[Diagnostic image quality of mammograms in german outpatient medical care]. / Die diagnostische Bildqualität von Mammografien in der vertragsärztlichen Versorgung Deutschlands.

PURPOSE: A total of 79115 mammograms from statutory health insurance (SHI) physicians within German outpatient care were evaluated with respect to the diagnostic image quality. MATERIALS AND METHODS: Mammograms were randomly selected between 2006 and 2008 by the regional Associations of Statutory Health Insurance Physicians and submitted to regional boards of experts for external evaluation. The mammogram quality was evaluated using a 3-point scale (adequate, borderline, failure) and documented using a nationally standardized protocol. RESULTS: 87.6% of the mammograms were classified as adequate, 11.0% as borderline and 1.4% as failure. Mediolateral oblique mammograms (mlo) had worse ratings than craniocaudal mammograms (cc). Main reasons for classifying the mammograms as borderline or failure were "inframammary fold not adequately visualized" (mlo), "pectoral muscle not in the correct angle or not to the level with the nipple" (mlo), "the nipple not in profile" (mlo, cc) and "breast not completely or not adequately visualized" (cc). CONCLUSION: The results show a good overall quality of mammograms in German outpatient medical care. Failures can be associated predominantly with incorrect positioning of the breast. More precisely defined quality criteria using objective measures are recommended, especially for craniocaudal mammograms (cc).

Production processes of licensed recombinant factor VIII preparations.

The state-of-the-art treatment for hemophilia A is replacement therapy with recombinant factor VIII (rFVIII) made possible by genetic engineering advances. Currently, there are four different products licensed and available for hemophilia A patients. All are produced by recombinant mammalian cells in large-scale fermenter cultures, purified to high purity, formulated in stable formulations and freeze dried. The first-generation products Recombinate and Kogenate (also sold as Helixate by Aventis) are characterized as full-length human factor VIII molecules and formulated using human serum albumin as a stabilizer. The second-generation product ReFacto contains an improved albumin-free sucrose formulation and incorporates advanced antiviral safety procedures in the manufacturing process. It is a truncated B region-deleted form of factor VIII (FVIII) that makes use of a nonhuman peptide linker 14 amino acids in length to connect the 80 and 90 kD subunits. The most recently licensed rFVIII product is the second-generation Kogenate product called KOGENATE Bayer/Kogenate FS, which combines the advantages of the human full-length FVIII molecule with an albumin-free, sucrose-based synthetic formulation as well as an improved viral safety profile. In this article, the manufacturing processes for each of the four different products are discussed in detail, focusing on expression systems and cell lines, culture medium, technical culture systems, purification process (including viral removal potential), and final formulation.

Application of telemedicine in a pain clinic: the changing face of medical practice.

Telemedicine systems aim to provide quality health care services to persons whose access is otherwise restricted by geography and environment. The military medical department has a unique mission to provide all medical care for the battlefields and peacekeeping missions anywhere in the world. In addition, the medical department has to ensure the health of all soldiers, family members, and retirees during peacetime. Hospital closures coupled with a decreased number of military physicians have left many health care beneficiaries without readily available specialty care. They face long waiting lists or incur high out-of-pocket expenses in order to see medical specialists. As a result of the establishment of a virtual Telepain clinic, 56,400 miles were saved in patient and clinician travel. Use of technologies in the emerging field of telemedicine has lead to the creation of numerous military and civilian medical applications such as virtual dermatology, virtual psychiatry, virtual cardiology, virtual nuclear medicine/radiology, virtual pharmacology, and in future, virtual dentistry and ophthalmology.

Intravenous lecithin-coated microcrystals of dantrolene are effective in the treatment of malignant hyperthermia: an investigation in rats, dogs, and swine.

Dantrolene effectively treats malignant hyperthermia (MH) hut the current form, Dantrium, must be dissolved to a 0.33 mg/mL, pH 9.5 solution. This study describes lecithin-coated microcrystal formulations of sodium dantrolene (MC-NaD) and neutral dantrolene (MC-D) which reconstitute to 200 mg/mL within 1 min. In rats, the pharmacokinetics and pharmacodynamics of MC-NaD and Dantrium were similar: half-lives of 3.1 h, volume distributions of 0.54 and 0.59 L/kg, and 95% effective dose (ED95) values for depression of skeletal muscle twitch height (ED95T) of 2.6 +/- 0.7 and 2.8 +/- 0.5 mg/kg. In swine, the ED95T values for MC-NaD and Dantrium were also similar (2.8 +/- 0.4 vs 2.7 +/- 0.6 mg/kg), but MC-D and Dantrium were only similar at doses more than 2.5 mg/kg (ED95T: 3.5 +/- 0.4 vs 2.7 +/- 0.5 mg/kg). In susceptible swine, MC-NaD successfully treated five of six MH episodes and prevented MH in three of four swine. However, MC-NaD caused marked pulmonary hypertension in swine, while MC-D caused only a mild response that was eliminated by filtration. Likewise, MC-D caused no pulmonary response in dogs. These observations suggest that MC-D has potential to improve the treatment of MH.

Ultra-long-duration local anesthesia produced by injection of lecithin-coated tetracaine microcrystals.

This study was designed to determine if microencapsulated tetracaine would provide a longer duration of local anesthesia than nonmicroencapsulated (neat) tetracaine. Local anesthesia was determined by monitoring the response of the rat to tail clamping after the installation of a subcutaneous ring block. Ten percent microencapsulated tetracaine was found to provide local anesthesia of the tail for a 43-hour duration. Ten percent tetracaine solution was toxic. One percent tetracaine solution provided a tail block lasting 8 hours. Lecithin membranes without drug provided no block. This study demonstrates that lecithin-coated tetracaine microcrystals produce a local anesthetic effect that is ultra-long in duration, reversible, and not systemically toxic.

Lithium chloride: protective and antisecretory properties in rats.

Lithium chloride was evaluated as a potential protective agent against ethanol-induced hemorrhagic gastritis in rats. Rats received lithium chloride intragastrically (30, 60, or 90 mg/kg i.g.) or subcutaneously (3, 5, 10, 15, 20, 30, 60, or 90 mg/kg s.c.), or a placebo (H2O i.g. or 0.9% NaCl s.c.). Ninety minutes later 1 cm3 of 95% ethanol was administered intragastrically. After 30 min, the rats were killed and their stomachs were removed and visually scored for gross hemorrhagic gastritis. Lithium chloride at all doses less than 3 mg/kg significantly improved hemorrhagic gastritis when compared with the placebo. Moreover, rats treated with lithium chloride intragastrically had significantly less hemorrhagic gastritis than those treated subcutaneously even though serum lithium levels were similar. To determine if lithium's protective properties related to acid inhibition, pylorus-ligated and gastric fistula rats were studied. The median effective dose for lithium chloride was 20-30 mg/kg and the nonantisecretory dose was 3 mg/kg. No difference in hemorrhagic gastritis was noted between controls and animals receiving the nonantisecretory dose. However, at higher doses (LiCl 30, 60, and 90 mg/kg), lithium's protective properties persisted in spite of adding 150 mM HCl to the intragastrically administered ethanol (p less than 0.001). To determine further if lithium chloride stimulated endogenous prostaglandins, indomethacin, a prostaglandin inhibitor, was administered. Indomethacin did not alter lithium chloride's protective properties. In fact, when compared with exogenously administered 16,16-dimethyl prostaglandin E2 (5 and 500 micrograms/kg), high-dose LiCl (30, 60, or 90 mg/kg) resulted in significantly more protection against ethanol-induced injury (p less than 0.001). In contrast, when both nonantisecretory doses were compared, 16,16-dimethyl prostaglandin E2 (5 micrograms/kg) gave significantly better protection than LiCl (3 mg/kg). These data indicate that LiCl is a potent gastric antisecretory and protective agent. The protective properties of LiCl appear to be related to acid inhibition and be independent of endogenous prostaglandins, although other protective mechanisms may be present at higher LiCl doses. Additionally, this study indicates that LiCl may have clinical application in protecting the gastric mucosa against hemorrhagic gastritis.

Partial characterization of a renotropic factor.

In 70 experiments, the existence of a circulating renal growth factor was confirmed by 9.3% stimulation of 3H-thymidine into the DNA of renal fragments incubating for 90 min in the presence of sera from 20-hour unilaterally nephrectomized rats compared to sera from 20-hour sham-operated rats (p less than 0.001). Dialysis (7.4%, p less than 0.01) or removal of albumin (11.8%, p less than 0.001) from sera of both sham-operated and unilaterally nephrectomized rats did not appreciably change the magnitude of the statistically significant stimulation. When albumin-free sera were placed in boiling water for 1-3 min to coagulate protein, the stimulation was still significantly different from control (5%, p less than 0.05). Addition of sera from unilaterally nephrectomized rats (20 h) to isolated nuclei, even isolated nuclei removed from growing kidneys (72 h after unilateral nephroctomy), failed to enhance DNA synthesis significantly.