Antihypertensive Agents

抗高血压药
  • 文章类型: Journal Article
    目标:高血压(HT),血脂异常(DL),糖尿病(DM)是心血管疾病的主要危险因素。尽管有广泛的药物来降低这种风险,药物依从性差仍然是一个问题。这项研究的目的是评估这些疾病药物的普遍使用者的药物依从性(HT,DL,DM)使用索赔数据。还检查了与非依从性相关的因素。
    方法:对Tsuruoka代谢组学队列研究的7538名参与者,3693(HT:2702,DL:2112,DM:661)被确定为这些疾病药物的普遍使用者。通过问卷收集有关生活方式的信息。坚持通过覆盖天数(PDC)的比例来评估,PDC≥0.8的参与者被定义为坚持。通过进行多变量逻辑回归确定非依从性的预测因子。
    结果:药物依从性因治疗状态而异。在那些没有合并症的人中,仅使用HT的患者的依从性最高(90.2%),其次是仅DM(81.2%)和仅DL(80.8%)。与每个药物组的不依从性相关的因素是不吃早餐和使用HT药物的人对药物的理解不足。女性,有合并症,有心脏病史,以及那些服用DL药物的人的饮酒习惯,和良好的睡眠质量和不吃早餐的那些DM药物。
    结论:虽然参与者表现出较高的药物依从性,观察到不同药物组的差异。确定的非依从性预测因素可以帮助瞄准那些需要依从性支持的人。
    OBJECTIVE: Hypertension (HT), dyslipidemia (DL), and diabetes mellitus (DM) are major risk factors for cardiovascular diseases. Despite the wide availability of medications to reduce this risk, poor adherence to medications remains an issue. The aim of this study is to evaluate medication adherence of prevalent users in these disease medications (HT, DL, DM) using claims data. Factors associated with non-adherence were also examined.
    METHODS: Of 7538 participants of the Tsuruoka Metabolomics Cohort Study, 3693 (HT: 2702, DL: 2112, DM: 661) were identified as prevalent users of these disease medications. Information on lifestyle was collected through a questionnaire. Adherence was assessed by a proportion of days covered (PDC) and participants with PDC ≥0.8 were defined as adherent. Predictors of non-adherence were determined by performing multivariable logistic regression.
    RESULTS: Medication adherence differed by treatment status. Among those without comorbidities, those with HT-only showed the highest adherence (90.2%), followed by those with DM-only (81.2%) and those with DL-only (80.8%). Factors associated with non-adherence in each medication group were skipping breakfast and poor understanding of medications among those with HT medications, females, having comorbidities, having a history of heart disease, and drinking habit among those with DL medications, and good sleep quality and skipping breakfast among those with DM medications.
    CONCLUSIONS: While participants showed high medication adherence, differences were observed across medication groups. The identified predictors of non-adherence could help target those in need of adherence support.
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  • 文章类型: Journal Article
    目的:对高血压控制的顽固性高血压患者和健康对照者进行活性氮种类和抗氧化能力测定的适当试验的比较分析。
    结果:与干预前阶段的顽固性高血压(RHTN)患者(n=40)相比,控制性高血压患者(n=38)和健康对照(n=38)的平均血清NO2-和NOx水平明显较低,平均AOC明显较高(p<0.001)。血清NO2-,控制的高血压和健康对照的NOx和AOC水平与普萘洛尔治疗后的RHTN患者相当(n=18)。考虑到所有样本(n=114),我们注意到NO2-水平与收缩压(SBP)和舒张压(DBP)(r=0.396,p<0.001和r=0.292,p=0.004)以及总NOx水平与SBP和DBP(分别为r=0.636和r=0.480,p<0.001)。相反,AOC水平与SBP、DBP呈显著负相关(r=-0.846,r=-0.626,p<0.001)。
    OBJECTIVE: To perform a comparative analysis of the extended APPROPRIATE trial of measures of reactive nitrogen species and antioxidant capacity in patients having resistant hypertension with controlled hypertension and healthy controls.
    RESULTS: Mean serum NO2- and NOx levels were significantly lower and mean AOC was significantly higher in patients with controlled hypertension (n = 38) and healthy controls (n = 38) compared to resistant hypertension (RHTN) patients (n = 40) at the pre-intervention stage (p < 0.001). The serum NO2-, NOx and AOC levels of both controlled hypertension and healthy controls were comparable to those of the RHTN patients following treatment with propranolol (n = 18). Considering all samples (n = 114) we noted that there were significant weak and moderate positive correlations between NO2- levels with systolic blood pressure (SBP) and diastolic blood pressure (DBP) (r = 0.396, p < 0.001 and r = 0.292, p = 0.004) as well as total NOx levels with SBP and DBP (r = 0.636 and r = 0.480 respectively, p < 0.001). Conversely, there was a significant negative correlation between AOC levels with SBP and DBP (r= -0.846 and r = -0.626 respectively, p < 0.001).
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  • 文章类型: Journal Article
    目的:英格兰高血压的监测和管理存在不平等。COVID-19大流行对高血压等长期疾病的初级保健管理产生了重大影响。这项研究调查了大流行在患者群体中可能产生的不成比例的影响。
    方法:诊断为高血压的开放队列。
    方法:2019年1月至2022年10月的伦敦东北部初级保健实践。
    方法:所有224329名高血压成年人在193个初级保健实践中登记。
    结果:使用两个指标评估高血压的监测和管理:(i)在指标日期后1年内记录的血压和(ii)根据国家临床实践指南控制血压。
    结果:有同期血压记录的患者比例从大流行前的91%下降到大流行封锁结束时的62%,到研究结束时提高到77%。与此平行的是,患有受控高血压的个体比例从大流行前的73%下降到大流行封锁结束时的50%,并在研究结束时提高到60%。然而,当排除没有最近血压记录的患者时,控制高血压的患者比例增加到81%,分别为80%和78%。在整个研究过程中,与白人相比,黑人族裔群体实现适当血压控制的可能性较小(ORs0.81(95%CI0.78~0.85,p<0.001)~0.87(95%CI0.84~0.91,p<0.001)).相反,亚裔人群更有可能血压得到控制(ORs1.09(95%CI1.05~1.14,p<0.001)~1.28(95%CI1.23~1.32,p<0.001)).男人,年轻的个人,更富裕的人,种族未知或未记录的个体或未经治疗的个体在整个研究中血压控制目标的可能性也较小.
    结论:COVID-19大流行对血压记录的影响大于对血压控制的影响。在大流行期间,血压控制方面的不平等仍然存在,并且仍然很突出。
    OBJECTIVE: There are established inequities in the monitoring and management of hypertension in England. The COVID-19 pandemic had a major impact on primary care management of long-term conditions such as hypertension. This study investigated the possible disproportionate impact of the pandemic across patient groups.
    METHODS: Open cohort of people with diagnosed hypertension.
    METHODS: North East London primary care practices from January 2019 to October 2022.
    METHODS: All 224 329 adults with hypertension registered in 193 primary care practices.
    RESULTS: Monitoring and management of hypertension were assessed using two indicators: (i) blood pressure recorded within 1 year of the index date and (ii) blood pressure control to national clinical practice guidelines.
    RESULTS: The proportion of patients with a contemporaneous blood pressure recording fell from a 91% pre-pandemic peak to 62% at the end of the pandemic lockdown and improved to 77% by the end of the study. This was paralleled by the proportion of individuals with controlled hypertension which fell from a 73% pre-pandemic peak to 50% at the end of the pandemic lockdown and improved to 60% by the end of the study. However, when excluding patients without a recent blood pressure recording, the proportions of patients with controlled hypertension increased to 81%, 80% and 78% respectively.Throughout the study, in comparison to the White ethnic group, the Black ethnic group was less likely to achieve adequate blood pressure control (ORs 0.81 (95% CI 0.78 to 0.85, p<0.001) to 0.87 (95% CI 0.84 to 0.91, p<0.001)). Conversely, the Asian ethnic group was more likely to have controlled blood pressure (ORs 1.09 (95% CI 1.05 to 1.14, p<0.001) to 1.28 (95% CI 1.23 to 1.32, p<0.001)). Men, younger individuals, more affluent individuals, individuals with unknown or unrecorded ethnicity or those untreated were also less likely to have blood pressure control to target throughout the study.
    CONCLUSIONS: The COVID-19 pandemic had a greater impact on blood pressure recording than on blood pressure control. Inequities in blood pressure control persisted during the pandemic and remain outstanding.
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  • 文章类型: Journal Article
    目的:高血压构成了重大的公共卫生挑战。尽管高血压管理的临床实践指南,临床医生对这些指南的依从性仍然欠佳。
    目的:建立严重高血压的次优依从性分类方案,并确定指南依从性的障碍。
    使用耶鲁纽黑文卫生系统的电子健康记录(EHR)进行的定性内容分析包括在2013年1月1日至2021年12月31日期间至少连续2次就诊血压显着升高(BP;定义为至少2次连续读数收缩压≥160mmHg和舒张压≥100mmHg)的参与者,并且在第二次BP测量后90天内没有处方降压药。数据分析于2023年1月至12月进行。
    方法:主要结果是导致临床医生不遵守高血压管理指南的情景和影响因素。对EHR数据进行了主题分析,以生成严重高血压管理中临床医生指南依从性欠佳的情景的实用分类法。
    结果:在20654名符合标准的患者中,随机选择200名患者,并在分析100名患者后达到主题饱和(索引访视时的平均[SD]年龄,66.5[12.8]岁;50名女性[50%];8名黑人[8%];5名西班牙裔或拉丁裔[5%];85名白人[85%])。出现了三个内容领域:(1)与临床医生相关的场景(定义为由于与临床医生意图有关的问题而未开始或未加强治疗,能力,或范围),其中包括2个子类别(未解决和责任扩散);(2)与患者相关的情景(定义为由于患者行为考虑而未开始或未加强治疗),其中包括2个子类别(患者不依从性和患者偏好);(3)临床复杂性相关情景(定义为由于临床情境复杂性而未开始或未强化治疗),其中包括3个子类别(诊断不确定性,维持当前的干预,和相互竞争的医疗优先事项)。
    结论:在这项对EHR数据的定性研究中,本研究建立了重度高血压患者亚最佳依从性的分类法,并确定了指南依从性的障碍.这种实用分类法为开发有针对性的干预措施奠定了基础,以提高临床医生对指南和患者预后的依从性。
    OBJECTIVE: Hypertension poses a substantial public health challenge. Despite clinical practice guidelines for hypertension management, clinician adherence to these guidelines remains suboptimal.
    OBJECTIVE: To develop a taxonomy of suboptimal adherence scenarios for severe hypertension and identify barriers to guideline adherence.
    UNASSIGNED: This qualitative content analysis using electronic health records (EHRs) of Yale New Haven Health System included participants who had at least 2 consecutive visits with markedly elevated blood pressure (BP; defined as at least 2 consecutive readings of systolic BP ≥160 mm Hg and diastolic BP ≥100 mm Hg) between January 1, 2013, and December 31, 2021, and no prescription for antihypertensive medication within a 90 days of the second BP measurement. Data analysis was conducted from January to December 2023.
    METHODS: The primary outcome was scenarios and influencing factors contributing to clinician nonadherence to the guidelines for hypertension management. A thematic analysis of EHR data was conducted to generate a pragmatic taxonomy of scenarios of suboptimal clinician guideline adherence in the management of severe hypertension.
    RESULTS: Of the 20 654 patients who met criteria, 200 were randomly selected and thematic saturation was reached after analyzing 100 patients (mean [SD] age at index visit, 66.5 [12.8] years; 50 female [50%]; 8 Black [8%]; 5 Hispanic or Latino [5%]; 85 White [85%]). Three content domains emerged: (1) clinician-related scenarios (defined as noninitiation or nonintensification of treatment due to issues relating to clinician intention, capability, or scope), which included 2 subcategories (did not address and diffusion of responsibility); (2) patient-related scenarios (defined as noninitiation or nonintensification of treatment due to patient behavioral considerations), which included 2 subcategories (patient nonadherence and patient preference); and (3) clinical complexity-related scenarios (defined as noninitiation or nonintensification of treatment due to clinical situational complexities), which included 3 subcategories (diagnostic uncertainty, maintenance of current intervention, and competing medical priorities).
    CONCLUSIONS: In this qualitative study of EHR data, a taxonomy of suboptimal adherence scenarios for severe hypertension was developed and barriers to guideline adherence were identified. This pragmatic taxonomy lays the foundation for developing targeted interventions to improve clinician adherence to guidelines and patient outcomes.
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  • 文章类型: Journal Article
    背景:对于一些患有低血压和虚弱的老年患者,建议停用抗高血压药物。OPTiMISE试验表明,与常规护理相比,3个月时血压控制没有差异,可以实现这种非处方。我们旨在研究开处方对长期住院和死亡率的影响。
    方法:这项随机对照试验招募了来自英格兰中部和南部69个一般实践的参与者。80岁或以上的参与者,收缩压低于150mmHg,并且正在接受两种或两种以上的抗高血压药物,被随机分配(1:1)接受降压药减少(去除一种降压药)或常规治疗。全科医生和参与者知道随机化后的治疗分配,但在整个研究中,负责分析数据的个人被掩盖在治疗分配中。随机分组后至少3年,通过初级和二级保健电子健康记录对参与者进行了随访。主要结果是全因住院时间或死亡。使用Cox回归模型进行意向治疗分析。还对主要结果进行了符合方案的分析,排除干预组中未减少治疗或在初始试验12周随访期间恢复药物治疗的参与者.本研究已在欧盟药物监管机构临床试验数据库(EudraCT2016-004236-38)和ISRCTN注册中心(ISRCTN97503221)注册。
    结果:在2017年3月20日至2018年9月30日之间,共有569名参与者被随机分配。其中,564例(99%;干预=280;对照组=284)随访,中位随访时间为4·0年(IQR3·7-4·3)。参与者在基线时的平均年龄为84·8岁(SD3·4),其中273(48%)为女性。109名参与者在随访时持续减少药物治疗(干预组213名参与者中有51%活着)。与对照组相比,干预组参与者的抗高血压药物减少幅度更大(校正平均差异-0·35药物[95%CI-0·52至-0·18])。总的来说,干预组的202名(72%)参与者和对照组的218名(77%)参与者在随访期间经历了住院或死亡(调整后的风险比[aHR]0·93[95%CI0·76至1·12])。有一些证据表明,在干预组(aHR0·80[0·64to1·00])中,在符合方案人群中经历主要结局的参与者比例较低。
    结论:一半的参与者持续减少用药,没有证据表明全因住院或死亡率增加。这些发现表明,对于80岁或80岁以上血压控制的人,服用两种或多种抗高血压药的抗高血压药物可能是安全的。
    背景:英国心脏基金会和国家健康与护理研究所。
    BACKGROUND: Deprescribing of antihypertensive medications is recommended for some older patients with low blood pressure and frailty. The OPTiMISE trial showed that this deprescribing can be achieved with no differences in blood pressure control at 3 months compared with usual care. We aimed to examine effects of deprescribing on longer-term hospitalisation and mortality.
    METHODS: This randomised controlled trial enrolled participants from 69 general practices across central and southern England. Participants aged 80 years or older, with systolic blood pressure less than 150 mm Hg and who were receiving two or more antihypertensive medications, were randomly assigned (1:1) to antihypertensive medication reduction (removal of one antihypertensive) or usual care. General practitioners and participants were aware of the treatment allocation following randomisation but individuals responsible for analysing the data were masked to the treatment allocation throughout the study. Participants were followed up via their primary and secondary care electronic health records at least 3 years after randomisation. The primary outcome was time to all-cause hospitalisation or mortality. Intention-to-treat analyses were done using Cox regression modelling. A per-protocol analysis of the primary outcome was also done, excluding participants from the intervention group who did not reduce treatment or who had medication reinstated during the initial trial 12-week follow-up period. This study is registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT2016-004236-38) and the ISRCTN Registry (ISRCTN97503221).
    RESULTS: Between March 20, 2017, and Sept 30, 2018, a total of 569 participants were randomly assigned. Of these, 564 (99%; intervention=280; control=284) were followed up for a median of 4·0 years (IQR 3·7-4·3). Participants had a mean age of 84·8 years (SD 3·4) at baseline and 273 (48%) were women. Medication reduction was sustained in 109 participants at follow-up (51% of the 213 participants alive in the intervention group). Participants in the intervention group had a larger reduction in antihypertensives than the control group (adjusted mean difference -0·35 drugs [95% CI -0·52 to -0·18]). Overall, 202 (72%) participants in the intervention group and 218 (77%) participants in the control group experienced hospitalisation or mortality during follow-up (adjusted hazard ratio [aHR] 0·93 [95% CI 0·76 to 1·12]). There was some evidence that the proportion of participants experiencing the primary outcome in the per-protocol population was lower in the intervention group (aHR 0·80 [0·64 to 1·00]).
    CONCLUSIONS: Half of participants sustained medication reduction with no evidence of an increase in all-cause hospitalisation or mortality. These findings suggest that an antihypertensive deprescribing intervention might be safe for people aged 80 years or older with controlled blood pressure taking two or more antihypertensives.
    BACKGROUND: British Heart Foundation and National Institute for Health and Care Research.
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  • 文章类型: Journal Article
    背景:成人高血压患者的自我护理包括坚持生活方式和药物治疗。对于患有高血压的无偿护理人员,家庭照顾的负担可能会对自我照顾产生不利影响。我们研究了高血压护理人员的压力与高血压自我护理之间的关系。
    结果:我们纳入了REGARDS(卒中地理和种族差异的原因)研究的参与者,他们被确定为照顾者并患有高血压。看护者劳损,通过自我报告评估,被归类为“无/有些”或“高”。“高血压自我护理在5个领域进行了单独评估(停止高血压的饮食方法[DASH]饮食,身体活动,酒精使用,吸烟,和药物依从性)和综合自我护理评分,总结他们的表现。使用多变量线性回归检查了护理人员压力与高血压自我护理之间的关联。在2128名高血压患者中,18.1%的人报告护理人员压力较高。高应变的照顾者与无/有的照顾者对DASH饮食的依从性较低(50.8%对38.9%,P<0.002),身体不活动(44.4%对36.2%,P<0.009),目前的吸烟者(19.7%对13.9%,P<0.004),总体自我护理得分较低(6.6[SD1.7]对7.0[SD1.7],P<0.001)。在年龄调整模型中,高照顾者压力与高血压自我护理能力较差相关(β=-0.37[95%CI,-0.61至-0.13]);这仍然是显著的,但在调整社会人口统计学(β=-0.35[-0.59至-0.11])后,合并症(β=-0.34[-0.57至-0.10]),护理强度(β=-0.34[-0.59至0.10]),和心理因素(β=-0.26[-0.51至0.00])。
    结论:高照顾者压力与整体和个体领域较差的高血压自我护理相关。有必要提高对护理人员压力及其对高血压自我护理的潜在影响的认识。
    BACKGROUND: Self-care for adults with hypertension includes adherence to lifestyle behaviors and medication. For unpaid caregivers with hypertension, the burden of family caregiving may adversely impact self-care. We examined the association between caregiver strain and hypertension self-care among caregivers with hypertension.
    RESULTS: We included participants of the REGARDS (Reasons for Geographic and Racial Differences in Stroke) study who identified as caregivers and had hypertension. Caregiver strain, assessed by self-report, was categorized as \"none/some\" or \"high.\" Hypertension self-care was assessed individually across 5 domains (Dietary Approaches to Stop Hypertension [DASH] diet, physical activity, alcohol use, cigarette smoking, and medication adherence) and a composite self-care score summing performance across them. The association between caregiver strain and hypertension self-care was examined with multivariable linear regression. Among the 2128 caregivers with hypertension, 18.1% reported high caregiver strain. Caregivers with high strain versus those with none/some were less adherent to the DASH diet (50.8% versus 38.9%, P<0.002), physically inactive (44.4% versus 36.2%, P<0.009), current smokers (19.7% versus 13.9%, P<0.004), and had lower overall self-care scores (6.6 [SD 1.7] versus 7.0 [SD 1.7], P<0.001). In an age-adjusted model, high caregiver strain was associated with worse hypertension self-care (β=-0.37 [95% CI, -0.61 to -0.13]); this remained significant but was reduced in magnitude after adjustment for sociodemographics (β=-0.35 [-0.59 to -0.11]), comorbidities (β=-0.34 [-0.57 to -0.10]), caregiving intensity (β=-0.34 [-0.59 to 0.10]), and psychological factors (β=-0.26 [-0.51 to 0.00]).
    CONCLUSIONS: High caregiver strain was associated with worse hypertension self-care overall and across individual domains. Increased awareness of caregiver strain and its potential impact on hypertension self-care is warranted.
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  • 文章类型: Journal Article
    背景:尽管在HIV治疗方面取得了成功,在博茨瓦纳的HIV感染者(PLWH)中,高血压(HTN)和心血管疾病(CVD)的诊断和管理仍然欠佳,总体HTN控制仅为19%,而98%的HIV病毒被抑制。尽管有心血管疾病初级保健国家指南和包括抗高血压药物在内的免费医疗保健,但这些差距仍然存在。我们的研究旨在开发和测试策略,以缩小PLWH的HTN护理差距,通过融入艾滋病毒护理,利用成功的国家艾滋病毒护理和治疗计划和战略。
    方法:InterCARE试验是一项集群随机对照混合2型有效性实施试验,在14个地点进行,旨在招募4652名感染HIV和HTN的成年人以及多达2326名治疗伙伴。主要成果包括有效性(HTN控制)和使用达到有效性采用实施和维护框架的实施成果,使用解释性混合方法来理解结果的变异性。InterCARE试验的主要策略包括医护人员HTN和CVD护理培训以及长期实践促进,电子健康记录(EHR)文件的关键指标和使用提醒,以及使用治疗伙伴为艾滋病毒和HTN感染者提供社会支持。InterCARE从形成性研究开始,使用实施研究综合框架来确定影响护理差距的环境因素。结果用于调整初始和制定其他实施策略,以解决障碍和利用促进者。该包裹在两个诊所进行了试点测试,研究结果用于进一步调整或增加临床试验的策略。
    结论:如果成功,InterCARE模式可以扩大到全国的艾滋病毒诊所,以改善诊断,管理,在博茨瓦纳的支持。该试验将为该地区将HTN纳入艾滋病毒护理的扩大提供见解。
    背景:ClinicalTrials.gov参考NCT05414526。2022年5月18日注册,https://clinicaltrials.gov/study/NCT05414526?term=NCT05414526。&rank=1。
    BACKGROUND: Despite success in HIV treatment, diagnosis and management of hypertension (HTN) and cardiovascular disease (CVD) remains suboptimal among people living with HIV (PLWH) in Botswana, with an overall HTN control of only 19% compared to 98% HIV viral suppressed. These gaps persist despite CVD primary care national guidelines and availability of free healthcare including antihypertensive medications. Our study aims to develop and test strategies to close the HTN care gap in PLWH, through integration into HIV care, leveraging the successful national HIV care and treatment program and strategies.
    METHODS: The InterCARE trial is a cluster randomized controlled hybrid type 2 effectiveness-implementation trial at 14 sites designed to enroll 4652 adults living with HIV and HTN plus up to 2326 treatment partners. Primary outcomes included effectiveness (HTN control) and implementation outcomes using the Reach Effectiveness Adoption Implementation and Maintenance framework, with explanatory mixed methods used to understand variability in outcomes. InterCARE trial\'s main strategies include healthcare worker HTN and CVD care training plus long-term practice facilitation, electronic health record (EHR) documentation of key indicators and use of reminders, and use of treatment partners to provide social support to people living with HIV and HTN. InterCARE started with formative research to identify contextual factors influencing care gaps using the Consolidated Framework for Implementation Research. Results were used to adapt initial and develop additional implementation strategies to address barriers and leverage facilitators. The package was pilot tested in two clinics, with findings used to further adapt or add strategies for the clinical trial.
    CONCLUSIONS: If successful, the InterCARE model can be scaled up to HIV clinics nationwide to improve diagnosis, management, and support in Botswana. The trial will provide insights for scale-up of HTN integration into HIV care in the region.
    BACKGROUND: ClinicalTrials.gov reference NCT05414526. Registered 18 May 2022, https://clinicaltrials.gov/study/NCT05414526?term=NCT05414526.&rank=1 .
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  • 文章类型: Journal Article
    背景:原发性开角型青光眼(POAG),通常与眼内压(IOP)升高有关,会导致视神经的永久性损伤,伴随的视野丧失,和失明。拉坦前列素,前列腺素F2α类似物,降低IOP,用于治疗青光眼。在这个临床试验中,我们评估了拉坦前列素Polpharma的疗效,通用的无防腐剂拉坦前列素0.05mg/ml滴眼液,与鼻祖Xalatan®(拉坦前列素0.005%滴眼液,辉瑞)。
    方法:这是第三阶段,多中心,随机化,调查员-蒙面,cross-over,比较,在匈牙利和俄罗斯的5个地点进行了非劣效性试验。主要终点是评估测试产品在第1天(基线)和第29天的平均昼夜IOP的差异与参考产品相比时的非劣效性。次要终点包括疗效,眼公差,安全,和可用性。我们招募了患有开角型青光眼或高眼压的成年患者(18-75岁)。
    结果:49名患者被随机分组并接受至少一个剂量的测试或参考产品。用试验产品或参比产品治疗后,平均每日眼压下降几乎相同,为7.04±2.14mmHg或7.17±2.11mmHg。分别(N=44)。在对待分析的意图中,用试验产品或参比产品处理后,下降幅度为7.29±2.53mmHg(95%CI:6.55-8.04)或7.43±2.78mmHg(95CI:6.61-8.24),(N=47)。无严重不良事件发生。
    结论:拉坦前列素Polpharma被证明不劣于Xalatan®。两种研究产品同样具有良好的耐受性和安全性。数据显示了在充血症的严重程度和眼部不适的缓解速度方面有利于测试产品的趋势。拉坦前列素Polpharma,不含防腐剂,也避免了苯扎氯铵的细胞毒性,副作用可能会影响患者的依从性并降低生活质量。
    背景:该研究获得了美国国家药学与营养研究所(OGYEI,OGYEI/41,779-11/2018)和匈牙利临床药理学伦理委员会(KFEB)以及俄罗斯联邦卫生部(俄罗斯卫生部)在研究开始之前(642/25.12.2018)(临床试验标识号:848,300,144/0103/1-POP03;IND编号/EudraCT编号:2018-001727-39)。
    BACKGROUND: Primary open-angle glaucoma (POAG), often associated with increased intraocular pressure (IOP), can lead to permanent damage of the optic nerve, concomitant visual field loss, and blindness. Latanoprost, a prostaglandin F2α analogue, reduces IOP and is used to treat glaucoma. In this clinical trial, we evaluated the efficacy of Latanoprost Polpharma, a generic preservative-free latanoprost 0.05 mg/ml eye drops solution, in lowering IOP when compared to the originator Xalatan® (latanoprost 0.005% ophthalmic solution, Pfizer).
    METHODS: This was a Phase III, multicentre, randomized, investigator-masked, cross-over, comparative, non-inferiority trial carried out in 5 sites in Hungary and Russia. The primary endpoint was to evaluate the non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP on Day 1 (baseline) and Day 29. The secondary endpoints included efficacy, ocular tolerance, safety, and usability. We recruited adult patients (18-75 years) with open-angle glaucoma or ocular hypertension.
    RESULTS: Forty-nine patients were randomised and received at least one dose of the test or reference product. A virtually identical reduction of the mean diurnal IOP of 7.04 ± 2.14 mmHg or 7.17 ± 2.11 mmHg was found after treatment with test or reference product, respectively (N = 44). In the intention to treat analysis, the reduction was 7.29 ± 2.53 mmHg (95% CI: 6.55-8.04) or 7.43 ± 2.78 mm Hg (95%CI: 6.61-8.24) after treatment with test or reference product, respectively (N = 47). There were no serious adverse events.
    CONCLUSIONS: Latanoprost Polpharma was shown to be non-inferior to Xalatan®. Both investigational products were equally well tolerated and safe. The data show a trend in favour of the test product with regards to the severity of hyperaemia and to the velocity of remission of ocular discomfort. Latanoprost Polpharma, being preservative-free, also avoids the cytotoxicity of benzalkonium chloride, the side effects of which may affect patient compliance and lower the quality of life.
    BACKGROUND: The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI/41,779- 11/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642/25.12.2018) (clinical trial identification number: 848,300,144/0103/1 - POP03; IND number/EudraCT number: 2018-001727-39).
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  • 文章类型: Journal Article
    阻塞性睡眠呼吸暂停(OSA)与顽固性高血压(RH)有密切关系。然而,缺乏评估诊断和治疗OSA对这些患者血压(BP)控制的长期影响的研究.为了解决这个差距,我们从高血压病房招募了478例RH患者,并在通过睡眠研究筛查OSA后对他们进行了前瞻性随访.通过每年进行24小时动态血压监测(24小时ABPM),评估OSA管理的效果.患者的中位年龄为64[57.2;69.0]岁,67%是男性,大多数人都不困,中位呼吸暂停低通气指数(AHI)为15.8[7.9;30.7]事件/小时。中位随访时间为3.01[2.93;3.12]年。在基线,重度OSA与血压控制相关,夜间高血压,和非北斗星昼夜节律血压模式。此外,这些患者在随访期间的BP值高于其他组.然而,在中度和重度OSA患者中,睡眠呼吸紊乱的管理,包括实施CPAP治疗,与24小时ABPM参数的降低有关,尤其是夜间血压值,在为期一年的随访中。这些好处随着时间的推移而减弱,并且只有重度OSA的受试者在三年时保持ABPM夜间减少。此外,临床变量,如不受控制的血压,性别和年龄对随访1年的血压反应有预测价值.总之,在一组来自高血压单位的RH患者中,通过诊断和治疗OSA检测到BP的长期良好下降,但随着时间的推移,这种下降在重度OSA患者中仅部分维持(NCT03002558).
    BACKGROUND: There is a close relationship between obstructive sleep apnoea (OSA) and resistant hypertension (RH). However, studies assessing the long-term effect of diagnosing and treating OSA on blood pressure (BP) control in these patients are lacking.
    METHODS: To address this gap, we recruited 478 RH patients from hypertension units and followed them prospectively after they were screened for OSA through a sleep study. By performing 24-h ambulatory BP monitoring (ABPM) annually, the effect of OSA management was assessed.
    RESULTS: The patients had a median (interquartile range (IQR)) age of 64.0 (57.2-69.0) years, 67% were males and most were nonsleepy, with a median (IQR) apnoea-hypopnoea index (AHI) of 15.8 (7.9-30.7) events·h-1. The median (IQR) follow-up time was 3.01 (2.93-3.12) years. At baseline, severe OSA was associated with uncontrolled BP, nocturnal hypertension and a nondipper circadian BP pattern. Moreover, these patients had higher BP values during follow-up than did patients in the other groups. However, among patients with moderate and severe OSA, the management of sleep disordered breathing, including the implementation of continuous positive airway pressure treatment, was associated with a reduction in 24-h ABPM parameters, especially night-time BP values, at the 1-year follow-up. These benefits were attenuated over time and only subjects with severe OSA maintained an ABPM night-time reduction at 3 years. Furthermore, clinical variables such as uncontrolled BP, sex and age showed a predictive value for the BP response at 1 year of follow-up.
    CONCLUSIONS: A favourable long-term decrease in BP was detected by diagnosing and treating OSA in a cohort of RH patients from hypertension units, but over time this decrease was only partially maintained in severe OSA patients.
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  • 文章类型: Journal Article
    目的:评估临床决策支持系统(CDSS)在改善中国初级医疗机构中指南一致的抗高血压治疗的有效性。
    方法:务实,开放标签,集群随机试验。
    方法:2019年8月至2022年7月期间,中国四个城市地区的94项初级保健实践:洛阳(中国中部),济宁(华东),和深圳(华南,包括两个区域)。
    方法:94个实践是随机的(46到CDSS,48到常规护理)。纳入了12137名高血压患者,他们使用了多达两类抗高血压药物,收缩压<180mmHg,舒张压<110mmHg。
    方法:初级保健实践随机使用基于电子健康记录的CDSS,它推荐了一个具体的指导方针,滴定,或转换抗高血压药(干预),或在没有CDSS的情况下使用相同的电子健康记录,并照常提供治疗(对照)。
    方法:主要结局是高血压相关就诊的比例,在此期间提供了适当的(指南一致)治疗。次要结果是收缩压的平均降低和最后一次计划随访时血压控制(<140/90mmHg)的参与者比例。安全性结果为患者报告的降压治疗相关事件,包括晕厥,伤害性坠落,症状性低血压或收缩压<90mmHg,和心动过缓.
    结果:5755名参与者,干预组23113次访问,对照组6382名参与者,27868次访问。平均年龄为61(标准差13)岁,女性占42.5%。在中位11.6个月的随访期间,干预组给予适当治疗的就诊比例高于对照组(77.8%(17975/23113)对62.2%(17328/27868);绝对差异15.2个百分点(95%置信区间(CI)10.7~19.8);P<0.001;比值比2.17(95%CI1.75~2.69;P<0.001).与对照组的参与者相比,干预组患者收缩压降低1.6mmHg(95%CI-2.7~-0.5)(-1.5mmHgv0.3mmHg;P=0.006),血压控制率提高4.4个百分点(95%CI-0.7~9.5)(69.0%(3415/4952)v64.6%(3778/5845);P=0.07).两组患者报告的降压治疗相关不良反应均罕见。
    结论:在中国初级保健中使用CDSS改善了指导一致的抗高血压治疗的提供,并导致血压适度降低。CDSS提供了一种有希望的方法来提供更好的高血压护理,既安全又高效。
    背景:ClinicalTrials.govNCT03636334。
    To evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of guideline accordant antihypertensive treatment in primary care settings in China.
    Pragmatic, open label, cluster randomised trial.
    94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen (south China, including two regions).
    94 practices were randomised (46 to CDSS, 48 to usual care). 12 137 participants with hypertension who used up to two classes of antihypertensives and had a systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg were included.
    Primary care practices were randomised to use an electronic health record based CDSS, which recommended a specific guideline accordant regimen for initiation, titration, or switching of antihypertensive (the intervention), or to use the same electronic health record without CDSS and provide treatment as usual (control).
    The primary outcome was the proportion of hypertension related visits during which an appropriate (guideline accordant) treatment was provided. Secondary outcomes were the average reduction in systolic blood pressure and proportion of participants with controlled blood pressure (<140/90 mm Hg) at the last scheduled follow-up. Safety outcomes were patient reported antihypertensive treatment related events, including syncope, injurious fall, symptomatic hypotension or systolic blood pressure <90 mm Hg, and bradycardia.
    5755 participants with 23 113 visits in the intervention group and 6382 participants with 27 868 visits in the control group were included. Mean age was 61 (standard deviation 13) years and 42.5% were women. During a median 11.6 months of follow-up, the proportion of visits at which appropriate treatment was given was higher in the intervention group than in the control group (77.8% (17 975/23 113) v 62.2% (17 328/27 868); absolute difference 15.2 percentage points (95% confidence interval (CI) 10.7 to 19.8); P<0.001; odds ratio 2.17 (95% CI 1.75 to 2.69); P<0.001). Compared with participants in the control group, those in the intervention group had a 1.6 mm Hg (95% CI -2.7 to -0.5) greater reduction in systolic blood pressure (-1.5 mm Hg v 0.3 mm Hg; P=0.006) and a 4.4 percentage point (95% CI -0.7 to 9.5) improvement in blood pressure control rate (69.0% (3415/4952) v 64.6% (3778/5845); P=0.07). Patient reported antihypertensive treatment related adverse effects were rare in both groups.
    Use of a CDSS in primary care in China improved the provision of guideline accordant antihypertensive treatment and led to a modest reduction in blood pressure. The CDSS offers a promising approach to delivering better care for hypertension, both safely and efficiently.
    ClinicalTrials.gov NCT03636334.
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