triple therapy

三联疗法
  • 文章类型: Journal Article
    背景:在慢性阻塞性肺疾病(COPD)患者中,药物治疗不依从性是一个重要问题。解决这一问题的努力越来越受到重视。通过处方单吸入器三联疗法(SITT)作为多吸入器三联疗法(MITT)或智能吸入器来简化治疗通常被认为是潜在的解决方案。然而,这些创新对依从性和临床结局的实际影响尚不清楚.
    方法:为了解决这一知识差距,我们首先进行了文献综述,重点关注两个研究问题:1)COPD患者SITT和MITT患者的依从性差异,和2)智能吸入器对COPD依从性的影响。在PubMed中进行了单独的搜索,两名作者独立评估了文章。此外,我们提出了一项研究方案,以获取所发现差距的知识.
    结果:为了解决第一个研究问题,选择8项试验作进一步审查。所有试验都是观察性的,即缺乏随机对照试验。这些试验中有7项显示,与接受MITT的患者相比,接受SITT的患者的依从性和/或持久性更高。此外,4项研究显示SITT对各种临床结局有积极作用.对于第二个研究问题,选择11项试验进行审查。虽然大多数研究表明智能吸入器对依从性有积极影响,关于它们对其他临床结局的影响,结果存在相当大的差异.TRICOLON(在慢性阻塞性肺疾病中使用一种或多种吸入器和数字支持的三联疗法)试验旨在提高对SITT和智能吸入器在增强依从性方面的有效性的理解。这个开放标签,随机化,多中心研究将纳入10家参与医院需要三联疗法的COPD患者.总的来说,300名患者将被随机分为三组:1)MITT;2)SITT;3)SITT通过智能吸入器和电子健康平台提供数字支持。后续期为一年,在此期间,将使用三种测量依从性的方法:智能吸入器数据,使用吸入器依从性测试(TAI)问卷的自我报告数据,和头皮头发样本中的药物分析。最后,将比较研究组之间临床结局的差异.
    结论:我们的综述表明,关于SITT的作用,而不是MITT,和智能吸入器坚持。然而,由于缺乏随机对照试验和/或许多研究的随访时间较短,证据质量有限.此外,其对临床结局的影响显示出相当大的差异.TRICOLON试验旨在提供有关这些经常提及的COPD非依从性解决方案的可靠数据。在精心设计的随机对照试验中收集数据是具有挑战性的,但是本试验的设计同时解决了SITT和智能吸入器的实用性,同时确保对参与者日常生活的干扰最小.
    背景:NCT05495698(Clinicaltrials.gov),注册时间为08-08-2022。协议版本:版本5,日期27-02-2023。
    BACKGROUND: Medication non-adherence is a significant problem in patients with Chronic Obstructive Pulmonary Disease (COPD). Efforts to address this issue are receiving increased attention. Simplifying treatment by prescribing single-inhaler triple therapy (SITT) as an alternative to multi-inhaler triple therapy (MITT) or with smart inhalers are often considered potential solutions. However, the actual impact of these innovations on adherence and clinical outcomes is unclear.
    METHODS: To address this knowledge gap we first conducted a literature review focusing on two research questions: 1) the difference in adherence between SITT and MITT users in COPD, and 2) the effect of smart inhalers on adherence in COPD. Separate searches were conducted in PubMed and two authors independently assessed the articles. In addition, we present a protocol for a study to acquire knowledge for the gaps identified.
    RESULTS: To address the first research question, 8 trials were selected for further review. All trials were observational, i.e. randomized controlled trials were lacking. Seven of these trials showed higher adherence and/or persistence in patients on SITT compared with patients on MITT. In addition, four studies showed a positive effect of SITT on various clinical outcomes. For the second research question, 11 trials were selected for review. While most of the studies showed a positive effect of smart inhalers on adherence, there was considerable variation in the results regarding their effect on other clinical outcomes. The TRICOLON (TRIple therapy COnvenience by the use of one or multipLe Inhalers and digital support in ChrONic Obstructive Pulmonary Disease) trial aims to improve understanding regarding the effectiveness of SITT and smart inhalers in enhancing adherence. This open-label, randomized, multi-center study will enroll COPD patients requiring triple therapy at ten participating hospitals. In total, 300 patients will be randomized into three groups: 1) MITT; 2) SITT; 3) SITT with digital support through a smart inhaler and an e-health platform. The follow-up period will be one year, during which three methods of measuring adherence will be used: smart inhaler data, self-reported data using the Test of Adherence to Inhalers (TAI) questionnaire, and drug analysis in scalp hair samples. Finally, differences in clinical outcomes between the study groups will be compared.
    CONCLUSIONS: Our review suggests promising results concerning the effect of SITT, as opposed to MITT, and smart inhalers on adherence. However, the quality of evidence is limited due to the absence of randomized controlled trials and/or the short duration of follow-up in many studies. Moreover, its impact on clinical outcomes shows considerable variation. The TRICOLON trial aims to provide solid data on these frequently mentioned solutions to non-adherence in COPD. Collecting data in a well-designed randomized controlled trial is challenging, but the design of this trial addresses both the usefulness of SITT and smart inhalers while ensuring minimal interference in participants\' daily lives.
    BACKGROUND: NCT05495698 (Clinicaltrials.gov), registered at 08-08-2022. Protocol version: version 5, date 27-02-2023.
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  • 文章类型: Journal Article
    背景:肠套叠,儿童腹痛的常见原因,通常缺乏明确的根本原因,并且大多是特发性的。复发,虽然罕见,引起临床关注,每次发作后费率都在上升。病理性导联点和过敏性紫癜(HSP)等因素与复发病例有关。另一方面,幽门螺杆菌(H.pylori),通常无症状,儿童人数一直在下降。尽管据报道其感染与HSP有关,其在复发性肠套叠中的作用仍有待探索。需要进一步的研究来了解幽门螺杆菌(罪魁祸首病原体)之间的相互作用,HSP(触发器),以及顽固性肠套叠,从而制定有效的管理策略。
    方法:一个两岁的女孩在不同的部位经历了四次不典型的肠套叠,后来与HSP相吻合。尽管用类固醇治疗,复发性肠套叠持续存在,这表明HSP本身并不是棘手演讲的主要原因。随后确定幽门螺杆菌感染并采用三联疗法治疗可完全缓解其顽固性肠套叠。
    结论:这个有指导意义的案例强调了一个序列,其中幽门螺杆菌感染引发了HSP,随后导致复发性肠套叠。虽然幽门螺杆菌感染在幼儿中并不常见,顽固性肠套叠和激素耐药复发性HSP并存,需要考虑幽门螺杆菌感染是潜在的潜在病原体.
    BACKGROUND: Intussusception, a common cause of abdominal pain in children, often lacks clear underlying causes and is mostly idiopathic. Recurrence, though rare, raises clinical concerns, with rates escalating after each episode. Factors like pathological lead points and Henoch-Schönlein purpura (HSP) are associated with recurrent cases. On the other hand, the prevalence of Helicobacter pylori (H. pylori), often asymptomatic, in children has been declining. Although its infection is reported to be linked with HSP, its role in recurrent intussusception remains unexplored. Further research is needed to understand the interplay among H. pylori (culprit pathogen), HSP (trigger), and intractable intussusception so as to develop effective management strategies.
    METHODS: A two-year-old girl experienced four atypical episodes of intussusception at distinct locations, which later coincided with HSP. Despite treatment with steroids, recurrent intussusception persisted, suggesting that HSP itself was not a major cause for intractable presentations. Subsequent identification of H. pylori infection and treatment with triple therapy resulted in complete resolution of her recalcitrant intussusception.
    CONCLUSIONS: This instructive case underscored a sequence wherein H. pylori infection triggered HSP, subsequently resulting in recurrent intussusception. While H. pylori infection is not common in young children, the coexistence of intractable intussusception and steroid-resistant recurrent HSP necessitates consideration of H. pylori infection as a potential underlying pathogen.
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  • 文章类型: Journal Article
    胃溃疡和胃癌是由幽门螺杆菌引起的,定植在胃粘膜下。使用不同的药物治疗方案来去除它,但是疾病又回来了,变得更有抵抗力,这降低了治疗率。此外,这种细菌现在表现出急剧上升的多重耐药性,需要反复治疗。与常规疗法相比,合成药物的负面影响是非药物疗法的另一个重要因素。流行的抗胃溃疡药物最显著的副作用包括恶心,呕吐,和腹泻。胃溃疡以前已经用草药和补充治疗如益生菌治疗。当摄入益生菌时,宿主经历了一些可能通过改变消化系统中的细菌菌群而带来的优势。此外,更有效的化合物和植物提取物可用于治疗患者。在这篇文章中,我们来看看用于合成胃溃疡治疗的物质和药物。
    Gastric ulcers and gastric cancer are brought on by the Helicobacter pylori bacteria, which colonizes under the stomach mucous membrane. Different medication regimens are used to remove it, but the illness returns and becomes more resistant, which lowers the treatment rates. Additionally, this bacterium now exhibits a skyrocketing level of multi-drug resistance, necessitating recurrent therapeutic treatments. The negative effects of synthetic medications in comparison to conventional therapies are another significant factor in favor of non-pharmacological therapy. The most significant side effects of popular anti-gastric ulcer medications include nausea, vomiting, and diarrhea. Stomach ulcers have previously been treated with herbal remedies and complementary treatments like probiotics. When probiotics are ingested, the host experiences several advantages that may be brought about by altering the bacterial flora in the digestive system. Additionally, stronger-acting chemical compounds and plant extracts can be employed to treat patients. In this article, we look at the substances and medications that are utilized in place of synthetic stomach ulcer-curing treatments.
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  • 文章类型: Meta-Analysis
    美国心脏协会的临床实践指南建议考虑预防性抗凝以预防前部ST段抬高型心肌梗死患者的左心室血栓(LVT)形成。这些指南的证据确定性较低(IIb类,C级),主要依靠案例研究和专家共识来为实践提供信息。我们的目的是比较预防性抗凝的安全性和有效性,除了双重抗血小板治疗,在当前时代的及时直接经皮冠状动脉介入治疗。电子数据库,包括EMBASE,MEDLINE,和Cochrane图书馆,从2012年1月到2022年6月进行了系统搜索。共筛选了7,378份出版物,5篇出版物最终纳入这篇综述:1篇随机对照试验和4篇回顾性研究,涉及1,461例患者.使用固定效应模型汇总数据,并报告为比值比(ORs)和95%置信区间(CI)。感兴趣的主要结果是LVT形成率,次要结局是大出血和全身栓塞的发生率.汇总分析显示,与双重抗血小板治疗相比,三联疗法组的LVT形成率明显较低(OR0.28,95%CI0.11至0.73,p<0.01),出血率明显较高(OR2.85,95%CI1.13至7.24,p=0.03)。两组之间的全身性栓塞发生率没有显着差异(OR0.37,95%CI0.12至1.13,p=0.08)。在这个荟萃分析中,对于接受直接经皮冠状动脉介入治疗的前部ST段抬高型心肌梗死患者,没有确凿的证据支持或反对使用三联疗法预防LVT.有必要进行适当的随机对照试验,以进一步评估LVT预防对该人群大出血风险的益处。
    Clinical practice guidelines from the American Heart Association recommend consideration of prophylactic anticoagulation to prevent left ventricular thrombus (LVT) formation in patients with anterior ST-elevation myocardial infarction. These guidelines were given a low certainty of evidence (class IIb, level C), relying primarily on case studies and expert consensus to inform practice. Our objective was to compare the safety and efficacy of prophylactic anticoagulation, in addition to dual antiplatelet therapy, in the current era of timely primary percutaneous coronary intervention. Electronic databases, including EMBASE, MEDLINE, and Cochrane Library, were systematically searched from January 2012 through June 2022. A total of 7,378 publications were screened, and 5 publications were eventually included in this review: 1 randomized control trial and 4 retrospective studies involving 1,461 patients. Data were pooled using a fixed-effects model and reported as odds ratios (ORs) with 95% confidence intervals (CIs). The primary outcome of interest was the rate of LVT formation, and the secondary outcomes were the rate of major bleeding and systemic embolism. Pooled analysis showed a significantly lower rate of LVT formation (OR 0.28, 95% CI 0.11 to 0.73, p <0.01) and significantly higher rates of bleeding (OR 2.85, 95% CI 1.13 to 7.24, p = 0.03) in the triple therapy group compared with dual antiplatelet therapy. No significant difference was observed in the rate of systemic embolism between the groups (OR 0.37, 95% CI 0.12 to 1.13, p = 0.08). In this meta-analysis, there is no conclusive evidence to either support or oppose the use of triple therapy for LVT prevention in patients with anterior ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. Appropriately powered randomized controlled trials are warranted to further evaluate the benefits of LVT prevention against the risks of major bleeding in this population.
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  • 文章类型: Meta-Analysis
    背景:吸入性糖皮质激素治疗慢性阻塞性肺疾病(COPD)患者的骨折风险存在争议。而一些大规模的随机对照试验并没有解决这个问题。我们的系统评价和荟萃分析包括44项随机对照试验的目的是揭示吸入糖皮质激素对COPD患者骨折风险的影响。
    方法:两名评审者独立检索了PubMed的吸入糖皮质激素或吸入糖皮质激素组合治疗COPD的随机对照试验,Embase,Medline,科克伦图书馆,和WebofScience。主要结果是骨折事件。本研究在PROSPERO注册(CRD42022366778)。
    结果:87,594例患者共进行了44项随机对照试验。含ICS的吸入疗法(RR,1.19;95CI,1.04-1.37;P=0.010),特别是ICS/LABA(RR,1.30;95CI,1.10-1.53;P=0.002)和三联疗法(RR,1.49;95CI,1.03-2.17;P=0.04)与COPD患者的骨折风险增加显著相关。亚组分析显示,治疗持续时间≥12个月(RR,1.19;95CI,1.04-1.38;P=0.01),布地奈德治疗(RR,1.64;95CI。,1.07-2.51;P=0.02),糠酸氟替卡松治疗(RR,1.37;95CI,1.05-1.78;P=0.02),研究参与者的平均年龄≥65岁(RR,1.27;95CI,1.01-1.61;P=0.04),和黄金阶段III(RR,1.18;95CI,1.00-1.38;P=0.04)与骨折风险增加显着相关。此外,布地奈德≥320ug通过MDI投标(RR,1.75;95CI,1.07-2.87;P=0.03)与骨折风险增加显着相关。
    结论:用ICSs吸入治疗,尤其是ICS/LABA或三联疗法,与不使用ICS的吸入治疗相比,COPD患者的骨折风险增加.治疗持续时间,参与者的平均年龄,黄金舞台,药物剂型,和药物剂量参与了这个协会。此外,同一药物的不同吸入装置在骨折风险上也有差异。
    BACKGROUND: The fracture risk of patients with chronic obstructive pulmonary disease (COPD) treated with inhaled corticosteroids is controversial. And some large-scale randomized controlled trials have not solved this problem. The purpose of our systematic review and meta-analysis including 44 RCTs is to reveal the effect of inhaled corticosteroids on the fracture risk of COPD patients.
    METHODS: Two reviewers independently retrieved randomized controlled trials of inhaled corticosteroids or combinations of inhaled corticosteroids in the treatment of COPD from PubMed, Embase, Medline, Cochrane Library, and Web of Science. The primary outcome was a fracture event. This study was registered at PROSPERO (CRD42022366778).
    RESULTS: Forty-four RCTs were performed in 87,594 patients. Inhaled therapy containing ICSs (RR, 1.19; 95%CI, 1.04-1.37; P = 0.010), especially ICS/LABA (RR, 1.30; 95%CI, 1.10-1.53; P = 0.002) and triple therapy (RR, 1.49; 95%CI, 1.03-2.17; P = 0.04) were significantly associated with the increased risk of fracture in COPD patients when compared with inhaled therapy without ICSs. Subgroup analyses showed that treatment duration ≥ 12 months (RR, 1.19; 95%CI, 1.04-1.38; P = 0.01), budesonide therapy (RR, 1.64; 95%CI., 1.07-2.51; P = 0.02), fluticasone furoate therapy (RR, 1.37; 95%CI, 1.05-1.78; P = 0.02), mean age of study participants ≥ 65 (RR, 1.27; 95%CI, 1.01-1.61; P = 0.04), and GOLD stage III(RR, 1.18; 95%CI, 1.00-1.38; P = 0.04) were significantly associated with an increased risk of fracture. In addition, budesonide ≥ 320 ug bid via MDI (RR, 1.75; 95%CI, 1.07-2.87; P = 0.03) was significantly associated with the increased risk of fracture.
    CONCLUSIONS: Inhalation therapy with ICSs, especially ICS/LABA or triple therapy, increased the risk of fracture in patients with COPD compared with inhaled therapy without ICS. Treatment duration, mean age of participants, GOLD stage, drug dosage form, and drug dose participated in this association. Moreover, different inhalation devices of the same drug also had differences in risk of fracture.
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  • 文章类型: Journal Article
    灾难性抗磷脂综合征(CAPS)是一种罕见的实体,世界各地报告了大约600例病例,墨西哥的患病率未知。
    目的:确定墨西哥CAPS的估计患病率。
    方法:在不同的搜索引擎中对孤立的临床病例或病例系列进行了文献检索,使用以下术语:“灾难性抗磷脂综合征”和“墨西哥”,2022年5月。
    结果:我们在尸检中发现了一系列回顾性病例,其中包括12例,两份报告,各包括2例,以及11例孤立临床病例的报告;这些出版物产生于2003年至2020年之间。总的来说,我们收集了27例CAPS的数据,其中16对应于原发性抗磷脂综合征,10与系统性红斑狼疮有关,1例对应于系统性硬化症。2022年墨西哥人口的估计患病率为每1000万居民2例。在该病例系列中,估计死亡率为68%。
    结论:墨西哥的灾难性抗磷脂综合征病例报告不足;识别它们将有助于改善该国目前使用的诊断和治疗策略,鼓励实施三联疗法,在难治性病例中,使用依库珠单抗,降低目前的死亡率。
    Catastrophic antiphospholipid syndrome (CAPS) is a rare entity, approximately 600 cases have been reported around the world, and the prevalence in Mexico is unknown.
    OBJECTIVE: To determine the estimated prevalence of CAPS in Mexico.
    METHODS: A literature search of isolated clinical cases or case series was conducted in diverse search engines, using the terms: \"Catastrophic Antiphospholipid Syndrome\" and \"Mexico\" in May 2022.
    RESULTS: We found a series of retrospective cases in autopsies that included 12 cases, two reports that included 2 cases each, and reports of 11 isolated clinical cases; these publications were generated between 2003 and 2020. In total, we collected data on 27 cases of CAPS, of which 16 correspond to primary antiphospholipid syndrome, 10 are associated with systemic lupus erythematosus, and 1 case corresponds to systemic sclerosis. The estimated prevalence rate in the Mexican population in 2022 is 2 cases per 10,000,000 inhabitants. The estimated mortality was 68% in this case series.
    CONCLUSIONS: Cases of catastrophic antiphospholipid syndrome in Mexico are underreported; identifying them will help improve current diagnostic and therapeutic strategies used in the country, encouraging the implementation of triple therapy and, in refractory cases, the use of eculizumab, to reduce current mortality.
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  • 文章类型: Review
    未经证实:吸入性皮质类固醇(ICS)三联方案治疗哮喘的价值,长效β2-激动剂(LABA),和使用多种吸入器(MITT)递送的长效毒蕈碱拮抗剂(LAMA),或者单个吸入器(SITT)得到越来越多证据的支持,尽管关于使用MITT的研究仍然有限。
    未经证实:临床特征,治疗模式,疾病负担,以及与哮喘中MITT使用相关的持久性/依从性。为了识别参考,从数据库开始到2022年10月搜索MEDLINE数据库。
    UASSIGNED:在哮喘患者中使用MITT不是很频繁,虽然它可以改善肺功能并降低严重加重的发生率。这可能是由于对使用不同设备对治疗依从性和持久性的影响的现有担忧。对结果有负面影响,并担心患者会停止ICS/LABA而不是LAMA。然而,尽管目前的趋势倾向于采用SITT方法,一些医生可能会被诱导开MITT而不是SITT,因为它允许增加或减少三联疗法的单个成分的滴定。显然,有必要进行务实的现实生活研究,以记录何时选择SITT以及何时使用MITT。
    The value of treating asthma with the triple regimen of inhaled corticosteroid (ICS), long-acting β2-agonist (LABA), and long-acting muscarinic antagonist (LAMA) delivered using multiple inhalers (MITT), or a single inhaler (SITT) is supported by a growing body of evidence, although research is still limited regarding the use of MITT.
    Clinical characteristics, treatment patterns, disease burden, and persistence/adherence associated with MITT use in asthma. The MEDLINE database was searched to identify references from inception until October 2022.
    The use of MITT is not very frequent in asthma patients, although it improves lung function and reduces the incidence of severe exacerbations. This may be due to existing concerns about using different devices on adherence and persistence to treatment, with a negative influence on outcomes, and to the fear that the patient will discontinue ICS/LABA but not LAMA. Nevertheless, although the current trend favors the SITT approach, some physicians may be induced to prescribe MITT over SITT because it allows the titration of individual components of triple therapy to be increased or decreased. Therefore, there is an evident need for pragmatic real-life studies to document when to prefer SITT and when MITT should be used.
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  • 文章类型: Journal Article
    未经证实:肺静脉狭窄(PVS)是心房颤动(AF)消融的严重并发症,导致受影响的肺静脉(PV)变窄。介入治疗包括有或没有PV支架的血管成形术。最佳的术后抗血栓治疗尚不清楚。
    UNASSIGNED:探讨抗血栓药物治疗对PV血管成形术后PVS复发的影响。
    UNASSIGNED:在德国的两个中心进行了一项回顾性研究,研究对象是接受PV血管成形术伴或不伴支架植入的患者。介入后抗血栓治疗包括双重抗血小板治疗(DAPT)或口服抗凝与单一或双重抗血小板治疗的组合,干预后3-12个月。建议在干预后3、6和12个月以及症状复发后进行血管造影随访。
    未经授权:30例患者接受了42例PVS的治疗。干预后,28例患者接受三联疗法,14例患者接受双联疗法/DAPT;5/22(22.7%)例患者接受三联疗法,8/14(57.1%)例患者接受双联疗法/DAPTPV(p=.001)发生再狭窄.500天后肺静脉再狭窄的估计自由为18.8±15.8%(双联疗法/DAPT)和76.2±10.5%(三联疗法)(p=.003)。单因素回归分析显示术后药物治疗是再狭窄的重要危险因素(p=0.019)。无论应用抗血栓治疗,均未发生出血事件。
    UNASSIGNED:与双重抗血小板治疗或联合抗凝和单一抗血小板治疗相比,PV血管成形术后三重抗血栓治疗的再狭窄频率较低。三联疗法患者未发生严重出血事件。这些发现需要在更大的患者队列中得到证实。
    UNASSIGNED: Pulmonary vein stenosis (PVS) is a severe complication of atrial fibrillation (AF) ablation resulting in narrowing of affected pulmonary veins (PVs). Interventional treatment consists of angioplasty with or without PV stenting. The optimal postprocedural antithrombotic therapy is not known.
    UNASSIGNED: To investigate the impact of antithrombotic medical therapy on recurrence of PVS after PV angioplasty.
    UNASSIGNED: A retrospective study of patients undergoing PV angioplasty with or without stent implantation in two German centers was performed. Postinterventional antithrombotic therapy consisted of either dual antiplatelet therapy (DAPT) or a combination of oral anticoagulation with single or dual antiplatelet therapy for 3-12 months after intervention. Angiographic follow-up was recommended 3, 6, and 12 months after intervention and in case of symptom recurrence.
    UNASSIGNED: Thirty patients underwent treatment of 42 PVS. After intervention, twenty-eight patients received triple therapy and 14 patients received dual therapy/DAPT; restenosis occurred in 5/22 (22.7%) patients with triple therapy and 8/14 (57.1%) patients with dual therapy/DAPT PV (p = .001). Estimated freedom from PV restenosis after 500 days was 18.8 ± 15.8% (dual therapy/DAPT) and 76.2 ± 10.5% (triple therapy) (p = .003). Univariate regression analysis revealed postprocedural medication as a significant risk factor for restenosis (p = .019). No bleeding events occurred regardless of applied antithrombotic therapy.
    UNASSIGNED: Triple antithrombotic therapy after PV angioplasty is associated with less frequent restenosis as compared to dual antiplatelet therapy or a combination of anticoagulation and single antiplatelet therapy. No severe bleeding events occurred in patients on triple therapy. These findings need to be confirmed in larger patient cohorts.
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  • 文章类型: Systematic Review
    背景:幽门螺杆菌(H.pylori)感染是全球最常见的慢性细菌感染之一。幽门螺杆菌对抗生素的耐药性可能会增加治疗失败的风险。仍然需要补充和替代方案。本研究旨在严格评估京花胃康胶囊(JWC)根除幽门螺杆菌的疗效和安全性。材料和方法:PubMed,Embase,WebofScience,科克伦图书馆,中国国家知识基础设施,万方数字期刊,和中国科技期刊数据库从成立到2022年4月进行了检索。考虑纳入比较JWC和常规治疗组合与常规治疗单独或与安慰剂联合根除幽门螺杆菌的随机对照试验(RCT)。主要结果是幽门螺杆菌根除率。在可能的情况下进行荟萃分析和试验序贯分析(TSA)。结果:共有34项研究纳入统计分析。合并结果显示,与单独使用三联/四联疗法相比,持续2周的JWC可以显着提高幽门螺杆菌的根除率(RR:1.13,95%CI:1.05至1.21,p=0.0008)。然而,TSA未确认获益证据.另一个汇总结果表明,与单独的三联/四联疗法相比,持续4周的JWC联合三联/四联疗法可以显着提高幽门螺杆菌的根除率(RR:1.21,95%CI:1.15至1.27,p<0.00001)。TSA证实了获益的证据。两组不良反应发生率差异无统计学意义。结论:本研究表明,持续4周的JWC可以显着提高H.pylori的根除率,应被视为常规根除H.pylori方案的补充治疗。然而,仍需要更多高质量的RCT来证实这些发现.
    Background: Helicobacter pylori (H. pylori) infection is one of the most common chronic bacterial infections worldwide. The resistance of H. pylori to antibiotics may increase the risk of treatment failure. Complementary and alternative regimens are still needed. This study aimed to critically assess the efficacy and safety of Jinghua Weikang capsule (JWC) for H. pylori eradication. Materials and methods: PubMed, Embase, Web of Science, Cochrane library, China National Knowledge Infrastructure, Wanfang Digital Periodicals, and Chinese Science and Technology Periodicals database were searched from inception to April 2022. Randomized controlled trials (RCTs) comparing a combination of JWC and conventional treatments with conventional treatments alone or combined with a placebo for H. pylori eradication were considered for inclusion. The primary outcome was H. pylori eradication rate. The meta-analysis and trial sequential analysis (TSA) were conducted where possible. Results: A total of 34 studies were included in the statistical analysis. A pooled result showed that JWC with the duration of 2 weeks combined with the triple/quadruple therapy could significantly increase the H. pylori eradication rate compared with the triple/quadruple therapy alone (RR: 1.13, 95% CI: 1.05 to 1.21, p = 0.0008). However, the evidence of benefit was not confirmed by TSA. Another pooled result showed that JWC with the duration of 4 weeks combined with the triple/quadruple therapy could significantly increase the H. pylori eradication rate compared with the triple/quadruple therapy alone (RR: 1.21, 95% CI: 1.15 to 1.27, p < 0.00001). The evidence of benefit was confirmed by TSA. There were no statistically significant differences in the incidence of adverse reactions between the two groups. Conclusion: The present study suggests that JWC with the duration of 4 weeks can significantly improve the H. pylori eradication rate and should be considered as a complementary treatment to conventional regimens for H. pylori eradication. However, more high-quality RCTs are still needed to confirm these findings.
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  • 文章类型: Journal Article
    本研究旨在比较单一吸入器三联疗法和单独三联疗法治疗中重度慢性阻塞性肺疾病(COPD)的疗效和安全性。
    PubMed,Embase,WebofScience,科克伦图书馆,搜索了ClinicalTrials.gov数据库,搜索日期从数据库开始到2022年2月15日。单吸入器三联疗法与单独三联疗法的随机对照试验,从中提取与疗效和安全性相关的结果,并评估了方法学质量和偏倚风险。
    从3437篇文章中筛选了5篇已发表的文章(6项临床试验),共有4075名患者接受单吸入器三联疗法,3533名患者接受单独三联疗法。与单独三联疗法相比,单一吸入器三联疗法显著增加了1秒内从基线开始的用力呼气量的变化(平均差异=0.02L;95%CI,0.00-0.05L;P<0.01),两组间差异有统计学意义。在中重度加重率方面,单一吸入器三联疗法组和单独三联疗法组之间没有发现显着差异(相对风险[RR]=0.97;95%CI,0.85-1.10;P=0.63),圣乔治呼吸问卷相对于基线的变化(平均差异=0.34;95%CI,-0.88至1.57;P=0.58),圣乔治呼吸问卷应答者的比例(RR=0.99;95%CI,0.92-1.06;P=0.77),不良事件(RR=1.07;95%CI,0.90-1.27;P=0.42),严重不良事件(RR=1.02;95%CI,0.88-1.18;P=0.81),死亡率(RR=1.10;95%CI,0.65-1.86;P=0.72),肺炎风险(RR=0.86;95%CI,0.62-1.18;P=0.34),和心血管事件的风险(RR=1.22;95%CI,0.91-1.65;P=0.18)。
    与单独三联疗法相比,单一吸入器三联疗法似乎可以改善中度至重度COPD患者的肺功能,特别是在1秒用力呼气量方面有优势。对于中度至重度COPD患者,单一吸入器三联疗法可能是一种可行且简化的选择;然而,这一结论需要未来的随机对照试验进一步证实.(ClinTher。2022;XX:XXX-XXX)©2022ElsevierHS期刊,Inc.
    This study aimed to compare the efficacy and safety of single inhaler triple therapy and separate triple therapy in the treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD).
    PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov databases were searched, and the search date was set from database inception until February 15, 2022. Randomized controlled trials of single inhaler triple therapy versus separate triple therapy, from which the results related to efficacy and safety profiles were extracted, and the methodologic quality and risk of bias were evaluated.
    Five published articles (6 clinical trials) were screened from 3437 articles with a total of 4075 patients receiving single inhaler triple therapy and 3533 patients receiving separate triple therapy. Compared with separate triple therapy, single inhaler triple therapy significantly increased the change in forced expiratory volume in 1 second from baseline (mean difference = 0.02 L; 95% CI, 0.00-0.05L; P < 0.01), and there was a statistical difference between the 2 groups. No significant difference was found between the single inhaler triple therapy and separate triple therapy groups in terms of moderate to severe exacerbation rate (relative risk [RR] = 0.97; 95% CI, 0.85-1.10; P = 0.63), the change in St. George\'s Respiratory Questionnaire from baseline (mean difference = 0.34; 95% CI, -0.88 to 1.57; P = 0.58), proportion of St. George\'s Respiratory Questionnaire responders (RR = 0.99; 95% CI, 0.92-1.06; P = 0.77), adverse events (RR= 1.07; 95% CI, 0.90-1.27; P = 0.42), serious adverse events (RR = 1.02; 95% CI, 0.88-1.18; P = 0.81), mortality (RR = 1.10; 95% CI, 0.65-1.86; P = 0.72), risk of pneumonia (RR = 0.86; 95% CI, 0.62-1.18; P = 0.34), and risk of cardiovascular events (RR = 1.22; 95% CI, 0.91-1.65; P = 0.18).
    Compared with separate triple therapy, single inhaler triple therapy appears to improve lung function in patients with moderate to severe COPD, especially in terms of forced expiratory volume in 1 second advantages. Single inhaler triple therapy may be a feasible and simplified option for patients with moderate to severe COPD; however, this conclusion needs to be further confirmed by future randomized controlled trials. (Clin Ther. 2022;XX:XXX-XXX) © 2022 Elsevier HS Journals, Inc.
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