| Objective:To evaluate whether Xinnaning capsule can effectively reduce the level of high-sensitive C-reactive protein(hs-CRP)in stable state patients with high residual inflammation risk after acute coronary syndrome,and whether it can improve the efficacy of early anti-angina pectoris and improve the quality of life of patients.Methods: This study was derived from a national multicenter clinical study designed as a randomized,placebo-controlled,double-blind multicenter clinical study.A total of 312 subjects were enrolled in this study,with 28 cases shedding and 10 cases removed.302 cases were included in statistical analysis,including 153 cases in group A and 149 cases in group B.A total of 274 subjects completed the 12-week interview.The control group was loaded with Xinnaoning capsule simulation agent,and the experimental group was loaded with Xinnaoning capsule.The treatment course was 12 weeks.The changes of hs-CRP level and baseline value,the rate of nitroglycerin withdrawal and the score of the fivedimension Health Index Scale(EQ-5D-5L)at the end of 12 weeks after treatment were used as outcome indexes.Results: Before treatment,there were no statistical differences in general information and baseline characteristics between the two groups(P>0.05),which was comparable.Before treatment,there was no significant difference in the baseline hs-CRP level between the two groups(P>0.05).After treatment,the hs-CRP level of the experimental group and the control group decreased,but there was no difference between the two groups(P>0.05),and there was no difference between the two groups(P>0.05).Before and after treatment,there were no significant differences between the control group and the experimental group in five dimensional health index scale health questionnaire scores(P>0.05);After treatment,the stopping rate of nitroglycerin in experimental group was 85.40%(117/137)higher than that in control group52.55%(72/137),with statistical difference(P<0.05).During the clinical trial,there was no statistical difference between the two groups in the self-rating scale of fatigue and statin muscle symptom score(P<0.05).Although there were 12 subjects with varying degrees of adverse events,they could be alleviated after active treatment.The occurrence of these adverse events was assessed by professionals to be less likely to be related to the test drug and did not affect the trial process.Conclusion: For patients with stable state and high risk of residual inflammation after acute coronary syndrome(ACS),the therapeutic effect of GDMT combined with Xinnaoning capsule was better than that of GDMT alone in improving symptoms of obvious angina pectoris,but there was no significant difference in reducing hs-CRP level and improving patients’ quality of life.In the interim analysis of 3 months,GDMT-loaded Xinnaoning capsule treatment did not further reduce the level of hs-CRP or improve the quality of life of patients,but it may further improve the symptoms of angina pectoris. |
