海博麦布治疗高胆固醇血症有效性和安全性的meta分析  

Efficacy and safety of hybutimibe in the treatment of hypercholesterolemia:a meta‑analysis

作　　者：方振威[1] 赵翊如 张颖[1] 林阳[1] Fang Zhenwei;Zhao Yiru;Zhang Ying;Lin Yang(Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京安贞医院药事部,北京100029

出　　处：《药物不良反应杂志》2024年第1期25-32,共8页Adverse Drug Reactions Journal

摘　　要：目的评价海博麦布治疗高胆固醇血症的有效性及安全性。方法检索国内外有关数据库与临床试验注册网站(截至2023年3月27日),收集海博麦布治疗高胆固醇血症的随机对照试验(RCT)。试验组为海博麦布单药或联合其他降血脂药,对照组为安慰剂或与试验组相同的其他降血脂药。有效性主要结局指标为低密度脂蛋白胆固醇(LDL⁃C)的变化率,安全性主要结局指标为总体不良事件(AE)、严重AE(SAE)、因AE终止试验、与研究药物相关AE的发生率,安全性次要结局指标为≥2项研究中报道的主要AE发生率。使用RevMan 5.4软件进行meta分析。计数资料效应指标为相对危险度(RR)及其95%置信区间(CI);计量资料效应指标为均数差(MD)及其95%CI。结果纳入分析的RCT共4项,涉及1488例患者,其中试验组952例,对照组536例。meta分析结果显示,治疗8~12周时试验组(海博麦布20 mg/d和10 mg/d联合或不联合阿托伐他汀10 mg/d)LDL⁃C降幅显著大于对照组(海博麦布20 mg/d:MD=-13.36%,95%CI:-15.28%~-11.44%,P<0.001;海博麦布10 mg/d:MD=-10.80%,95%CI:-14.90%~-6.71%,P<0.001);治疗52周时海博麦布20 mg/d或10 mg/d联合阿托伐他汀10 mg/d组患者LDL⁃C较基线平均下降幅度均明显大于阿托伐他汀10 mg/d单药治疗组的患者(-41.92%和-39.34%比-31.56%,均P<0.001)。试验组与对照组8~12周时的总体AE发生率[47.94%(338/705)比49.75%(202/406),RR=0.99,95%CI:0.87~1.12]、SAE发生率[2.64%(16/606)比2.79%(10/358),RR=1.19,95%CI:0.53~2.66]、因AE终止试验率[4.11%(29/705)比4.68%(19/406),RR=0.67,95%CI:0.17~2.65]和与研究药物相关AE发生率[12.38%(75/606)比11.45%(41/358),RR=0.87,95%CI:0.37~2.06]均相似(均P>0.05)。结论海博麦布可以有效降低高胆固醇血症患者的LDL⁃C水平,且安全性良好。Objective To evaluate the efficacy and safety of hybutimibe in the treatment of hypercholesterolemia.Methods Relevant databases and clinical trial registration websites at home and abroad were searched(up to March 27,2023),and randomized controlled trials(RCTs)of hybutimibe in the treatment of hypercholesterolemia have been collected.Patients in the trial group were given hybutimibe with or without other hypolipidemic agents,and those in the control group were given placebo or other hypo⁃lipidemic agents as same as that in the trial group.The primary outcome in effectiveness was the change rate of low⁃density lipoprotein cholesterol(LDL⁃C).The primary outcomes in safety were incidences of overall ad⁃verse events(AEs),serious AEs(SAEs),the trial termination due to AEs,and trial drug⁃related AEs.The secondary outcome in safety was incidence of the major AE reported in≥2 trials.Meta⁃analysis was per⁃formed using RevMan 5.4 software.The effect sizes of counting data were expressed by the relative risk(RR)and its 95%confidence interval(CI).The effect sizes of measurement data were expressed by mean dif⁃ference(MD)and its 95%CI.Results A total of 4 RCTs and 1488 patients were entered in the analysis,including 952 patients in the trial group and 536 in the control group.The results of meta⁃analysis showed that at 8⁃12 weeks of treatment,the decrease rate of LDL⁃C in the trial group(hybutimibe 20 or 10 mg daily with or without atorvastatin 10 mg daily)was significantly greater than that in the control group(hybutimibe 20 mg daily:MD=-13.36%,95%CI:-15.28%⁃-11.44%,P<0.001;hybutimibe 10 mg daily:MD=-10.80%,95%CI:-14.90%⁃-6.71%,P<0.001);at 52 weeks of treatment,the average decrease rate(from baseline)of LDL⁃C in the trial group(hybutimibe 20 or 10 mg combined with atorvastatin 10 mg daily)was significantly greater than that in the control group with atorvastatin 10 mg daily monotherapy(-41.92%and-39.34%vs.-31.56%,all P<0.001);the incidences of overall AEs[47.94%(338/705)vs.49.75%(202/406),RR=0.9

关 键 词：高胆固醇血症 抗胆固醇血症药 META分析 有效性 安全性 海博麦布 

分 类 号：R969.3[医药卫生—药理学]