Aspartate-ornithine granules in the treatment of nonalcoholic steatohepatitis: a multiple-dose parallel controlled clinical trial / 中华肝脏病杂志

<p><b>OBJECTIVE</b>To investigate the therapeutic efficacy and safety of aspartate-ornithine granules in patients with nonalcoholic steatohepatitis (NASH).</p><p><b>METHODS</b>Seventy-two patients with NASH were included in this multiple-dose parallel controlled clinical trial and received a 12-week course of aspartate-ornithine granule treatment at either high-dose (6 g bid po; n = 38) or low-dose (3 g bid po; n = 34). Clinical efficacy was assessed by monitoring data from urinalysis, serologic tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and triglyceride (TG)), and abdominal computed tomography (CT) scan. Safety was assessed by occurrence of adverse events (fatigue, anorexia, abdominal distension, nausea, and vomiting). Statistical analyses were conducted to determine the significance of differences between parameters before (baseline) and after treatment.</p><p><b>RESULTS</b>After 12 weeks of treatment, the liver and spleen CT ratios in both the high-dose group (0.89 +/- 0.19) and the low-dose group (0.80 +/- 0.15) were significantly higher than at baseline (S = 329, P less than 0.0001 and S = 246, P less than 0.0001); the overall improvement was more robust in the high-dose group (52.63%) than in the low-dose group (38.23%) (Z = -2.1042, P less than 0.05). After 6 and 12 weeks of treatment, the serum ALT levels in both the high-dose group and the low-dose group were significantly lower than at baseline (6 weeks: S = 324.5, P less than 0.0001 and S = 223, P less than 0.0001; 12 weeks: S = 370.5, P less than 0.0001 and S = 297.5, P less than 0.0001); the overall improvement was more robust in the high-dose group (79.0%) than in the low-dose group (53.0%) (Z = -2.0533, P less than 0.05). Similar trends were seen for the serum levels of AST and GGT after 6 and 12 weeks of treatment (all P less than 0.01) and serum levels of TG after 12 weeks of treatment. The rate of adverse reactions was low and similar between the two groups (high-dose: 4.8% and low-dose: 4.4%; all gastrointestinal).</p><p><b>CONCLUSION</b>Aspartate-ornithine granule therapy was an effective and safe treatment of nonalcoholic steatohepatitis, with the higher dose of 6 g bid po providing more robust clinical benefit without affecting the safety profile.</p>

Polypeptide P110 enhances the growth-inhibitory effect of cisplatin on colon cancer HCT-116 cells and xenotransplanted tumors in mice / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To observe the growth-inhibitory effect of polypeptide P110, designed with G3BP protein targets, plus cisplatin on human colon cancer HCT-116 cells and mouse colon cancer C26 xenotransplanted tumors in mice.</p><p><b>METHODS</b>The proliferation inhibition of HCT-116 cells and HUVEC cells in vitro was evaluated by MTT assay. A mouse model of xenotransplanted C26 mouse colon cancer was established. The inhibitory effects of P110 and cisplatin at different concentrations on C26 xenotransplanted tumors were assessed.</p><p><b>RESULTS</b>P110 enhanced the inhibitory effect of cisplatin on proliferation of HCT-116 cells. By treated with 20 µmol/LP110 + 10, 30, 90 µmol/L cisplatin, the proliferation inhibitory rates were (43.3 ± 3.2)%, (46.4 ± 4.6)% and (47.6 ± 5.8)%, respectively, significantly higher than that in the cisplatin group (P < 0.05). 20 µmol/L P110 + 10 µmol/L cisplatin effectively killed HCT-116 cells, whereas with less toxicity to HUVEC cells. The tumor inhibition rates in mice of P110 (25 mg/kg, 50 mg/kg, 100 mg/kg) plus cisplatin (1 mg/kg) were 23.0%, 30.4% and 34.2%, respectively. While, the tumor inhibition rates in mice of the cisplatin group (1 mg/kg) was 22.7%. Compared with cisplatin at the same concentration, the tumor inhibition rates in mice of the P110 plus cisplatin groups were all increased.</p><p><b>CONCLUSIONS</b>P110 can enhance the growth inhibitory effects of cisplatin on HCT-116 cells and C26 xenotransplanted tumors in mice. P110 plus cisplatin can reduce the effective dose of cisplatin and decrease the toxicity of cisplatin.</p>