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目的比较国产动脉导管未闭封堵器与Amplatzer动脉导管未闭封堵器(amplatzer duct occluder,ADO) 治疗动脉导管未闭(PDA)的疗效、安全性及费用。方法对80例接受PDA封堵术的患儿进行回顾性分析,其中国产器械组50例,ADO组30例,比较两种方法的疗效、并发症及费用。结果两组技术成功率比较差异无显著性(100% vs 98%,P>0.05)。即刻完全封堵率国产器械组明显高于ADO组(75% vs 43%,P<0.05),但术后24 h,1, 3,6,12个月不同时间点随访完全封堵率两组差异无显著性(P>0.05)。国产器械组并发症1例(2%),ADO组并发症2例(6.7%),两组比较差异无显著性(P>0.05)。国产器械组住院费用明显低于ADO组[(29 457.54±220.36)元vs (39012.65±143.73)元](P<0.001)。两组均无死亡病例。结论国产动脉导管未闭封堵器与ADO 疗效、并发症均无明显差异,但应用国产器械费用明显低于ADO,值得推广应用。
Objective To compare the efficacy, safety and cost of domestic patent ductus arteriosus occluder and amplatzer duct occluder (ADO) in the treatment of patent ductus arteriosus (PDA). Methods A retrospective analysis was performed on 80 children who underwent PDA occlusion. Among them, 50 were in the domestic equipment group and 30 were in the ADO group. The curative effects, complications and costs of the two methods were compared. Results There was no significant difference in technical success rate between the two groups (100% vs 98%, P> 0.05). Immediate occlusion rate was significantly higher in the domestic device group than in the ADO group (75% vs 43%, P <0.05), but at 24 h, 1, 3, 6 and 12 months after operation, There was no significant difference (P> 0.05). There were 1 case (2%) of complications in domestic equipment group and 2 cases (6.7%) of complications in ADO group. There was no significant difference between the two groups (P> 0.05). The hospitalization cost of the domestic equipment group was significantly lower than that of the ADO group [(29 457.54 ± 220.36) yuan vs (39012.65 ± 143.73) yuan] (P <0.001). No deaths were reported in both groups. Conclusion The patent ductus arteriosus closure device and ADO efficacy, complications were no significant differences, but the cost of domestic equipment was significantly lower than ADO, it is worth promoting the application.