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With recruitment of trial subjects. Ultimately, we recruited only four patients to our institute, Kyoto University Hospital, for treatment with the initial dose of rh-HGF. Predicted adverse events included a decrease in BP, by dilatation of capacitance vessels, and proteinuria. Therefore, we established a stepwise infusion method to avoid a rapid reduction of BP, and confirmed reversibility of renal toxicity through additional preclinical studies. In this clinical trial, rh-HGF was administered intravenously Methyl 3-amino-2,4-dichloro-5-fluorobenzoate for 12 to 14 days, and severe side effects andIdo et al. Journal of Translational Medicine 2011, 9:55 http://www.translational-medicine.com/content/9/1/Page 9 ofT-Bil (mg/dL)serum albumin (g/dL)1 8 1 7 14 (days)6405 4 3 2 1 0 1 8 1 7 14 (days)PT-INR2 1 0 1 8 11014 (days)rh-HGF dosing observation 500rh-HGF 4-((2-Hydroxyethyl)(methyl)amino)benzaldehyde dosing observationrh-HGF dosing observationAFP (ng/ml)ALT (IU/L)400 300 200 100 0 1 8 140 30 20 10#1 #2 #3 #14 (days)14 (days)rh-HGF dosing observationrh-HGF dosing observationFigure 5 Changes in laboratory data results during rh-HGF dosing and observation period. PT-INR, T-Bil, serum albumin, ALT and AFP, were measured before rh-HGF administration (day 1 of rh-HGF dosing); on day 7 of the rh-HGF dosing period; and one, seven and 14 days after the protocol therapy (days 1, 7 and 14 of the observation period, respectively). Laboratory data results were not affected during or after rh-HGF administration.complications caused by rh-HGF dosing were not observed. BP was gradually reduced during stepwise infusion of rh-HGF in three of the four patients, 6-Trichloronicotinic acid 8-Oxa-3-azabicyclo[3.2.1]octane hydrochloride 3-Hydroxyanthranilic acid PigmentRed179 4-CHLORO-2-NITROBENZALDEHYDE Diethyl 4-oxocyclohexane-1 whereas repeated doses of rh-HGF did not affect albuminuria. In the first patient, when BP decreased during rh-HGF administration, 200-300 mL of infusion was sufficient to restore BP immediately; prior infusion ameliorated HGF-induced BP reduction, as observed in preclinical animal experiments (Figure 1C). In any event, the decrease in BP observed during HGF infusion was reversible, and did not affect patients' general condition. Although patients 2 and 3, but not 4, also exhibited BP reduction during rh-HGF infusion, their general condition was stable without additional infusion or cessation of rh-HGF. Of particular importance, patient 2, who had awakened from hepatic encephalopathy, showed no symptom or sign during rh-HGF administration. Therefore, we PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/7780048 concluded that rh-HGF administeredTable 3 Effect of rh-HGF administration on survival timehazard ratio Survival time from: onset of hepatic encephalopathy onset of disease 0.20 0.28 0.03 1.45 0.04 2.04 0.08 0.18 95 CI p valueintravenously with a stepwise increase for up to 14 consecutive days was very well tolerated. In this study, although two of four patients survived, there was no evidence that rh-HGF was effective in improving outcome of patients with FHSA or LOHF. There are three potential reasons for the failure of this trial to demonstrate the efficacy of rh-HGF in patients with FH or LOHF. First, the dose of rh-HGF and/or the 14-day treatment schedule used in this study might have been too low to produce beneficial effect. The dose chosen for this study was based on a scaling of the doses used in pre-clinical animal studies, and ensured safety in several repeated PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/14445666 dose toxicity tests. Also, this dose, corresponding to 0.1 mg/kg in rodents, has been reported to accelerate liver regeneration in normal and partially hepatectomized rats [11]. Conversely, the treatment duration was based on a nationwide survey of FH and LOHF in Japan be.

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