| Objectives The aim of the study was to evaluate the efficacy and safety of xuezhikang600mg Bid plus rosuvastatin5mg Qn for Chinese patients with hyperlipidemia. Meanwhile, the effects of xuezhikang600mg Bid plus rosuvastatin5mg Qn on PCSK9(proprotein convertase subtilisin/kexin type9, PCSK9) and sLDL(small and dense low-density lipoprotein) in these patients were observed.Methods A randomized, open study was performed on a total of30Patients (including14males and16females) with hyperlipidemia. The patients were randomly assigned to a group A (xuezhikang600mg Bid plus rosuvastatin5mg Qn, n=15) or group B (rosuvastatin lOmg Qn, n=15) Respectively, according to the above treatment taking for8weeks, after eight weeks, exchanging the treatment for another8weeks.The level of serum total cholesterol (TC),low density lipoprotein cholesterol (LDL-C),high density lipoprotein cholesterol (HDL-C), triglyceride (TG),PCSK9and sLDL were measured at baseline8weeks and after16weeks.The serum PCSK9and sLDL levels were determined by ELISA. Adverse effects of drugs were monitored during the following-up.Results1. After8weeks, TG, LDL-C, TC in group A significantly decreased to1.27±0.55mmol/l,1.88±0.33mmol/l,3.77±0.50mmol/l,respectively. After16weeks, TG, LDL-C, TC in group A significantly increased to 1.32±0.47mmol/l,2.02±0.40mmol/l,3.93±0.65mmol/1, respectively. After8weeks, TG, LDL-C, TC in group B significantly decreased to1.41±0.59mmol/l,2.29±0.52mmol/l,4.22±0.61mmol/1, respectively,. After16weeks, TG, LDL-C, TC in group B significantly decreased to1.27±0.54mmol/l,2.22±0.45mmol/l,4.03±0.85mmol/1, respectively.A and B treatment program were significant differences in LDL-C, HDL-C, TG and TC serum levels (all P<0.05).2.After8weeks, PCSK9in group A and B significantly increased to11.25±2.33ng/ml、14.06±2.63ng/ml,respectively (all P<0.05). After16weeks, PCSK9in group A significantly increased to14.51±2.16ng/ml,but in group B decreased to8.74±3.11ng/ml.After8weeks,sLDL in group A and B significantly decreased to2.40±1.10ng/ml、2.88±1.07ng/ml, respe-ctively, Compared with pre-treatment there were significant decrease (all P<0.05). After16weeks, in group A significantly increased to2.58±1.06ng/ml,However, in group B decreased to2.43±0.93ng/ml.A and B trea-tment program were significant differences in PCSK9and sLDL serum levels (all P<0.05).3.Pearson related analysis showed that negative correlations were found between sLDL levels and HDL-C levels (r=-0.467, p<0.01),. Positive corre-lations were found between sLDL levels and TG levels (r=0.824, p<0.01), sLDL levels and LDL-C levels (r=0.385, p<0.05), sLDL levels and TC levels (r=0.461, p<0.05).3.During the following-up, ALT of one patient in group B increased to143U/L after8weeks,but after another8weeks treatment, it decreased to95.8U/L, no adverse events including nausea, vomiting, irritability, abdominal thirst, weakness, statin-related myalgia, rhabdomyolysis and other phenomena were found.Conclusion1.Xuezhikang plus5mg rosuvastatin had better effect on lipids, compared with lOmg rosuvastatin.2.10mg rosuvastatin,compared Xuezhikang plus5mg rosuvastatin, significantly elevated PCSK9, while the latters effect of reducing sLDL less than the former, suggesting that the clinical application of the latter was better than the former.3. sLDL level was mainly affected by TG.4.Xuezhikang plus rosuvastatin5mg had good safety. |
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