血脂康胶囊联合他汀类药物治疗高脂血症的系统评价

Systematic Review of Xuezhikang Capsules Combined with Statins in the Treatment of Hyperlipidemia

目的:系统评价血脂康胶囊联合他汀类药物治疗高脂血症的临床疗效。方法:通过计算机检索PubMed、Cochrane图书馆、中国知网、万方数据库和维普数据库,检索建库至2020年12月血脂康胶囊治疗高脂血症相关文献,纳入随机对照试验(randomized controlled trial,RCT)文献(研究组患者服用血脂康胶囊联合他汀类药物,对照组患者单独服用他汀类药物),采用纽卡斯尔-渥太华量表(Newcastle-Ottawa scale,NOS)进行文献质量评价,提取血脂水平甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)及低密度脂蛋白胆固醇(LDL-C)的参数,应用Rev Man 5.3软件进行荟萃分析(Meta分析)、敏感性分析及发表偏倚检测。结果:共纳入11篇符合标准的RCT文献,总病例数为1559例,研究组782例,对照组777例;其中6篇文献提及不良反应。Meta分析结果显示,研究组患者的总有效率明显高于对照组(OR=3.60,95%CI=2.56~5.07,Z=7.33,P<0.00001,I^(2)=0%<50%),TC(MD=-0.58,95%CI=-0.66~-0.50,Z=14.23,P<0.00001,I^(2)=49%<50%)、TG(MD=-0.24,95%CI=-0.28~-0.20,Z=11.39,P<0.00001,I^(2)=46%<50%)和LDL-C(MD=-0.40,95%CI=-0.45~-0.35,Z=14.54,P<0.00001,I^(2)=48%<50%)等指标水平明显低于对照组,HDL-C水平明显高于对照组(MD=0.23,95%CI=0.20~0.26,Z=16.13,P<0.00001,I^(2)=44%<50%),不良反应发生率明显低于对照组(OR=0.41,95%CI=0.19~0.91,Z=2.19,P<0.03,I^(2)=5%<50%),上述差异均有统计学意义。结论:血脂康胶囊联合他汀类药物治疗高脂血症的综合疗效以及不良反应发生情况优于单独使用他汀类药物,在降低TG、TC、LDL-C和升高HDL-C方面的效果明显优于单独使用他汀类药物。

OBJECTIVE:To systematically evaluate the clinical efficacy of Xuezhikang capsules combined with statins in the treatment of hyperlipidemia.METHODS:PubMed,the Cochrane Library,CNKI,Wanfang database and VIP database were retrieved to collect the randomized controlled trial(RCT)of Xuezhikang capsules combined with statins in the treatment of hyperlipidemia(the study group was given Xuezhikang capsules combined with statins,while the control group received statins).The retrieval time was from the establishment of the database to Dec.2020.Newcastle-Ottawa scale(NOS)was used to evaluate the quality of the literature.Parameters of triglyceride(TG),total cholesterol(TC),high density lipoprotein cholesterol(HDL-C)and low density lipoprotein cholesterol(LDL-C)were extracted.RevMan5.3 software was used for Meta-analysis,sensitivity analysis and publication bias detection.RESULTS:A total of 11 literature that met the criteria were included,with a total of 1559 cases,including 782 cases in the study group and 777 cases in the control group.Adverse drug reactions were mentioned in 6 literature.Metaanalysis showed that the total effective rate of the study group was significantly higher than that of the control group(OR=3.60,95%CI=2.56-5.07,Z=7.33,P<0.00001,I^(2)=0%<50%),the levels of TC(MD=-0.58,95%CI=-0.66--0.50,Z=14.23,P<0.00001,I^(2)=49%<50%),TG(MD=-0.24,95%CI=-0.28--0.20,Z=11.39,P<0.00001,I^(2)=46%<50%)and LDL-C(MD=-0.40,95%CI=-0.45--0.35,Z=14.54,P<0.00001,I^(2)=48%<50%)and other indicators were significantly lower than those of the control group,the level of HDL-C was significantly higher than that of the control group(MD=0.23,95%CI=0.20-0.26,Z=16.13,P<0.00001,I^(2)=44%<50%),and the incidence of adverse drug reactions was significantly lower than that of the control group(OR=0.41,95%CI=0.19-0.91,Z=2.19,P<0.03,I^(2)=5%<50%),with statistically significant differences.CONCLUSIONS:Xuezhikang capsules combined with statins in the treatment of hyperlipidemia has better comprehensive efficacy and lower incidence of adverse drug reactions than statins alone,and its effects in reducing TG,TC,LDL-C and increasing HDL-C are significantly better than that of statins alone.