| Objective: Compared with modern standard therapy,to evaluate the effects of loading Xinnaoning capsule in angina pectoris,plasma homocysteine(Hcy)level and quality of life in patients with post-acute coronary syndrome(ACS).Methods: In this study,a randomized,double-blind,placebo-controlled trial design was used.A total of 60 patients with plasma Hcy > 15μmol/L 1to 90 days after ACS were selected and divided into control group(n=27)and experimental group(n=33)by central random system.Subjects in both groups received guideline determined medical therapy(GDMT),the experimental group received Xinnaoning Capsule with 3 tid,and the control group received Xinnaoning capsule simulation with 3 tid.The treatment course was 12 weeks.Reduction rate of nitroglycerin,plasma Hcy level,and seattle angina questionnaire(SAQ)were used as outcome indexes after 12 weeks of treatment.Results:(1)Baseline data: The baseline characteristics of the two groups before treatment were comparable(P > 0.05).(2)Reduction rate of nitroglycerin: After treatment,the reduction rate of nitroglycerin in experimental group was 78.79%(26/33)higher than that in control group,51.85%(14/27),and the difference was statistically significant(P < 0.05).(3)Plasma Hcy level: After treatment,the plasma Hcy level in both groups was lower than before,but there was no statistically significant difference before and after the treatment(P > 0.05);Hcy level in experimental group had a further downward trend,but there was no statistically significant difference between groups(P > 0.05),and there was no statistically significant difference in baseline change value(P > 0.05).(4)SAQ score: after treatment,SAQ scores in all dimensions of the two groups were improved compared with before,but there was no statistically significant difference between the two groups before and after the treatment(P > 0.05),and there was no statistically significant difference between the two groups(P > 0.05).(5)Safety analysis: there were no significant abnormalities in vital signs and laboratory indicators of the two groups after treatment;After treatment,there was no significant difference between the two groups in the physical fatigue assessment of fatigue scale(FS-14)(P > 0.05).During the trial,there were 2 adverse events(AE)in the control group and the experimental group,which were all alleviated within a short time and did not affect the trial process.No serious adverse events(SAE)occurred.Conclusions: Compared with GDMT alone,loading Xinnaoning capsule can improve the rate of nitroglycerin abatement,relieve the obvious angina symptoms of patients with post-ACS,and reduce the frequency and duration of attacks in the short term,but it does not show the superior effect of reducing the plasma Hcy level and improving the quality of life of patients in the short term. |