Fundus EDucation: Analysing the utility of an online education tool in improving the diagnostic accuracy of non-mydriatic fundus photography image interpretation amongst Emergency Doctors and Medical Students

开始日期2021-07-19

申办/合作机构

The University of New South Wales

NCT02808026 / Completed临床3期

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)

To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).

开始日期2016-06-01

申办/合作机构

Daiichi Sankyo Co., Ltd.

JPRN-jRCT2080221859 / Unknown status临床3期

A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Patients With Severe Hypertension

开始日期2012-07-23

申办/合作机构

Novartis Pharma KK

100 项与高血压，严重相关的临床结果

登录后查看更多信息

100 项与高血压，严重相关的转化医学

登录后查看更多信息

0 项与高血压，严重相关的专利（医药）

登录后查看更多信息

152

项与高血压，严重相关的文献（医药）

2024-09-01·American Journal of Obstetrics & Gynecology MFM

Implementing a nurse-initiated protocol to improve response to perinatal severe hypertension

Article

作者: Young, Megan Lacy ; Mccarley, Charlotte B ; Swaggerty, Robin ; White, Carrie ; Nelson, Cecil H ; Heidel, Robert E ; Otten, Kelsie J ; Zite, Nikki B ; Edwards, Tanika N

BACKGROUNDAn institutional standardized, nurse-initiated protocol was implemented to improve the recognition of and response to perinatal hypertensive emergency.OBJECTIVE(S)The primary aim was to evaluate if the rate of guideline-based treatment of perinatal hypertensive emergency improved with implementation of the protocol.STUDY DESIGNThis quality improvement initiative was developed by a multidisciplinary team and consisted of clinician and nursing education and the implementation of a standardized, nurse-initiated severe hypertension protocol. The project took place in three phases: pre-implementation (July 2020-October 2020), implementation (November 2020-June 2021), and sustainment (July 2021-May 2022). The primary aim was to increase guideline-based treatment of hypertensive emergency among pregnant and postpartum persons. Guideline-based treatment was defined as repeat blood pressure within 30 minutes of severe hypertension to diagnose hypertensive emergency, antihypertensive medication administration within 30 minutes of diagnosis, and appropriately timed repeat blood pressure following treatment. Process measures included time to confirm the diagnosis, initiate the protocol, antihypertensive medication administration, repeat blood pressure after antihypertensive medication administration, and administration of a secondary dose as appropriate. Balancing measures included maternal intensive care unit admission, clinically significant maternal hypotension, fetal demise, neonatal birthweight, and Apgar <7 at 5 minutes. Data were evaluated using between-subjects statistics and a run chart was developed to assess relationship between the protocol and changes in guideline-based treatment over time.RESULTSOverall, 503 hypertensive emergency encounters were identified during the project period (98 [20%] pre-implementation, 172 [34%] implementation, 233 [46%] sustainment). There were higher rates of persons with chronic hypertension and who self-identified as non-Hispanic Black race in the sustainment phase compared to the other phases. Guideline-based treatment increased from 18.4% pre-implementation to 75.1% in sustainment (p<0.001). Each component of guideline-based treatment also improved significantly from pre-implementation to sustainment (p<0.001). No episodes of clinically significant maternal hypotension occurred in any phase. There were four maternal intensive care unit admissions and three fetal demises during the initiative; none were related to hypertensive emergency.CONCLUSION(S)The nurse-initiated protocol for treatment of hypertensive emergency significantly increased guideline-based treatment of perinatal hypertensive emergency, reduced time to diagnose and treat hypertensive emergency, and increased the number of patients receiving treatment when indicated. This protocol was pragmatic, utilizing resources already available on obstetric units. Use of similar protocols may be considered at institutions providing obstetric care to improve recognition of and response to hypertensive emergency which may decrease maternal and neonatal morbidity and mortality related to hypertensive emergency.

2024-08-12·Cureus

Management Strategies for Hypertensive Crisis: A Systematic Review

Review

作者: Jurays, Najwa S ; Alqahtani, Mohammed A ; Althabet, Abdullah A ; Alghamdi, Sara F ; Khan, Naveed N ; Alghamdi, Afyaa M ; Abdalla, Esra M ; Althabet, Abdullah A ; Alassiri, Abdullah M ; Alassiri, Abdullah M ; Zurayyir, Elaf J ; Abdalla, Esra M ; Alzahrani, Hatoon A

A hypertensive crisis is defined as a sudden and significant rise in blood pressure. The blood pressure reading is 180/120 mmHg or higher. A hypertensive crisis is a medical emergency. It can lead to a heart attack, stroke, or other life-threatening medical problems. Investigating the management of the hypertensive crisis was the goal of this study. English-language articles were collected from 2010 to 2024 demonstrating the management of the hypertensive crisis. Overall, there were 15 articles. Surveys and analyses of national databases were the most widely used methods (n=15). The scientific studies documented (1) all investigative studies or reports that included a hypertensive crisis diagnosis, (2) data integrity and reproducibility, and (3) management studies. Other studies show that acute severe hypertension in the hospital is associated with high rates of mortality and morbidity, particularly with new or worsening end-organ damage. The problem is linked to poor medical adherence, but alarmingly low follow-up rates are likely to contribute to a high recurrence rate. The treatment of acute severe hypertension varies according to the hospital unit (medical ward or intensive care unit), medication, and blood pressure targets or thresholds. Because of a lack of evidence-based guidance, arbitrary blood pressure control targets are used, or blood pressure targets are crudely extrapolated from guidelines intended primarily for outpatient management. Patients with acute aortic dissection need to be administered intravenous esmolol within 5 to 10 minutes in order to lower their blood pressure right away. The goal is to maintain a systolic reading of less than 120 mm Hg. Vasodilators such as nitroglycerin or nitroprusside may be administered if the blood pressure persists following beta blocking. Intravenous administration of clevidipine, nicardipine, or phentolamine is required; the initial dose is 5 mg, with subsequent doses given every 10 minutes as necessary to achieve the desired reduction in blood pressure.

2024-08-01·American Journal of Obstetrics and Gynecology

Magnesium sulfate prophylaxis for late-postpartum severe hypertension

Letter

作者: Sibai, Baha ; Cagino, Kristen ; Prabhu, Malavika

We acknowledge that in certain cases, cerebral symptoms may persist for >24 h.In these cases, magnesium sulfate should continue until a full neurol. workup with imaging is complete.

项与高血压，严重相关的新闻（医药）

2024-09-15

·石药集团

石药集团一项Ⅲ期临床研究招募晚期胰腺癌患者

项目介绍：目前，“注射用多西他赛（白蛋白结合型）联合最佳支持治疗对比安慰剂联合最佳支持治疗在晚期胰腺癌中的随机、双盲、多中心Ⅲ期临床研究”正在国内多家医院进行，本试验主要目的是评价注射用多西他赛（白蛋白结合型）联合最佳支持治疗对比安慰剂联合最佳支持治疗在晚期胰腺癌中的疗效（OS），计划招募142例患者。注射用多西他赛（白蛋白结合型）属于化学药品2.2类新药，其有效成分为多西他赛，可作用于细胞微管，促进微管蛋白聚合，同时抑制微管解聚，使细胞停滞于G2/M期，抑制有丝分裂，从而杀死肿瘤细胞。白蛋白结合型制剂降低过敏反应的发生，有助于提高疗效。本试验将为符合条件且自愿参加本研究的患者免费提供研究治疗药物以及研究中规定的检查费用。研究期间，您将得到专业医生团队的指导和用药观察。如果您是晚期胰腺癌患者，您可以关注此招募信息。主要入选标准： 1. 年龄大于等于18周岁（以签署知情同意书当天为准）且自愿签署知情同意书者； 2. 经组织学或细胞学证实为胰腺腺癌（包括腺鳞癌）； 3. 既往经标准治疗（含吉西他滨和含氟尿嘧啶类的方案）后疾病进展或毒性不耐受； 4. 根据RECIST 1.1标准至少有一个可评估病灶； 5. ECOG PS评分0~2分； 6. 良好的器官功能（进行相关检查采血前14天内没有接受过输血或生长因子支持治疗）； 7. 参与者必须同意从签署知情同意书开始至末次给药后至少6个月内采取有效的避孕措施，育龄女性在首次使用试验用药品前7天内的血清妊娠试验为阴性。主要排除标准： 1. 对试验用药品的任何辅料或紫杉烷类药物有严重过敏史者，或对糖皮质激素过敏和/或禁忌症者（包括但不限于活动性消化道溃疡、重症高血压、严重的低钾血症、青光眼等）； 2. 经积极治疗无法缓解的部分或完全性肠梗阻、完全性胆道梗阻的参与者； 3. 既往存在炎性肠病、慢性腹泻、胃肠道出血病史； 4. 首次使用试验用药品前2年内存在过活动性恶性肿瘤，除外本试验中研究的胰腺癌以及任何已经接受过根治性治疗的局部可治愈的肿瘤（例如已切除的基底细胞或鳞状细胞皮肤癌、浅表性膀胱癌、宫颈或乳腺原位癌等）； 5. 活动性乙型肝炎（HBsAg和/或HbcAb阳性但HBV DNA<2000 IU/mL可以纳入）、活动性丙型肝炎（HCV抗体阳性但HCV RNA阴性可以纳入）、HIV抗体阳性的参与者； 6. 既往抗肿瘤治疗毒性未恢复至≤1级（脱发、色素沉着或研究者认为对参与者无安全性风险的其他毒性除外）； 7. 有严重的心血管疾病史，包括但不限于： a. 首次使用试验用药品前6个月内有严重的心脏节律或传导异常，包括但不限于需要临床干预的室性心律失常、Ⅲ度房室传导阻滞等； b. 首次使用试验用药品前6个月内有心肌梗塞、不稳定型心绞痛、血管成形术、冠状动脉搭桥外科手术史； c. 心力衰竭，NYHA分级为Ⅲ级及以上； d. 长QTc综合征或QTc间期> 480毫秒； e. 控制不良的高血压（筛选期收缩压≥160 mmHg和/或舒张压≥100 mmHg）。 8. 首次使用试验用药品前14天内，存在不能控制的需要频繁引流或医疗干预的浆膜腔积液（如胸腔积液、腹腔积液、心包积液等）；需要进行系统性抗细菌、抗真菌或抗病毒治疗的严重或活动性感染（包括结核菌感染等），允许病毒性肝炎参与者接受抗病毒治疗； 9. 其他研究者认为不适合参加临床试验的情况，包括但不限于：参与者并发严重或无法控制的医学病症，存在安全性风险，干扰研究结果的解读，影响试验依从性等情况。联系方式：如果您是符合以上标准的晚期胰腺癌患者，且有意愿参见本临床研究，您可以到以下医院进行垂询，或者直接联系纪老师：15690305919。以下为中心列表：

临床结果临床3期

2024-02-18

·医药地理

新品获批，为先天性高胰岛素血症患者带来新选择

2024年1月16日，亿帆医药全资子公司宿州亿帆药业有限公司申报的二氮嗪口服混悬液（规格：30ml:1.5g）获得国家药品监督管理局的上市批准（批准文号：国药准字H20243049），并视同通过一致性评价。这是国内首家获批的二氮嗪口服混悬液。据CDE公开信息显示，该药品于2022年5月提交注册申请，以“临床急需的短缺药品、防治重大传染病和罕见病等疾病的创新药和改良型新药”为由被纳入优先审评审批程序。01CHI难题待解，二氮嗪成首选治疗药先天性高胰岛素性低血糖血症（Congenital Hyperinsulinemic Hypoglycemia，CHI）又称婴儿持续性高胰岛素血症性低血糖症(PHHI)，于1954年由MacQuarrie首次描述，是由遗传性异常引起胰岛β细胞不适当分泌胰岛素导致的一组严重低血糖症，患者持续、反复发作的低血糖极易造成永久性脑损伤，遗留癫痫、脑性瘫痪（脑瘫）等神经系统损害，后遗症发生率高达25%~50%。2018年5月，CHI被中国第一批《罕见病目录》收录，列于第20条。CHI的发病机制与多种基因突变有关。迄今已发现的致病基因包括GLUD1、GCK、UCP2、HADH、SLC16A1、ABCC8、KCNJ11、HNF4A、HNF1A、HK1、PGM1、PMM2、CACNA1D和FOXA2等。其中，编码胰腺β细胞中腺嘌呤核苷三磷酸（ATP）敏感性K通道的基因（ABCC8和KCNJ11）突变是最常见的病因。二氮嗪作为一种非利尿剂苯并噻嗪类全身性血管扩张剂，最初用于治疗重度高血压。在1960年代，二氮嗪被注意到具有致糖尿病性，并怀疑二氮嗪会阻断胰岛素的释放。二氮嗪通过抑制胰岛素分泌来提高葡萄糖浓度，其作用机制是通过与β细胞上ATP敏感钾通道的磺酰脲类受体１亚基结合后，促使细胞膜电位复极化，使钾通道处于开放状态，从而减少β细胞分泌胰岛素。02二氮嗪供应困境暂缓，罕见病治疗迎来新希望图1：《先天性高胰岛素血症性低血糖诊治专家共识（2022）》在《先天性高胰岛素血症性低血糖诊治专家共识（2022）》中，二氮嗪是被推荐用于治疗先天性高胰岛素性低血糖血症的一线药物（见图1）。根据中国儿童用药数据库的查询结果，二氮嗪口服混悬液上市之前，国内仅有两款注射剂，且均已停产，国内患者面临无药可用的困境。虽然二氮嗪口服混悬液在国内的药品供应情况不容乐观，但这一药物在全球范围内已有较长的应用历史。二氮嗪的混悬剂型最早于1976年在美国获批上市，原研企业是以色列梯瓦公司，该原研产品并未进入国内市场。中国儿童用药数据库中2024年新上线的全球上市药品筛选模块查询结果显示，截至目前为止，中美日已上市且批文状态为有效的二氮嗪药品共8款，其中，美国有3款混悬剂，日本仅有1款胶囊剂，中国有1款混悬剂与2款注射剂（见图2）。图2：二氮嗪全球上市药品剂型规格分布情况来源：中国儿童用药数据库2022年二氮嗪全球销售额为1625万美元，自2015年以来整体呈上升趋势，2020年以后略有下降（见图3）。图3：二氮嗪全球销售额来源：Pharma ONE智能药物大数据分析平台二氮嗪干混悬剂的面世为先天性高胰岛素性低血糖血症患者带来了新的曙光，成为他们目前在国内可以直接购买到的唯一可用的二氮嗪类治疗药物。然而，我们仍需认识到，还有许多罕见病目前尚未有对应的治疗药物，这仍然是一个需要持续关注和努力的领域。近年来，我国罕见疾病药物上市数量呈现明显上升态势，这得益于政府和社会各界的共同努力。国内已发布的《第一批罕见病目录》和《第二批罕见病目录》共收录207种罕见病，其中接近4成已有对应的治疗药物，这些药物的出现，不仅代表了医学研究的成果，更是对罕见病患者的巨大福音。然而，尽管取得了明显的进展，但我国罕见病药物的可及性仍然面临较大的挑战。一些高值药物仍然难以获得，患者的治疗需求仍未得到完全满足。此外，罕见病药物的研发和生产也需要更多的支持和投入，以提高药物的疗效和安全性。长远看来，提升罕见病患者的药物可及性是一个长期而艰巨的任务，需要政府、企业和社会各界等多方协同推进。只有通过合作和创新，我们才能为罕见病患者带来更多的治疗选择和希望。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

上市批准优先审批一致性评价

2024-02-01

·Business Wire

Jason Colodne and Colbeck Capital Support the Weill Cornell Hypertension Center

NEW YORK--( BUSINESS WIRE )--Colbeck Capital Management (“Colbeck”) today announced its support of the Weill Cornell Hypertension Center (the “Hypertension Center”), one of the few U.S. practices dedicated to investigating all forms of hypertension, while providing the most comprehensive and personalized care to patients. Affecting more than one billion people, hypertension, also known as high blood pressure, is the leading cause of death worldwide. The Hypertension Center, part of New York-Presbyterian/Weill Cornell Medicine’s Division of Nephrology and Hypertension, was established over 35 years ago by Dr. John Laragh and offers patients the unique benefits of collaboration between researchers and specialists striving to deliver the latest breakthroughs in medicine. Providing treatment tailored to each patient, the Hypertension Center is committed to understanding the condition’s heterogeneity through ongoing research and innovative clinical therapies. Support from Colbeck, Founding Partner Jason Colodne and his wife Anita, and other donors will help advance the Hypertension Center’s ultimate mission of reducing morbidity and mortality associated with hypertension and ending hypertension-related organ damage which afflicts more than 60% of the U.S. population. Under the Hypertension Center’s world-class care, patients perform much better than the national average with respect to blood pressure control and are significantly better protected from the damaging effects of uncontrolled blood pressure. More information can be found at https://weillcornell.org/hypertension-center . About Colbeck Capital Management Colbeck Capital Management ( colbeck.com ) is a leading, middle-market private credit manager focused on strategic lending. Colbeck lends to companies going through periods of transition, providing creative capital solutions and risk mitigation strategies. Leveraging its deep relationships, Colbeck sponsors its portfolio companies through consistent engagement with management teams in areas such as finance, capital markets and growth strategies, distinguishing itself from traditional lenders. Colbeck was founded in 2009 by Jason Colodne and Jason Beckman, and its principals have extensive experience investing through different market cycles at leading institutions, including Goldman Sachs and Morgan Stanley.