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目的该实验应用DZAS-Ⅰ型Z型覆膜食管支架,与已经进行临床使用的同类产品CZES-Ⅱ型覆膜食管支架进行对比,验证其临床适用性。方法入选病例64例,病例包括:食管癌、贲门癌合并食管狭窄26例,食管胃吻合口狭窄15例,食管癌、贲门癌术后吻合口瘘11例,食管物理化学烧伤引起的瘢痕狭窄8例,食管破裂4例。随机置入DZAS-Ⅰ型食管支架33个(实验组),CZES-Ⅱ型食管支架34个(对照组)。根据支架植入对狭窄段食管缓解程度和稳定性和对食管瘘口封堵效果及稳定性观察设定临床适用性标准并对其进行评价。结果DZAS-Ⅰ型和CZES-Ⅱ型食管支架可靠性和有效性差异均无显著性(P>0.05)。结论DZAS-Ⅰ型食管支架可以有效应用于临床。
Objective To evaluate the clinical applicability of DZAS-Ⅰ type Z-covered esophageal stent in comparison with the CZES-Ⅱ type coated esophageal stent which has been used clinically. Methods Totally 64 cases were enrolled in this study. Among them, 26 cases were esophageal and cardia carcinoma complicated with esophageal stenosis, 15 cases were esophagogastrostomy stenosis, 11 cases were anastomotic fistula after esophageal and gastric cardiactomy, 8 were stenosis caused by esophageal physical and chemical burn 8 Cases, 4 cases of esophageal rupture. Thirty-three DZAS-Ⅰ esophageal stents (experimental group) and 34 CZES-Ⅱ esophageal stents (control group) were randomly allocated. The clinical applicability criteria were set and evaluated according to the extent and stability of esophageal stricture esophageal stenosis and the occlusion and stability of esophageal fistula. Results There was no significant difference in reliability and validity between DZAS-Ⅰ and CZES-Ⅱ esophageal stents (P> 0.05). Conclusion DZAS-Ⅰ esophageal stent can be effectively used in clinical practice.