本文選題：Evolocumab + AMG145��； 參考：《重慶醫(yī)科大學(xué)》2015年碩士論文

【摘要】：目的：采用Meta分析的方法評(píng)價(jià)相關(guān)的隨機(jī)對(duì)照研究以明確Evolocumab治療高膽固醇血癥的有效性及安全性。方法：通過電子數(shù)據(jù)庫檢索所有評(píng)價(jià)Evolocumab治療高膽固醇血癥的隨機(jī)對(duì)照研究。對(duì)符合納入／排除標(biāo)準(zhǔn)的文獻(xiàn)由兩位作者分別提取有效性評(píng)估指標(biāo)(治療后低密度脂蛋白膽固醇的百分率變化)和安全性評(píng)估指標(biāo)(治療后轉(zhuǎn)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、嚴(yán)重不良事件、因藥物不良事件導(dǎo)致停藥發(fā)生率),采用RevMan5.2軟件進(jìn)行Meta分析。結(jié)果：一共納入5項(xiàng)前瞻性隨機(jī)對(duì)照研究,包括1396例患者,其中Evolocumab治療組883例,對(duì)照組513例。與安慰劑相比,Evolocumab治療后患者低密度脂蛋白膽固醇明顯降低[WMD=-55.04,95%CI(-57.45～52.62)],差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。兩組在治療后轉(zhuǎn)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)]、嚴(yán)重不良事件[OR=1.49,95%CI(0.82～2.73)]、因藥物不良事件導(dǎo)致停藥[OR=1.17,95%CI(0.51-2.72)]發(fā)生等方面均無統(tǒng)計(jì)學(xué)差異(P0.05)。結(jié)論：現(xiàn)有臨床試驗(yàn)數(shù)據(jù)表明,Evolocumab治療高脂血癥是安全有效的。上述結(jié)論仍需更多大樣本、多中心、前瞻性臨床研究證實(shí)。
[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 鹵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.
【學(xué)位授予單位】：重慶醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R589.2

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本文編號(hào)：2095100