Background Availability of safe and affordable human plasma‐derived products (factor VIII, prothrombin complex concentrate/FIX, albumin and intravenous immunoglobulin) is a main concern of healthcare providers, particularly in resource‐limited countries. Several mechanisms may be used at national levels to secure the supply of these products, including import of finished products, contract fractionation and/or domestic fractionation. Contract fractionation may be considered only when there is a sufficient and steady amount of plasma (typically well over 10 000 l/year) complying with the international quality and regulatory requirements for fractionation, prepared following good manufacturing practice (GMP) principles, and ideally generated by a nationally coordinated blood transfusion organization. Fractionated products obtained by contract fractionation are not necessarily cheaper than imported ones. A domestic fractionation facility requires the guarantee to have access to a larger volume of plasma (typically over 100 000–200 000 l/year) that should also strictly comply with international quality and regulatory requirements. This option implies the construction, qualification and validation of a very high cost GMP pharmaceutical fractionation facility, use of state‐of‐the‐art technologies, and availability and training of highly qualified staff. The local market should have the capacity to use at least three out of the main four products to ensure the financial viability of the project. Due to these constraints, both contract fractionation and domestic fractionation may not currently be feasible for a number of resource‐limited countries.Objectives As an initial alternative to the conventional approaches to secure the supply of plasma products, our group started in 2003 to develop a new concept for the preparation of plasma protein components at a ‘mini‐pool’ fractionation scale (MPFS).Methods The main feature relies on the application of a single‐use sterile bag system process that can be implemented by blood establishments or a national service centre. The technology is straightforward and uses equipment that is largely available at blood establishments. The current pool size of 5–10 l of plasma can be largely processed, in an enclosed single‐use bag system, without the need of expensive fixed large‐scale equipment. A validated universal virus inactivation technology (solvent‐detergent) has been successfully integrated into this MPFS process, using such single‐use disposable bags.Results Mini‐pool, in‐bag, virus inactivation of cryoprecipitate, fresh‐frozen plasma and cryo‐poor plasma have been successfully developed and the medical device will soon be marketed. A factor VIII‐enriched preparation, also containing von Willebrand factor, has been obtained at a yield of about 300 IU/l, a concentration of 20–25 IU/ml, and a specific activity of 5–10 IU/mg. A chromatographic separation process of a PCC component from cryo‐poor plasma at a yield of 300 IU factor IX/l, containing factors II, VII and X was also developed. Work on separation of albumin‐ and Intravenous immunoglobulin‐enriched preparations is in progress.Conclusion This MPFS offers numerous advantages, among which is avoiding the need of an expensive GMP facility. The plasma mini‐pool size (5–10 l) gives flexibility of production of different combination of plasma component fractions. The concept that should be applied following GMP represents a gateway for resource‐limited countries to make use of their domestic plasma to improve the supply of plasma protein fractions and the standard of care of patients. The technology can also be used for preparation of safe plasma products for rare bleeding disorders.

The aim of the current study is to evaluate the different treatment modalities used in the management of high-risk metastatic gestational trophoblastic tumors (GTT) between June 1992 and December 2004 at the Gynecologic Oncology Unit, Ain Shams University. Out of 261 patients diagnosed and treated for GTT, 70 (26.8%) were high risk metastatic patients based on the National Institutes of Health clinical classification. The mean age was 29.39 ± 9.38 years (16–55 years), with six patients (8.6%) being older than 39 years, and the mean duration of follow-up was 79.74 ± 40.44 months (6–157 months). Forty patients (57.14%) were diagnosed after molar pregnancy, 22 (31.43%) after abortion, and 8 (11.43%) after term pregnancy. Forty-two patients (60%) were diagnosed within 4 months of the occurrence of the disease, and 28 (40%) were diagnosed after more than 4 months. Sixty-seven patients were treated using different regimens according to the protocol of treatment at that time. The MAC regimen was used initially but has been subsequently abandoned in favor of EMA-CO (etoposide, methotrexate, dactinomycin, cyclophosphamide, and vincristine [Oncovin]) regimen, which was later modified by omitting the CO arm to decrease its toxicity. If resistance developed, platinum-based therapy was given in the form of EMA-EP. Recently, our unit incorporated paclitaxel in the third-line treatment. Surgical intervention was used selectively. Fifty-seven (81.4%) patients could be cured; 43 by initial chemotherapy, with a mean of 7 ± 0.46 courses (6–15), and 14 were salvaged by second- or third-line chemotherapy. Fourteen patients (20%) died during the study period; one was unrelated to GTT, while three died of acute respiratory distress syndrome before instituting proper therapy and two died of treatment complications. Using univariate and multivariate Cox regression analyses, the presence of brain and/or liver metastases was found to be the worst prognostic variable affecting the survival, followed by resistance to combination chemotherapy and then the type of antecedent pregnancy. The projected 5-year survival as estimated by Kaplan–Meier method was 78%.

PURPOSE:To evaluate the role of ultrasound and Doppler velocimetry in the diagnosis of breast cancer.METHODS:Thirty breast cancer patients, diagnosed by clinical examination, mammography and fine needle aspiration, or trucut biopsy were assessed by breast ultrasound including Doppler velocimetry to evaluate blood flow in the axillary and lateral thoracic arteries. Postoperative histopathological examination proved malignancy in all cases. This cohort was compared to another group of 30 patients with proven benign breast disease and a cross-matched control group of 30 asymptomatic women with no breast disease.RESULTS:In the 30 cancer patients, the size of masses ranged from 1-4 cm (2.51 +/- 1.13), the mean axillary artery resistance index (RI) ranged from 0.8-0.88 (0.84 +/- 0.03), and the lateral thoracic artery RI ranged from 0.45-0.59 (0.55 +/- 0.106). However, power Doppler did not detect any increased perfusion. In the benign group, the lateral thoracic artery RI ranged from 0.78-0.86 (0.85 +/- 0.8) and the axillary artery RI ranged from 0.81-0.89 (0.81 +/- 0.05), while in the control group, the mean lateral thoracic artery RI ranged from 0.85 to 0.89 (0.87 +/- 0.082), and the axillary artery RI ranged from 0.84-0.9 (0.88 +/- 0.16). Statistical analysis revealed only a high statistical significance (p < 0.01) for the lateral thoracic artery indices between the malignant group as compared to the benign and normal groups. There was no statistical significant difference in the axillary artery RI between the three groups.CONCLUSION:It is suggested that a marked decrease in the lateral thoracic artery RI with a cut-off value less than 0.6 is highly suggestive of malignancy. Taking the pilot nature of the results, further studies with much larger numbers are needed to corroborate such findings.