Plasma fibronectin is an opsonic glycoprotein which augments reticuloendothelial phagocytic clearance of nonbacterial particulates. We evaluated the influence of intravenous infusion of plasma cryoprecipitate on circulating immunoreactive fibronectin and associated opsonic activity at 0.5, 2.0, 4.0, 10, and 21 hr postinfusion in septic (n = 8) and nonseptic (n = 6) surgical and/or trauma patients with documented plasma fibronectin deficiency. The study was a randomized, double-blind, crossover clinical protocol in which fibronectin-poor (0.116 +/- 0.025 mg/ml) cryoprecipitate extracted plasma (placebo) was compared to fibronectin-rich (2.139 +/- 0.161 mg/ml) plasma cryoprecipitate. Septic injured patients (149.37 +/- 17.11 micrograms/ml) had lower (p less than 0.05) plasma fibronectin levels than nonseptic injured patients (212.17 +/- 7.14 micrograms/ml) and both were less (p less than 0.05) than normal (330 +/- 30 micrograms/ml). As tested in vitro with a peritoneal macrophage monolayer assay, cryoprecipitate manifested opsonic activity related to its fibronectin concentration. Intravenous infusion of fibronectin rich cryoprecipitate reversed both the immunoreactive fibronectin and opsonic deficiency, while infusion of the placebo at a comparable total protein load did not reverse either deficient parameter. Reversal of fibronectin deficiency was more sustained in nonseptic injured patients as compared to septic injured patients. Thus, reversal of opsonic deficiency in septic and nonseptic injured patients is observed after infusion of plasma cryoprecipitate and not with infusion of fibronectin deficient plasma at comparable protein loads. Also, cryoprecipitate extracted plasma may serve as an appropriate control solution for randomized studies evaluating the therapeutic value of fibronectin-rich plasma cryoprecipitate.

This article presents the statistical methodology for estimating stratum cumulative distribution functions (cdf's) when the sample is drawn according to a complex design. Justification for the use of this methodology is offered, and examples are presented to demonstrate the expanded inference possible when estimated cdf's are used in addition to stratum means. The methods are applied to data from a survey of the patterns of care in radiation therapy facilities in the United States.

A Phase II clinical trial of mithramycin was performed in 99 patients with evaluable metastatic testicular tumors. Patients received 25 μg/kg/day until therapy was stopped because of toxicity. In the absence of persistent toxicity or progression, subsequent courses were begun 4 weeks after discontinuance of the previous course. In the 74 patients with acceptable studies, responses occurred in 26% (5 complete responses and 14 partial responses). Complete responses were persistent for periods of up to 77+ months, and three patients with complete responses were alive and well at last report. Death occurred within 3 weeks after the onset of therapy in 10 patients, and coagulopathy was present in five of these patients. Toxicity of mithramycin was relatively unpredictable, and patients who exhibited severe toxicity received relatively little benefit from therapy. Responses were most common in young men with asymptomatic metastatic disease, and complete responses occurred only in patients with embryonal carcinoma.

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