【摘要】：背景:急性冠脈綜合征(ACS)起病急驟,血清膽固醇水平及動脈粥樣硬化斑塊形成是其主要的危險因素。他汀類藥物能夠有效地降低膽固醇水平及穩(wěn)定動脈粥樣硬化斑塊,同時還可以降低心血管事件的發(fā)生風險。近年來,強化劑量的他汀治療已經逐步應用于西方發(fā)達國家,而我國仍處于常規(guī)劑量的治療階段。因此,對于ACS患者強化劑量他汀治療是否較常規(guī)劑量他汀治療能帶來更大的獲益及安全性值得我們進一步思考。目的:本研究擬收集相關RCT研究,針對強化劑量及常規(guī)劑量他汀治療ACS患者的有效性及安全性進行meta分析,分析比較兩組的降脂療效和不良反應的發(fā)生情況。方法:全面檢索Cochrane Library、PubMed、EMBASE、Web of Science、中國知網(wǎng)、中國生物醫(yī)學文獻數(shù)據(jù)庫(CBM)、維普數(shù)據(jù)庫(VIP)。檢索時限為各數(shù)據(jù)庫建庫時間至2017年2月27日。兩名研究者依據(jù)納入和排除標準篩選及提取相關數(shù)據(jù)。文獻質量評價采用Cochrane協(xié)作網(wǎng)偏倚風險評價工具進行。定量分析依據(jù)異質性檢驗及I2選擇相對應的效應模型進行分析。P0.05為差異有統(tǒng)計學意義。結果:按照納入與排除標準最終納入8篇RCT,共9442例ACS患者。定量分析結果表明:有效性方面,強化劑量較常規(guī)劑量能更加顯著的降低LDL-C(SMD=-0.76,95%CI:-1.04~-0.48,I2=96%)、TC(SMD=-0.66,95%CI:-0.72~-0.60,I2=18%)及TG(SMD=-0.20,95%CI:-0.25~-0.14,I2=0%)水平,HDL-C(SMD=0.01,95%CI:-0.05~0.06,I2=50%)水平在兩組之間差異無統(tǒng)計學意義;安全性方面,強化劑量較常規(guī)劑量能更加顯著降低全因死亡率(RR=0.75,95%CI:0.61~0.93,I2=0%)、MACE(RR=0.85,95%CI:0.76~0.96,I2=19%)、心源性死亡(RR=0.75,95%CI:0.59~0.95,I2=0%)及冠脈重建術(RR=0.87,95%CI:0.76~0.99,I2=0%)的發(fā)生風險,然而大劑量的他汀類藥物治療更加容易發(fā)生肝功能異常(RR=2.76,95%CI:1.85~4.12,I2=0%),同時,心肌梗死(RR=0.90,95%CI:0.78~1.05,I2=17%)、中風(RR=0.84,95%CI:0.58~1.21,I2=0%)及肌肉不良反應(RR=1.20,95%CI:0.91~1.58,I2=0%)在兩組之間差異無統(tǒng)計學意義。敏感性分析提示本研究的結果穩(wěn)健,具有較高的可信度。結論:強化劑量較常規(guī)劑量能更加顯著的降低LDL-C、TC及TG水平;同時,強化劑量與常規(guī)劑量組相比較更優(yōu)于降低全因死亡率、MACE、心源性死亡及冠脈重建術的發(fā)生風險,盡管強化劑量治療更加容易發(fā)生肝功能異常。對于ACS患者進行強化劑量的他汀類藥物治療可以帶來更大的獲益,但同時也需密切監(jiān)測肝功能的變化。上述結果仍需更多高質量、多中心、大樣本的RCT進一步證實。
[Abstract]:Background: acute coronary syndrome (ACS) is a major risk factor for acute coronary syndrome (ACS). Serum cholesterol level and atherosclerotic plaque formation are the main risk factors. Statins can effectively reduce cholesterol levels and stabilize atherosclerotic plaques, as well as reduce the risk of cardiovascular events. In recent years, statin therapy with intensive dose has been gradually applied in western developed countries, but it is still in the stage of routine dose therapy in China. Therefore, whether the intensive dose of statins in patients with ACS can bring more benefits and safety than the conventional dose of statins deserves further consideration. Objective: to collect relevant RCT studies and to analyze the efficacy and safety of statin in the treatment of ACS by meta, and to compare the effect of lipid-lowering and the occurrence of adverse reactions between the two groups. Methods: a comprehensive search for Cochrane Library,PubMed,EMBASE,Web of Science, China knowledge Network, China Biomedical Literature Database, (CBM), Weip Database (VIP). The time limit for retrieval is the time for each database to be built up to February 27, 2017. The two researchers screened and extracted data based on inclusion and exclusion criteria. The evaluation of literature quality was carried out with the Cochrane collaboration Network bias risk Assessment tool. Quantitative analysis was based on heterogeneity test and I2 selection of the corresponding effect model analysis. P0.05 as the difference was statistically significant. Results: 9442 patients with ACS were included in 8 RCT, according to inclusion and exclusion criteria. The results of quantitative analysis show that the amount of enhancer can significantly reduce LDL-C (SMD=-0.76,95%CI:-1.04~-0.48,I2=96%), TC (SMD=-0.66,95%CI:-0.72~-0.60,) compared with the conventional dose in terms of effectiveness. There was no significant difference between the two groups in the levels of I2P (18%), TG (SMD=-0.20,95%CI:-0.25~-0.14,I2=0%) and HDL-C (SMD=0.01,95%CI:-0.05~0.06,I2=50%). In terms of safety, the dose of enhancer significantly reduced the all-cause mortality (RR=0.75,95%CI:0.61~0.93,I2=0%), MACE (RR=0.85,95%CI:0.76~0.96,I2=19%) compared with the conventional dose. Risk of cardiac death (RR=0.75,95%CI:0.59~0.95,I2=0%) and coronary artery reconstruction (RR=0.87,95%CI:0.76~0.99,I2=0%), However, large doses of statins are more likely to cause liver dysfunction (RR=2.76,95%CI:1.85~4.12,I2=0%) and myocardial infarction (RR=0.90,95%CI:0.78~1.05,I2=17%). There was no significant difference in stroke (RR=0.84,95%CI:0.58~1.21,I2=0%) and muscle adverse reaction (RR=1.20,95%CI:0.91~1.58,I2=0%) between the two groups. Sensitivity analysis shows that the results of this study are robust and reliable. Conclusion: the level of LDL-C,TC and TG can be significantly decreased by the dosage of fortifier compared with the conventional dose. At the same time, the enhanced dose is better than the conventional dose group in reducing the all-cause mortality, MACE, cardiogenic death and the risk of coronary artery reconstruction, although the enhanced dose treatment is more prone to liver dysfunction. Intensive doses of statins in patients with ACS can benefit more, but changes in liver function also need to be closely monitored. These results need to be further confirmed by high quality, multi-center, and large sample RCT.
【學位授予單位】：南昌大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R541.4

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