Yulan Yan1, Yongsen Mo, Dongmei Zhang. 1. Department of Hematologly, the Fifth Central Hospital in Tianjin, Tianjin 300450, China.
Abstract
OBJECTIVE: To investigate the preventive effect of magnesium isoglycyrrhizinate against acute drug-induced liver damage from initial chemotherapy treatment in patients with gastrointestinal cancer. METHODS: A total of 216 cases with early stage gastric cancer and indications for systemic chemotherapy that had been diagnosed with gastrointestinal malignant tumors by pathology in our hospital were enrolled for study during the period of January 2011 to June 2013.Using a prospective randomized controlled study design,differences were assessed between groups treated with glycyrrhizic acid magnesium (experimental group; n=114) or glutathione (control group; n=102) and the FOLFOX regimen (n=104) or the XELOX regimen (n=112).Patients in the FOLFOX group received intravenous infusion of L-OHP (85 mg/m²) at day 1,followed by a bolus injection of 5-FU (400 mg/m²) at days 1-2 and continuous intravenous infusion of 5-FU (600 mg/m²) for 22 h at days 1-2,with one cycle comprising 2 weeks. Patients in the XELOX group received intravenous infusion of L-OHP (130 mg/m²) at day 1, followed by capecitabine (1 000 mg/m²) oral twice a day at days 1-14,with one cycle comprising 3 weeks.In the first cycle of chemotherapy,serum was extracted from the patients at 1 day before chemotherapy and 1 week after chemotherapy.An automated biochemistry analyzer was used to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil) and alkaline phosphatase (ALP). Differences between groups were statistically analyzed by the t-test and x² test. RESULTS: Among the total 216 cases treated with chemotherapy,40 showed hepatic biochemical abnormalities (12 cases in the experimental group, 28 cases in the control group), and the effect of prevention was significantly different between the two groups (10.53% vs. 27.25%; x² =10.219, P less than 0.005).The acute and subacute hepatic toxicity reaction degrees for the experimental and the control groups were: 0:94.78% vs. 88.2%; 1:5.3% vs. 11.8% (x² =6.99, P < 0.01). One week after chemotherapy, the liver biochemical indexes in the experimental group (ALT:35.93 ± 8.33 U/L; AST:24.84 ±2.91 U/L; TBil:13.29 ± 5.89 mumol/L; ALP:125.1 ± 53.61 U/L) were statically different from those in the control group (all P < 0.05). The liver biochemical indexes before and after chemotherapy were also significantly different between the experimental group (ALT:13.18t3.23 U/L; AST:5.39 ± 2.57 U/L; TBil:2.79 ± 0.23 mumol/L; ALP:52.08 ± 4.83 U/L) and the control group (all P < 0.05).One week after chemotherapy in the experimental group, the groups treated with the FOLFOX regimen or the XELOX regimen showed no statistical differences in the liver biochemical indexes.One week after chemotherapy in the control group, though, the groups treated with the FOLFOX regimen showed significantly lower AST (26.24 ± 3.50 U/L vs. 29.80 ± 6.57 U/L, t=-2.431, P < 0.05),but the residual liver biochemical indexes were not significantly different.In the experimental group, the FOLFOX group showed significantly lower ALP (53.44 ± 2.47 U/L vs. 56.58 ± 6.70 U/L, t =-2.201, P < 0.05), AST (6.48 ± 3.15U/L vs. 9.88 ± 4.57 U/L, t =-5.223, P < 0.05), but the residual liver biochemical index was not significantly different. CONCLUSION:Magnesium isoglycyrrhizinate is an effective drug for the prevention of drug-induced liver damage after initial chemotherapy in patients with early stage gastrointestinal cancer.
RCT Entities:
OBJECTIVE: To investigate the preventive effect of magnesium isoglycyrrhizinate against acute drug-induced liver damage from initial chemotherapy treatment in patients with gastrointestinal cancer. METHODS: A total of 216 cases with early stage gastric cancer and indications for systemic chemotherapy that had been diagnosed with gastrointestinal malignant tumors by pathology in our hospital were enrolled for study during the period of January 2011 to June 2013.Using a prospective randomized controlled study design,differences were assessed between groups treated with glycyrrhizic acid magnesium (experimental group; n=114) or glutathione (control group; n=102) and the FOLFOX regimen (n=104) or the XELOX regimen (n=112).Patients in the FOLFOX group received intravenous infusion of L-OHP (85 mg/m²) at day 1,followed by a bolus injection of 5-FU (400 mg/m²) at days 1-2 and continuous intravenous infusion of 5-FU (600 mg/m²) for 22 h at days 1-2,with one cycle comprising 2 weeks. Patients in the XELOX group received intravenous infusion of L-OHP (130 mg/m²) at day 1, followed by capecitabine (1 000 mg/m²) oral twice a day at days 1-14,with one cycle comprising 3 weeks.In the first cycle of chemotherapy,serum was extracted from the patients at 1 day before chemotherapy and 1 week after chemotherapy.An automated biochemistry analyzer was used to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil) and alkaline phosphatase (ALP). Differences between groups were statistically analyzed by the t-test and x² test. RESULTS: Among the total 216 cases treated with chemotherapy,40 showed hepatic biochemical abnormalities (12 cases in the experimental group, 28 cases in the control group), and the effect of prevention was significantly different between the two groups (10.53% vs. 27.25%; x² =10.219, P less than 0.005).The acute and subacute hepatic toxicity reaction degrees for the experimental and the control groups were: 0:94.78% vs. 88.2%; 1:5.3% vs. 11.8% (x² =6.99, P < 0.01). One week after chemotherapy, the liver biochemical indexes in the experimental group (ALT:35.93 ± 8.33 U/L; AST:24.84 ±2.91 U/L; TBil:13.29 ± 5.89 mumol/L; ALP:125.1 ± 53.61 U/L) were statically different from those in the control group (all P < 0.05). The liver biochemical indexes before and after chemotherapy were also significantly different between the experimental group (ALT:13.18t3.23 U/L; AST:5.39 ± 2.57 U/L; TBil:2.79 ± 0.23 mumol/L; ALP:52.08 ± 4.83 U/L) and the control group (all P < 0.05).One week after chemotherapy in the experimental group, the groups treated with the FOLFOX regimen or the XELOX regimen showed no statistical differences in the liver biochemical indexes.One week after chemotherapy in the control group, though, the groups treated with the FOLFOX regimen showed significantly lower AST (26.24 ± 3.50 U/L vs. 29.80 ± 6.57 U/L, t=-2.431, P < 0.05),but the residual liver biochemical indexes were not significantly different.In the experimental group, the FOLFOX group showed significantly lower ALP (53.44 ± 2.47 U/L vs. 56.58 ± 6.70 U/L, t =-2.201, P < 0.05), AST (6.48 ± 3.15U/L vs. 9.88 ± 4.57 U/L, t =-5.223, P < 0.05), but the residual liver biochemical index was not significantly different. CONCLUSION:Magnesium isoglycyrrhizinate is an effective drug for the prevention of drug-induced liver damage after initial chemotherapy in patients with early stage gastrointestinal cancer.