Application of evacuated blood collection combined with non sealing technique in venous blood collection of phase I clinical drug test
10.3760/cma.j.cn115682-20201016-05774
- VernacularTitle:负压真空采血联合免封管技术在Ⅰ期临床药物试验静脉采血中的应用
- Author:
Jia ZHANG
1
;
Yuhua CUI
;
Yanyan XIA
;
Lingxiang LIU
Author Information
1. 江苏省人民医院/南京医科大学第一附属医院肿瘤科，南京 210029
- Keywords:
Negative pressure vacuum blood collection;
Non sealing technique;
Phase I clinical trial;
Continuous venous blood collection
- From:
Chinese Journal of Modern Nursing
2021;27(1):43-46
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the feasibility and effect of evacuated blood collection combined with non sealing technique in the collection of pharmacokinetic blood samples in phase I clinical trials.Methods:Using convenient sampling method, 60 patients in phase I clinical trial who were admitted between November 2017 and October 2019 were selected as the research objects, and were divided into control group and improvement group according to the admission sequence. Among them, 31 patients collected from November 2017 to October 2018 were taken as the control group, and blood samples were collected in 390 tubes by syringe in open indwelling needle; from November 2018 to October 2019, 29 patients were selected as the improvement group, and 388 blood samples were collected by evacuated blood collection combined with non sealing technique in the open indwelling needle. The incidence of indwelling needle plugging, hemolysis of blood samples and the duration of single blood sampling were compared between the two groups.Results:In the incidence of indwelling needle plugging, the improvement group was 3.09% (12/388) , the control group was 2.05% (8/390) , there was no significant difference between the two groups (χ 2=0.800, P>0.05) ; in the incidence of hemolysis of blood samples, the improvement group was 2.66% (10/376) , the control group was 7.33% (28/382) , the difference between the two groups was statistically significant (χ 2=7.857, P<0.01) ; the improvement group was (29.40±1.99) seconds in the duration of single blood sampling, the control group was (40.74±0.88) seconds, the difference between the two groups was statistically significant ( t=101.15, P<0.01) . Conclusions:In the collection of pharmacokinetic blood samples of phase I clinical trials of new drugs, evacuated blood collection combined with non sealing technique can not only protect the blood vessels of the subjects, but also control the time of intensive blood collection within 12 hours, save the operation time of blood collection and guarantee the quality of blood samples. It is worth popularizing to ensure the scientific and standard test.
