目的 探討語(yǔ)音播報(bào)提醒功能對(duì)早期藥物臨床試驗(yàn)中采血時(shí)間準(zhǔn)確性的影響。方法 自Sample Guide智能樣本管理系統(tǒng)數(shù)據(jù)庫(kù)中調(diào)取2018年6月—2019年10月無(wú)語(yǔ)音播報(bào)提醒功能條件下6 558個(gè)血液樣本采集時(shí)間作為對(duì)照組；2019年12月—2021年2月啟用語(yǔ)音播報(bào)提醒功能后12 768個(gè)血液樣本采集時(shí)間作為試驗(yàn)組。比較兩組實(shí)際采血時(shí)間與計(jì)劃采血時(shí)間的偏離程度、采血時(shí)間超窗發(fā)生率、采血時(shí)間記錄異常發(fā)生率。結(jié)果 啟用語(yǔ)音播報(bào)提醒功能后，實(shí)際采血時(shí)間與計(jì)劃采血時(shí)間的偏離程度較小，差值絕對(duì)值比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）；采血時(shí)間超窗發(fā)生率明顯降低，差異有統(tǒng)計(jì)學(xué)意義（P<0.05）；采血時(shí)間記錄異常的發(fā)生率明顯降低，差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。結(jié)論 語(yǔ)音播報(bào)提醒功能可以縮短實(shí)際采血時(shí)間與計(jì)劃時(shí)間的偏離程度，有效減少藥物臨床試驗(yàn)中采血時(shí)間超窗次數(shù)的發(fā)生，提高了早期藥物臨床試驗(yàn)中采血時(shí)間的準(zhǔn)確度。

Objective To investigate the influence of voice broadcast reminder on the accuracy of blood collection time in early phase clinical trial. Methods A total of 6 558 blood samples collected from June 2018 to October 2019 under the condition of Sample Guide intelligent Sample management system without voice notification were selected as the control group, and 12 768 blood samples collected from December 2019 to February 2021 after the use of voice broadcast reminder were selected as the experimental group. The deviation degree of actual blood collection time and planned blood collection time, the incidence of beyond time window of blood collection time, and the incidence of abnormal blood collection time record were compared between the two groups. Results With the voice broadcast reminder, the deviation degree and fluctuation range of actual blood collection time and planned blood collection time was much smaller (P < 0.05), the incidence of beyond time window of blood collection time was significantly decreased (P < 0.05), and the incidence of abnormal blood collection time record was significantly decreased (P < 0.05). Conclusion Voice broadcast reminder effectively shorten the deviation between actual blood collection time and planned time, reduced the rate of beyond time window of blood sample collection, and improved the accuracy of blood collection time.

R965.2

北京市醫(yī)院管理中心“登峰”計(jì)劃專項(xiàng)經(jīng)費(fèi)資助項(xiàng)目（DFL20190803）；北京市醫(yī)院管理中心“青苗”計(jì)劃專項(xiàng)經(jīng)費(fèi)資助項(xiàng)目（QMS20200811）；首都科技領(lǐng)軍人才項(xiàng)目（Z191100006119017）