To observe the safety and efficacy of Xuezhikang (血脂康) in combination with proprotein convertase subtilisin/kexin type 9 (PCSK9i) in the treatment of the patients with statin-intolerant coronary atherosclerotic heart disease (coronary artery disease).

A total of 104 cases of statin-intolerant coronary heart disease patients admitted to the Department of Cardiology of the Affiliated Hospital of Jilin Medical University from 2023.2 to 2024.2 were selected as the study population, and were divided into the routine group and the Xuezhikang group using the lottery method, and both groups were given coronary heart disease secondary preventive drug treatment, 52 cases in the routine group were given iloyuzumab treatment, 52 cases in the Xuezhikang group were given Xuezhikang Capsule combined with iloyuzumab treatment, and both groups were continuously treated for half a year. The lipid levels of the two groups before treatment, after 1, 3 and 6 months of treatment were compared. The levels of PCSK9, cholesterol ester transfer protein (CETP), apolipoprotein B (ApoB), cardiac function, 6-minute walk test, glutamic acid aminotransferase (ALT), glutamine transaminase (AST), creatine kinase isoenzymes (CK-MB) and traditional Chinese medicine syndrome scores in the two groups before treatment and after 6 months of treatment were compared. The cumulative endpoint events in both groups within six months were counted.

There was no difference in the levels of lipid indexes before treatment between the two groups (P>0.05). The levels of total cholesterol (TG), triglyceride (TC) and low-density lipoprotein cholesterol (LDL-C) after 1, 3 and 6 months of treatment in both groups were lower than those before treatment, and the levels of TG, TC and LDL-C in the Xuezhikang group were lower than those of the routine group after 1, 3 and 6 months of treatment (P<0.05). Comparison of high-density lipoprotein cholesterol (HDL-C) levels after 1, 3 and 6 months of treatment in the two groups showed no difference (P>0.05). Comparison of PCSK9, CETP, ApoB, AST, ALT, and CK-MB levels before treatment between the two groups showed no difference (P>0.05). The levels of PCSK9, ApoB, AST, ALT and CK-MB were lower than those before treatment after 6 months of treatment in both groups, and the levels of PCSK9 and ApoB in the Xuezhikang group were lower than those in the routine group after 6 months of treatment (P<0.05). There was no difference in the levels of CETP, AST, ALT or CK-MB after 6 months of treatment between the two groups (P>0.05). Comparison of cardiac function and 6-minute walk test levels before treatment between the two groups showed no difference (P>0.05). The levels of left ventricular ejection fraction (LVEF), cardiac output (CO) and 6-minute walk test were higher in both groups after 6 months of treatment compared with the pre-treatment levels, and the levels of LVEF, CO and 6-minute walk test were higher in the Xuezhikang group than those in the routine group after 6 months of treatment (P<0.05). The levels of left ventricular end-diastolic internal diameter (LVESD) were lower in both groups after 6 months of treatment than those before treatment, and the levels of LVESD were lower in the Xuezhikang group than those in the routine group after 6 months of treatment (P<0.05). Comparison of cumulative endpoint events between the two groups showed no difference (P>0.05). Before treatment, there was no difference in traditional Chinese medicine syndrome scores between the two groups (P>0.05). The scores of the two groups after 6 months of treatment were lower than those before treatment, and the score of the Xuezhikang group was lower than that of the routine group (P<0.05).

Xuezhikang combined with PCSK9 inhibitor for statin-intolerant coronary artery disease can regulate the lipid metabolism and improve the cardiac function with high safety.