin B12 and biotin levels were measured using standard techniques. The mean vitamin levels of first-time and repeat blood donors did not significantly differ. Vitamin deficiencies occurred in both first-time and repeat blood donors but not on vitamin supplements. Vitamin status was affected by alcohol, nicotine and contraceptives. Blood donation does not decrease the level of water-soluble vitamins. Vitamin deficiencies occur in apparently healthy first-time as well as in repeat blood donors and can be prevented by vitamin supplementation.

Sufficient penetration of peracetic acid into drilled human femoral heads.

Chemical sterilisation methods for musculoskeletal transplants have the problem of penetration into all tissue strata. The present study examined if a peracetic acid/ethanol solution penetrated to a sufficient extent into specifically prepared femoral heads. To this effect, 10 femoral heads have been provided with drillings (diameter 2 mm, depth 10 mm) at a distance of 15 mm (series B) and placed in a diffusion chamber with sterilisation solution. From an additional central drilling at the femoral neck junction, the sample drawing was made after 30 min each over a period of 4 h for the iodometric determination of peracetic acid (PAA) concentration. Ten femoral heads, which did contain only the central drilling, served as controls (series A). In 9 of the examined femoral heads of series A the defined minimum concentration of PAA of 0.2% (inactivation of bacteria, spores, fungi) has been clearly exceeded over the complete period of measurement. About 0.8% PAA (inactivation of viruses) was achieved within 4 h only with six femoral heads. Nine out of the 10 examined femoral heads in series B show a clearly improved penetration behaviour which was expressed in smaller standard deviations, a faster increase in concentration, as well as in higher starting and final concentrations (approx. 0.9%) of PAA. Previous drying in air leads to a faster penetration into the centre of the bone. Standardised drilling of de-cartilaged femoral heads creates favourable conditions for the penetration of the PAA sterilisation solution into the whole tissue and guarantees a sufficient inactivation of microorganisms.

[Perioperative antithrombotic prophylaxis in varicose vein surgery]. / Perioperative Thromboseprophylaxe bei Varizenoperationen.

Antithrombotic regimens to prevent venous thromboembolism are standard in the treatment of in-and outpatients with thrombotic risk factors. A classification of the level of risk is made depending on the age, kind of operation, existing hereditary or acquired thrombophilic diatheses and concomitant disease. The antithrombotic prophylaxis is performed in accordance with the classification of risk level in low, moderate, high and highest risk levels. Varicose disease is a thrombotic risk factor. Varicose vein surgery may be classified as thrombogenic. Patients with varicose vein surgery and without other clinical risk factors are low-risk patients. In case of other acquired or hereditary risk factors antithrombotic prophylaxis in varicose vein surgery with low molecular weight heparin should be used. Compression elastic stockings are obligatory.

Effects of an onion-olive oil maceration product containing essential ingredients of the Mediterranean diet on blood pressure and blood fluidity.

Twenty-four patients with arterial hypertension (WHO class I) received either 4 capsules of an onion-olive oil maceration product, containing essential ingredients of the Mediterranean diet, or placebo daily over a period of one week. In order to investigate the acute effect on arterial blood pressure, measurements were performed before and 5 h after the administration of the first dose of 4 capsules verum or placebo, respectively. For the evaluation of the long term effect further blood pressure measurements were performed after one week's treatment with a daily dose of 4 capsules. After a wash-out phase of 2 weeks followed by a crossover, the second study phase, which was identical in design, was carried out. In addition patients were instructed to measure their blood pressure 4 times daily at home for the whole study period. Haemorheological parameters (platelet aggregation, erythrocyte aggregation, plasma viscosity and haematocrit) were also determined at the measuring points mentioned above. The onion-olive oil maceration product led to a significant decrease in systolic blood pressure. There was also a trend towards a decrease in diastolic blood pressure. The improved blood fluidity observed resulted from a decrease in haematocrit. All effects could be shown immediately and after one week's administration.

Patients with malignant lymphomas experience a higher rate of documented infections than patients with breast cancer after high-dose chemotherapy with autologous peripheral stem cell transplantation.

The influence of underlying disease on documented infections has rarely been addressed in patients treated with high-dose chemotherapy (HDCT) and subsequent autologous peripheral blood stem cell transplantation (PBSCT). Because autografting has been used most frequently for malignant lymphomas and breast cancer, we analyzed in a retrospective study the data of 100 consecutive adult patients with either malignant lymphomas (group A, n = 50) or breast cancer (group B, n = 50) treated with HDCT at a single institution. The number of autografted CD34+ cells was not statistically different in either group. In this paper, we show for the first time that there is a significant difference in clinically or microbiologically documented infections in these groups of patients: documented infections occurred in 30% of malignant lymphoma patients but only in 4% of breast cancer patients (P=0.001). Of all isolated microorganisms, 78% were gram-positive. Because most of the documented infections were due to staphylococci, further studies should prospectively evaluate preventive measures to reduce the high incidence of these infections. This is especially important for lymphoma patients, who can be regarded as a high-risk group concerning gram-positive bacteremia.

Influence of the onion as an essential ingredient of the Mediterranean diet on arterial blood pressure and blood fluidity.

Mediterranean diet has got a favourable effect on life expectancy. One of the crucial components of the diet are onions. In an open and a randomized, placebo-controlled, double-blind, cross-over phase-I study a spontaneous pharmacological effect 5 h after administration of an onion-olive-oil maceration capsule formulation on arterial blood pressure could be demonstrated in apparently healthy subjects. In addition to a decrease in arterial blood pressure, a significant reduction in plasma viscosity and haematocrit were observed. These results are indicating a vasodilative effect of the onion-olive-oil-maceration product. The stickiness of the platelets was reduced. The effects were stronger in subjects with reduced blood fluidity compared to those subjects with normal rheological parameters.

Efficacy of orally administered extract of red vine leaf AS 195 (folia vitis viniferae) in chronic venous insufficiency (stages I-II). A randomized, double-blind, placebo-controlled trial.

UNLABELLED: Red vine leaf extract (RVLE) is a herbal medicine containing several flavonoids, with quercetin-3-O-beta-glucuronide and isoquercitrin (quercetin-3-O-beta-glycoside) as the main components. OBJECTIVE: To assess the efficacy and safety of once-daily doses of 360 and 720 mg RVLE (pharmaceutical extract code AS 195; Antistax Venenkapseln) compared to placebo in patients with stage I and incipient stage II chronic venous insufficiency (CVI). DESIGN: A 12-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center study. PATIENTS: Male and female outpatients aged 25 to 75 years with stage I to stage II CVI (i.e. without extensive trophic changes), not having any other significant medical conditions and not treated with compression stockings, diuretics or other drugs affecting fluid balance. INTERVENTION: Patients were randomly assigned to a double-blind treatment with placebo, 360 mg AS 195 or 720 mg AS 195 once daily for 12 weeks, preceded and followed by a single-blind 2-week placebo treatment for baseline run-in and end-of-trial washout, respectively. Study criteria were evaluated at baseline, after 6 and 12 weeks of treatment and 2 weeks after discontinuation of treatment. RESULTS: Of the 260 patients enrolled and randomized, 219 completed the study in accordance with the protocol. In the intention-to-treat analysis (N = 257), the mean (+/- SD) lower leg volume (measured by water displacement plethysmography) of the patients treated with placebo (N = 87) increased by 15.2 +/- 90.1 g (displaced water mass) and by 33.7 +/- 96.1 g after 6 and 12 weeks compared to baseline. In contrast, for patients treated with AS 195, lower leg volume decreased, and after 12 weeks of treatment, the difference in mean lower leg volume between the active treatment groups and the placebo group was -75.9 g (95% CI: -106.1 to -45.8 g) and -99.9 g (95% CI: -130.3 to -69.6 g) for the group treated with 360-mg AS 195 (N = 86) and 720-mg AS 195 (N = 84), respectively. The changes in calf circumference showed a similar pattern: in patients treated with AS 195, both the higher dose (720 mg) and, albeit to a lesser extent, the lower dose (360 mg) resulted in a clear reduction in circumference over time, whereas, circumference remained largely unchanged in patients treated with the placebo (95% CI of the estimated treatment effects vs. placebo after 12 weeks: -1.40 to -0.56 cm and -1.73 to -0.88 cm for 360 and 720 mg AS 195, respectively). These differences were statistically significant (p < 0.001). The reductions in ankle circumference were qualitatively similar but quantitatively less marked. Subjectively, there was an improvement in key CVI symptoms (VAS) at 6 weeks with all treatments, but a further improvement at week 12 was seen only in the active treatment groups; at 12 weeks, the changes compared to baseline were significantly greater (p < 0.001) in both active treatment groups than in the placebo group. The treatments were well tolerated; Adverse events were rare and usually mild. Two adverse events (AEs) during treatment with the placebo led to hospitalization and were hence labeled as 'serious'. Three further patients were withdrawn because of AEs which occurred during treatment with the placebo. CONCLUSION: Once-daily doses of 360 and 720 mg AS 195 were confirmed to be safe and effective in the treatment of mild CVI, reducing significantly lower leg edema and circumference whilst improving key CVI-related symptoms to a clinically relevant extent. The edema reduction is at least equivalent to that reported for compression stockings and/or other edema-reducing agents. The higher dose was as well tolerated as the lower dose but resulted in a slightly greater and more sustained improvement.