Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study

PurposeThis study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions.MethodsA total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE).ResultsAt 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%–23.2%), primary patency was 89.1% (95% CI: 82.6%–93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%–94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%–9.4%) experienced MAEs, but none were determined to be related to device or procedure.ConclusionsThe LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries.     

氯化汞对大鼠血管内皮损伤的毒性研究

目的 研究不同剂量氯化汞对SD大鼠的血管内皮损伤情况.方法 将54只雄性SD大鼠简单随机分为四组,高、中、低氯化汞中毒组,每组15只,对照组9只;采用高(17 mg·kg-1·d-1)、中(8.5 mg·kg-1·d-1)、低剂量(4.25 mg·kg-1·d-1)浓度氯化汞盐水溶液灌胃建立SD大鼠亚急性汞中毒动物模型.中毒后7 d、14 d、21 d分别测定大鼠血细胞汞值、血清一氧化氮(NO)和内皮素-1(ET-1)值,同时行循环内皮细胞(CEC)计数.结果 对照组血细胞汞值接近于零,中毒组与对照组差异均有统计学意义(P<0.05).血清ET-1组间比较,高剂量组与对照组差异有统计学意义(P<0.05);组内比较,不同时期ET-1值差异有统计学意义(P<0.05).血清NO组间比较,各剂量组与对照组差异均有统计学意义(P<0.05);同期比较,不同中毒剂量组之间比较差异也有统计学意义(P<0.05);组内比较,不同时期之间差异均有统计学意义(P<0.05).血循环内皮细胞计数组间比较,各剂量组与对照组差异均有统计学意义(P<0.05);组内比较,不同时期之间差异均有统计学意义(P<0.05).结论 氯化汞可对血管内皮细胞有直接损伤作用,且损伤作用与剂量、时间存在同一变化趋势.     

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.     

ACOP对大鼠血中NO、ET-1和CEC的影响及高压氧的作用

目的 探讨急性一氧化碳中毒（ACOP）对大鼠血管内皮及其细胞功能的影响和高压氧治疗（HBOT）的作用。方法 参照Jiang式染毒法制成ACOP大鼠模型,有相应对照地、分别对中毒后即刻和次日起每日1次HBOT的第1,3,7,14天后,血中一氧化氮（NO）、内皮素－1（ET－1）水平和循环内皮细胞（CEC）计数进行测定。结果（1）ACOP后即刻机体血中NO水平显著降低,ET－1水平和CEC计数显著升高（P＜0．05）;（2）HBOT后中毒大鼠血中NO水平显著回升（P＜0．05）,ET－1水平和CEC计数显著回降;其后上述指标都趋于恢复到正常水平。结论 （1）ACOP可导致机体严重的血管内皮及其细胞功能的损伤;（2）0．2MPa（绝对压）HBOT对ACOP导致的血管内皮及其功能损伤具有显著的改善和作用;（3）血中NO、ET－1水平和CEC计数指标的单独或联合检测,可作为临床上判断ACOP患者血管内皮及其功能损伤程度、评估疗效、预测预后的重要手段。     

Evaluation of proton beam radiation sensitivity of proliferating choroidal endothelial and retinal ganglion cells with clonogenic assay

Context: Proton beam therapy offers the advantage of precise delivery with limited damage to the healthy tissue and is being tested in the management of exudative age-related macular degeneration (AMD). However, the dosages tested are empirical and not based on preclinical studies.

Objective: In this study we evaluated the effects of varying doses of proton beam radiation on choroidal endothelial cells (CECs) and retinal ganglion cells (RGCs) using clonogenic assay to determine differential sensitivity.

Materials and methods: Each cell type has different efficiency to replicate (plating efficiency (PE)). PE of CEC (RF/6A) and RGC (RGC-5) grown in culture flasks was determined by plating 250 cells each (without any treatment) and counting the number of colonies after 13 days. Radiation induced sensitivity was determined by exposing the semi-confluent RF/6A and RGC-5 cells to proton beam at the doses of 0 (control), 2, 4, 8 and 12 cobalt gray equivalent (CGE). The ability of the cells to repair and replicate to form colonies were analyzed 13 days after radiation with crystal violet stain and the survival ratio was calculated. The significance of survival was analyzed using ANOVA (Graphpad Instat.3).

Results: The PE of CEC and RGC was 12.96?±?0.29% and 40.7?±?1.48%, respectively. A survival ratio of CEC at 2, 4, 8 and 12 CGE proton radiation was 66.0?±?8.6%, 44.3?±?6.5%, 7.6?±?0.3% and 1.14?±?0.06% on exposure to 2, 4, 8 and 12 CGE proton radiation, respectively, p?<?0.01). Survival ratio of RGC was 71.1?±?22.4% (p?=?0.05), 40.2?±?7.9%, 8.89?±?2.6% and 0.78?±?0.31% at 2, 4, 8 and 12 CGE dosages (p?<?0.001).

Discussion: CEC showed dose-dependent decrease in survival rate with values attaining significance at all radiation dosages. In contrast, RGC was comparatively radio resistant and were able to replicate at lower doses and sensitive at higher doses after proton beam radiation.

Conclusion: Since CECs proliferate during neovascularization, this clonogenic assay is a useful assay to assess the sensitivity of CEC to radiation. This study identified that CEC were more sensitive to proton beam radiation than RGC at all doses. This may provide a therapeutic window for administration of proton beam radiation in the management of AMD.     

复方降脂胶囊对实验性动脉粥样硬化鹌鹑血液中炎症因子的影响

目的观察复方降脂胶囊对实验性动脉粥样硬化(AS)鹌鹑血液中炎症因子的影响。方法采用高脂饲养法复制鹌鹑高脂血症模型,并诱发AS模型。采用复方降脂胶囊及洛伐他汀分组治疗;于第12周经右侧颈静脉采血,测定血浆中循环内皮细胞(CEC)数,酶联免疫吸附法检测血清中CD40、CD40L、转化生长因子(TGF)-β、血管细胞间黏附分子(sVCAM-1)、细胞间黏附分子(sICAM-1)的含量。结果 实验动物经复方降脂胶囊干预治疗后,可明显降低血液中循环内皮细胞的数量,降低血清中CD40、CD40L、TGF-β、sVCAM-1及sICAM-1的含量,与模型组对比有显著差异。结论复方降脂胶囊可降低血管内皮的损伤,抑制AS斑块发生发展过程中的炎症反应过程,可能是其治疗AS的机制。     

Role of tumor necrosis factor receptor 2 (TNFR2) in colonic epithelial hyperplasia and chronic intestinal inflammation in mice.

BACKGROUND & AIMS: Tumor necrosis factor (TNF) induces multiple effects including cell proliferation and death by ligation with TNF receptor type II (TNFR2). We studied the role of TNFR2 in chronic inflammation-induced colonic epithelial alteration. METHODS: TNFR2 expression in colonic epithelial cells (CECs) was assessed by ribonuclease protection assay (RPA) and immunohistochemistry (IHC) in patients with inflammatory bowel disease (IBD) and murine colitis models. TNFR2 expression was also analyzed using COLO205 cells. The role of TNFR2 in colonic epithelial homeostasis was examined by generating interleukin 6-deficient TCR alpha KO (alpha IL-6DKO) or TNFR2-deficient TCR alpha (alpha TNFR2DKO) mice. RESULTS: TNFR2 expression was up-regulated in CEC in both human ulcerative colitis and Crohn's disease. In vitro studies showed that TNFR2 expression was up-regulated by a cooperative effect of key proinflammatory cytokines. By RPA, the increased expression of TNFR2 was detectable in TCR alpha KO mice with colitis compared with TCR alpha KO mice without colitis or wild-type mice. In alpha IL-6DKO mice, TNFR2 expression, proliferation, and nuclear factor kappa B activation of CECs were markedly reduced compared with TCR alpha KO mice. alpha TNFR2 mice also showed significantly less colonic epithelial proliferation compared with TCR alpha KO mice. CONCLUSIONS: Expression of TNFR2 is consistently increased on CECs in both murine colitis models as well as patients with IBD. TNFR2 may play an important role in colonic inflammation-associated alteration in the intestinal epithelium.     

Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial

Objectives

The aim of the present study was to evaluate the angiographic efficacy, clinical safety, and effectiveness of the Restore paclitaxel-coated balloon in a randomized trial designed to enable the approval of the new device in China.

老年高血压病患者血管内皮功能与氧化低密度脂蛋白变化关系的探讨

目的探讨老年高血压患者血管内皮功能与氧化低密度脂蛋白变化关系，寻求较好的治疗方法。方法按WHO高血压诊断标准，选择年龄为60—72岁的Ⅱ期老年高血压患者60例，与30例正常健康者进行对照，比较两组一般特点，同时检测氧化低密度脂蛋白（OX—LDL）、内皮依赖舒张因子（NO），血管内皮素（ET），血管内皮细胞计数（CEC）。结果两组结果显示，正常对照组与高血压组在年龄，性别组成方面无显著差异，但两组的血压比较则有显著差异（P〈0．001），高血压组的OX—LDL、ET、CEC结果均高于正常对照组，NO结果则低于正常对照组。结论本研究结果提示与Ⅱ期老年高血压发生发展有肯定关系，提示临床在治疗中不仅注重血管内皮功能保护，同时加强抗氧化治疗，延缓高血压发展。