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

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”計劃專項經(jīng)費資助項目（DFL20190803）；北京市醫(yī)院管理中心“青苗”計劃專項經(jīng)費資助項目（QMS20200811）；首都科技領(lǐng)軍人才項目（Z191100006119017）