| Objective: Through a clinical study,we observed the clinical efficacy and safety of Jieyu Tongmai Decoction in patients with coronary heart disease combined with anxiety(liver qi stagnation syndrome),aiming to enrich the ideas for the treatment of this disease in Chinese medicine and provide more options for clinical use.Methods: Sixty-three patients with coronary heart disease combined with anxiety with evidence of liver qi stagnation were included in this study.The cases were grouped by the random number table method,32 cases in the combined Chinese medicine group and 31 cases in the control group.Three cases fell off during the study(those who voluntarily withdrew due to exacerbation and personal reasons,two in the combined herbal medicine group and one in the control group),and finally a total of 60 patients completed the trial.The control group was given western medicine basic treatment,and the combined Chinese medicine group was treated with Jieyu Tongmai Decoction on the basis of the control group.The observation period was 4 weeks,and the Generalized Anxiety Disorder-7(GAD-7),Seattle Angina Questionnaire(SAQ),Somatization Symptom Self-Rating Scale(SSS),Chinese Medicine Evidence Score,blood lipid levels efficacy and safety and adverse effects were observed in both groups before and after treatment.Results: 1.GAD-7: After treatment,the GAD-7 scores of both groups were lower than those before treatment(P < 0.05),and the anxiety scores of the combined herbal medicine group were lower than those of the control group(P< 0.05).2.SAQ: The scores of the two groups in the degree of limitation of Physical limitations(PL),Angina stable(AS),Angina frequency(AF),Treatment Satisfaction(TS),and Disease Awareness(DS)were higher than those before treatment(P < 0.05).The scores of the combined herbal medicine group were better than those of the control group in AS,AF,TS,and DS(P< 0.05).In terms of PL scores,the difference between groups was not statistically significant(P > 0.05),but the difference between groups was more significant in the combined herbal medicine than the control group in improving PL scores(P < 0.05).3.SSS: The SSS scores of patients in both groups were lower than before treatment(P < 0.05),and the combined herbal medicine group was better than the control group in reducing patients’ SSS scores(P< 0.05).4.TCM evidence points and efficacy: After treatment,the total TCM evidence points of patients in both groups were lower than before treatment(P < 0.05),and the total effective rate after treatment was 83.33% in the combined herbal medicine group and 63.33% in the control group,and the combined herbal medicine group was significantly better than the control group(P < 0.05).When comparing the TCM single symptom scores,the individual scores of chest pain,chest tightness,chest distension,cachexia,heart trouble,sleeplessness,palpitation,impatience and irritability,and good sighing were lower in both groups than before treatment(P < 0.05).After treatment,the combined herbal medicine group had lower scores than the control group in chest pain and palpitations(P < 0.05).The combined herbal medicine group was significantly better than the control group in the degree of improvement of sleeplessness,impatience and irritability,good sighing,and tongue symptoms(P < 0.05).5.Blood lipids: the blood lipid levels in both groups were improved compared with those before treatment(P < 0.05),and the combined Chinese medicine group was better than the control group in improving blood lipid levels(P < 0.05).6.Safety and adverse effects: The safety indexes of blood,urine,stool routine,liver function and kidney function of patients in both groups before and after treatment did not show any significant abnormalities,and no adverse reactions occurred during the treatment period.Conclusion: Jieyu Tongmai Decoction can reduce the anxiety score of patients with coronary artery disease combined with anxiety,improve patients’ somatization symptoms,reduce the frequency of angina attacks,improve the quality of life,improve blood lipid levels,and is safe for clinical application. |