A Compelling Case for the Use of Perioperative Zymogen Protein C for Increased Patient Safety.

It is imperative to maintain normal blood flow to provide adequate oxygen supply to specific organs and cells, as well as for the removal of metabolic byproducts. Therefore, any situation that results in blood clotting can injure or kill living tissues. In this paper, we describe a case where a protein C deficient subject who would, by all medical indicators, be at 100 % risk of experiencing thrombophlebitis, deep vein thrombosis, and or lung emboli, is able to escape all pathologies by using perioperative zymogen protein C (ZPC). This protein C deficient patient has a long history of blood clotting, particularly from surgical procedures. The patient is 81 years old and first experienced clotting due to hernia surgery in 1964, when he was hospitalized for 16 days post-surgery with life threatening complications. It was later determined in 1980, after many episodes, that the patient had hereditary protein C deficiency at the 38 % level. In his hernia surgery, perioperative ZPC was used along with accepted anticoagulation procedures with no blood clots or other related side effects occurring. This procedure can greatly benefit protein C deficient patients, and could potentially find use for non-PC deficient patients in surgeries and a variety of other medical treatments. This particular case helps to validate the importance of ZPC in effecting safer surgery in high-risk patients. It also supports the mechanism of ZPC acting as an anticoagulant without causing bleeding. Most importantly, each clinical case study represents a unique combination of surgeon, hematologist, medical staff, and patient functioning as a coordinated team. In this case, smaller amounts of very expensive ZPC achieved safe and efficacious results, which is hugely important for future clinical applications when considering the production cost of ZPC. More studies must be done to establish minimum dosing while achieving safe and efficacious outcomes.

Fungal endophthalmitis. An experimental study with a review of 17 human ocular cases.

Pseudallescheria boydii is an opportunistic fungus that is histologically indistinguishable from Aspergillus fumigatus. Pseudallescheria boydii has been reported to cause endophthalmitis, orbital cellulitis, and corneal ulceration and is, thus, important to the ophthalmologist. A clinical review of 17 patients with P boydii ophthalmic infections is presented. In addition, animal models of endophthalmitides caused by A fumigatus and P boydii were created and compared. Dutch-Belted rabbits used for the experimental models were immunosuppressed with methylprednisolone acetate (Depomedrol). Exogenous and endogenous models of P boydii endophthalmitis were created in immunocompetent and immunosuppressed animals. An exogenous model of A fumigatus endophthalmitis was created in immunocompetent and immunosuppressed animals for comparison. The clinical and histopathologic features of A fumigatus and P boydii endophthalmitis are indistinguishable in the immunocompetent and immunosuppressed exogenously infected rabbits. Endogenous P boydii endophthalmitis has a similar fundus appearance to that caused by Nocardia asteroides.

Anaerobic orbital cellulitis: a clinical and experimental study.

In this article we have reviewed the clinical and bacteriologic aspects of anaerobic orbital cellulitis and have presented six patients to illustrate these points. Physicians who treat patients with orbital cellulitis should have a high index of suspicion for possible instances involving anaerobes, so that appropriate management can be started early. To investigate this problem further, we created an animal model of anaerobic orbital cellulitis. This model may be useful in future studies of the pathogenesis and treatment of this serious and often devastating disease.

Biomedical information, peer review, and conflict of interest as they influence public health.

The peer review process serves a vital role in the publication of biomedical information. When properly functioning, review should focus exclusively on questions of scientific validity and should avoid becoming enmeshed in questions such as "authorization" and "data ownership." We present a case in which the dissenting views of a coinvestigator were suppressed because the principal investigator and grantee institution informed a medical journal that the coinvestigator was not "authorized" to use the data generated by a publicly funded grant and because the editor of a scholarly journal refused to review the dissenting manuscript and to submit that dissent to external reviewers for peer review. The current peer review system, as shown by this case, is unable to embrace dissent within the peer review process and to use dissent to serve scientific truth and the public interest.

KIE: The authors present a case involving the University of Pittsburgh School of Medicine in which the dissenting views of one of the authors, Cantekin, a coinvestigator for a National Institutes of Health funded trial, were surpressed from publication. The principle investigator and the grantee institution claimed that the coinvestigator was not authorized to use data from the publicly funded grant, and the editor of a scholarly journal refused to review the dissenting manuscript or submit it for external peer review. At the time this article was submitted, the case had attracted the attention of the media and of the U.S. Congress. It raises the issues of ownership of data from publicly financed research and of the failure of the current peer review process to deal with dissent in scientific publication.

Antimicrobial therapy for otitis media with effusion ('secretory' otitis media).

OBJECTIVE: To determine the effectiveness of antimicrobial treatment for otitis media with effusion ("secretory" otitis media) in children. DATA SOURCE: We report the reexamination of a previously published study by Mandel et al that evaluated the efficacy of a 2-week course of antimicrobials (amoxicillin trihydrate) with and without a 4-week course of an oral decongestant-antihistamine combination in a double-blind, placebo-controlled, randomized trial involving 518 infants and children with otitis media with effusion. DATA SYNTHESIS: At 4 weeks, amoxicillin efficacy as determined by a tympanometric criterion (P = .121) or by a measure of improvement in hearing (P = .311) was insignificant. Only by otoscopic judgment, which is shown to contain a systematic bias as used in this clinical trial, could an argument be made for a marginal efficacy of amoxicillin at the 4-week end point. Logistic regression analyses of the combined effects of treatment and prognostic factors showed no significant differences between placebo- and antibiotic-treated groups for unilateral effusions and for bilateral effusions. When subjects with unilateral and bilateral effusions were combined, the estimated efficacy of antibiotic treatment was 12.3% by otoscopy (P = .014) and 4.8% by tympanometry (P = .171). We also demonstrate the sensitivity of outcome to diagnostic measures used and provide statistical evidence questioning the validity of otoscopic observations in this study. Six weeks after the termination of amoxicillin therapy, the recurrence of effusion was two to six times higher in the amoxicillin-treated children than in those treated with placebo (P = .001), and resolution of effusion was not significantly different among antibiotic and placebo groups (13.6% and 11.3%, respectively; P = .477). CONCLUSIONS: Amoxicillin with and without decongestant-antihistamine combination is not effective for the treatment of persistent asymptomatic middle-ear effusions in infants and children.