本文選題：全血治療藥物監(jiān)測(cè) + 室內(nèi)質(zhì)量控制�。� 參考：《中國臨床藥理學(xué)雜志》2015年18期

【摘要】：目的調(diào)查全血治療藥物監(jiān)測(cè)(環(huán)孢霉素A、他克莫司、西羅莫司)室內(nèi)質(zhì)量控制的精密度現(xiàn)狀。方法用基于英特網(wǎng)方式的室間質(zhì)量評(píng)價(jià)軟件系統(tǒng)收集參加2014年2月全國全血治療藥物監(jiān)測(cè)室間質(zhì)量評(píng)價(jià)的179家實(shí)驗(yàn)室的室內(nèi)質(zhì)量控制數(shù)據(jù),用Excel 2007和SPSS 13.0對(duì)數(shù)據(jù)進(jìn)行分析,并計(jì)算允許總誤差(TEa)、1/3TEa和1/4Tea這3個(gè)項(xiàng)目的室內(nèi)質(zhì)量控制變異系數(shù)的通過率。結(jié)果最終分別有116家、108家和21家實(shí)驗(yàn)室回報(bào)了環(huán)孢霉素A、他克莫司、西羅莫司批號(hào)1的室內(nèi)質(zhì)量控制數(shù)據(jù),59家、56家和4家回報(bào)了環(huán)孢霉素A、他克莫司、西羅莫司批號(hào)2的室內(nèi)質(zhì)量控制數(shù)據(jù)。約半數(shù)實(shí)驗(yàn)室(40.7%~57.1%)用伯樂檢測(cè)系統(tǒng)。西羅莫司室內(nèi)質(zhì)量控制變異系數(shù)除累積1/4TEa的通過率在項(xiàng)目間差異有統(tǒng)計(jì)學(xué)意義外(P0.05),其余情況不同項(xiàng)目間的通過率差異無統(tǒng)計(jì)學(xué)意義(P0.05)。環(huán)孢霉素A各檢測(cè)系統(tǒng)室內(nèi)質(zhì)量控制變異系數(shù)的通過率差異無統(tǒng)計(jì)學(xué)意義(P0.05)。他克莫司除累積室內(nèi)質(zhì)量控制不精密度在1/4TEa評(píng)價(jià)標(biāo)準(zhǔn)時(shí)的通過率不同檢測(cè)系統(tǒng)間差異無統(tǒng)計(jì)學(xué)意義外(P0.05),其他3種情況差異均有統(tǒng)計(jì)學(xué)意義(P0.01)。結(jié)論西羅莫司是室內(nèi)質(zhì)量控制變異系數(shù)通過率最高的檢驗(yàn)項(xiàng)目,環(huán)孢霉素A不存在不同檢測(cè)系統(tǒng)間室內(nèi)質(zhì)控變異系數(shù)通過率的差異,而他克莫司存在。通過對(duì)當(dāng)月和累積的室內(nèi)質(zhì)量控制數(shù)據(jù)的變異系數(shù)的監(jiān)測(cè),并將室內(nèi)質(zhì)量控制數(shù)據(jù)計(jì)算的變異系數(shù)與相關(guān)要求進(jìn)行比較,可以評(píng)價(jià)該檢測(cè)系統(tǒng)的不精密度水平是否滿足規(guī)定的質(zhì)量要求。
[Abstract]:Objective to investigate the precision of indoor quality control in whole blood therapy monitoring (cyclosporine A, tacrolimus, sirolimus). Methods Excel 2007 and SPSS 13.0 were used to analyze the indoor quality control data collected from 179 laboratories participating in the whole blood therapy monitoring laboratory quality evaluation in February 2014 using the internet-based indoor quality assessment software system. The passage rate of the coefficient of variation in indoor quality control was calculated for the three items, the total allowable error of 1 / 3 TEa and 1/4Tea. Results in the end, 116, 108 and 21 laboratories reported cyclosporine A, tacrolimus, sirolimus batch 1, indoor quality control data 59, 56, and 4 cyclosporine A, tacrolimus. Indoor quality control data for sirolimus batch 2. About half of the laboratories use the Bole detection system. The coefficient of variation of sirolimus indoor quality control had no statistical significance except that the pass rate of accumulated 1/4TEa was significantly different between items (P 0.05). There was no significant difference in the passing rate of the coefficient of variation of indoor quality control between different detection systems of cyclosporine A (P 0.05). Tacrolimus had no significant difference in pass rate among different detection systems except for accumulative inaccuracy of indoor quality control in 1/4TEa evaluation standard, but there were significant differences in other three conditions (P 0.01). Conclusion sirolimus is the highest test item for indoor quality control coefficient of variation. Cyclosporine A does not exist the difference of coefficient of variation of indoor quality control among different detection systems, but tacrolimus has. By monitoring the coefficient of variation of the indoor quality control data of the current month and accumulated, and comparing the coefficient of variation calculated by the indoor quality control data with the relevant requirements, It is possible to evaluate whether the inaccuracy level of the detection system meets the required quality requirements.
【作者單位】： 北京醫(yī)院衛(wèi)生部臨床檢驗(yàn)中心;
【基金】：北京市自然科學(xué)基金資助項(xiàng)目(7143182)
【分類號(hào)】：R95

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