阿托伐他汀联合复合益生菌治疗高脂血症的临床试验

Atorvastatin plus compound probiotics in the treatment of hyperlipidemia:clinical trials

目的探讨阿托伐他汀联合复合益生菌治疗高脂血症人群的有效性。方法2019年1月至12月在内蒙古自治区人民医院临床招募33例高脂血症患者,采用随机、双盲、对照的试验设计,将患者随机分为试验组(n=18)与对照组(n=15)。试验组给予阿托伐他汀20 mg(每日1次)以及复合益生菌(每日1次,每次1袋2 g),对照组给予阿托伐他汀20 mg(每日1次)以及安慰剂(每日1次,每次1袋2 g)。观察12周,每4周测定1次血脂水平。比较两组间、各时间点间血脂水平的差异。结果两组基线数据比较差异无统计学意义(P>0.05)。TC、TG、LDL-C等血脂水平在组间的主效应中差异无统计学意义(P>0.05);在不同时间干预下,差异有统计学意义(P<0.05);干预时间与两种干预方式在TC、TG、LDL-C等血脂水平上不存在交互作用(P>0.05)。结论阿托伐他汀单独治疗及联合复合益生菌治疗,均可降低高脂血症患者的血脂水平,但联合方法并未增加降脂疗效。

Objective To explore the efficacy of atorvastatin combined with compound probiotics in the treatment of hyperlipidemia.Methods From January 2019 to December 2019,33 patients with hyperlipidemia were recruited from the People's Hospital of Inner Mongolia Autonomous Region and were randomly divided into the test group(n=18)and the control group(n=15)using a randomized,double-blind,controlled trial design.The 20 mg atorvastatin(once a day)plus compound probiotics(once a day,2 g each time)was given in test group,and the same dose of atorvastatin plus placebo was given in control group.The blood lipid level was measured once every 4 weeks for 12 weeks to compare the blood lipid levels at each time point between two groups.Results There were no significant differences in the baseline data between two groups(P>0.05).There were no significant differences in the levels of TC,TG,LDL-C and other blood lipid levels related to the treatment effects between two groups(P>0.05).At the different time points,there were statistical differences in the levels of TC,TG,LDL-C and other blood lipids(P<0.05).There was no interaction between the intervention time and the two intervention methods on the levels of TC,TG,LDL-C and other blood lipids(P>0.05).Conclusion Both atorvastatin alone and it combined with probiotics can reduce the blood lipid level in the patients with hyperlipidemia,with similar lipid-lowering efficacy.