全过程质量控制对注射用紫杉醇合理安全用药的影响

Impact of whole-process quality control on rational and safe administration of injectable albumin bound paclitaxel

目的探讨注射用紫杉醇(白蛋白结合型)的适宜配置方法,提高成品输液的质量,保障用药的安全性和合理性。方法考察配置方法改进对注射用紫杉醇(白蛋白结合型)配置时间和泡沫量的影响,改进方法包括抵消西林瓶内负压、缩短溶媒注入时间、使用螺口注射器、等压抽吸、预先抽净输液袋内空气等。结果向西林瓶内注入空气抵消负压后缩短溶媒注入时间,使药液在静置5min和摇动2min后的可配置率分别由10%和30%提高到90%和100%,同时,溶解总时长由(9.05±1.12)min降低到(6.10±1.02)min;使用螺口注射器和等压抽吸方法,药液的抽吸时间为(9.60±0.15)s,低于对照组的(23.10±0.20)s;配置完成后实验组成品输液内泡沫量为(2.65±0.46)m L,小于对照组的(11.45±0.63)m L,差异均有统计学意义(P<0.05)。对照组成品输液送达科室后泡沫量较配置完成后有所增加,而实验组成品输液送达科室后泡沫量无明显增多。结论改进后的配置流程可减少药品损耗,保证患者临床用药安全有效;减少注射用紫杉醇(白蛋白结合型)的配置时间,提高静脉用药调配中心(PIVAS)的工作效率和医院的服务水平,减少医患纠纷的发生。

Objective To explore the appropriate dispensing techniques for injectable albumin bound paclitaxel,so as to improve the quality of infusions and ensure the safety and rationality of drug administration.Methods The effects of the improved dispensing techniques(including relieving the negative pressure inside the vial,shortening the solvent injection time,use of syringes with a screw port,isobaric suction,and pre-pumping the air inside the infusion bag)on the dispensing time and foam volume were examined.Results Shortening the solvent injection time after relieving the negative pressure by injecting air into the vial increased the dispensability rate of the drug solution from 10%and 30%to 90%and 100%after 5 min of standing and after 2 min of shaking,respectively;the total dissolution time was reduced from(9.05±1.12)min to(6.10±1.02)min.The use of syringes with a screw port and isobaric suction shortened the suction time from(23.10±0.20)s in the control group to(9.60±0.15)s in the experimental group.Upon the completion of dispensing,the foam volume was(2.65±0.46)mL in the experiment group,significantly smaller than that[(11.45±0.63)mL] in the control group(P<0.05).The foam volume in the control group increased after the infusions were delivered to the clinical departments compared with that immediately after the dispensing;in contrast,there was no significant increase in the foam volume in the experimental group.Conclusions The improved dispensing techniques reduce drug loss and ensure the safety and effectiveness of the clinical use of injectable albumin bound paclitaxel.These techniques also shorten the dispensing time,improve the efficiency of the pharmacy intravenous admixture services(PIVAS)and the hospital's service level while reducing doctor-patient disputes.