By combining clinical data from independent Phase II trials, the logistic model developed could predict the probability of fotemustine hematologic and hepatic toxicity.
To help in determining management strategy as an alternative to amputation by using a synthetic prostacycline, a preliminary study was undertaken in 12 patients (11 men and one woman), with a mean age of 71.08 years, ie, 13 limbs evaluated at the stage of amputation. All patients were treated with a combination of iloprost and physical therapy (massage, specific exercises, cardiorespiratory training). Static transcutaneous oxygen pressure (TcPO2) was measured, with a sensitization test by verticalization and inhalation of oxygen, on day (D) D0, D15, D28, D60, D180, and D365. Results were analyzed in absolute terms and by tissue oxygenation ratio (TOR) (ratio between absolute values of TcPO2 in the foot and those of a reference chest electrode). Supine TOR and vertical TOR, with values of 36.67 and 65.08, respectively, appeared to be significantly linked to the variable "preservation of limb". At 1 year, seven limbs were preserved (53.85%) while amputation had been scheduled for all the patients treated. Evidence was found in all patients who kept their limb of stability (7.69%) and a decrease in (30.77%) or disappearance of pain (15.38%) at 1 year.
Following an earlier study, the investigators sought to identify and define objective prognostic criteria of viability at 1 year of a limb with severe chronic ischemia. A study was undertaken in 116 patients (118 limbs) (74 men and 42 women), with a mean age of 71.9 years for men and 81.6 years for women. Static transcutaneous oxygen pressure (TcPO2) was measured with a verticalization sensitization test and inhalation of oxygen on JO and viability of the limb noted 1 year later. Logistic analysis was made of 13 oximetry parameters and two demographic parameters (age and gender). Results were analyzed in absolute terms and by tissue oxygenation ratio (TOR) (ratio between absolute TcPO2 at the foot and at a chest reference electrode). Six factors appeared to be prognostic factors of limb viability at 1 year, statistically significant at 6% according to threshold values: age, verticalization TcPO2, TcPO2 after 1 minute's inhalation of oxygen, TcPO2 after 4 minutes' inhalation of oxygen, and slope of TcPO2 and slope of TOR between 1 and 4 minutes' inhalation. A 1 year viability index integrating these criteria is suggested.
By combining clinical data from independent Phase II trials, the logistic model developed could predict the probability of fotemustine hematologic and hepatic toxicity.
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