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PubMed2001

Biostability and pharmacokinetics of LJP 920, an octameric Gal (alpha1-3) Gal conjugate for the inhibition of xenotransplantation rejection.

Antibodies to an alpha-galactosyl saccharide structure present in human serum are associated with hyperacute rejection and delayed xenograft rejection after pig-to-primate xenotransplantation. To overcome this major barrier to the xenotransplantation, LJP 920, a galactosyl alpha1-3 galactose (Gal (alpha1-3) Gal) coupled to a non-immunogenic platform at a valency of eight Gal (alpha1-3) Gal molecules/platform, was synthesized to clear circulating antibodies and to inhibit their production by B cells that produce these antibodies. Herein we report on the stability of UP 920 in biological media and its pharmacokinetic profile. Incubation of LJP 920 with mouse serum or liver microsomes at 37 degrees C for 2 days showed no indication of degradation of the conjugate as detected by a reversed-phase HPLC method, indicating that the conjugate is not subject to enzymatic metabolism. After intravenous administration of LJP 920 to mice at the doses of 20 and 100 mg kg(-1), UP 920 serum concentration decreased rapidly, showing a biphasic pattern, with a distribution half-life of 3 min and an elimination half-life of more than 30 min, respectively. The serum-to-erythrocyte concentration ratio of UP 920 was 33- and 36-fold excess at 0.5 and 5 min, respectively, after intravenous administration (100 mg kg(-1)). Both Cmax and AUC values increased in a dose-proportional manner. UP 920 displayed a great distribution to well-perfused tissues. It was eliminated mainly through renal excretion in the unchanged form, which accounted for 23% of the total amount within 8 h of dosing.

Animals↗
PubMed1992

Commentary: methods women can use that may prevent sexually transmitted disease, including HIV.

Although sexually transmitted diseases, including human immunodeficiency virus (HIV), are a major concern for women, few prevention messages are targeted specifically to women. Those that are generally stress abstaining, altering the number or selection of partners, and urging partners to use condoms. But these behaviors may be unrealistic for many women, particularly women who are at highest risk for sexually transmitted diseases, because they require significant changes in life-style or depend on male-controlled condom use. Recommendation of contraceptives for prevention of sexually transmitted diseases depends largely on how well specific methods perform under controlled conditions, either in the laboratory or in clinical trials. Observational studies, which better reflect day-to-day use, indicate that condoms, barriers, and spermicides, used properly and consistently, can provide substantial protection against various sexually transmitted diseases. Condoms can similarly help protect against HIV, but studies of barriers and spermicides are scant and currently inconclusive. Finally, those methods that are controlled by women are consistently more effective in preventing sexually transmitted diseases. Thus, although condoms used well are still the best choice, the imperative for female-controlled methods indicates that diaphragms and spermicides should receive greater emphasis in prevention messages.

Condoms↗
PubMed1983

The influence of systemic arterial pressure and intracranial pressure on the development of cerebral vasogenic edema.

The influence of intracranial pressure (ICP), systemic arterial pressure (SAP), and cerebral perfusion pressure (CPP) upon the development of vasogenic cerebral edema is largely unknown. To study their relationship, the authors have produced an osmotic disruption of the blood-brain barrier unilaterally in rabbits by injecting 1 cc/kg of 2M NaCl into the left internal carotid artery. The amount of vasogenic edema produced was assessed by quantitation of the extravasation of Evans blue dye into the area of maximum blood-brain barrier breakdown by means of optical densitometry following formamide extraction. The ICP was measured using a cisterna magna catheter into which mock cerebrospinal fluid could be infused at a predetermined pressure. The SAP was controlled by exsanguination from a femoral artery catheter. In 18 animals in which blood pressure was not controlled, no significant relationship between the ICP and the degree of Evans blue dye extravasation was noted. In these animals, however, a direct relationship between CPP (defined as mean arterial pressure minus mean ICP) and extravasation of Evans blue dye was found (correlation coefficient 0.630; p less than 0.001). When ICP was held constant at 0 to 5 mm Hg in another group of 16 animals and different levels of blood pressure were produced by exsanguination, a significant direct relationship between extravasation of Evans blue dye and the SAP was found (correlation coefficient 0.786; p less than 0.001). In a third group of 20 animals, the blood pressure was held constant at 90 to 100 mm Hg and the ICP was varied between 0 and 75 mm Hg. There was a highly significant result indicating increasing Evans blue dye extravasation with lower levels of ICP (p less than 0.001). Cerebral blood flow determinations by the hydrogen clearance method indicated loss of autoregulation in all animals in the areas of brain injured by intracarotid hypertonic saline. These results indicate that high SAP and low ICP (that is, a large CPP) promote Evans blue dye extravasation in this model of blood-brain barrier disruption. This finding has implications for the management of patients with vasogenic edema.

Animals↗
PubMed2002

Radiosurgery for residual or recurrent nonfunctioning pituitary adenoma.

OBJECT: Nonfunctioning pituitary adenomas comprise approximately 30% of all pituitary tumors. The purpose of this retrospective study is to evaluate the efficacy and role of gamma knife radiosurgery (GKS) in the management of residual or recurrent nonfunctioning pituitary adenomas. METHODS: A review was conducted of the data obtained in 42 patients who underwent adjuvant GKS at the University of Pittsburgh between 1987 and 2001. Prior treatments included transsphenoidal resection, craniotomy and resection, or conventional radiotherapy. Endocrinological, ophthalmological, and radiological responses were evaluated. The duration of follow-up review varied from 6 to 102 months (mean 31.2 months). Fifteen patients were observed for more than 40 months. The mean radiation dose to the tumor margin was 16 Gy. Conformal radiosurgery planning was used to restrict the dose to the optic nerve and chiasm. Tumor control after GKS was achieved in 100% of patients with microadenomas and 97% of patients with macroadenomas. Gamma knife radiosurgery was equally effective in controlling adenomas with cavernous sinus invasion and suprasellar extension. No patient developed a new endocrinological deficiency following GKS. One patient's tumor enlarged with an associated decline in visual function. Another patient experienced a deterioration of visual fields despite a decrease in tumor size. CONCLUSIONS: Gamma knife radiosurgery can achieve tumor control in virtually all residual or recurrent nonfunctioning pituitary adenomas. Dose sparing facilitates tumor management even when the adenoma is close to the optic apparatus or invades the cavernous sinus.

Adenoma↗
PubMed1989

Reliability of the Cobb angle index derived by traditional and computer assisted methods.

The reliability of the traditional Cobb angle index, which at present exhibits a wide range of reported values, was determined in this study and amounted to a within subject error of +/-4.3 degrees and a between subject error of +/-4.9 degrees. An attempt to pinpoint the source of this variability by investigating the influence of choice of end vertebrae proved inconclusive. The reliability of a computer assisted Cobb angle index, developed to improve measurement accuracy, was also examined and an estimated within subject error of +/-1.5 degrees and a between subject error of +/-1.6 degrees obtained. A comparison of the traditional and computer assisted methods indicates a high correlation between the Cobb angle derived using the two methods when measuring like curves and an improved reliability obtained by the computer method. Such an improvement is worth implementing clinically but of course the availability of a computer and digitizer and a little extra time for an operator to input the X-ray coordinates may be a barrier to its general use.

Diagnostic Errors↗
PubMed1981

Contraception.

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Abortion, Induced↗