Pathogen reduction of double-dose platelet concentrates from pools of eight buffy coats: Product quality, safety, and economic aspects.

BACKGROUND: Pathogen reduction (PR) of platelet concentrates (PCs) contributes to the safety of platelet (PLT) transfusion by reducing the risk of transfusion-transmitted infections and transfusion-associated graft-versus-host disease. In vitro quality of pathogen-reduced double-dose PC (PR-PC) made of eight whole blood (WB)-derived buffy coats (BCs) were evaluated. METHODS: Eight small-volume WB BCs from donors with at least 200 × 109 PLT/L were pooled with an additive solution to produce double-dose PCs (DD-PCs), which were treated with amotosalen/ultraviolet A light in a dual storage processing set, yielding 2 units of PR-PC. Quality controls were undertaken as per European Directive for the Quality of Medicines (EDQM) guidelines. PLT recovery rates were measured. Production costs and savings were compared over the 3 years before and after PR implementation. RESULTS: In the pre-PR period, 19 666 PCs were produced, compared to 17 307 PCs in the PR period. Single BC in the PR period had 41 ± 2 mL, hematocrit 0.39 ± 0.04 and 1.06 ± 0.18 × 1011 PLTs, and showed a recovery of 91% ± 8%. After pooling, separation, PR treatment of DD-PC, and splitting, each single PC had 189 ± 6 mL with 2.52 ± 0.34 × 1011 PLTs, compared to 2.48 ± 0.40 in the pre-PR period. The PLT recovery rate after PR was 87% ± 14%. EDQM requirements were met. An increase of about €12 (+7.5%) per PC from the pre-PR to the PR period was identified. CONCLUSION: A new production method resulting in two PR-PCs made from pools of 8 BCs with use of one PR set was successfully introduced, and our experience of nearly 3 years demonstrated the high efficacy and in vitro quality of the PR-PCs obtained.

[Correspondence analysis between traditional commercial specifications and quantitative quality indices of Notopterygii Rhizoma et Radix].

This paper aims to explore a comprehensive assessment method combined traditional Chinese medicinal material specifications with quantitative quality indicators. Seventy-six samples of Notopterygii Rhizoma et Radix were collected on market and at producing areas. Traditional commercial specifications were described and assigned, and 10 chemical components and volatile oils were determined for each sample. Cluster analysis, Fisher discriminant analysis and correspondence analysis were used to establish the relationship between the traditional qualitative commercial specifications and quantitative chemical indices for comprehensive evaluating quality of medicinal materials, and quantitative classification of commercial grade and quality grade. A herb quality index (HQI) including traditional commercial specifications and chemical components for quantitative grade classification were established, and corresponding discriminant function were figured out for precise determination of quality grade and sub-grade of Notopterygii Rhizoma et Radix. The result showed that notopterol, isoimperatorin and volatile oil were the major components for determination of chemical quality, and their dividing values were specified for every grade and sub-grade of the commercial materials of Notopterygii Rhizoma et Radix. According to the result, essential relationship between traditional medicinal indicators, qualitative commercial specifications, and quantitative chemical composition indicators can be examined by K-mean cluster, Fisher discriminant analysis and correspondence analysis, which provide a new method for comprehensive quantitative evaluation of traditional Chinese medicine quality integrated traditional commodity specifications and quantitative modern chemical index.

[Usefulness and necessity of unsynchronized photosolotherapy and bath-PUVA--two variants of balneophototherapy--in funded ambulatory health care]. / Nutzen und Notwendigkeit der nicht-synchronen Photosoletherapie und Bade-PUVA.--zweier Varianten der Balneophototherapie--in der ambulanten vertragsärztlichen Versorgung.

The Standing Committee of Statutory Health Insurance Physicians and Sickness Funds is the legal body that makes decisions on reimbursement for health care services in the German ambulatory health care sector. In 1994 the committee declined the reimbursement of balneophototherapy. Balneophototherapy comprises a bath in a saline solution followed by ("non-synchronous") or simultaneous ("synchronous") UVB-irradiation. Photochemotherapy with bath-water delivery of psoralens combined with UVA light is also covered by the term balneophotherapy. The main indication for both procedures is serious psoriasis. Bath PUVA was also recommended for atopic dermatitis, pityriasis lichenoides, lichen ruber and mycosis fungoides. An effectiveness study sponsored by the sickness funds with rather poor methodological design and conduct was not able to show an unbiased effect of balneophototherapy despite inclusion of thousands of patients. On the contrary, a poor adherence of patients and doctors was documented, since 63% of patients suffering from psoriasis and treated with saline bath followed by UVB-irradiation stopped early or used additional therapies like cortisone or vitamin D3 derivatives. Only 43% of patients suffering from psoriasis and treated by bath PUVA did not stop the initial therapy and did not receive additional therapy (UVB, cortisone). In addition, the committee also conducted a thorough review of the literature, guidelines and status in other health care systems. Finally the two modifications of balneophototherapy were again declined from reimbursement in the German ambulatory health care sector. There were no controlled clinical trials showing efficacy of saline bath followed by UVB irradiation. Up to now bath PUVA was only evaluated in small equivalence trials which despite the fact that a drug was tested did not apply basic ICH standards (international conference on harmonisation) for equivalence trials. Additionally, the long-term cancer risk inherent to the application of psoralenes must be considered. Since the definition of "severe psoriasis" is not trivial a wide use of bath PUVA in ambulatory health care has to be based on the results of rigorously conducted clinical trials showing the effectiveness, safety and appropriateness in comparison to other treatment modalities. In reaction to the decision of of the committee two randomised controlled trials for the evaluation of the efficacy of balneophototherapy are planned.