Jiao Yang, Tian Sen, Liu Jian, Shen Xiaping, Wang Qin, Li Xiang, Zhang Wei, Dong Yuchao, Li Yonghua, Bai Chong, Huang Haidong
Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Naval Medical University, Shanghai, China.
Department of Respiratory and Critical Care Medicine, No. 906 Hospital of the Chinese People's Liberation Army Joint Logistic Support Force, Ningbo, China.
Front Med (Lausanne). 2024 May 1;11:1293940. doi: 10.3389/fmed.2024.1293940. eCollection 2024.
To evaluate the operability and safety of bronchoscopic domestic one-way endobronchial valves (EBV) on animals.
Nine pigs were randomly assigned (2:1) to receive domestic one-way EBV (the experimental group, = 6) and Zephyr EBV (the control group, = 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.
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.
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.
评估国产支气管镜单向支气管内瓣膜（EBV）在动物身上的可操作性和安全性。
将9头猪随机分为两组（2:1），分别接受国产单向EBV（实验组，n = 6）和Zephyr EBV（对照组，n = 3）。在手术前1天、术后1周和1个月进行常规血液检查、动脉血气分析和肺部CT扫描，以评估血液指标和肺容积的变化。术后1个月，处死动物，然后通过支气管镜取出所有瓣膜。随后对关键器官进行病理检查。
实验组共置入15个瓣膜，对照组置入6个瓣膜，均未出现严重并发症。两组在手术前1天、术后1周和术后1个月的常规血液检查和动脉血气分析结果无显著差异。支气管镜检查未发现EBV移位，术后1个月瓣膜可通过支气管镜顺利取出。术后1周，两组肺部CT均观察到不同程度的目标肺叶容积缩小。两组术后1个月均实现了肺容积缩小，差异无统计学意义。虽然实验组有3例、对照组有1例出现不同程度的肺炎，但在实验期间炎症反应未随时间增加。病理检查显示两组关键器官均无明显异常变化。
我们的结果表明，国产EBV在内科级实验用白猪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估要求。
