通阳宽胸方配方颗粒与传统汤剂治疗冠心病稳定型心绞痛的疗效及对糖脂代谢与内皮损伤指标的作用比较OA

Objective To compare the clinical efficacy of Tongyang Kuanxiongfang Formula dispensing granules versus its traditional decoction in the treatment of stable angina pectoris of coronary heart disease(with qi stagnation and phlegm stasis syndrome)and their effects on glucose-lipid metabolism and endothelial injury markers.Methods A randomized,single-blind,placebo-controlled clinical trial was conducted.A total of 76 patients with stable angina pectoris who met the diagnostic criteria and were treated at the outpatient or inpatient departments of Guangdong Second Traditional Chinese Medicine Hospital from May 2024 to May 2025 were enrolled.They were divided into a trial group and a control group using a random number table,with 38 cases in each group.On the basis of original western medical treatment,the trial group received Tongyang Kuanxiongfang Formula dispensing granules plus a placebo of traditional herbal decoction,while the control group received the traditional Tongyang Kuanxiongfang Formula decoction plus a placebo of dispensing granules.After 4 weeks of treatment,the two groups were compared in terms of traditional Chinese medicine(TCM)syndrome efficacy,TCM syndrome score,Seattle Angina Questionnaire(SAQ)score,average weekly frequency of angina attacks,average duration of each angina attack,serum glucose-lipid metabolism markers[low-density lipoprotein cholesterol(LDL-C),oxidized low-density lipoprotein(ox-LDL),advanced glycation end products(AGEs),soluble receptor for advanced glycation end products(sRAGE)],and serum endothelial injury markers[vascular endothelial growth factor(VEGF),vascular cell adhesion molecule-1(VCAM-1),intercellular adhesion molecule-1(ICAM-1)].Results After treatment,the total response rate for TCM syndrome efficacy was 92.1％(35/38)in both groups,with a difference in total response rates of 0(95％CI:-0.12 to 0.12).The lower limit of the 95％CI was>-0.18,establishing non-inferiority.After treatment,TCM syndrome scores were significantly decreased in both groups(P<0.05);SAQ scores were significantly increased in both groups(P<0.05);the average weekly frequency of angina attacks were significantly decreased(P<0.05);the average duration of each angina attack was significantly shortened(P<0.05);serum levels of LDL-C,ox-LDL,AGEs,VCAM-1,and ICAM-1 were significantly decreased in both groups(P<0.05);and serum levels of sRAGE and VEGF were significantly increased in both groups(P<0.05).There were no statistically significant differences in the above-mentioned indicators between the two groups(P>0.05).Conclusion Both Tongyang Kuanxiongfang Formula dispensing granules and the traditional Tongyang Kuanxiongfang Formula decoction demonstrate favorable clinical efficacy in treating stable angina pectoris of coronary heart disease(with qi stagnation and phlegm stasis syndrome),with no significant differences between the two formulations in alleviating angina symptoms,regulating glucose-lipid metabolism,or improving endothelial function.