本文關(guān)鍵詞：糖尿病臨床試驗(yàn)中低血糖事件的統(tǒng)計(jì)分析　出處：《華東師范大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 發(fā)生與否 發(fā)生比率 生存時(shí)間 復(fù)發(fā)事件生存時(shí)間 邏輯回歸模型 負(fù)二項(xiàng)回歸模型 Anderson-Gill 模型

【摘要】：糖尿病是一組以持續(xù)高血糖為特征的代謝性疾病。糖尿病治療的主要手段就是要降低血糖,但是過(guò)低的血糖也是不好的。因此監(jiān)測(cè)服用藥物后低血糖事件的發(fā)生,是很重要的一個(gè)藥物安全分析終點(diǎn)。特別是當(dāng)受試者因?yàn)槟撤N原因多服用了藥物,那么會(huì)不會(huì)導(dǎo)致更多低血糖事件,甚至是嚴(yán)重低血糖事件的發(fā)生呢?國(guó)外的某個(gè)藥廠就此為研究目的進(jìn)行了一個(gè)分為兩個(gè)周期的交換設(shè)計(jì)(Crossover)臨床試驗(yàn)。在這個(gè)試驗(yàn)中,大約64名受試者被分為兩組,然后研究者監(jiān)測(cè)在每個(gè)周期服用雙倍劑量藥物后84小時(shí)內(nèi)發(fā)生低血糖事件的情況。我們?cè)谶@個(gè)研究中涉及到的數(shù)據(jù)分析指標(biāo)有低血糖事件的發(fā)生與否,發(fā)生比率,生存時(shí)間和復(fù)發(fā)事件生存時(shí)間。通過(guò)對(duì)這些指標(biāo)的統(tǒng)計(jì)分析,我們想要探索的目標(biāo)是試驗(yàn)藥是否比對(duì)照藥在安全性上更好。我們首先從獨(dú)立性的研究開(kāi)始,用到的方法有卡方檢驗(yàn),Odds比等。而邏輯回歸模型的引入,則讓我們同時(shí)可以考慮其他一些協(xié)變量的影響。以上這些方法針對(duì)的是發(fā)生與否。而負(fù)二項(xiàng)分布回歸模型是對(duì)發(fā)生比率的分析。同時(shí)本文中還運(yùn)用了生存分析,Anderson-Gill模型等一些方法,對(duì)生存時(shí)間和復(fù)發(fā)事件生存時(shí)間進(jìn)行了分析。我們的統(tǒng)計(jì)分析結(jié)果符合我們的預(yù)期,試驗(yàn)藥比對(duì)照藥在安全性上更好。同時(shí)由于我們的分析基于不用的分析指標(biāo),運(yùn)用了不同的統(tǒng)計(jì)分析方法,得到了比較一致的結(jié)果,因此我們有比較大的把握認(rèn)為我們的分析結(jié)果是穩(wěn)定可靠的。
[Abstract]:Diabetes is a metabolic disease characterized by sustained high blood glucose. The main means for the treatment of diabetes is to reduce blood glucose, but low blood sugar is not good. So monitoring the incidence of hypoglycemic events after taking the drug, a drug safety end point analysis is very important. Especially when the subjects for some reason take the medicine, it will not lead to more hypoglycemic events, even severe hypoglycemia events? A foreign pharmaceutical companies this is a purpose for the study was divided into two periods of exchange (Crossover) clinical trials. In this experiment, approximately 64 subjects were divided into two the researchers then monitoring group, taking hypoglycemic events occurred 84 hours after the double dose of the drug in each cycle. We involved in the study of data analysis indicators of hypoglycemia in hair The ratio of students or not, the survival time and survival time of recurrent events. Through the statistic analysis of these norms, we want to explore the goal was to test whether the drug is better than that of the control drug in security. We started from the independent research, use methods of chi square test, Odds ratio is introduced. And the logistic regression model, so we can also consider the impact of some of the other covariates. Based on the above method is occurring or not. And two negative binomial regression model is the analysis on the occurrence rate. At the same time this paper has been used in survival analysis, Anderson-Gill model and some other methods, the survival time and recurrent events the survival time was analyzed. The statistical analysis of our results are consistent with our expectations, the test drug better than control drug safety. At the same time because our analysis index not based on the use of different The statistical analysis method has obtained a relatively consistent result, so we have a relatively large grasp that our analysis results are stable and reliable.

【學(xué)位授予單位】：華東師范大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：O212.1

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