国产聚四氟乙烯胆道支架的研制与临床应用

目的:研制适合内镜下应用的国产聚四氟乙烯(Teflon)胆道支架,并验证其临床疗效.方法:研制9F Teflon胆道支架.选取80例恶性肝外胆管梗阻患者,随机分为两组各40例:实验组应用自行研制的国产9F Teflon支架,对照组采用进口8.5F Teflon支架.结果:操作后两组发热的发生率分别为22.2％和24.0％,高淀粉酶血症发生率分别为27.8％和27.3％,退黄总有效率为81.0％和87.0％,均无统计学差异.经1.5～15个月随访发现,两组支架的平均通畅期均为6个月,患者的平均存活期均为7个月.结论:国产9F胆道Teflon支架操作性能良好,主要疗效指标已达到国外同类产品的水平.

Development and clinical application of a new biliary Teflon stent

Objective:To develop a new type of polytetrafluoroethylene(Teflon) biliary stent for endoscopic use, and to evaluate its therapeutic effect.Methods:Eighty patients with malignant ultrahepatic bile duct obstruction were randomly divided into the test groups (with above stent) and control group (with 8.5F imported Teflon stent).The near and late effects were compared between the 2 groups. Results:Post procedure fever occurred in 22.2% patients in the test group and in 24.0% in the control group, hyperamylasia occurred in 27.8% and 27.3% of patients, and effective rate of jaundice control was 81.0% and 87.0% in patients in test and control group respectively.There was no significant difference in near effects between the 2 groups.The median stent patency was just the same (6 months) and median survival was 7 months in both group.Conclusion:The new stent has good capability and its main therapeutic parameters are similar to that of oversea products.