摘要
目的综合分析海博麦布单用或联合他汀类药物对高胆固醇血症患者的疗效和安全性。方法将Meta文献分析与真实世界研究相结合。首先,通过Meta分析评价海博麦布的疗效和不良反应发生率;然后,从我院HIS系统中导出并纳入符合条件的患者信息,根据患者使用的降脂药物分为4组(海博麦布20 mg组、阿托伐他汀20 mg组、海博麦布20 mg+阿托伐他汀20 mg组、海博麦布20 mg+瑞舒伐他汀10 mg组),并观察各组患者的降脂效果及不良反应;最后,比较文献分析与真实世界研究的异同性。结果Meta分析显示,试验组(海博麦布或联合他汀类药物)TG、LDL-C、Apo B水平较基线降低率大于对照组(安慰剂或他汀类药物)(P<0.05),但不良反应差异无统计学意义(P>0.05)。真实世界研究,4组患者TC、TG、LDL-C、ApoB水平较基线均降低(P<0.05);4组患者TC、TG、LDL-C、Apo B水平较基线降低率的组间两两比较,差异均存在统计学意义(P<0.05),且海博麦布20 mg+阿托伐他汀20 mg组LDL-C、TG、ApoB水平降低最明显,海博麦布20 mg+瑞舒伐他汀10 mg组次之,海博麦布20 mg+阿托伐他汀20 mg组TC水平降低最明显;4组患者均未出现明显不良反应。文献分析和真实世界研究均表明,海博麦布或联合他汀类药物有显著的降血脂作用,而在降脂强度方面,文献分析和真实世界研究的结果存在一定的差异。结论海博麦布单用或联合他汀类药物,降低血脂水平显著,且无明显或严重不良反应。
Objective To comprehensively analyze the efficacy and safety of hybutimibe or its combination with statins in patients with hypercholesterolemia.Methods The literature analysis in meta-analysis was combined with real‑world study.First,meta-analysis was performed to evaluate the efficacy and adverse reactions of hybutimibe.Then,information of eligible patients was extracted from HIS system and included.Patients were divided into 4 groups according to the lipid-lowering drugs used(hybutimibe 20 mg group,atorvastatin 20 mg group,hybutimibe 20 mg+atorvastatin 20 mg group,hybutimibe 20 mg+rosuvastatin 10 mg group),and the lipid-lowering effects and adverse reactions of patients in each group were observed.Finally,the differences between literature analysis and realworld study were compared.Results Meta-analysis showed that the reduction rates of TG,LDL-C and Apo B levels in experimental groups(hybutimibe or hybutimibe combined with statins)were significantly higher than those in control group(placebos or statins)from baseline(P<0.05),while there was no significant difference in adverse reactions between the two groups(P>0.05).In the real world study,the levels of TC,TG,LDL-C and ApoB in 4 groups were significantly decreased compared with baseline(P<0.05).Pairwise comparison of TC,TG,LDL-C and ApoB levels in 4 groups,compared with baseline,showed significant differences(P<0.05),and hybutimibe 20 mg+atorvastatin 20 mg group had the most significant effect on reducing LDL-C,TG and ApoB levels,followed by hybutimibe 20 mg+rosuvastatin 10 mg group.The most significant reduction of TC level was in hybutimibe 20 mg+atorvastatin 20 mg group.There were no obvious adverse reactions in the 4 groups.Both literature analysis and real-world study showed that hybutimibe or hybutimibe combined with statins had significant lipid-lowering effects,but there were some differences in the intensity of lipid-lowering between literature analysis and real world study.Conclusion Hybutimibe or hybutimibe combined with statins significantly reduces lipid levels without significant or serious adverse effects.
作者
刘胜
敬怀志
陈敏
凃远珍
Liu Sheng;Jing Huaizhi;Chen Min;Tu Yuanzhen(Mianyang Central Hospital,School of Medicine/University of Electronic Science and Technology of China,Mianyang 621000,China)
出处
《实用药物与临床》
CAS
2024年第6期423-430,共8页
Practical Pharmacy and Clinical Remedies
基金
2022年四川省医院协会青年药师科研专项资金项目(22021)。