Clinical study of Qishenyiqi dropping pills in patients with ACS due to PCI and diabetes melli-tus
Objective To evaluate the effectiveness and safety of Qishenyiqi dropping pills in patients with ACS due to PCI and diabetes mellitus.Methods 635 patients with ACS due to PCI and diabetes mellitus were enrolled in 40 A-class hospitals,and were entered in-to Qishenyiqi dropping pills group and conventional medicine group according to whether they took Qishenyiqi dropping pills as exposure factor.All patients were given secondary cardiovascular prophylaxis according to the guidelines.Patients in Qishenyiqi dropping pill group took Qishenyiqi dropping pill for 12 months on the basis of secondary prophylaxis.The primary outcome was the primary and sec-ondary endpoints.The secondary outcome was the score of blood stasis syndrome.Results 590 patients were followed up,including 286 patients in Qishenyiqi dropping pills group and 304 patients in conventional medicine group.Cox analysis showed that 29 cases(10.14％)in Qishenyiqi dropping pill group and 43 cases(14.14％)in conventional medicine group had primary endpoints(adjusted HR 0.60;95％CI 0.36～1.01;P=0.055);Secondary endpoints occurred in 29 cases(10.14％)of Qishenyiqi dropping pill group and 53 cases(17.43％)of conventional medicine group(adjusted HR 0.61;95％CI 0.38～0.99;P=0.045).The generalized esti-mation equation analysis showed that Qishenyiqi dropping pills reduced the blood stasis score compared with conventional medicine group.Adverse events were not significantly different between the two groups.Conclusion Qishenyiqi dropping pills can reduce the risk of sec-ondary endpoints and the score of blood stasis syndrome,and have good safety.
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