| Objective:The effect of different dose of domestic GPⅡb/Ⅲa inhibitor (tirofiban) on bleeding, ischemic events and thrombocytopenia was observated and analyzed in order to find the efficacy and safety of low-dose domestic GPⅡb/Ⅲa inhibitor, furthermore, to find the suitable dosage of domestic GPⅡb/Ⅲa inhibitor during the perioperation of PCI procedure.Method:234 patients in moderate or high risk patients with acute coronary syndrome were enrolled and randomly divided into three groups, one was the group A (recommended-dose group), the other was the group B (low-dose group), and another was the group C (control group, no-GPⅡb/Ⅲa inhibitor). All patients were given aspirin 100mg/d and clopidogrel 75mg/d after first loading-dose of 300mg at least 3 days before PCI procedure, low molecular weight heparin(LMWH) was also given to patients(Clexane for 1.2ml/d or Dalteparin for 10000u/d),GPⅡb/Ⅲa inhibitor was used before PCI at least 6 hours in group A and group B, the dosage of GPⅡb/Ⅲa inhibitor for group A was 0.18ml/kg/h, the dosage of GPⅡb/Ⅲa inhibitor for group B was 0.15ml/kg/h. Heparin was used in PCI procedure at 70-120u/kg, ACT was tested as soon as the PCI procedure was over. The dose of LMWH was adjusted after PCI procedure (Clexane for 0.6ml/d or Dalteparin for 5000u/d), but the dosage of GPⅡb/Ⅲa inhibitor wasn't changed until 36 hours after using. Bleeding, ischemic events, thrombocytopenia and laboratory test results were observed and analyzed during hospitalization, Bleeding and ischemic events were also recorded 1 month after PCI procedure.Result: 1. There were 30 patients who had TIMI Minimal bleeding events in group A,16 patients in group B and 10 patients in group C during the perioperation of PCI procedure. TIMI Minimal bleeding events of the three groups were obvious significant(39.5% vs 21.3% vs 12.0%,p<0.001), and there was obvious significance between group A and B (39.5% vs 21.3%,p<0.05), and also between group A and C (39.5% vs 12.0%,p<0.001), however, there was no significance between group B and C (21.3% vs 12.0%,p>0.05).2. There were no TIMI minor bleeding events for all three groups, and there were no TIMI major bleeding events in group B and C, however, the group A had 2 cases of TIMI major bleeding events. There was no significance among the three groups for TIMI major bleeding events(2.6% vs 0.0% vs 0.0%,p>0.05).3.The group A had 3 cases of ischemic events while the group B had 7 cases, and 9 cases for group C during the perioperation of PCI procedure, there was no significance among them(5.3% vs 9.3% vs 12.0%,p>0.05). After 1 month, no case of bleeding events was found, but we found 1 cases of ischemic event in group A and B each other, and we found 7 cases in group C, there was obvious significance among them(1.31% vs 1.33% vs 8.43%,p<0.05),however, there was no significance between group A and group B(p>0.05).4. All groups had some cases of thrombocytopenia, but there was no significance among them(3.9% vs 4.0% vs 4.8%,p>0.05), and there was no significance among the three groups for the degree of thrombocytopenia(p>0.05).5.There was no difference in platelet aggregation ratio (PAg) [47.66 (44.15-49.86)% vs 47.02(43.14-49.00)% vs 47.08(42.39-49.73)%,p>0.05]before PCI procedure, however, there was obvious significance among the three groups after PCI procedure[0.64(0.00-4.92)% vs 3.08(0.69-6.49)% vs 46.98(40.8-51.1)%,p< 0.001], but there was no significance for each two group(p>0.05).6.The time of bleeding onset was significant for all groups[200.0 (97.5-555.0) min vs 787.5 (245.0-1068.8) min vs 1140.0 (322.5-1262.5) min,p<0.01], but there was no significance between group B and group C(p>0.05).Conclusion:It is safe and effective to use low-dose domestic GPⅡb/Ⅲa inhibitor during the perioperation of PCI, the protocol can decrease bleeding events without increasing ischemic events and thrombocytopenia comparing with the recommended-dose. 0.15ml/kg/h is a suitable dosage of domestic GPⅡb/Ⅲa inhibitor during the perioperation of PCI procedure. |
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