Evolocumab降低LDL-C有效性及安全性的Meta分析

发布时间：2018-07-03 21:43

本文选题：Evolocumab + AMG145　；参考：《重庆医科大学》2015年硕士论文

【摘要】：目的：采用Meta分析的方法评价相关的随机对照研究以明确Evolocumab治疗高胆固醇血症的有效性及安全性。方法：通过电子数据库检索所有评价Evolocumab治疗高胆固醇血症的随机对照研究。对符合纳入／排除标准的文献由两位作者分别提取有效性评估指标(治疗后低密度脂蛋白胆固醇的百分率变化)和安全性评估指标(治疗后转氨酶升高大于3倍正常值上限、肌酸激酶升高大于5倍正常值上限、严重不良事件、因药物不良事件导致停药发生率),采用RevMan5.2软件进行Meta分析。结果：一共纳入5项前瞻性随机对照研究,包括1396例患者,其中Evolocumab治疗组883例,对照组513例。与安慰剂相比,Evolocumab治疗后患者低密度脂蛋白胆固醇明显降低[WMD=-55.04,95%CI(-57.45～52.62)],差异具有统计学意义(P0.05)。两组在治疗后转氨酶升高大于3倍正常值上限[OR=0.57,95%CI (0.20～1.61)]、肌酸激酶升高大于5倍正常值上限[OR=2.52, 95%CI(0.63-10.00)]、严重不良事件[OR=1.49,95%CI(0.82～2.73)]、因药物不良事件导致停药[OR=1.17,95%CI(0.51-2.72)]发生等方面均无统计学差异(P0.05)。结论：现有临床试验数据表明,Evolocumab治疗高脂血症是安全有效的。上述结论仍需更多大样本、多中心、前瞻性临床研究证实。
[Abstract]:Objective: to evaluate the efficacy and safety of Evolocumab in the treatment of hypercholesterolemia by meta-analysis. Methods: all randomized controlled trials of Evolocumab in the treatment of hypercholesterolemia were searched by electronic database. For articles that met the inclusion / exclusion criteria, the two authors extracted the effectiveness assessment indicators (percentage changes in LDL cholesterol after treatment) and the safety assessment indicators (the transaminase elevation after treatment was more than three times the upper limit of normal values). The increase of creatine kinase was more than 5 times the upper limit of normal value, serious adverse events, the incidence of drug withdrawal due to adverse events), Revman 5.2 software for Meta-analysis. Results: a total of 5 prospective randomized controlled trials were conducted, including 1396 patients, including 883 patients in Evolocumab treatment group and 513 patients in control group. Compared with placebo, low density lipoprotein cholesterol (LDL-C) was significantly decreased in Evolocumab patients [WMD-55.04-95 CI (-57.45 卤52.62)]. The difference was statistically significant (P0.05). After treatment, the elevation of aminotransferase was more than 3 times of normal value [ORO 0.5795 CI (0.201.61)], creatine kinase increased more than 5 times normal value [ORT 2.52,95CI (0.63-10.00)], serious adverse events [ORO1.49995 CI (0.822.73)], no significant difference (P0.05) in the occurrence of drug withdrawal (ORL 1.17995 CI (0.51-2.72)]. Conclusion: the available clinical trial data show that Evolocumab is safe and effective in the treatment of hyperlipidemia. These conclusions need to be confirmed by more large, multicenter, prospective clinical studies.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R589.2

【相似文献】