PDF(Pubmed)
Abstract：
UNASSIGNED: To evaluate the operability and safety of bronchoscopic domestic one-way endobronchial valves (EBV) on animals.
UNASSIGNED: Nine pigs were randomly assigned (2:1) to receive domestic one-way EBV (the experimental group, n = 6) and Zephyr® EBV (the control group, n = 3). Routine blood tests, arterial blood gases, and CT scans of the lungs were performed 1 day pre-procedure in addition to 1 week and 1 month post-procedure to assess changes in blood markers and lung volumes. At 1 month post-procedure, the animals were sacrificed, followed by removal of all valves via bronchoscopy. Pathological examinations of critical organs were subsequently performed.
UNASSIGNED: A total of 15 valves were placed in the experimental group and 6 valves were placed in the control group, without serious complications. Routine blood tests and arterial blood gas examinations at 1 day pre-procedure, 1 week post-procedure, and 1 month post-procedure did not differ significantly in both groups. No EBV displacement was noted under bronchoscopy, and the valve was smoothly removable by bronchoscope at 1 month post-procedure. At 1 week post-procedure, varying degrees of target lung lobe volume reduction were observed on lung CT in both groups. Lung volume reduction was achieved at 1 month post-procedure in both groups, without significant statistical difference. Although 3 cases in the experimental group and 1 case in the control group developed varying degrees of pneumonia, the inflammatory response did not increase over time during the experimental period. Pathological examination revealed no significant abnormal changes in the critical organs for both groups.
UNASSIGNED: Our results demonstrate that domestic EBV is safe and reliable for endobronchial application in general-grade laboratory white pigs. The safety of domestic EBV is similar to that of Zephyr® EBV, with good ease of use and operability. This kind of domestic EBV can meet the safety evaluation requirements for animal testing.
UNASSIGNED: Nine pigs were randomly assigned (2:1) to receive domestic one-way EBV (the experimental group, n = 6) and Zephyr® EBV (the control group, n = 3). Routine blood tests, arterial blood gases, and CT scans of the lungs were performed 1 day pre-procedure in addition to 1 week and 1 month post-procedure to assess changes in blood markers and lung volumes. At 1 month post-procedure, the animals were sacrificed, followed by removal of all valves via bronchoscopy. Pathological examinations of critical organs were subsequently performed.
UNASSIGNED: A total of 15 valves were placed in the experimental group and 6 valves were placed in the control group, without serious complications. Routine blood tests and arterial blood gas examinations at 1 day pre-procedure, 1 week post-procedure, and 1 month post-procedure did not differ significantly in both groups. No EBV displacement was noted under bronchoscopy, and the valve was smoothly removable by bronchoscope at 1 month post-procedure. At 1 week post-procedure, varying degrees of target lung lobe volume reduction were observed on lung CT in both groups. Lung volume reduction was achieved at 1 month post-procedure in both groups, without significant statistical difference. Although 3 cases in the experimental group and 1 case in the control group developed varying degrees of pneumonia, the inflammatory response did not increase over time during the experimental period. Pathological examination revealed no significant abnormal changes in the critical organs for both groups.
UNASSIGNED: Our results demonstrate that domestic EBV is safe and reliable for endobronchial application in general-grade laboratory white pigs. The safety of domestic EBV is similar to that of Zephyr® EBV, with good ease of use and operability. This kind of domestic EBV can meet the safety evaluation requirements for animal testing.
摘要：
■评估支气管镜家用单向支气管瓣膜（EBV）对动物的可操作性和安全性。
■将9头猪随机分配（2：1）接受国产单向EBV（实验组，n=6)和Zephyr®EBV(对照组，n=3)。常规血液检查,动脉血气，术前1天,术后1周和1个月进行肺部CT扫描,以评估血液标志物和肺容积的变化.术后1个月，动物被处死，然后通过支气管镜切除所有瓣膜。随后进行了关键器官的病理检查。
■实验组共放置15个瓣膜，对照组共放置6个瓣膜，无严重并发症。术前1天进行常规血液检查和动脉血气检查，术后1周,两组患者术后1个月无显著差异.支气管镜检查未发现EBV移位,术后1个月通过支气管镜顺利取出瓣膜。术后1周，两组肺部CT均观察到不同程度的靶肺叶容积减少。两组均在术后1个月实现肺容积减少，无显著统计学差异。虽然实验组3例,对照组1例出现不同程度的肺炎,在实验期间,炎症反应没有随时间增加.病理检查显示两组的关键器官均无明显异常变化。
■我们的结果表明，国产EBV在普通级实验室白猪的支气管内应用是安全可靠的。国产EBV的安全性与Zephyr®EBV相似，具有良好的易用性和可操作性。这种国产EBV能够满足动物试验的安全性评价要求。
■将9头猪随机分配（2：1）接受国产单向EBV（实验组，n=6)和Zephyr®EBV(对照组，n=3)。常规血液检查,动脉血气，术前1天,术后1周和1个月进行肺部CT扫描,以评估血液标志物和肺容积的变化.术后1个月，动物被处死，然后通过支气管镜切除所有瓣膜。随后进行了关键器官的病理检查。
■实验组共放置15个瓣膜，对照组共放置6个瓣膜，无严重并发症。术前1天进行常规血液检查和动脉血气检查，术后1周,两组患者术后1个月无显著差异.支气管镜检查未发现EBV移位,术后1个月通过支气管镜顺利取出瓣膜。术后1周，两组肺部CT均观察到不同程度的靶肺叶容积减少。两组均在术后1个月实现肺容积减少，无显著统计学差异。虽然实验组3例,对照组1例出现不同程度的肺炎,在实验期间,炎症反应没有随时间增加.病理检查显示两组的关键器官均无明显异常变化。
■我们的结果表明，国产EBV在普通级实验室白猪的支气管内应用是安全可靠的。国产EBV的安全性与Zephyr®EBV相似，具有良好的易用性和可操作性。这种国产EBV能够满足动物试验的安全性评价要求。
