药物涂层球囊在股腘动脉狭窄闭塞疾病中的临床应用

正由于腔内治疗的良好疗效及微创可重复的特点,腔内手术已经成为治疗周围动脉疾病的首选方法。经皮球囊扩张术(percutaneous transluminal angioplasty,PTA)是腔内治疗的首选技术之一,利用PTA开通血管技术的成功率超过95%,但再狭窄率高达20%~65%~([1])。再狭窄发生率高及远期疗效不佳,已成为现阶段周围动脉腔内治疗领域亟待解决的主要问题。药物涂层球囊(drug-coated balloon,DCB)是在标准     

股腘动脉闭塞症的诊断和治疗中国专家共识

股腘动脉闭塞症是下肢动脉硬化闭塞症中最常见的疾病,表现为间歇性跛行、静息痛、肢体溃疡坏疽等症状,严重影响患者生活质量,甚至危及肢体及生命。随着腔内血管外科技术和器械的发展,其治疗理念和技术有了很大的改变,本共识根据国内近年来的临床实践经验,结合最新循证资料以及国外相关指南,提出适合中国人群特点的诊疗规范推荐意见,旨在为国内血管外科及相关领域医师提供最新的临床实践依据。     

药物球囊治疗股腘动脉硬化闭塞症的临床研究

目的评估药物涂层球囊(DCB)治疗股腘动脉硬化闭塞的有效性及安全性。方法回顾性分析2016年6月至2017年5月哈尔滨医科大学附属第一医院血管外科及群力分院血管外科行球囊治疗的股腘动脉病变患者162例(Rutherford2~4级)。其中采用DCB治疗的患者102例(DCB组),采用普通球囊即经皮腔内血管成形术(PTA)治疗的患者60例(PTA组)。患者在术后30 d、6个月和12个月后于我院复诊并对其进行随访。收集2组患者一般资料,观察患者疗效终点和安全终点。采用SPSS 19.0软件对数据进行分析。根据数据类型,组间比较采用独立样本t检验、χ~2检验(Pearson χ~2或四表格校正公式)或Wilcoxon符号秩和检验。结果 2组患者一般资料差异无统计学意义(P0.05),但男性、有吸烟史患者比例均50%。2组患者病变特点及手术相关指标差异均无统计学意义(P0.05)。随访12个月后,与PTA组患者比较,DCB组一期通畅率[76.5%(78/102)vs 56.7%(34/60),P=0.008]和踝肱指数[(0.89±0.14)vs(0.82±0.20),P=0.027]显著升高,靶病变血运重建(TLR)比例显著降低[5.9%(6/102)vs 27.1%(16/60),P0.001],差异有统计学意义,但2组患者在提高步行受损问卷(WIQ)[22.3(8.0,39.4)vs 21.4(5.4,37.7)分,P=0.403]、手术成功比例[100%(102/102)vs 100%(60/60),P=1.000]方面差异无统计学意义。DCB组1例男性患者因严重慢性阻塞性肺疾病伴严重肺感染于随访6个月后死亡,PTA组1例糖尿病患者于随访6个月后因足外伤后感染严重行膝下截肢术;但2组患者安全终点事件及主要不良事件发生率差异均无统计学意义(P0.05)。结论 DCB治疗初发性股腘动脉硬化闭塞效果明显优于PTA,安全性不劣于PTA。     

双导丝球囊在处理分叉病变中的应用

目的 评价冠状动脉分叉病变主支植入支架联合分支,双导丝球囊(Dual-Wire Balloon)单纯扩张治疗分叉病变的有效性和安全性.方法 Lefevre Ⅰ型冠状动脉分叉病变36例共41处,采用双导丝球囊行边支和(或)主支扩张,主支植入支架,观察住院及随访期间的疗效及主要心脏不良事件的发生率.结果 41处分叉病变主支支架植入前行边支双导丝球囊预扩张均成功,4例主支行直接支架术,37处分叉病变主支双导丝球囊预扩张成功后植入主支支架,主支支架后5例边支明显受压,心肌梗死试验性溶栓疗法(thrombolysis in myoxardial infarction trial,TIMI)血流不足3级的分叉病变行对吻扩张均成功.住院期间无Q波心肌梗死、急诊血运重建及死亡;平均随访16个月,期间无Q波心肌梗死、再次血运重建、死亡等严重临床并发症,心绞痛复发3例,强化药物治疗后均缓解.结论 用双导丝球囊处理分叉病变可以获得较好的效果,主支支架联合分支双导丝球囊单纯扩张治疗分叉病变是一种简单和有效的处理方法.     

双导丝球囊治疗冠状动脉分叉病变的影响因素

目的:分析双导丝球囊治疗冠状动脉分叉病变中影像学效果的影响因素。方法:回顾性分析冠状动脉分叉病变210例,分别按照主支/边支血管参考直径、成角对边支血管即刻管径获得进行亚组分析。结果:球囊扩张主支血管后,在绝大多数病例中,双导丝球囊组边支血管即刻管径获得的绝对值比普通球囊组小(P0.05)。而在主支血管置入支架后,只有在主支血管狭窄程度最重的≥95%[-0.25±0.26)mm vs(-0.54±0.40)mm,P0.01]、边支血管参考直径较小的2.0~2.4mm[(-0.29±0.28)vs(-0.52±0.31)mm,P0.01]、边支血管狭窄程度相对较轻的50%[(-0.09±0.13)mm vs(-0.14±0.06)mm,P0.05]、主支和边支血管成角较小的70°[(-0.30±0.35)mm vs(-0.60±0.37)mm,P0.01]这部分病例中,可以观察到边支血管即刻管径获得的绝对值比普通球囊组小。结论:双导丝球囊用于分叉病变预处理可以在一定程度上减轻主支血管斑块向边支血管位移的程度,特别是对于主支血管狭窄程度较重、边支血管较细、边支血管狭窄程度较轻、Y型分叉病变,即便是在主支血管置入支架后仍然可以观察到双导丝球囊预处理分叉病变后的获益。     

双导丝球囊在冠状动脉分叉病变中的应用

目的:观察双导丝球囊在冠状动脉分叉病变应用中的有效及安全性。方法:本研究入选210例冠状动脉分叉病变患者,随机分为双导丝球囊组和普通球囊组。用定量冠状动脉造影的方法分别测量了术前、球囊扩张后、支架置入后分叉部位最小管腔直径、即刻管径获得和直径狭窄率。结果:研究的有效性指标,在球囊扩张后,使用双导丝球囊的病例与使用普通球囊的病例相比,前者边支血管的直径狭窄率更低[(43.38±16.81)vs.(51.68±15.01)%,P<0.01]、最小管腔直径更大[(1.34±0.47)vs.(1.15±0.39)mm,P<0.01]、即刻管径获得的绝对值更少[(-0.11±0.04)vs.(-0.25±0.09)mm,P<0.01],差异均具有统计学意义。170例患者在球囊扩张主支血管后置入了支架。双导丝球囊组与普通球囊组相比,前者边支血管的直径狭窄率更低[(50.34±16.82)vs.(66.09±22.60)%,P<0.01]、最小管腔直径更大[(1.14±0.40)vs.(0.93±0.34)mm,P<0.01]、即刻管径获得的绝对值更少[(-0.30±0.12)vs.(-0.54±0.19)mm,P<0.01],差异均具有统计学意义。安全性指标,血管夹层、边支闭塞、主要不良心血管事件发生率在两组间无明显差异。结论:用双导丝球囊扩张主支血管,边支血管受到的影响相对较小,这可能和导丝切割斑块的作用有关。双导丝球囊可能成为分叉病变介入治疗中的一种选择。     

双导丝聚力球囊与普通球囊在小血管病变介入治疗中的对比观察

目的:比较双导丝聚力球囊与普通球囊在直径≤2.5 mm小血管病变介入治疗中的即刻效果及远期预后。方法:连续入选冠状动脉(冠脉)造影显示小血管病变(参考血管直径≤2.5 mm)需行介入治疗的患者,连续入选的150例小血管病变患者随机分成试验组75例,对照组75例。试验组:双导丝聚力球囊单纯扩张;对照组:普通球囊单纯扩张。观察介入治疗即刻成功率、血管并发症发生率。6～9个月时复查冠脉造影,观察小血管病变再狭窄发生率。观察12个月内小血管病变相关的心脏不良事件(MACE)。结果:采用双导丝聚力球囊对小血管病变进行介入治疗手术试验组成功率97.3%,对照组86.7%(P=0.015),术中并发症发生率两组分别为1.3%与6.7%(P=0.032)。6～9个月复查冠脉造影,试验组与对照组靶病变再狭窄发生率分别为12.7%与31.8%(P<0.05),12个月与小血管病变相关的MACE发生率两组分别为5.4%及18.5%(P=0.035),差异均有统计学意义。结论:双导丝聚力球囊与普通球囊相比,可降低小血管病变手术并发症,提高手术成功率,降低1年内靶病变再狭窄及MACE发生率。是小血管病变介入治疗又一可选择的介入治疗方法。     

老年TASCⅡC、D型LEAOD完全闭塞病变腔内治疗的疗效

目的探讨血管腔内治疗老年主-髂动脉闭塞(TASC)ⅡC、D型下肢动脉硬化闭塞症(LEAOD)完全闭塞病变的可行性及近期临床疗效。方法回顾性分析采用腔内治疗的27条患肢(21例患者)老年下肢TASCⅡC、D型LEAOD的临床资料。结果手术成功率为88.9%(24/27),其中经皮腔内血管成形术(PTA)治疗3条,PTA联合支架植入术(PTAS)治疗21条,共置入支架57枚。手术成功病例平均随访8.75个月(6¹8个月),术后3个月足背动脉踝肱指数(ABI)由术前的0.39±0.14上升至0.8±0.19(P<0.01);胫后动脉ABI由术前的0.45±0.12上升至0.90±0.10(P<0.01)。术后6个月动脉通畅率83.3%(20/24),保肢率95.8%(23/24)。结论对于老年TASCⅡC、D型LEAOD完全闭塞病变,血管腔内治疗安全有效,创伤小,近期临床疗效满意。     

股深动脉成形术治疗下肢动脉硬化闭塞症5例

下肢动脉硬化闭塞症目前尚无特效治疗方法。1990年6月至今,我们对5例下肢动脉硬化闭塞症患者施行了股深动脉成形术,效果良好。现报告如下。     

A prospective,multi‐center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry

The Chocolate BAR study is a prospective multicenter post‐market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow‐limiting dissection); secondary long‐term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12‐months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all‐cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an “all‐comers” population achieved excellent procedural outcomes with low dissection rates and bailout stent use.     

Drug-coated balloon angioplasty versus balloon angioplasty for treating patients with in-stent restenosis in the femoropopliteal artery: A meta-analysis

Background:The introduction of endovascular surgery has led to frequent stent use, although in-stent restenosis (ISR) remains a challenging issue. Drug-coated balloon (DCB) and conventional balloon angioplasty (BA) are common endovascular procedures for addressing ISR in the femoropopliteal artery. However, there is controversy regarding which procedure provides the greatest benefit to patients.Methods:The PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched for prospective controlled trials that compared DCB and BA for patients with ISR in the femoropopliteal artery. The study has been approved by Ethics Committee of Wuhan Central Hospital.Results:The meta-analysis included 6 prospective trials with 541 patients. We found that DCB use was associated with significant reductions in binary restenosis at 6 months (relative risk [RR]: 0.45, 95% confidence interval [CI]: 0.33–0.63; P < .00001), binary restenosis at 1 year (RR: 0.44, 95% CI: 0.34–0.57; P < .00001), target lesion revascularization (TLR) at 6 months (RR: 0.36, 95% CI: 0.20–0.65; P = .0006), and TLR at 1 year (RR: 0.38, 95% CI: 0.27–0.54; P < .00001). The DCB group also had significantly better clinical improvement (RR: 1.39, 95% CI: 1.13–1.71; P = .002), although we did not detect inter-group differences in terms of death, target vessel thrombosis, or ipsilateral amputation. The brand of DCB may a cause of heterogeneity.Conclusion:Relative to BA, DCB use increases the durability of treatment for ISR in the femoropopliteal artery, based on significant reductions in binary restenosis and TLR at 6–12 months after the procedure. Furthermore, DCB use was associated with better clinical improvement. However, additional randomized controlled trials are needed to validate these findings.     

自体富血小板凝胶与标准疗法治疗糖尿病难治性皮肤溃疡的随机对照研究

目的评价自体富血小板凝胶（APG）治疗糖尿病难治性皮肤溃疡的有效性和安全性。方法2007年4月至2008年2月在我科住院治疗的糖尿病皮肤溃疡患者46例,随机分人APG治疗组（23例）和标准治疗组（23例）。两组患者均使用胰岛素控制血糖,严格控制血压、血脂,同时给予抗血小板、改善微循环、抗感染等一般治疗和局部溃疡创面标准处理。APG治疗组患者根据创面体积／面积用自制APG并外敷速愈乐敷料;标准治疗组直接外敷速愈乐敷料。疗程直至创面愈合、行皮瓣移植手术或12周满。结果除标准治疗组失访1例,其余患者均完成试验。APG治疗组溃疡愈合率为22／23（95．7％）,总有效率为100％;标准治疗组溃疡愈合率为13／23（56．5％）,总有效率为73．9％,两组比较差异有统计学意义（P值分别为0．002,0．009）;Kaplan-Meier溃疡时间愈合曲线和窦道闭合曲线分析提示P〈0．05,显示APG治疗明显优于标准治疗;治疗过程中未发现APG治疗相关副作用发生。结论APG治疗糖尿病难治性皮肤溃疡优于标准治疗法,且治疗伴窦道的溃疡更有优势;APG治疗糖尿病难治性皮肤溃疡是安全、有效、可行的。     

A long-term prospective randomized controlled study of non-specific interstitial pneumonia (NSIP) treatment in scleroderma

The association of cyclophosphamide (CYC) and prednisone (PRED) for the treatment of lung fibrosis in systemic sclerosis (SSc) was only evaluated in uncontrolled studies, although in idiopathic interstitial lung disease (ILD) this association seems to be beneficial in patients with non-specific interstitial pneumonia (NSIP). Objectives: To treat SSc-ILD in a prospective open-label controlled study based on lung pattern during 12 months of treatment. Methods: A 3-year analysis was also performed. Twenty-four consecutive patients with SSc and ILD were submitted to an open lung biopsy. Eighteen patients (NSIP) were randomized in two groups: CYC versus CYC + PRED during 12 months. Lung function tests (diffusion lung capacity of monoxide carbone corrected for hemoglobin concentration (DLCO-Hb), forced vital capacity (FVC), total lung capacity) and Modified Rodnan Skin Score (MRSS) were performed before, after one of treatment and after 3 years from the end of the treatment. Results: Pulmonary function tests were similar in both groups on baseline. After 1 year of treatment, FVC% was comparable between CYC groups (p = 0.72) and in CYC + PRED (p = 0.40). Three years after the end of treatment, FVC% values (p = 0.39 in group CYC and p = 0.61 in CYC + PRED and p = 0.22 in CYC + PRED) and DLCO-Hb (p = 0.54 in CYC and p = 0.28 in CYC + PRED) were similar compared to 1 year of treatment. We observed a reduction of the MRSS in the CYC + PRED group after 1 year of treatment (p = 0.02); although after 3 years, MRSS values remained stable in both groups. Conclusions: CYC was effective to stabilize lung function parameters in NSIP lung pattern of SSc disease for 3 years after the end of a 1-year therapy.     

药物涂层球囊在冠状动脉分叉病变边支介入治疗中的临床应用

目的探讨药物涂层球囊应用于冠状动脉分叉病变边支血管保护的可行性分析。方法选择2015年3月~2016年3月在解放军总医院经冠状动脉造影证实冠状动脉分叉病变患者20例,Medina分型1,1,1;1,0,1;0,1,1,分别为11、5、4例。行PCI,于主支血管置入药物洗脱支架,边支血管用药物涂层球囊主动保护技术处理,术后即刻冠状动脉造影检查。术后6个月临床随访,统计患者主要心脑血管不良事件。结果20例患者PCI成功率为100%。20例患者主支置入药物洗脱支架,边支血管用药物涂层球囊主动保护技术处理,主支血管最小管腔直径由术前(1.49±0.46)mm增加至术后(3.20±0.53)mm(P=0.001),分支血管由术前(1.36±0.66)mm增加至术后(1.78±0.61)mm(P=0.048)。术后6个月患者无主要心脑血管不良事件发生。结论药物涂层球囊主动保护技术应用于冠状动脉分叉病变边支血管保护安全、有效。     

Long-term clinical outcomes and cause of death after endovascular treatment for femoropopliteal artery lesions

BackgroundEndovascular treatment (EVT) for femoropopliteal artery disease is common in clinical practice. However, little is known about its prognostic factors, causes of death, and long-term clinical outcomes.MethodsTwo hundred eighty-five consecutive patients (mean age, 72±8 years, 73% men) undergoing their first EVT for de-novo femoropopliteal artery disease from 2009 to 2018 were studied. Patients were divided in two groups according to the presence of critical limb ischemia (CLI). We evaluated the incidence of major adverse limb events (MALE) including clinically driven target vessel revascularization and target limb major amputation, and all-cause death.ResultsThe procedure was successful in 97.9% of cases. The non-CLI group comprised 205 patients (72%), and the CLI group comprised 80 patients (28%). The CLI group exhibited higher high-sensitivity C-reactive protein (hs-CRP) levels and a higher rate of hemodialysis than the non-CLI group. During the median follow-up period of 3.5 years, there were 62 deaths (21.8%) including cardiovascular (32.3%), infection (32,3%), and malignancy-related (22.6%) deaths. Kaplan-Meier analysis revealed that the CLI group had a significantly higher incidence of MALE and all-cause death (log-rank, both p<0.001, respectively). The leading causes of death in the CLI group were cardiovascular- and infection-related death; the leading cause of death in the non-CLI group was malignancy-related. On multivariate Cox hazard analysis, hemodialysis, TASC II classification C/D lesions, and CLI were significant predictors of MALE (p<0.001, p=0.005, and p=0.012, respectively). Hemodialysis, age, higher hs-CRP levels, and CLI were significant predictors of all-cause death (p<0.001, p=0.003, p=0.009, and p=0.021, respectively).ConclusionsAlthough EVT for femoropopliteal artery disease appears feasible with a high rate of procedural success, a high incidence of MALE and all-cause death was observed. Further studies are needed to improve the outcomes in patients with CLI.     

A randomized controlled clinical study on Zuo's acupuncture treatment for prediabetes

Introduction:Prediabetes is a high-risk stage of transition to type 2 diabetes mellitus. Previous studies suggest that acupuncture has potential to prevent prediabetes’ conversion to type 2 diabetes mellitus, which lack of high-quality evidence. Zuo''s acupuncture, a kind of acupuncture technique, is formed through long-term and repeated clinical practice by professor Zuo Changbo who integrates the internal meaning of Dong extra acupoints and Taoist medicine principle according to the theories of traditional Chinese medicine. It is used clinically to increase the regression toward normo-glycemi on prediabetes. The objective of this trial is to clarify the clinical effectiveness and safety of Zuo acupuncture for prediabetes.Methods and analysis:This study is a prospective randomized controlled trial in which 60 patients with prediabetes will be randomly allocated in a 1:1 ratio into either an acupuncture treatment group or a control group. Prediabetes patients in the control group will receive prediabetes health education for lifestyle interventions, whereas patients in the acupuncture group will receive lifestyle interventions plus Zuo Daliji and Yueku stitch treatment. Twenty-four treatment sessions will be performed over 3 months. The primary outcome is conversion rate from prediabetes to normal blood glucose. Secondary outcomes include fasting plasma glucose, 2-hour plasma glucose, glycosylated hemoglobin and blood lipid concentration.Ethics and dissemination:This study was approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (permission number: YF2020-107-01) and the protocol conforms to the principles of the Declaration of Helsinki. Data collection will be completed by June 2022. Publications will be ready for submission in July 2022.     

Improving the discomfort and satisfaction of colonoscopy by distraction with smartphones: A prospective randomized controlled study

Background:Colonoscopy is an uncomfortable procedure. Distraction is thought to reduce pain by decreasing the amount of attention a person spends on a painful stimulus. We aimed to assess the usefulness of smartphones on discomfort associated with the colonoscopy.Methods:We designated 360 enrolled patients according to prospective randomized controlled study into two groups, including smartphone (SP) group (Relaxation by smartphones) and Control group (No relaxation). Measured outcomes included the discomfort, satisfaction, polyp detection rate and the willingness to repeat colonoscopy were analyzed between groups.Results:The pain and distension scores of SP group patients were significantly lower than those of the Control group (2.18 ± 2.80 vs 3.55 ± 3.07, P < .001; 4.15 ± 2.35 vs 4.79 ± 2.36, P = .011, respectively). Importantly, patient-reported satisfaction scores of the SP group were significantly higher than those of the Control group (96.45 ± 7.17 vs 91.12 ± 10.49, respectively; P < .001). Moreover, although there were no statistical differences, patients using smartphones were more likely to have shorter reach cecum times (09m:11 s vs 07m:37 s, P = .116) and more polyp detection rate (13.3% vs 9.4%, P = .246). In addition, more patients using smartphones were willing to repeat colonoscopy but no statistical difference (85.0% vs 81.7%, P = .396).Conclusion:Patient using smartphone is a special manner to increase satisfaction during colonoscopy with a less discomfort and is more likely to be polyp detection rate.