本文選題：唐氏綜合征 + 血清學(xué)篩查　； 參考：《浙江大學(xué)》2014年博士論文

【摘要】：孕期血清學(xué)篩查、絨毛和羊水的細(xì)胞遺傳學(xué)診斷及超聲診斷仍然是目前唐氏綜合征二級(jí)預(yù)防的主流干預(yù)措施。高檢出率、低假陽(yáng)性率、高衛(wèi)生經(jīng)濟(jì)學(xué)效益的產(chǎn)前篩查方案一直是產(chǎn)前診斷領(lǐng)域?qū)＜易非蟮哪繕?biāo),通過(guò)近三十年的努力也確實(shí)卓有成效。新篩查標(biāo)志物的開(kāi)發(fā)及新篩查方案的建立可以獲得更大的篩查效能,而完善的質(zhì)量管理則是為了使某一篩查方案最大化地發(fā)揮其篩查效能,因此建立適宜的產(chǎn)前篩查質(zhì)量控制體系是高效能篩查方案更好地向臨床轉(zhuǎn)化的基石。在我國(guó)雖然產(chǎn)前篩查工作開(kāi)展已經(jīng)13年,規(guī)模日益增大,但質(zhì)量控制基本上仍停留在臨床檢驗(yàn)質(zhì)量控制最基本的室內(nèi)質(zhì)控與室間質(zhì)評(píng)階段。以大樣本篩查數(shù)據(jù)的統(tǒng)計(jì)學(xué)評(píng)價(jià)為基礎(chǔ),對(duì)所有這些質(zhì)量控制過(guò)程進(jìn)行分析,進(jìn)而推動(dòng)質(zhì)量提高,在我國(guó)還是空白。唐氏綜合征產(chǎn)前篩查的質(zhì)量控制具有特殊性,產(chǎn)前篩查的結(jié)果通常以胎兒罹患某一先天異常的風(fēng)險(xiǎn)率為報(bào)告形式,其質(zhì)量控制的核心是唐氏綜合征風(fēng)險(xiǎn)評(píng)估的可靠性。目前各篩查機(jī)構(gòu)常規(guī)進(jìn)行的實(shí)驗(yàn)室室內(nèi)質(zhì)控與室間質(zhì)評(píng)只涉及生化標(biāo)志物檢測(cè)的準(zhǔn)確性,只是產(chǎn)前篩查質(zhì)量控制的組成部分。完善的產(chǎn)前篩查質(zhì)量控制應(yīng)涉及影響風(fēng)險(xiǎn)計(jì)算可靠性的每一個(gè)重要環(huán)節(jié)及關(guān)鍵因素,包括孕婦年齡、體重、孕周等基本參數(shù),實(shí)驗(yàn)室測(cè)定結(jié)果的準(zhǔn)確性,風(fēng)險(xiǎn)計(jì)算軟件及參比中位數(shù)的選擇等。另一方面,產(chǎn)前篩查在早、中孕期進(jìn)行而篩查假陽(yáng)性率與異常胎兒的檢出率等是在胎兒出生后才能統(tǒng)計(jì)評(píng)價(jià)的指標(biāo),存在時(shí)間跨度;孕婦的血清學(xué)篩查,高危孕婦進(jìn)一步的產(chǎn)前診斷及最終的分娩并非均在一個(gè)醫(yī)療機(jī)構(gòu),同時(shí)血樣的采集、轉(zhuǎn)運(yùn)、檢測(cè)、軟件應(yīng)用可涉及幾家不同的醫(yī)療機(jī)構(gòu),亦存在地域跨度。這使得產(chǎn)前篩查的質(zhì)量評(píng)價(jià)和管理工作更加復(fù)雜和艱巨。對(duì)于每一個(gè)環(huán)節(jié)的評(píng)估更涉及到非常專(zhuān)業(yè)的統(tǒng)計(jì)學(xué)知識(shí),選取哪些統(tǒng)計(jì)學(xué)指標(biāo),如何通過(guò)統(tǒng)計(jì)學(xué)指標(biāo)的變化及時(shí)發(fā)現(xiàn)篩查的質(zhì)量問(wèn)題,分析原因,提出整改方法也是需要解決的問(wèn)題。建立產(chǎn)前篩查質(zhì)量管理軟件系統(tǒng)并實(shí)現(xiàn)網(wǎng)絡(luò)化,可以實(shí)時(shí)高效地對(duì)各級(jí)篩查機(jī)構(gòu)的篩查質(zhì)量進(jìn)行評(píng)估,促進(jìn)產(chǎn)前篩查管理體系的實(shí)際推廣及長(zhǎng)期應(yīng)用。目的:為了在我國(guó)也能規(guī)范化地開(kāi)展產(chǎn)前篩查質(zhì)量管理,本研究以浙江省2010年～2012年的篩查病例作為數(shù)據(jù)基礎(chǔ),探討質(zhì)量評(píng)估的關(guān)鍵性統(tǒng)計(jì)學(xué)指標(biāo),重點(diǎn)評(píng)估環(huán)節(jié)及評(píng)估流程和篩查質(zhì)量改善的方法,以期最終建立起適合我國(guó)國(guó)情的產(chǎn)前篩查診斷質(zhì)量評(píng)價(jià)及管理體系,改善產(chǎn)前篩查效率,提升我國(guó)產(chǎn)前診斷的質(zhì)量。方法:收集2010～2012年浙江省17家產(chǎn)前篩查機(jī)構(gòu)的產(chǎn)前篩查數(shù)據(jù),涉及篩查孕婦數(shù)1,227,388例。通過(guò)孕婦年齡、體重、孕周等基本參數(shù)的描述性分析,使用Q-Q圖、年齡校正的篩查陽(yáng)性率(screening positive rate,SPR)、95%置信區(qū)間內(nèi)標(biāo)志物中位數(shù)的倍數(shù)中值(MedianMoM)隨篩查月份、孕周及體重的分布圖及累積和圖(CUSUM圖)對(duì)17家篩查機(jī)構(gòu)進(jìn)行篩查質(zhì)量評(píng)估。通過(guò)以上方法對(duì)17家篩查機(jī)構(gòu)的篩查質(zhì)量進(jìn)行評(píng)估,發(fā)現(xiàn)篩查質(zhì)量可提升的環(huán)節(jié),選取具有代表性的部分,如標(biāo)本質(zhì)量、實(shí)驗(yàn)室檢測(cè)、風(fēng)險(xiǎn)軟件及參比中位數(shù)選擇等環(huán)節(jié)進(jìn)一步深入分析,尋找可能的原因及提出整改優(yōu)化措施。評(píng)價(jià)血清標(biāo)志物中位數(shù)的選擇、分析軟件使用等對(duì)篩查結(jié)果的影響。結(jié)果:本研究收集了 2010年、2011年及2012年346,195、417,347及463,846例唐氏綜合征產(chǎn)前篩查數(shù)據(jù)。全省產(chǎn)前篩查孕婦年齡基本呈正態(tài)分布,不同篩查機(jī)構(gòu)年齡分布不一致。全省及各篩查機(jī)構(gòu)體重分布趨勢(shì)相似,在體重高值部分有拖尾。篩查孕周集中在17周左右,孕周確定方式各篩查機(jī)構(gòu)存在顯著差異。使用LifeCycle軟件的SPR高于使用2T軟件的SPR,9家機(jī)構(gòu)SPR各月份波動(dòng)明顯。各篩查機(jī)構(gòu)SPR隨月份波動(dòng)明顯,95%置信區(qū)間內(nèi)標(biāo)志物Median MoM值隨篩查月份、孕周及體重變化超過(guò)10%或CUSUM圖反映的正、負(fù)偏倚可以及時(shí)反映篩查機(jī)構(gòu)的篩查質(zhì)量。代表性問(wèn)題舉例分析:1、對(duì)標(biāo)志物MedianMoM出現(xiàn)正、負(fù)偏倚的機(jī)構(gòu),采用2011年本地人群的參比中位數(shù)后,篩查標(biāo)志物MedianMoM值更接近于1,篩查陽(yáng)性率下降,但不影響檢出率。2、以13號(hào)篩查機(jī)構(gòu)為例,其2012年各月份21-三體SPR波動(dòng)較明顯,使用LifeCycle軟件年齡校正篩查陽(yáng)性率為4.98%。對(duì)同一時(shí)期該篩查機(jī)構(gòu)由不同采血點(diǎn)采集的標(biāo)本分開(kāi)進(jìn)行分析發(fā)現(xiàn)2012年篩查機(jī)構(gòu)采血標(biāo)本與采血點(diǎn)送檢標(biāo)本篩查陽(yáng)性率不同,采血點(diǎn)送檢標(biāo)本SPR較高,兩組標(biāo)本甲胎蛋白(fetoprotein,AFP)相近且均負(fù)偏,游離絨毛膜促性腺激素β 亞基(free Beta human chorionic gonadotrophin,Free βhCG)的 Median MoM 不同,采血點(diǎn)送檢標(biāo)本Free βhCG正偏倚,高于篩查機(jī)構(gòu)采血標(biāo)本。兩組標(biāo)本未結(jié)合雌激素(unconjugaed estriol,uE3)的Median MoM不同,波動(dòng)明顯且均正偏倚,且采血點(diǎn)送檢標(biāo)本尤其明顯。3、對(duì)篩查機(jī)構(gòu)11更換檢測(cè)儀器前后篩查數(shù)據(jù)進(jìn)行比較,更換前后篩查標(biāo)志物MoM值不同,更換儀器后AFP,Free βhCG的正偏倚更明顯,未結(jié)合雌三醇(unconjugaedestriol,uE3)負(fù)偏倚明顯。4、本研究共隨訪到213例陽(yáng)性病例,對(duì)陽(yáng)性病例進(jìn)行分析,Lifecycle軟件代替2T軟件后多檢出6例陽(yáng)性病例,可提高檢出率。結(jié)論:1、本研究建立了中國(guó)地區(qū)特色的產(chǎn)前篩查質(zhì)量改進(jìn)"DQASS"模式。產(chǎn)前篩查質(zhì)量控制涉及孕婦年齡、體重、孕齡等基本參數(shù),標(biāo)本質(zhì)量、實(shí)驗(yàn)室檢測(cè)、風(fēng)險(xiǎn)分析軟件及參比中位數(shù)選擇等多個(gè)環(huán)節(jié);2、年齡校正SPR、95%置信區(qū)間內(nèi)標(biāo)志物Median MoM值隨篩查月份、孕周及體重的分布圖及累積和圖(CUSUM圖)是用于篩查質(zhì)量監(jiān)測(cè)的有效統(tǒng)計(jì)學(xué)指標(biāo),基于這些評(píng)估指標(biāo)及統(tǒng)計(jì)學(xué)方法建立產(chǎn)前篩查質(zhì)量管理軟件系統(tǒng);3、定期使用本實(shí)驗(yàn)室的篩查數(shù)據(jù)更新中位數(shù)校正方程及體重校正方程,可以糾正系統(tǒng)誤差,降低SPR及FPR。當(dāng)篩查人群、儀器設(shè)備等發(fā)生改變時(shí),需更新參比中位數(shù),但在更新應(yīng)用前應(yīng)評(píng)價(jià)參比中位數(shù)的準(zhǔn)確性及穩(wěn)定性;4、標(biāo)本質(zhì)量影響篩查效能,對(duì)多采血點(diǎn)的篩查機(jī)構(gòu)應(yīng)定期對(duì)各采血點(diǎn)標(biāo)本質(zhì)量進(jìn)行單獨(dú)評(píng)價(jià),將各采血點(diǎn)標(biāo)本在同一個(gè)篩查機(jī)構(gòu)進(jìn)行風(fēng)險(xiǎn)計(jì)算時(shí)應(yīng)注意采血機(jī)構(gòu)與篩查機(jī)構(gòu)標(biāo)本質(zhì)量同質(zhì)化。5、風(fēng)險(xiǎn)計(jì)算軟件的優(yōu)化可以降低假陰性,提高檢出率。
[Abstract]:Serological screening during pregnancy, cytogenetic diagnosis of chorionic and amniotic fluid and ultrasound diagnosis are still the mainstream interventions in the two level prevention of Down's syndrome. High detection rate, low false positive rate and high health economic benefits are always pursued by experts in the field of prenatal diagnosis. It is also true through the efforts of nearly thirty years. The development of new screening markers and the establishment of new screening programmes can achieve greater screening effectiveness, while perfect quality management is to maximize the screening effectiveness of a screening program. Therefore, the establishment of an appropriate quality control system for prenatal screening is the basis for the better effectiveness of the high efficiency screening program to the clinical transformation. Although the scale of prenatal screening has been carried out for 13 years in China, the scale is increasing, but the quality control remains basically the most basic indoor quality control and interventricular quality assessment stage. Based on the statistical evaluation of the large sample screening data, all these quality control processes are analyzed, and the quality control is promoted. It is still blank in China. The quality control of prenatal screening for Down syndrome is special. The results of prenatal screening usually take the risk rate of a congenital anomaly as the report form. The core of the quality control is the reliability of the risk assessment of Down's syndrome. The evaluation of interventricular quality only involves the accuracy of biochemical markers, only part of the quality control of prenatal screening. The quality control of prenatal screening should involve every important link and key factors affecting the reliability of the risk calculation, including the basic parameters of pregnant women's age, weight, pregnancy weeks, and the accuracy of the laboratory test results, and the risk of the risk. On the other hand, prenatal screening for false positive rates and abnormal fetus detection rate in early and middle pregnancy is the index of statistical evaluation after birth, and there is a time span, serological screening for pregnant women, further prenatal diagnosis and final delivery of high-risk pregnant women are not all. In a medical institution, the collection, transport, testing and software application of blood samples can involve several different medical institutions and also have a geographical span. This makes the quality evaluation and management of prenatal screening more complex and arduous. How to find out the quality problems of screening, analyze the reasons, and put forward the rectification method is also a problem that needs to be solved through the change of statistical indicators. The quality management software system of prenatal screening and the realization of network can be used to evaluate the screening quality of screening institutions at all levels and efficiently, and promote the system of prenatal screening management. Objective: to promote the quality management of prenatal screening in our country. In order to standardize the quality management of prenatal screening in our country, this study takes the screening cases from 2010 to 2012 in Zhejiang as the data base, and discusses the key statistical indicators of quality assessment, the key assessment link, the evaluation flow and the methods of improving the quality of screening. The quality evaluation and management system of prenatal screening diagnosis suitable for the national conditions of our country, improve the efficiency of prenatal screening and improve the quality of pre - diagnosis in China. Methods: the data of prenatal screening for 2010~2012 years before 17 home production screening institutions in Zhejiang province were collected, involving 1227388 cases of pregnant women screening, through the basic parameters of pregnant women's age, weight, pregnancy weeks and so on. The Q-Q map, the Q-Q map, the age corrected screening positive rate (screening positive rate, SPR), the median median of the median of the 95% confidence interval (MedianMoM) with the screening month, the distribution map of pregnancy and weight, and the accumulation and graph (CUSUM chart) for screening the quality of the 17 screening machines. Through the above methods, 17 screening institutions To evaluate the quality of screening, find the link of screening quality, select representative parts, such as specimen quality, laboratory testing, risk software and reference median selection, to find out possible reasons and put forward improvement and optimization measures. Evaluation of the median of serum markers, analysis software Results: This study collected data of prenatal screening for 346195417347 and 463846 cases of Down's syndrome in 2010, 2011 and 2012. The age of prenatal screening of pregnant women was basically normal distribution, and the age distribution of different screening institutions was not consistent. The body weight distribution trend of the province and the screening institutions was similar, and the weight was high. The value part has trailing. The screening of pregnancy weeks is concentrated for about 17 weeks. There are significant differences in the method of screening for pregnancy. The SPR using LifeCycle software is higher than that of SPR using 2T software. The fluctuation of SPR in each month is obvious in 9 institutions. The Median MoM value of the marker in the 95% confidence interval varies with the month of screening, pregnancy week and in the 95% confidence interval. The negative bias can reflect the screening quality of screening institutions in time. The negative bias can reflect the screening quality in time. Representative problems are analyzed with examples: 1, the positive and negative bias of the marker MedianMoM, with the median of the local population in 2011, the screening marker MedianMoM is closer to 1, the positive rate of screening is decreased, but no shadow is found. The detection rate of.2 was taken as an example. The 21- trisomy SPR fluctuation in 2012 was more obvious. The positive rate of the LifeCycle software age correction screening was 4.98%. on the samples collected at the same period from different blood collecting points in the same period, and found that the screening machine and blood samples were screened in 2012. The sex rate was different, the sample of blood sampling was higher in SPR. The two groups were similar and negative to alpha fetoprotein (fetoprotein, AFP), and the Median MoM of free chorio gonadotropin beta subunit (free Beta human chorionic gonadotrophin, Free beta hCG) was different. The Median MoM which was not combined with unconjugaed estriol (uE3) was different, and the fluctuation was obvious and positive bias, and the blood sampling inspection specimens were especially.3. The screening data were compared before and after the replacement of the screening apparatus 11. The MoM value of the screening markers before and after the replacement was different. After the replacement of the instrument, the positive bias of the Free beta hCG was more obvious and uncombined. The negative bias of female three alcohol (unconjugaedestriol, uE3) was obvious.4. This study was followed up to 213 positive cases. The positive cases were analyzed. 6 positive cases were detected by Lifecycle software instead of 2T software. Conclusion: 1. This study established the quality improvement "DQASS" model of prenatal screening in China. Quantity control involves the basic parameters of pregnant women's age, weight, gestational age, specimen quality, laboratory testing, risk analysis software and selection of reference median. 2, age correction SPR, 95% confidence interval marker Median MoM value with screening month, gestational and weight distribution and accumulation and map (CUSUM chart) are used for screening quality monitoring Effective statistical indicators, based on these evaluation indicators and statistical methods to establish the quality management software system for prenatal screening. 3, regular use of the laboratory screening data to update the median correction equation and weight correction equation, can correct the system error, reduce SPR and FPR. when screening people, equipment and other changes, need to be updated. The median of the reference ratio, but the accuracy and stability of the median of the reference ratio should be evaluated before the renewal of the application. 4, the quality of the specimen affects the screening effectiveness. The screening institutions for the multiple blood sampling should evaluate the quality of the samples on a regular basis, and should pay attention to the blood collecting mechanism and screening in the same screening organization for the risk calculation. Check the quality of the specimen is homogeneous.5, the optimization of risk calculation software can reduce false negative and improve the detection rate.
【學(xué)位授予單位】：浙江大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2014
【分類(lèi)號(hào)】：R714.5

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