细胞毒性药物集中调配的环境污染及密闭式药物配制和转运系统应用评估

Evaluation of environmental contamination of centralized preparation of cytotoxic drugs and the application of closed-system drug transfer device

目的评估在静配中心应用密闭式药物配制和转运系统(closed-system drug transfer device,CSTD)对细胞毒性药物在工作环境中污染残留量的影响。方法利用环磷酰胺为示例药物,通过WIPE采样法和高效液相色谱法定量检测复旦大学附属肿瘤医院静配中心配制舱内环境中环磷酰胺残留量。在常规配制方法配药的一个工作日配药结束时清理前、清理后以及连续应用3周CSTD进行配药工作后,分别进行3批采样。采样位置包括3个生物安全柜(BSC)操作台面、转运小推车、出舱台等19个位置。比较3批样本中环磷酰胺的残留量。结果常规配药清理去污前各监测点中位值为1.30(IRQ:0.24,2.60)ng/cm^2,去污后中位值为0.22(IRQ:0.08,0.53)ng/cm^2,前后比较差异有统计学意义(P<0.001)。CSTD系统配药后,各监测点中位值为0.06(0.02,0.88)ng/cm^2,明显低于常规方法去污前(P<0.001),也低于常规方法去污后,但差异无统计学意义(P=0.299)。结论应用CSTD可有效减少细胞毒性药物在配制转运过程中的渗漏污染,从而显著减少相关医务人员的毒性药物职业暴露。

Objective To evaluate the effect of closed system drug transfer device(CSTD)on the residual amount of cytotoxic drugs in the pharmacy intravenous admixture services(PIVAS).Methods Using cyclophosphamide as an example drug,WIPE samples and High performance liquid chromatography(HPLC)are used to quantitatively detect the residual of cyclophosphamide in the PIVAS of Fudan University Shanghai Cancer Center.Three batches of samples were taken before and after-cleaning at the end of one working day of dispensing in a conventional formulation method,and also after three weeks of continuous application of CSTD for dispensing.The samples were taken from 19 positions including the working surfaces of three biological safety cabinet,transport cart and export table.The residual amount of cyclophosphamide in the three batches of samples was compared.Results The median value of monitoring points before decontamination was 1.30(IRQ:0.24,2.60)ng/cm^2,and the median value after decontamination was 0.22(IRQ:0.08,0.53)ng/cm^2.There were significant differences between before and after decontamination(P<0.001).After implementation in the CSTD,the median value of monitoring points before decontamination was 0.06(0.02,0.88)ng/cm^2,which was significantly lower than that before the regular decontamination(P<0.001),and also lower than the after regular decontamination,but the difference was not significant(P=0.299).Conclusion The application of CSTD can effectively reduce environmental contamination of cytotoxic drug in the process of dispensing and transportation,thus significantly reduce occupational exposure to toxic drugs by relevant medical staff.