Objective:To assess the efficacy and safety of Guanxin Danshen Dripping Pills(GXDS)in the treatment of depression or anxiety in patients with coronary heart disease(CHD)after percutaneous coronary intervention(PCI).Me...Objective:To assess the efficacy and safety of Guanxin Danshen Dripping Pills(GXDS)in the treatment of depression or anxiety in patients with coronary heart disease(CHD)after percutaneous coronary intervention(PCI).Methods:From September 2017 to June 2019,200 CHD patients after PCI with depression and anxiety were included and randomly divided into GXDS(100 cases)and placebo control groups(100 cases)by block randomization and a random number table.Patients in the GXDS and control groups were given GXDS and placebo,respectively,0.4 g each time,3 times daily for 12 weeks.The primary outcomes were scores of Patient Health Questionnaire-9(PHQ-9),Generalized Anxiety Scale(GAD-7)and the Seattle Angina Pectoris Scale(SAQ).The secondary outcomes included 12 Health Survey Summary Form(SF-12)scores and the first onset time and incidence of major adverse cardiovascular events(MACEs).Other indices including blood pressure,blood lipids,microcirculation and inflammatory-related indices,etc.were monitored at baseline,week 4,and week 12.Results:In the full analysis set(200 cases),after treatment,the PHQ-9 and GAD-7 scores in the GXDS group were considerably lower than those in the control group(P<0.05).Compared with the baseline,the total PHQ-9 scores of the experimental and control groups decreased by 3.97 and 1.18,respectively.The corrected mean difference between the two groups was–2.78(95%CI:–3.47,–2.10;P<0.001).The total GAD-7 score in the GXDS group decreased by 3.48%compared with the baseline level,while that of the placebo group decreased by 1.13%.The corrected mean difference between the two groups was–2.35(95%CI:–2.95,–1.76;P<0.001).The degree of improvement in SAQ score,SF-12 score,endothelin and high-sensitive C-reactive protein levels in the GXDS group were substantially superior than those in the placebo group,and the differences between the two groups were statistically significant(P<0.05).Similar results were obtained in the per protocol population analysis of 177 patients.Three cases of MACES were reported in this study(1 in the GXDS group and 2 in the placebo group),and no serious adverse events occurred.Conclusions:GXDS can significantly alleviate depression and anxiety,relieve symptoms of angina,and improve quality of life in patients with CHD after PCI.(Registration No.ChiCTR1800014291)展开更多
文摘Objective:To assess the efficacy and safety of Guanxin Danshen Dripping Pills(GXDS)in the treatment of depression or anxiety in patients with coronary heart disease(CHD)after percutaneous coronary intervention(PCI).Methods:From September 2017 to June 2019,200 CHD patients after PCI with depression and anxiety were included and randomly divided into GXDS(100 cases)and placebo control groups(100 cases)by block randomization and a random number table.Patients in the GXDS and control groups were given GXDS and placebo,respectively,0.4 g each time,3 times daily for 12 weeks.The primary outcomes were scores of Patient Health Questionnaire-9(PHQ-9),Generalized Anxiety Scale(GAD-7)and the Seattle Angina Pectoris Scale(SAQ).The secondary outcomes included 12 Health Survey Summary Form(SF-12)scores and the first onset time and incidence of major adverse cardiovascular events(MACEs).Other indices including blood pressure,blood lipids,microcirculation and inflammatory-related indices,etc.were monitored at baseline,week 4,and week 12.Results:In the full analysis set(200 cases),after treatment,the PHQ-9 and GAD-7 scores in the GXDS group were considerably lower than those in the control group(P<0.05).Compared with the baseline,the total PHQ-9 scores of the experimental and control groups decreased by 3.97 and 1.18,respectively.The corrected mean difference between the two groups was–2.78(95%CI:–3.47,–2.10;P<0.001).The total GAD-7 score in the GXDS group decreased by 3.48%compared with the baseline level,while that of the placebo group decreased by 1.13%.The corrected mean difference between the two groups was–2.35(95%CI:–2.95,–1.76;P<0.001).The degree of improvement in SAQ score,SF-12 score,endothelin and high-sensitive C-reactive protein levels in the GXDS group were substantially superior than those in the placebo group,and the differences between the two groups were statistically significant(P<0.05).Similar results were obtained in the per protocol population analysis of 177 patients.Three cases of MACES were reported in this study(1 in the GXDS group and 2 in the placebo group),and no serious adverse events occurred.Conclusions:GXDS can significantly alleviate depression and anxiety,relieve symptoms of angina,and improve quality of life in patients with CHD after PCI.(Registration No.ChiCTR1800014291)
