通阳宽胸颗粒与丹蒌片治疗冠心病稳定型心绞痛的临床疗效及对血脂、炎症因子、血液流变学影响的对比研究OA

Objective To evaluate the clinical efficacy of Tongyang Kuanxiong Granules versus Danlou Tablets in patients with stable angina pectoris(SAP)of coronary heart disease(CHD)presenting with the phlegm blended with stasis syndrome,and to compare their effects on lipid metabolism,inflammatory response,and hemorheology.Methods A randomized,single-blind design was adopted.A total of 150 patients with CHD-SAP and the phlegm blended with stasis syndrome admitted to the outpatient and inpatient departments of Guangdong Second Traditional Chinese Medicine Hospital from January 2024 to September 2025 were enrolled.The patients were assigned to three groups using a random number table method:Tongyang Kuanxiong Granules group,Danlou Tablets group,and control group,with 50 cases in each group.All patients received the same secondary prevention western medical baseline therapy for CHD.Additionally,the Tongyang Kuanxiong Granules group received Tongyang Kuanxiong Granules,the Danlou Tablets group received Danlou Tablets,and the control group received a granule placebo.The treatment duration for all groups was 4 weeks.Changes in traditional Chinese medicine(TCM)syndrome scores,four lipid parameters[total cholesterol(TC),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C)],serum inflammatory cytokines[interleukin-1β(IL-1β),interleukin-6(IL-6)],and hemorheological parameters were observed before and after treatment.TCM syndrome efficacy,electrocardiogram(ECG)efficacy,and safety profiles were evaluated among the three groups.Results(1)Efficacy:After 4 weeks of treatment,the total response rates for TCM syndrome efficacy and ECG efficacy were 92.00%(46/50)and 56.00%(28/50)in the Tongyang Kuanxiong Granules group,90.00%(45/50)and 58.00%(29/50)in the Danlou Tablets group,and 76.00%(38/50)and 30.00%(15/50)in the control group,respectively.Both the Tongyang Kuanxiong Granules group and the Danlou Tablets group showed significantly superior TCM syndrome and ECG efficacy compared to the control group(P＜0.05),with no significant difference between the two Chinese medicine groups(P＞0.05).(2)TCM syndrome scores:After treatment,TCM syndrome scores were significantly decreased in all three groups compared to baseline(P＜0.05).Intergroup comparison showed that the treatment groups demonstrated significantly greater reductions than the control group(P＜0.05),with no significant difference between the two treatment groups(P＞0.05).(3)Lipid parameters:After treatment,levels of TC,LDL-C,and TG were significantly decreased,while HDL-C was significantly increased in all three groups compared to baseline(P＜0.05).Intergroup comparison showed that the treatment groups showed significantly greater improvements in all lipid parameters than the control group(P＜0.05),with no significant difference between the two treatment groups(P＞0.05).(4)Inflammatory cytokines:After treatment,serum IL-1β and IL-6 levels were significantly decreased in all three groups compared to baseline(P＜0.05).Both treatment groups showed significantly greater reductions than the control group(P＜0.05),with no significant difference between the two treatment groups(P＞0.05).(5)Hemorheology:After treatment,whole blood viscosity at high,medium,and low shear rates,as well as the erythrocyte aggregation index,significantly decreased in all three groups compared to baseline(P＜0.05).Both treatment groups showed significantly greater reductions in all hemorheological parameters than the control group(P＜0.05),with no significant difference between the two treatment groups(P＞0.05).(6)Safety:During the trial,no significant adverse events were observed in any of the three groups.No significant differences were found in liver and kidney function parameters(alanine aminotransferase,aspartate aminotransferase,blood urea nitrogen,serum creatinine)before and after treatment among the three groups(P＞0.05).Conclusion Both Tongyang Kuanxiong Granules and Danlou Tablets demonstrate favorable clinical efficacy in treating CHD-SAP patients with the phlegm blended with stasis syndrome.No significant differences were identified between the two Chinese herbal preparations in alleviating clinical symptoms,regulating blood lipids,suppressing inflammatory responses,or improving hemorheological profiles.