冻干粉抗凝针剂三种皮下注射方法的安全评析  

Safety evaluation of three subcutaneous injection methods of freeze-dried anticoagulant powder injection preparation

作　　者：葛静萍[1] 顾建平[1] 许秀芳[2] 甘舒琴 李燕[1] GE Jingping;GU Jianping;XU Xiufang;GAN Shuqin;LI Yan(Department of Interventional Vascular Diseases,Nanjing First Hospital,Nanjing Medical University,Nanjing,Jiangsu Province 210006,China)

机构地区：[1]南京医科大学附属南京医院(南京市第一医院)介入血管科,210006 [2]介入放射学杂志编辑部

出　　处：《介入放射学杂志》2020年第11期1159-1164,共6页Journal of Interventional Radiology

基　　金：国家自然科学基金(81871463);南京市科技发展计划项目(201803006);南京市卫生科技发展专项资金项目(YKK19086)。

摘　　要：目的比较三种方法在冻干粉针剂皮下注射抗凝治疗中的安全性及可行性。方法纳入2018年3月至2019年12月注射用那屈肝素钙抗凝治疗的106例患者,BD注射器组(A组)34例;1 mL无菌注射器组(B组)36例;1 mL无菌注射器+无菌注射针组(C组)36例:1 mL无菌注射器,先替换无菌注射针配制药液后,再更换配套针头皮下注射组,对药液残留量、针头受力后形态变化及并发症进行评价。结果加药后针头倾斜发生率及倾斜度:42.5%、35.18°±17.12°(A组),20.0%、18.00°±13.97°(B组),P<0.05;加药后针尖倒钩发生率及倒钩角度:57.5%、19.83°±17.14°(A组),35.0%、11.79°±8.55°(B组),P<0.05;注射部位皮下出血发生率及疼痛评分:17.23%、2.90±0.54(A组),11.90%、1.6±0.49(B组),4.96%、0.70±0.64(C组),P<0.05;冻干粉针剂西林瓶(以下简称西林瓶)瓶内药液残留量:(0.05±0.01)mL(A组),(0.11±0.06)mL(B组),0.01±0.00 mL(C组),P<0.05;针头腔内药液残留量:0.005±0.001 mL(A组),0.013±0.007 mL(B组),(0.03±0.003)mL(C组),P<0.05;抽液时间:(7.23±0.96)s(A组),(5.09±0.52)s(B组),(1.84±0.22)s(C组),P<0.05。结论冻干粉针剂皮下注射抗凝治疗中,使用1 mL注射器,先替换无菌注射针充分溶解冻干粉后静置5 s,瓶底抽取药液后,再更换配套针头皮下注射的方案,具有较高的药液利用率,在注射部位物理性损伤、并发症发生率、护理时效的安全性及可行性方面,明显优于BD注射器组及1mL注射器不换针头配制药液组。Objective To compare the safety and feasibility of three subcutaneous injection methods of freeze-dried anticoagulant powder injection preparation in anticoagulant therapy.Methods A total of 106 patients,who received anticoagulant therapy with injection of nalaparin calcium during the period from March2018 to December 2019,were enrolled in this study.The patients were divided into BD syringe group(group A,n=34,using BD syringe),1-mL sterile syringe group(group B,n=36),and 1-mL sterile syringe+aseptic injection needle group(group C,n=36).In group C,1-mL sterile syringe was used to replace sterile needle to prepare drug solution,and then to replace the matching needle.The residual amount of drug solution in the injection bottle and in the needle cavity,the morphological changes of the needle due to injection force,and complications were compared among three groups.Results After loading drug,the incidence of needle tilt and the needle inclination angle in group A were 42.5%and(35.18±17.12)°respectively,which were 20.0%and(18.00±13.97)°respectively in group B(P<0.05).After loading drug,the incidence of needle tip barb formation and barb angle in group A were 57.5%and(19.83±17.14)°respectively,which were 35.0%and(8.55±11.79)°respectively in group B(P<0.05).The incidence of subcutaneous hemorrhage and pain score at the injection site in group A were 17.23%and(2.90±0.54)points respectively,which were 11.90%and(1.60±0.49)points respectively in group B,and were 4.96%and(0.70±0.64)points respectively in group C(P<0.05).The residual volumes of freeze-dried anticoagulant powder injection preparation in the injection bottle in group A,group B and group C were(0.05±0.01)mL,(0.11±0.06)mL and(0.01±0.00)mL respectively(P<0.05),and the residual volumes of freeze-dried anticoagulant powder injection preparation in the needle cavity in group A,group B and group C were(0.005±0.001)mL,(0.013±0.007)mL and(0.030±0.003)mL respectively(P<0.05).The time taken to withdraw the liquid in group A,group B and group C was(7.23±

关 键 词：冻干粉针剂 皮下注射 抗凝治疗 安全评析 

分 类 号：R654.4[医药卫生—外科学]