Evaluation on the efficacy and safety of domestic bivalirudin during percutaneous coronary intervention.

BACKGROUND: Bivalirudin was widely used as an anticoagulant during coronary interventional procedure in western countries. However, it was not available in China before this clinical trial was designed. This randomized, single-blind and multicenter clinical trial aimed to evaluate the efficacy and the safety of domestic bivalirudin during percutaneous coronary intervention (PCI). METHODS: A randomized, single-blind, multicenter trial was designed. Elective PCI candidates in five centers were randomized into a bivalirudin group and a heparin group, which were treated with domestic bivalirudin and non-fractional heparin during the PCI procedure. The efficacy was evaluated by comparing the activated coagulation time (ACT), the procedural success rate (residual stenosis < 20% in target lesions without any coronary artery related adverse events within 24 hours after PCI), and the survival rate without major adverse cardiac events at 30 days after PCI between the two groups. Safety was evaluated by the major/minor bleeding rate. RESULTS: A total of 218 elective PCI patients were randomized into a bivalirudin group (n = 110) and heparin group (n = 108). Except for two patients needing additional dosing in the heparin group, the ACT values of all other patients in both groups were longer than 225 seconds at 5 minutes after the first intravenous bolus. Procedural success rates were respectively 100.0% and 98.2% in the bivalirudin group and heparin group (P > 0.05). Survival rates without major adverse cardiac events at 30 days after PCI were 100.0% in the bivalirudin group and 98.2% in the heparin group (P > 0.05). Mild bleeding rates were 0.9% and 6.9% (P < 0.05) at 24 hours, and 1.9% and 8.8% (P < 0.05) at 30 days after PCI in the bivalirudin group and heparin group respectively. There was one severe gastrointestinal bleeding case in the heparin group. CONCLUSIONS: Domestic bivalirudin is an effective and safe anticoagulant during elective PCI procedures. The efficacy is not inferior to heparin, but the safety is superior to heparin.

[Herbs for calming liver and suppressing liver-yang in treatment of migraine with hyperactive liver-yang syndrome and its effects on lymphocyte protein expression: a randomized controlled trial].

OBJECTIVE: To observe the efficacy of herbs for calming liver and suppressing liver-yang in treatment of migraine patients with hyperactivity of liver-yang syndrome and to investigate its effects on the lymphocyte protein expression. This approach may lay a foundation for the further investigation of pathogenic mechanisms in migraine with hyperactive liver-yang syndrome and the curative mechanisms of calming liver and suppressing liver-yang treatment. METHODS: A total of 32 migraine patients with hyperactivity of liver-yang syndrome were randomly divided into treatment group (16 cases) and control group (16 cases). The patients in the treatment group were treated with herbs for calming liver and suppressing liver-yang in accordance with traditional Chinese medicine (TCM) theory and the patients in the control group were treated with Flunarizine Capsules for two courses of treatment. The therapeutic effects, the score of TCM symptom and the changes of headache attack were observed in both groups before and after the treatment. The side effects were also observed in both groups. The level of differential protein expression was analyzed by two-dimensional electrophoresis and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS). RESULTS: The herbs for calming liver and suppressing liver-yang had better effects on headache improvement than the Flunarizine Capsules (P<0.01). The cure rates in the treatment and control groups were 87.5% and 75.0% respectively. Vertigo, restlessness and tantrum, and prosopo-heat in the treatment group were also improved as compared with those in the control group (P<0.05). After treatment, the score of TCM symptom in the two groups were all decreased (P<0.01), and there was a significant difference between the treatment group and the control group (P<0.01). The herbs for calming liver and suppressing liver-yang had no side effects. The average protein spots in the blood lymphocyte of normal people, migraine patients with hyperactivity of liver-yang syndrome in the treatment group before and after the treatment were (534+/-42), (552+/-54) and (529+/-55) spots respectively. Six down-regulated protein expressions and 14 up-regulated protein expressions were obtained in the treatment group. Four strengthened protein expressions in the six down-regulated proteins and 11 low protein expressions in the 14 up-regulated proteins were also obtained after treatment. Ten of the total 12 differential protein spots were successfully identified by MALDI-TOF-MS. The functions of these proteins were involved in metabolism, energy generation, transportation, antioxidation, signal transduction and immune, etc. According to information provided by NCBI and MSDB database, there were some proteins closely related to migraine with hyperactivity of liver-yang syndrome, such as peroxiredoxin 2, heat shock protein 27 and annexin A1. CONCLUSION: Herbs for calming liver and suppressing liver-yang is effective in treating migraine, and can improve TCM symptoms. The effects on migraine patients with hyperactivity of liver-yang syndrome may be related to regulating the blood lymphocyte protein expression.

[Effect of pinggan qianyang on hypothalamic proteome in the hyperthyroid rats with hyperactivity of liver-yang].

OBJECTIVE: To investigate the effect of pinggan-qianyang (PGQY), a Chinese medicine, on hypothalamic proteome in the hyperthyroid rats with hyperactivity of liver-yang, and to explore its mechanism. METHODS: The rat model was established by intraperitoneal injection of levo-thyroxine (L-T4) and fuzi decotion. All the quantitative and qualitative changes of the protein expressions were compared among the normal group,the model group and the treatment group by proteomic techniques. RESULTS: The protein spots in the 3 groups were mainly displayed at the isoelectric point (pI) 3 approximately 10, and the molecular weights were 13.8 approximately 98.8 kD.Compared with the normal group, 6 spots of protein expression increased and 10 decreased in the model group. All the changed protein in the model group returned to normal level after PGQY treatment. Mass-spectrometer and bio-informatics indicated that these proteins were Prohibitin, Peroxiredoxin-6, histidine triad nucleotide-binding protein 1, protein-tyrosine-phosphatase, predicted protein, profilin-2, peroxir doxin-II, heat shock protein-27, and annexin-A1. CONCLUSION: There are differences in the expression of hypothalamus proteins in the hyperthyroid rats with hyperactivity of liver-yang after the treatment with PGQY, and the 9 identified protein spots may be associated with the mechanism of PGQY.