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中华血管外科杂志
中华血管外科杂志

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中华血管外科杂志/Journal Chinese Journal of Vascular Surgery
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    内脏动脉瘤治疗进展

    辛世杰王丽萍
    315-318页
    查看更多>>摘要：内脏动脉瘤是指腹腔干、肠系膜上动脉或肠系膜下动脉及其分支的动脉瘤，其中以脾动脉瘤和肝动脉瘤最为常见。内脏动脉瘤发病率较低，但其破裂率高，且常导致失血性休克甚至死亡。内脏动脉瘤起病隐匿，早期缺少典型临床表现，因此早期诊断较为困难。不同类型的内脏动脉瘤又有其自身特点，本文从多角度分析各个类型内脏动脉瘤的临床特点及诊疗方案，旨在为内脏动脉瘤的诊治提供一定的理论依据。 Visceral artery aneurysms refer to aneurysms of the celiac trunk, superior mesenteric artery or inferior mesenteric artery and their branches, among which splenic artery aneurysm and hepatic artery aneurysm are the most common. Visceral artery aneurysms have a low incidence, but have a high rupture rate and often lead to hemorrhagic shock and even death. The onset of visceral aneurysms is insidious, difficult to detect, and lacks typical clinical manifestations in the early stages, making early diagnosis difficult. However, different types of visceral artery aneurysms have their characteristics. This paper analyzes the clinical characteristics, diagnosis and treatment of each type of visceral artery aneurysms from multiple perspectives, and aims to provide a theoretical basis for the diagnosis and treatment of visceral artery aneurysms.

    内脏动脉瘤临床特点诊断方式治疗方法

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    腔内时代肾动脉瘤治疗策略的把控

    刘冰韩鹏王丽萍
    319-322页
    查看更多>>摘要：肾动脉瘤是一种临床上少见的肾动脉疾病。随着腔内治疗和外科机器人辅助技术的发展，其手术治疗的理念也在逐步更新，本文归纳总结了国内外近年来肾动脉瘤相关文献和指南，通过对不同类型肾动脉瘤的治疗策略分析，以及腔内治疗和开放手术疗效和操作细节的探讨，旨在为临床治疗提供一些依据。 Renal artery aneurysm is a rare disease of renal artery in clinical practice. With the development of endovascular therapy and surgical robot-assisted technology, the concept of treatment is gradually being updated. This article summarizes the relevant literature and guidelines related to renal artery aneurysms at home and abroad in recent years and aims to provide some evidences for clinical treatment by analyzing the treatment methods of different types of renal artery aneurysms, as well as exploring the efficacy and operational details of endovascular therapy and open surgery.

    肾动脉瘤弹簧圈栓塞覆膜支架动脉瘤切除

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    孤立性肠系膜上动脉夹层当前的诊疗问题及思考

    王伟孙金剑王丽萍
    323-326页
    查看更多>>摘要：随着影像学技术的进步与普及，既往认为较为少见的孤立性肠系膜上动脉夹层（ISMAD）患者越来越多地被诊断。目前对ISMAD的认识及治疗决策存在诸多争议，各项诊疗推荐建议尚缺乏高质量的循证医学证据支持。本文从ISMAD的地域流行病学特点、现有临床分型的局限性、临床诊疗过程中的争议点及未来开展ISMAD临床研究的必要性和展望等方面进行简要介绍，以期读者更好地认识和了解ISMAD这一疾病。 With the advancement and popularization of imaging techniques, isolated superior mesenteric artery dissection (ISMAD), which was considered a rare condition, is increasingly diagnosed. Currently, there still exist many debates on the understanding and treatment of ISMAD and recommendations for diagnosis and treatment still lack high-quality evidence-based medical evidence. This article provides a brief introduction to the geographical and epidemiological characteristics of ISMAD, the limitations of existing clinical classifications, the controversial points in clinical diagnosis and treatment, and the necessity and prospect of conducting ISMAD clinical research in the future, with the aim of providing readers with a better knowledge and understanding of ISMAD.

    孤立性肠系膜上动脉夹层治疗临床研究

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    基于慢性髂股静脉阻塞性疾病分型的治疗方式选择

    蒋劲松陈磊朴龙王丽萍...
    327-330页
    查看更多>>摘要：慢性髂股静脉阻塞性疾病（CIVO）常见病因有髂静脉压迫综合征（IVCS）和血栓形成后综合征（PTS），这类疾病在我国有着庞大的患者基数，并且以往传统手术的疗效不甚理想。近年来，静脉腔内技术的发展为这一疾病的诊治提供了新的思路，但临床上普遍存在一些相对不规范或不合理的情况，涉及疾病的诊断方式、治疗决策及用药方案等方面。本文就该疾病目前在国内外的研究进展及各大指南做一梳理。 The common causes of chronic iliofemoral venous obstruction (CIVO) include iliofemoral vein compression syndrome (IVCS) and post-thrombotic syndrome (PTS). The curative effect of traditional surgery has not achieved expectations. In recent years, the development of intravenous technology has provided new ideas for diagnosing and treating this disease. However, there are some inappropriate or sub-standard clinical practices involving diagnosis, treatment decision-making and medication. This article summarizes the current research progress and major guidelines for the disease at home and abroad.

    慢性髂股静脉阻塞性疾病髂静脉压迫综合征血栓形成后综合征治疗

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    6例肠系膜上动脉瘤的诊治经验

    连利珊赵宁杨洋吴志远...
    331-336页
    查看更多>>摘要：目的 总结肠系膜上动脉瘤（SMAA）的诊治经验。 方法 本研究为回顾性纵向研究。回顾性分析2015年1月至2023年1月北京友谊医院和北京医院两个中心的6例SMAA患者的临床资料，其中4例为真性动脉瘤，包括肠系膜上动脉（SMA）主干动脉瘤2例及SMA分支动脉瘤2例；另2例为肠系膜上动脉夹层动脉瘤。所有患者均通过盆腹腔增强CT确诊，其中腹痛4例，均为脐周隐痛。SMAA瘤体直径为（25.0±3.7）mm。总结分析患者的病因、发病特点、影像学表现、解剖特点及治疗方法等。 结果 6例患者中，2例分支动脉SMAA，其中1例保守治疗，另1例行瘤体弹簧圈栓塞术治疗；2例主干SMAA，行SMAA切除加人工血管重建及SMAA成形术及肝总动脉-SMA自体大隐静脉重建；另2例夹层动脉瘤，其中1例行假腔弹簧圈栓塞及真腔支架重塑，1例行两层裸支架植入。4例腹痛患者术后症状缓解。随访时间为（19.1±5.2）个月，随访期内复查CT血管造影可见SMA支架、人工血管及自体静脉桥均通畅，无再发SMAA。 结论 症状性SMAA且直径超过2 cm，应积极手术干预，但具体的手术方法应根据SMAA的解剖部位及交通动脉的评估而定。 Objective To investigate the diagnosis and treatment of superior mesenteric artery aneurysm (SMAA). Methods This study was a retrospective longitudinal study. A total of 6 cases with SMAA from two centers, Beijing Friendship Hospital and Beijing Hospital were retrospectively reviewed from January 2015 to January 2023. Among the six patients, 4 cases had true aneurysms, including superior mesenteric artery (SMA) trunk aneurysm and SMA branch aneurysm, and the other 2 cases were SMA dissecting aneurysms. All patients were confirmed by the enhanced computed tomography (CT) of the abdomen and pelvis. Four patients (66.7%, 4/6) had abdominal pain, all of which were periumbilical pain. The mean diameter of SMAA was (25.0±3.7) mm. The clinical data were analyzed, including etiology, pathogenesis, imaging findings, anatomical location of the aneurysms, and their treatment methods. Results Among the 6 patients, 2 patients with SMAA on the branch underwent conservation treatment in 1 case and spring coil embolization in 1 case 2 patients with SMAA on the main trunk underwent SMAA resection, artificial vessel reconstruction, and the reconstruction of hepatic artery-SMA with autologous great saphenous vein besides, in 2 cases with SMA dissecting aneurysms, 1 case was embolized with spring coils at the false cavity and remodeled with a true cavity stent, and the other one was implanted with double-layer bare stents. Abdominal pain relieved in 4 patients postoperative. The follow-up time was (19.1±5.2) months, which reported no recurrence of SMAA in patients after surgery, according to the CT. The SMA stents, artificial blood vessels, and autologous vein bypass featured patency. Conclusion Symptomatic SMAA with a diameter of more than 2 cm should be actively treated with surgical or endovascular intervention, but the optimal method depends on the anatomical site and the evaluation of communicating arteries of SMAA.

    肠系膜上动脉瘤腹痛腔内治疗开放手术

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    国产紫杉醇药物涂层球囊与普通球囊治疗股浅动脉支架内再狭窄的效果对比

    卫任黄伯儒刘杰贾鑫...
    337-342页
    查看更多>>摘要：目的 比较紫杉醇药物涂层球囊血管成形术（DCBA）与普通球囊血管成形术（POBA）治疗股浅动脉支架内再狭窄（SFA-ISR）病变的临床效果。 方法 本研究为回顾性队列研究。回顾性分析解放军总医院血管外科2020年1月至2022年8月收治的79例SFA-ISR患者的临床资料。主要观察终点为术后12及24个月的一期通畅率，次要终点为手术相关并发症、术后12和24个月的临床症状改善比例、免于靶病变再干预（TLR）率，以及重大血管相关不良事件（MAVEs）发生情况。 结果 共纳入79例患者，其中DCBA组43例，POBA组36例，两组靶病变长度分别为（160.2±65.5）mm和（151.4±69.4）mm，支架内闭塞发生率分别为69.8%（30/43）和77.8%（28/36）。术后12个月DCBA组一期通畅率优于POBA组（74.4% 比 54.8%，P=0.045），差异有统计学意义；术后24个月一期通畅率两组差异无统计学意义（39.8%比22.6%，P=0.200）。两组患者术后12及24个月临床症状改善率相当，且差异无统计学意义［12个月：75.6%（28/37）比 58.3%（17/24），P=0.67；24个月：46.1%（6/13）比 30.0%（3/10），P=0.72］；但免于TLR率方面，DCBA组均优于POBA组，差异具有统计学意义（12个月：83.2%比 59.8%，P=0.021；24个月：63.5% 比 33.4%，P=0.049）。两组均无严重手术相关不良事件发生，术后24个月两组各发生MAVEs 2例。 结论 DCBA较POBA在治疗SFA-ISR中有更好的临床获益。 Objective To compare the clinical effects of paclitaxel drug-coated balloon angioplasty (DCBA) with plain old balloon angioplasty (POBA) in the treatment of superficial femoral artery in-stent restenosis (SFA-ISR). Methods This study was a retrospective cohort study. The clinical data of 79 SFA-ISR cases admitted to the Department of Vascular Surgery of The First Medical Center of PLA General Hospital from January 2020 to August 2022 were collected and analyzed. The main observation endpoint was the primary patency rate at 12 months and 24 months after operation, and the secondary endpoints were the operation-related complications, the improvement of clinical symptoms at 12 months and 24 months after operation, freedom from target lesions revascularization (TLR), and major adverse vascular events (MAVEs). Results Seventy-nine patients were included, in which there are 43 cases with DCBA and 36 cases with POBA. The mean lesion length of the DCBA group and POBA group were (160.2±65.5) mm and (151.4±69.4) mm, and the incidence of in-stent restenosis was 69.8% and 77.8%, respectively. The primary patency rate at 12 months after the operation was significantly better in DCBA group than that in POBA group (74.4% vs 54.8%, P=0.045) and the difference was statistically significant. However, their primary patency rate at 24 months showed no statistical significance on their difference (39.8% vs 22.6%, P=0.200). The proportion of patients with clinical improvement was similar in both groups. However, in terms of the freedom from TLR, DCBA group was better than POBA group with differences of statistical significance (12th month: 83.2% vs 59.8%, P=0.021 24th month: 63.5% vs 33.4%, P=0.049). No serious operation-related adverse events occurred in both groups. Two MAVEs occurred within 24 months after the operation in each group. Conclusion DCBA has better clinical benefits than POBA in the treatment of SFA-ISR.

    药物涂层球囊普通球囊血管成形术支架内再狭窄股浅动脉动脉硬化闭塞症

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    药物涂层球囊与普通球囊治疗膝下动脉病变中短期疗效的单中心回顾性研究

    谭家铖张艳李承志李王海...
    343-347页
    查看更多>>摘要：目的 评价药物涂层球囊（DCB）和普通球囊在动脉硬化闭塞症膝下动脉病变的中短期疗效及安全性。 方法 本研究为回顾性队列研究。回顾性分析2019年1月至2022年1月暨南大学附属第一医院介入血管外科诊断为下肢动脉硬化闭塞症且不合并腘动脉病变的膝下动脉病变患者101例（124条靶血管）的临床资料，根据治疗方式分为普通球囊组（PTA组，51例，65条靶血管）及药物涂层球囊组（DCB组，50例，59条靶血管），采用两独立样本t检验或x2检验比较两组患者一般情况和随访期结果，采用Kaplan-Meier生存曲线分析比较两组一期通畅率。 结果 χ χ DCB组技术成功率为96.0%（48/50），PTA组为94.1%（48/51）。101例患者中，94例（99条靶血管）获得随访，其中DCB组45例，PTA组49例，中位随访时间为12（9，12）个月。DCB组症状改善33例（73.3%），再狭窄12例（26.7%），靶病变血运重建6例（13.3%），踝肱指数（ABI）0.72±0.11；PTA组症状改善26例（53.1%），再狭窄19例（38.9%），靶病变血运重建10例（20.0%），ABI 0.68±0.09。DCB组症状改善率和ABI优于PTA组，差异有统计学意义（2=4.125，P=0.042；t=1.998，P=0.049）。DCB组12个月一期通畅率优于PTA组，差异有统计学意义（72.9%比43.2%，Log-rank 2=5.155，P=0.023）。 结论 相比于普通球囊，DCB在动脉硬化闭塞症膝下动脉病变中具有更好的中短期疗效和一致的安全性。 Objective To evaluate the short- and mid-term efficacy and safety of drug-coated balloon (DCB) versus percutaneous transluminal angioplasty (PTA) for treating infrapopliteal artery lesions in lower extremity arteriosclerosis obliterans. Methods This study was a retrospective cohort study. A total of 101 patients (124 target vessels) were included in this study. They were diagnosed with lower extremity arteriosclerosis obliterans without concomitant popliteal artery lesions and underwent interventional vascular surgery at the First Affiliated Hospital of Jinan University from January 2019 to January 2022. The patients were divided into the PTA group (51 patients, 65 target vessels) and the DCB group (50 patients, 59 target vessels). General conditions and follow-up outcomes were analyzed using independent sample t-tests or chi-square tests. Kaplan-Meier survival curves were used to compare the primary patency rates between the two groups. Results χ χ The technical success rates in the DCB group and PTA group were 96.0%(48/50) and 94.1%(48/51). Out of the 101 patients, 94 cases (99 target vessels) were followed up, including 45 cases in the DCB group and 49 cases in the PTA group, for a median duration of 12 (9, 12) months. In the DCB group, symptom improvement was observed in 33 patients (73.3%), restenosis in 12 patients (26.7%), target vessel revascularization in 6 cases (13.3%), and ankle brachial index (ABI) was 0.72 ± 0.11. In the PTA group, symptoms improved was observed in 26 cases (53.1%), restenosis in 19 cases (38.9%), target lesion revascularization in 10 cases (20.0%), and ABI was 0.68 ± 0.09. The symptom improvement rate and ABI in the DCB group were better than those in the PTA group, with statistically significant differences (2=4.125, P=0.042 t=1.998, P=0.049). The 12-month primary patency rate in the DCB group was higher than that in the PTA group with statistically significant difference (72.9% vs 43.2%, Log-rank 2=5.155, P=0.023). Conclusion Compared to conventional percutaneous transluminal angioplasty, drug-coated balloon demonstrates similar safety and favorable short- and mid-term efficacy in treating popliteal artery lesions in lower extremity arteriosclerosis obliterans.

    下肢动脉硬化闭塞症膝下病变经皮血管腔内成形术药物涂层球囊

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    骨创伤并发下肢深静脉血栓形成不同治疗方法的对比性研究

    于洪波兰浩昌林明强姜红江...
    348-353页
    查看更多>>摘要：目的 比较不同治疗方法治疗骨创伤并发下肢深静脉血栓形成（DVT）患者的临床效果。 方法 本研究为回顾性队列研究。回顾性分析2019年1月至2021年12月山东省文登整骨医院骨科收治的367例骨创伤并发DVT患者的临床资料。根据治疗方法分为单纯抗凝组（A组）、抗凝+滤器置入组（B组）、抗凝+滤器置入+导管接触性溶栓组（C组）、抗凝+滤器置入+药物-机械血栓清除组（D组），每组根据随机表法随机抽取30例纳入分析。对比分析各组患者治疗后临床有效率、治疗前后凝血功能指标、治疗后并发症发生率及死亡率情况。 结果 A~D组患者治疗后临床有效率分别为16.7%（5/30）、26.7%（8/30）、96.7%（29/30）及100%（30/30），C组和D组高于A组和B组，差异有统计学意义（均P<0.05）。四组治疗后D-二聚体较治疗前均降低，差异有统计学意义（均P<0.05）。相较于A~C组，D组治疗后D-二聚体和凝血酶原时间较低，差异有统计学意义（均P<0.05）。A~D组治疗后出血发生率分别为6.7%（2/30）、3.3%（1/30）、10.0%（3/30）及3.3%（1/30），肺栓塞（PE）发生率分别为6.7%（2/30）、0、0及0，血栓形成后综合征（PTS）发生率分别为60.0%（18/30）、40.0%（12/30）、3.3%（1/30）及0，死亡率分别为3.3%（1/30）、0、0和0；C组与D组治疗后PTS发生率低于A组和B组，差异有统计学意义（均P<0.05）；出血、PE发生率和死亡率组间比较差异无统计学意义（均P>0.05）。 结论 骨创伤并发DVT患者采用抗凝+滤器置入+药物-机械血栓清除治疗效果更好且安全性更高，能及时清除血栓，恢复血管通畅，具有更低的PTS发生率，改善患者凝血功能，。 Objective To compare the clinical effect of different treatment methods on patients with deep vein thrombosis (DVT) of lower extremity complicated by bone trauma. Methods The clinical data of 367 patients with bone trauma complicated by DVT admitted to the Department of Orthopedics of Wendeng Osteopathic Hospital of Shandong Province from January 2019 to December 2021 were retrospectively analyzed. According to the treatment methods, the patients were divided into simple anticoagulation group (group A), anticoagulation+filter placement group (group B), anticoagulation+filter placement+catheter-directed thrombolysis group (group C), anticoagulation+filter placement+pharmamechanical thrombectomy group (group D), and 30 cases were randomly selected for analysis in each group using random table method. Clinical effective rate, coagulation function index before and after the treatment, incidence of complications and mortality of all groups were compared and analyzed. Results The clinical effective rates of patients in groups A to D after treatment were 16.7% (5/30), 26.7% (8/30), 96.7% (29/30) and 100% (30/30) respectively, and groups C and D were higher than groups A and B with statistically significant differences (all P<0.05). The D-dimer of the four groups after treatment was lower than that before treatment, and the differences were statistically significant (allP<0.05). Compared with groups A to C, group D after treatment demonstrated lower D-dimer and shorter prothrombin time , and the differences were statistically significant (allP<0.05). The incidence of hemorrhage after treatment of groups A to D was 6.7% (2/30), 3.3% (1/30), 10.0% (3/30) and 3.3% (1/30) the incidence of pulmonary embolism (PE) was 6.7% (2/30), 0, 0 and 0 the incidence of post-thrombotic syndrome (PTS) was 60.0% (18/30), 40.0% (12/30), 3.3%(1/30) and 0, and the mortality was 3.3% (1/30), 0, 0 and 0. The incidence of PTS in group C and D after treatment were lower than those in group A and B, and the differences were statistically significant (allP<0.05). The differences of the incidence of hemorrhage, PE and mortality among the four groups were not statistically significant (allP>0.05). Conclusion For patients with bone trauma complicated by DVT, anticoagulation+filter placement+pharmamechanical thrombectomy treatment is safer, which can remove thrombus in time and restore patency of blood vessels. With a lower incidence of PTS, this treatment can improve the coagulation function of patients, promoting early recovery of patients.

    骨创伤深静脉血栓形成肺栓塞血栓形成后综合征

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    阿哌沙班治疗和预防癌症相关静脉血栓栓塞症的疗效与安全性的Meta分析

    李朋何虎强陈豪徐通洁...
    354-361页
    查看更多>>摘要：目的 系统评价阿哌沙班治疗和预防癌症相关静脉血栓栓塞症（VTE）的疗效与安全性。 方法 系统检索PubMed、Cochrane 图书馆、Embase等数据库建库至2023年2月关于阿哌沙班治疗或预防癌症相关VTE的随机对照试验。采用Cochrane提供的RevMan 5.4软件进行Meta分析。VTE与出血风险被纳入分析，并根据是否有深静脉血栓形成与肺栓塞进行亚组分析。 结果 共纳入7项研究进行Meta分析，共3 157例患者。结果显示：（1）阿哌沙班治疗癌症相关VTE：阿哌沙班组较对照组VTE的复发减少，差异具有统计学意义（OR=0.52，95%CI：0.35~0.77，P<0.01）；与对照组相比，阿哌沙班组不会增加大出血发生率（OR=0.70，95%CI：0.43~1.15，P=0.16）及临床相关的非大出血发生率（OR=0.96，95%CI：0.41~2.23，P=0.93）。（2）阿哌沙班预防癌症相关VTE：阿哌沙班组较对照组VTE发生率降低，差异具有统计学意义（OR=0.35，95%CI：0.19~0.66，P<0.01）；与对照组相比，阿哌沙班组不会增加大出血发生率（OR=1.54，95%CI：0.61~3.91，P=0.36）及临床相关的非大出血发生率（OR=0.97，95%CI：0.60~1.57，P=0.90）。亚组分析显示，阿哌沙班组较对照组癌症相关肺栓塞的发生减少，差异具有统计学意义（OR=0.26，95%CI：0.10~0.70，P<0.01），而无论是癌症相关肺栓塞的复发，还是癌症相关深静脉血栓形成的复发和发生（OR=0.57，95%CI：0.32~1.01，P=0.05；OR=0.60，95%CI：0.32~1.10，P=0.10；OR=0.22，95%CI：0.02~2.56，P=0.23），两组差异无统计学意义。 结论 阿派沙班是安全有效的，可以减少癌症相关VTE的发生，同时不增加出血发生率。 Objective To systematically evaluate the efficacy and safety of apixaban in treating and preventing cancer-related venous thromboembosis(VTE). Methods PubMed, Cochrane Library and Embase were searched, and the data concerning randomized controlled trials of apixaban in treating or preventing cancer-related VTE were collected until February 2023. Meta-analysis was performed using RevMan5.4, which was provided by Cochrane. VTE and bleeding risk were included in the meta-analysis. Subgroup analysis was carried out according to whether there was deep vein thrombosis(DVT) and pulmonary embolism(PE). Results A total of 7 studies with 3 157 patients were included in the meta-analysis. The results showed: (1) Apixaban for treating VTE in cancer-related patients: compared with the control group, apixaban reduced the recurrence of VTE, and the difference was statistically significant (OR=0.52, 95%CI: 0.35-0.77, P=0.001) compared with the control group, apixaban did not increase the incidence of major bleeding (OR=0.70, 95%CI: 0.43-1.15, P=0.16) and clinically relevant non-major bleeding (OR=0.96, 95%CI: 0.41-2.23, P=0.93). (2) Apixaban for preventing VTE in cancer-related patients: compared with the control group, apixaban reduced the incidence rate of VTE, and the difference was statistically significant (OR=0.35, 95%CI: 0.19-0.66, P<0.01) compared with the control group, apixaban did not increase the onset of major bleeding (OR=1.54, 95%CI: 0.61-3.91, P=0.36) and clinically relevant non-major bleeding (OR=0.97, 95%CI: 0.60-1.57, P=0.90). By subgroup analysis, it was found that apixaban could reduce the onset of cancer-related PE compared with the control group with significant difference (OR=0.26, 95%CI: 0.10-0.70, P=0.007). Whether in the recurrence of cancer-related pulmonary embolism or the onset and recurrence of cancer-related VTE, there was no statistically significant difference between two groups (OR=0.57, 95%CI: 0.32-1.01, P=0.05 OR=0.60, 95%CI: 0.32-1.10, P=0.10 OR=0.22, 95%CI: 0.02-2.56, P=0.23). Conclusion Apixaban is safe and effective and can reduce the incidence of cancer-related VTE without increasing the incidence of bleeding.

    阿哌沙班癌症静脉血栓栓塞症随机对照试验Meta分析

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    国产新型肺动脉取栓装置的动物实验研究

    张文广张萌帆陈鹏飞石晓静...
    362-367页
    查看更多>>摘要：目的 评价国产新型肺动脉血栓取出装置在动物模型中的有效性和安全性。 方法 本研究为前瞻性随机对照研究。将15只实验白猪以随机数字表法随机分为肺动脉急性血栓取栓组（取栓组，n=6）、模拟肺动脉取栓组（模拟取栓组，n=6）和对照组（n=3）。取栓组肺动脉血栓建模成功后，用国产新型肺动脉取栓装置行经导管肺动脉抽栓实验，观察取栓前后肺动脉血流动力学变化和血栓负荷量的变化。模拟取栓组模拟取栓后观察30 d，将动物实施安乐死、解剖观察及取材进行组织病理学分析，观察测试段肺动脉组织，评估器械相关不良事件。对照组实验动物目标血管无血栓堵塞，不进行任何操作，组织病理学分析时与测试品作用过的血管作对照，评价血管修复情况。 结果 取栓组均成功建立肺动脉血栓模型，取栓（3.1±0.6）次，取栓后平均肺动脉压（mPAP）由（30.1±6.9）mmHg降至（18.7±3.4）mmHg（t=8.01，P=0.004），右心室收缩压（RVSP）由（51.2±7.6）mmHg降至（39.2±6.1）mmHg（t=6.37，P=0.021），差异均有统计学意义；肺动脉测试段直径由（10.6±1.5）mm减小至（9.7±1.7）mm，差异无统计学意义（t=0.77，P=0.475）；取栓后血栓即刻清除率Ⅲ级为100%（6/6）。模拟取栓组取栓后30 d的靶血管管壁血栓、内皮化及肉芽肿与对侧血管相比，差异均无统计学意义（P>0.05），未出现器械相关不良事件。 结论 肺动脉血栓经导管机械取栓后mPAP、PVSP下降，国产新型肺动脉取栓装置治疗白猪肺动脉血栓安全有效。 Objective To evaluate the efficacy and safety of a novel domestic pulmonary artery thrombectomy device (NDPATD) in animal experiment. Method This was a prospective randomized controlled study. Fifteen white pigs were divided into three groups using the random number table, including 6 pigs in the transcatheter mechanical thrombectomy (TMT) group, 6 in the simulated pulmonary artery thrombectomy (PAT) group, and 3 in the blank control group. In the TMT group, the acute pulmonary artery thrombosis model was first established, followed by the application of TMT via the NDPATD, and the hemodynamic alterations in the pulmonary artery and thrombus burden were analyzed. In the simulated PAT group, the simulated thrombus removal was used and then analyzed. The animals in the blank control group were neither complicated with thrombus in the target vessels nor underwent invasive procedures and were only used as blank control to compare the histology across the groups. After 30 days, all animals were euthanized and studied by proper histologic and pathological methods, including the evaluation of pulmonary artery tissues and the adverse events of the NDPATD. Result In the TMT group, all animals successfully accessed PAT, and the times of thrombectomy was 3.1±0.6. After thrombectomy, the mean pulmonary artery pressure(mPAP) decreased from (30.1±6.9)mmHg to (18.7±3.4)mmHg (t=8.01,P=0.004), the right ventricular systolic pressure (RVSP) declined from (51.2±7.6)mmHg to (39.2±6.1)mmHg (t=6.37, P=0.021), and all these differences were statistically significant. The diameter of the tested pulmonary artery dropped from (10.6±1.5)mm to (9.7±1.7)mm, which was not statistically significant (t=0.77,P=0.475). The immediate clearance rate of thrombus reached Grade Ⅲ in all 6 cases (6/6,100%). No statistically significant differences were found in the target vessel wall thrombus, endothelialization, and granulomas in the simulated PAT group at 30d after simulated thrombus removal compared with the contralateral vessels (P>0.05). No device-related adverse events occurred. Conclusion The mPAP and RVSP were significantly decreased after applying TMT. Notably, the NDPATD was safe and effective for treating PAT in white pigs.

    动物实验肺动脉血栓清除肺动脉血栓

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