基于大型不良反應(yīng)數(shù)據(jù)庫的他汀類藥物安全性分析
發(fā)布時間：2018-08-14 18:55
【摘要】：研究目的:①基于美國食品藥品監(jiān)督管理局不良反應(yīng)自發(fā)呈報系統(tǒng)數(shù)據(jù)庫，探討他汀類藥物的使用與認知能力下降，糖尿病及癌癥之間的統(tǒng)計學(xué)關(guān)系。②探索他汀類藥物與雷諾嗪合并用藥是否會增大橫紋肌溶解癥的發(fā)生風(fēng)險。 研究方法：利用國際上常用的不良反應(yīng)信號挖掘算法，報告比值比法（ROR），貝葉斯判別區(qū)間遞進神經(jīng)網(wǎng)絡(luò)法（BCPNN），伽瑪泊松縮減法（GPS），對不良反應(yīng)自發(fā)呈報系統(tǒng)數(shù)據(jù)庫進行大規(guī)模的數(shù)據(jù)挖掘，明確他汀類藥物的使用與認知能力下降，糖尿病及癌癥之間的統(tǒng)計學(xué)關(guān)系。采用Ω收縮法和logistic回歸法來探索他汀類藥物與雷諾嗪合并用藥時發(fā)生橫紋肌溶解癥的風(fēng)險。 研究結(jié)果：在分析他汀類藥物與認知能力下降之間的關(guān)系中，三種不良反應(yīng)信號挖掘算法的信號檢測值分別為2.03，0.80和1.77，即ROR，BCPNN檢測到他汀類藥物的使用可能會導(dǎo)致患者的認知能力下降；在分析他汀類藥物與糖尿病之間的統(tǒng)計學(xué)關(guān)系中，三種不良反應(yīng)信號挖掘算法的信號檢測值分別為2.42，1.09和2.12，即ROR，BCPNN，GPS均檢測到他汀類藥物的使用可能會誘發(fā)糖尿�。辉诜治鏊☆愃幣c癌癥之間的統(tǒng)計學(xué)關(guān)系中，三種不良反應(yīng)信號檢測算法的信號檢測值分別為0.89，-0.17和1.00，即ROR，BCPNN，GPS均沒有發(fā)現(xiàn)他汀類藥物的使用可能會引發(fā)癌癥。在logistic回歸模型中，發(fā)現(xiàn)他汀類藥物與雷諾嗪合并用藥時發(fā)生橫紋肌溶解癥的風(fēng)險是他汀類藥物單用時的3.28倍。Ω收縮法中，omega值為1.51，omega_025值為1.17，表明他汀類與雷諾嗪合并用藥會增大橫紋肌溶解癥的發(fā)生風(fēng)險。通過應(yīng)用logistic回歸法和Ω收縮法，發(fā)現(xiàn)他汀類藥物和雷諾嗪合并用藥可能會增大橫紋肌溶解的發(fā)生風(fēng)險。 研究結(jié)論：美國食品藥品監(jiān)督管理局不良反應(yīng)自發(fā)呈報系統(tǒng)數(shù)據(jù)庫是探索他汀類藥物不良反應(yīng)的有力工具，，臨床應(yīng)用他汀類藥物時應(yīng)注意與之相關(guān)的不良反應(yīng)，尤其是他汀類藥物與雷諾嗪合并用藥的情況。
[Abstract]:Objective: 1 to explore the use and cognitive decline of statins based on the FDA database of spontaneous notification of adverse reactions. The statistical relationship between diabetes and cancer .2 to explore whether the combination of statins and ranolazine increases the risk of rhabdomyolysis. Methods: using the commonly used adverse reaction signal mining algorithm in the world, Reporting ratio method (ROR), Bayesian discriminant interval progressive neural network method (BCPNN), gamma-Poisson reduction method (GPS), was used to mine large scale data of spontaneous adverse reaction reporting system database, and it was clear that statins use and cognitive ability decreased. The statistical relationship between diabetes and cancer. 惟 contraction and logistic regression were used to explore the risk of rhabdomyolysis when statins were combined with ranolazine. Results: in analyzing the relationship between statins and cognitive decline, The detection values of the three adverse reaction signal mining algorithms were 2.030.80 and 1.77, respectively. RORBCPNN showed that the use of statins might lead to a decrease in cognitive ability of patients, and in the analysis of the statistical relationship between statins and diabetes, The detection values of the three adverse reaction signal mining algorithms were 2.42 / 1.09 and 2.12, respectively, i.e., the use of statins detected by RORBCPNN GPS could induce diabetes mellitus, and in analyzing the statistical relationship between statins and cancer, The signal detection values of the three adverse reaction signal detection algorithms were 0.89- 0.17 and 1.00 respectively. RORBCPNN- GPS did not find that the use of statins might lead to cancer. In the logistic regression model, The risk of rhabdomyolysis of statins combined with ranolazine was 3.28 times higher than that of statins alone. Omega value of omega in 惟 contraction method was 1.51 omega 0.25, indicating that statins combined with ranolazine could increase the rhabdomyolysis of rhabdomyolysis. The risk of dissolution. By using logistic regression method and 惟 contraction method, it was found that the combination of statins and ranolazine may increase the risk of rhabdomyolysis. Conclusion: the FDA database of spontaneous reporting of adverse reactions is a powerful tool for exploring the adverse reactions of statins, and the clinical application of statins should pay attention to the related adverse reactions. Especially the combination of statins and ranolazine.
【學(xué)位授予單位】：天津大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R95
本文編號：2183805
[Abstract]:Objective: 1 to explore the use and cognitive decline of statins based on the FDA database of spontaneous notification of adverse reactions. The statistical relationship between diabetes and cancer .2 to explore whether the combination of statins and ranolazine increases the risk of rhabdomyolysis. Methods: using the commonly used adverse reaction signal mining algorithm in the world, Reporting ratio method (ROR), Bayesian discriminant interval progressive neural network method (BCPNN), gamma-Poisson reduction method (GPS), was used to mine large scale data of spontaneous adverse reaction reporting system database, and it was clear that statins use and cognitive ability decreased. The statistical relationship between diabetes and cancer. 惟 contraction and logistic regression were used to explore the risk of rhabdomyolysis when statins were combined with ranolazine. Results: in analyzing the relationship between statins and cognitive decline, The detection values of the three adverse reaction signal mining algorithms were 2.030.80 and 1.77, respectively. RORBCPNN showed that the use of statins might lead to a decrease in cognitive ability of patients, and in the analysis of the statistical relationship between statins and diabetes, The detection values of the three adverse reaction signal mining algorithms were 2.42 / 1.09 and 2.12, respectively, i.e., the use of statins detected by RORBCPNN GPS could induce diabetes mellitus, and in analyzing the statistical relationship between statins and cancer, The signal detection values of the three adverse reaction signal detection algorithms were 0.89- 0.17 and 1.00 respectively. RORBCPNN- GPS did not find that the use of statins might lead to cancer. In the logistic regression model, The risk of rhabdomyolysis of statins combined with ranolazine was 3.28 times higher than that of statins alone. Omega value of omega in 惟 contraction method was 1.51 omega 0.25, indicating that statins combined with ranolazine could increase the rhabdomyolysis of rhabdomyolysis. The risk of dissolution. By using logistic regression method and 惟 contraction method, it was found that the combination of statins and ranolazine may increase the risk of rhabdomyolysis. Conclusion: the FDA database of spontaneous reporting of adverse reactions is a powerful tool for exploring the adverse reactions of statins, and the clinical application of statins should pay attention to the related adverse reactions. Especially the combination of statins and ranolazine.
【學(xué)位授予單位】：天津大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R95
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