药物临床试验中肝素钠封管对甘油三酯的影响

The effect of heparin sodium for lock flush on triglycerides in clinical drug trials

目的探讨使用肝素钠封管对甘油三酯水平的影响,为药物临床试验中非药物影响因素的控制提供参考。方法将30例健康受试者,随机分为对照组和低、高剂量试验组,每组10例。对照组给予生理盐水封管,低、高剂量试验组分别给予5、25 U·m L^(-1)肝素钠稀释液封管。3组受试者均封管48 h。比较3组受试者采血堵管情况及甘油三酯的变化情况。结果封管48 h后,对照组、低、高剂量试验组堵管率分别为6.67%,7.50%和0.84%;甘油三酯分别为(1.34±0.63),(1.71±0.77)和(2.14±0.96)mmol·L^(-1),低、高剂量试验组分别与对照组比较,差异均有统计学意义(均P<0.05)。结论高剂量试验组能显著降低堵管率,升高甘油三酯水平,低剂量试验组和对照组对甘油三酯的影响较小。

Objective To explore the effect of using heparin sodium to close tubes on the level of triglyceride,so as to provide reference for the control of non-drug influencing factors in clinical trials.Methods A total of 30 healthy subjects were randomly assigned to control group and low-,high-dose group,with 10 cases in each group.In control group,the normal saline was lock flush.The low-,high-dose group were given 5,25 U·m L^(-1)heparin sodium for lock flush,respectively.The three groups were treated for 48 h.The blockage rate and the changes in triglycerides were compared among the three groups.Results After 48 h-treatment,the blockage rates of the control group and low-,high-dose group were 6.67%,7.50%and 0.84%.The triglyceride after lock flush in three groups were(1.34±0.63),(1.71±0.77)and(2.14±0.96)mmol·L^(-1).There were statistical analysis in the above indexes between the control group and the low-,high-dose group(all P<0.05).Conclusion The high-dose group can significantly reduce the blockage rate and increase the triglyceride level.The low-dose group and control group have little effect on triglycerides.