General information of patients
The study included 186 ASCVD cases, according to random number table method were randomly divided into Xuezhikang group（group A，n=61）,rosuvastatin group（group B，n=62）, and combined group(group C,n=63). During the follow-up period, 6 patients withdrew from observation,2 cases (1.08%) had drug intolerance to stop their own medication, 1 case (0.54%) had increased their creatine after taking the Chinese medicine leech powder, and 3 cases(1.61%) had been lost due to the COVID-19. Finally, 180 patients completed the follow-up, 60 cases in each group. There were no significant differences in gender ratio, BMI, age, hypertension, coronary heart disease, cerebrovascular disease and diabetes history among the three groups (P < 0.05). The follow-up results of each group were comparable(Table 1).
Blood lipids were detected before and 1 week, 2 weeks, 1 month, 3 months and 6 months after treatment,the changes of blood lipid at each observation point of the three groups were visible,Except HDL-C, TC, TG, LDL-C showed a downward trend. Analysis of variance of repeated measurement data showed that TG, TC, LDL-C and HDL-C were not subject to mauchy's spherical test (P < 0.05), and the corrected part of Greenhouse-Geisser was the standard, TG (F = 1.888, P = 0.120), HDL-C (F=1.490，p=0.195）,P＞0.05,there was no significant difference in the levels of TG and HDL-C in the three groups at the same observation point, and the effects of each group on TG and HDL-C were similar; TC (F = 41.114, P < 0.001), LDL-C (F = 14.809, P < 0.001), P < 0.05, the levels of TC and LDL-C in the three groups were not equal at the same observation point, and the difference was statistically significant. The comparison between TC groups showed that group A: group B, P < 0.001; group A: group C, P < 0.001; group B: group C, P = 0.175. It can be seen that rosuvastatin group and combined group have the similar effect on reducing TC and are better than Xuezhikang group. LDL-C comparison between groups showed that group A: group B, P = 0.001; group A: group C, P < 0.001; group B: group C, P = 0.014. Obviously, the effect of combination group, rosuvastatin group and Xuezhikang group on reducing LDL-C in turn decreased(Table 2).
Carotid intima-media thickness and plaque total score
The carotid intima-media thickness of group A, group B and group C decreased from 1.17 ± 0.17mm, 1.18 ± 0.19mm, 1.17 ± 0.16mm to 1.13 ± 0.16mm, 1.09 ± 0.18mm and 1.06 ± 0.14mm before and after treatment, and the total plaque score decreased from 3.63 ± 2.22, 3.90 ± 3.17, 4.07 ± 3.25 to 3.28 ± 2.05, 3.16 ± 2.74 and 3.29 ± 2.73, respectively, P < 0.05 , the IMT and crouse scores of the latter groups were improved. The comparison of carotid intima-media thickness of each group showed that group B: group A, P = 0.003 (P < 0.05); group C: group A, P < 0.001; group C: group B, P = 0.111 (P > 0.05). The combined group and rosuvastatin group had similar improvement effect on IMT and were superior to the Xuezhikang group. The comparison between groups on the total plaque score (crouse score) showed that group B: group A, P = 0.047 (P < 0.05); group C: group A, P=0.027 (P < 0.05); group C: group A, P = 0.810 (P > 0.05). The effect of combined group and rosuvastatin group in improving IMT was similar and better than Xuezhikang group(Table 3) .
Cervical vascular plaque
The cervical vascular stable plaques in group A, Group B and group C before treatment were 118 (54.63%), 137 (60.09%) and 126 (53.85%) respectively, and 141 (65.28%), 166 (72.81%) and 171 (73.08%) respectively after treatment; the unstable plaques were 98 (45.37%), 91 (39.91%), 108 (46.15%) before treatment, and 75 (34.72%), 62 (27.19%) and 63 (26.92%) after treatment respectively. P value of each group before and after treatment were all < 0.05, the difference was statistically significant, that is,plaque stability could be improved in each group.Among groups, before treatment Χ 2= 2.143, P=0.342; after treatment Χ 2=4.163, P=0.125, P> 0.05, the difference was not statistically significant, it can be considered that the ability of plaque stability in each group is equal (Table 3).
Blood lipid success rate and time
The LDL-C level of group A began to reach the standard at 2W after administration, while that of group B and group C gradually reached the standard of LDL-C from 1W after medication. The cumulative number of persons reaching the target at each observation point in Group A was 0 (0.00%), 0 (0.00%), 2 (3.33%), 5 (8.33%), 14 (23.33%) and 19 (31.67%);0 (0.00%), 2 (3.33%), 9 (15.00%), 15 (25.00%), 30 (50.00%) and 43 (71.67%) in group B; 0 (0.00%), 8 (13.33%), 17 (28.33%), 28 (46.67%), 50 (83.33%) and 56 (93.33%) in group C ,respectively(Figure 2).Taking 6M observation point as an example, the success rate of each group was compared,among the groups, Χ2= 52.012, P < 0.001,the rate is not all the same. Further comparison shown that group A: group B, group A: Group C, P < 0.001, group B: group C, P=0.002 (P < 0.017),indicting that the LDL-C success rate of group C, group B and group A decreased in turn after 6 months’ medication (Table 3). In group A, group B and group C, the time to reach the standard of blood lipid was (96.21 ± 58.75) days, (92.61 ± 65.61) days, (62.07 ± 53.25) days,F= 4.363, P=0.015 (P < 0.05). Further comparison shown that group A: group B, P = 0.824 (P > 0.05); group A: Group C, P = 0.030 (P < 0.001), group B: Group C, P = 0.011 (P < 0.05). The time for reaching the standard of LDL-C in the treatment groups was earlier than that in the rosuvastatin group and Xuezhikang group. It was not considered that there was difference in the target time between rosuvastatin group and Xuezhikang group in the LDL-C reaching patients in this observation (Table 3).
During the treatment,1 (1.67%) patient had dizziness and headache in group A,1 (1.67%) patient had fatigue symptoms, and 1 (1.67%) patient presented liver function injury in group B ,1 (1.67%) patient occurred elevated CK/CKMB in group C. There was no statistically significant difference, and the treatment scheme is safe and reliable, no difference among groups (Table 4).