更新于：2024-05-01

Uterine Prolapse

子宫脱垂

更新于：2024-05-01

基本信息

别名

Descens uteri、Descensus uteri、Hernia, uterine

+ [45]

简介

Downward displacement of the UTERUS. It is classified in various degrees: in the first degree the UTERINE CERVIX is within the vaginal orifice; in the second degree the cervix is outside the orifice; in the third degree the entire uterus is outside the orifice.

关联

项与子宫脱垂相关的药物

Chaihu Oral Liquid

柴胡口服液

靶点-

作用机制-

在研机构

河南天方药业中药有限公司

原研机构

河南天方药业中药有限公司

在研适应症

发热 [+2]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2019-11-08

188

项与子宫脱垂相关的临床试验

CTRI/2023/07/055030 / Not yet recruiting临床2/3期

An Anatomico clinical study on comparative effect of Mulbandha and Matra Basti along with Pichu Dharan in Yonibhransha with special reference to to 1st and 2nd Degree Utero-vaginal Prolapse

开始日期2024-06-04

申办/合作机构-

ChiCTR2400082539 / Suspended早期临床1期IIT

Effect of ropivacaine combined with dexmedetomidine in quadrat block on postoperative analgesia of gynecological laparoscopic surgery

开始日期2024-04-01

申办/合作机构-

NCT06024109 / RecruitingN/A

Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.
Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

开始日期2024-03-19

申办/合作机构

Aesculap AG

100 项与子宫脱垂相关的临床结果

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100 项与子宫脱垂相关的转化医学

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0 项与子宫脱垂相关的专利（医药）

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2,534

项与子宫脱垂相关的文献（医药）

2024-02-16·Medicine

A case report of vaginal delivery in the second trimester of severe uterine prolapse complicated with cervical incarceration.

Article

作者: Xiaoyue Yang ; Tongfu Feng

BACKGROUND:

Uterine prolapse is a rare complication of pregnancy, and there is still no consensus on the choice of delivery method.

METHODS:

The patient's reproductive history included an abortion and eutocic delivery of a girl weighing 3200 g; the current pregnancy was the third pregnancy. Her cervical region was outside the vaginal opening and was red in color, with evident enlargement (6 × 4 cm) and a broken surface. The cervical area also showed white discharge. According to her Transvaginal ultrasonography revealed a fetus in the uterine cavity at approximately 19 weeks of gestation. Gynecological examination revealed prolapse of both the anterior and posterior vaginal walls. Evaluation of the pelvic organ prolapse-Q scores showed that the patient had uterine prolapse at stage IV.

RESULTS:

Vaginal delivery was performed smoothly after oral administration mifepristone and misoprostol tablets for a few days, obtaining a dead female fetus in cephalic, 25 cm in length. The cervix of the pregnant woman did not prolapse during the delivery.

CONCLUSION:

For pregnancy with uterine prolapse and cervical incarceration, transvaginal delivery is a potential treatment option. Maintenance of cervical retraction and oral mifepristone administration with misoprostol tablets is crucial during this delivery. This treatment can minimize the risk of cervical lacerations and uterine rupture, helping surgeons to complete the operation successfully.

2024-02-16·Journal of reproductive and infant psychology

Preterm premature rupture of the membranes (PPROM): a study of patient experiences and support needs.

Article

作者: Fiona L Challacombe ; Zuzana Suchomelova ; Carla Zampieri ; Megan Hall ; Ciara Curran ; Andrew Shennan ; Lisa Story

BACKGROUND:

Preterm prelabour rupture of membranes (PPROM) is a common obstetric condition but outcomes can vary depending on gestation. Significant maternal and foetal complications occur including preterm birth, infection, abruption, cord prolapse, pulmonary hypoplasia and even death. Although the need for psychological support is recognised it is unclear how much is actually offered to women and their families. This study aimed to survey the views of women and their families who have undergone PPROM in order to understand the care and psychological burden these families face.

METHODS:

An online survey was conducted, recruiting women via social media with collaboration from the patient advocacy support group Little Heartbeats. Responses were collated where fields were binary or mean and standard deviations calculated. Framework analysis was used to identify and analyse themes in free text responses.

RESULTS:

180PPROM pregnancies were described from 177 respondents. Although carewas variable and respondents were from across the world there werecommon themes. Five themes were highlighted which were: a lack ofbalanced information regarding the condition, support in decisionmaking and support with the process, specific psychological supportand ongoing psychological consequences of PPROM.

CONCLUSION:

This survey highlights areas in which care needs to be improved for women with PPROM. Previous studies have shown that providing good care during the antenatal period reduces long-term psychological morbidity for the whole family. The need for support, with regard both to information provided to women and their families and their psychological support needs to be addressed urgently.

2024-02-07·Journal of minimally invasive gynecology

Minimally invasive sacrohysteropexy versus vaginal hysterectomy with uterosacral ligament suspension for pelvic organ prolapse: a prospective randomized non-inferiority trial.

Article

作者: Woo Yeon Hwang ; Myung Jae Jeon ; Dong Hoon Suh

STUDY OBJECTIVE:

To investigate whether minimally invasive Sacrohysteropexy (SH) is non-inferior to Vaginal hysterectomy (VH) with uterosacral ligament suspension (USLS) in women with symptomatic uterovaginal prolapse.

DESIGN:

Prospective, randomized, non-inferiority study SETTING: Tertiary university-based hospital.

PATIENTS:

A total of 146 patients with uterovaginal prolapse between July 2016 and August 2019.

INTERVENTIONS:

Patients were randomly assigned in a 1:1 ratio to either laparoscopic or robotic SH surgery or VH with USLS surgery.

MEASUREMENTS AND MAIN RESULTS:

The primary outcome was prolapse recurrence at 1 year after surgery, defined as prolapse ≥ stage 2 evaluated using the pelvic organ prolapse quantification system, bothersome vaginal bulge symptoms, or retreatment for prolapse. The secondary outcomes included operation time, estimated blood loss, hospital stay, operation-related complications, pain intensity, quality of life, and activities of daily living. Of 146 women who underwent randomization, 73 in the SH group and 73 in the VH with USLS group were analyzed. SH was non-inferior for recurrence compared with VH with USLS (16.4% vs.15.8%, 95% confidence interval: -13.0%, 14.2%). Operating duration and transvaginal length were significantly longer in the SH group, while there were no significant differences in the estimated blood loss, length of hospital stay, or postoperative complication rates. Although perioperative pain intensity was greater from 1 week to 1 month in the SH group, the quality of life and activities of daily living did not differ between the groups throughout postoperative year 1.

CONCLUSION:

Laparoscopic or robotic SH was non-inferior to VH with USLS for the recurrence of pelvic organ prolapse at the 1-year follow-up.

项与子宫脱垂相关的新闻（医药）

2024-03-14

·Business Wire

Cosm Medical Achieves FDA Clearance for Gynethotics™ Pessaries, Pioneering the future of personalized pelvic care

TORONTO--( BUSINESS WIRE )--Cosm Medical proudly announces FDA clearance for Gynethotics™ Pessaries, marking it as the first personalized pessary available to patients. This milestone follows a recent Health Canada clearance and marks a significant advancement in pelvic care, emphasizing Cosm’s commitment to enhancing patient outcomes and revolutionizing treatment options for women worldwide. Gynethotics™ are the first pessary to be FDA cleared in about 5 years with almost 10 million pessary configurations that clinicians can conveniently order online. That is compared to about 100 configurations that are offered by other commercially available pessaries. The benefits of personalized Gynethotics™ Pessaries were demonstrated in a pilot study completed at Sinai Health Systems and published in Urogynecology, the Journal of the American Urogynecology Society, in 2023. “Our vision is to become the world leader in precision gynecological devices for unique bodies and needs.” said Derek Sham, Founder & CEO of Cosm Medical. “With our first FDA clearance, we are one step closer to realizing this vision and making a meaningful impact on the lives of over a million patients by 2030. This will set a new standard of care in gynecology like the established billion-dollar markets of custom orthotics, dental and hearing.” Half of all women will experience a pelvic floor disorder such as prolapse and incontinence in their lifetime. “Aging and women’s health are both severely underserved markets with high clinical unmet needs, demonstrated by the fact that Femtech and Agetech are both projected to be growing at over 15% CAGR.” said Ivneet Bhullar, Investment Partner at Fusion Fund and Cosm Board Member. “It’s been great supporting Cosm over the past 2 years as they’ve achieved major milestones towards driving precision care into gynecology.” Beyond pessaries, Cosm has signed a strategic partnership with the University of Alabama at Birmingham to work with Holly E. Richter, Ph.D., M.D. and Max Cadena, M.D. on a novel design and indication for Gynethotics. “We look forward to improving surgical outcomes and are currently completing Phase 1 of a clinical study with the goal of implementing a new paradigm for impacting post-operative healing,” Richter said. “This is especially important as there are limited evidence-based options for augmenting vaginal native tissue repairs.” About Cosm Medical Based in Toronto, Canada, Cosm Medical is personalizing gynecological devices for precision care because every woman is different. Cosm’s digital gynecology platform leverages novel diagnostics, AI, cloud software, and 3D printing to create patient-specific gynecological devices for unique bodies and needs. For more information, visit: www.cosm.care About Fusion Fund Based in Palo Alto, California, Fusion Fund is a venture capital firm that focuses on backing early-stage entrepreneurs in building forward-thinking companies with technical and data advantages. Since 2015, Fusion Fund has invested in over 80 portfolio companies across the US and Canada in the healthcare, enterprise AI, and industrial automation sectors. For more information, visit: www.fusionfund.com

临床1期

2024-03-05

·精准药物

含吲哚药物结构与靶点，药理与SAR 研究归纳

吲哚是一种芳香杂环分子，具有一个苯环和一个含氮吡咯环组成的双环结构。吲哚中的氮原子提供一对孤对电子，形成共轭体系，从而稳定了吲哚结构。这对孤电子使吲哚化合物呈现弱碱性(pKa=16.2和pK,=17.6)。由于吡咯环的电子密度相对较高以及氮原子的共轭效应，吲哚可以在其吡咯环的3位发生亲电取代反应(图la)。图 1 (a) 全球有超过70种含有吲哚的合成药物在市场上销售，并被证明具有良好的医疗效果(图1b)。用于治疗的疾病包括糖尿病、癌症、白血病、丙型肝炎、心理障碍和其他临床问题。自2015年起，美国(FDA)专门批准了14种含吲哚药物，其中3种是在2021年批准的(图2)。二氢麦角胺(DHE,1)的化学结构中含有吲哚支架，对头颅血管平滑肌中的5-HT1b受体具有激动活性，治疗偏头痛。昂丹司琼(2)是一种血清素5-HT3受体拮抗剂，用于预防癌症治疗期间和手术后的恶心和呕吐(图3a)。图 3 (a) 双氢麦角胺（1）和昂丹司琼（2）的结构。(b) 双氢麦角胺(1)与其靶点（左）和昂丹司琼(2)与其靶点（右）的关键靶点相互作用。替加色罗(3)在临床相关水平上被认为是5-HT(4)受体的激动剂和5-HT(2B)受体的拮抗剂，其作用之一是使受损的胃肠道运动恢复正常。多拉司琼(4)用于中度致吐的癌症化疗以及术后恶心和呕吐的治疗(图5)。它是一种高效、选择性的血清素5-HT3受体拮抗剂。 Tropisetron（5）可抑制5HT3受体上血清素的活性，从而抑制放疗和化疗引起的呕吐。 Vilazodone(6)是5HT-1A受体的部分激动剂，专门抑制中枢神经系统对血清素的再摄取。在治疗偏头痛急性发作方面，三苯氧胺药物(5-羟色胺受体激动剂)比其他药物更有效、更耐受。这类药物具有起效快、用药时间长、不良反应少等优点。Sumatriptan(7),zolmitriptan(8),naratriptan(9), rizatriptan(10), almotriptan (11), frovatriptan (12), eletriptan (13), 和 oxitriptan (14) 是国外已商业化的曲坦类药物的代表。(图7)。环氧化酶(COX)被称为前列腺素G/H合成酶，而吲哚美辛是一种非特异性的可逆性环氧化酶抑制剂。吲哚美辛(18)属于吲哚-3-乙酸类，其官能团包括对氯苯甲酰基、甲基和甲氧基。它是一种非甾体抗炎药(NSAID), 具有消炎、镇痛和解热的特点(图11a)。 Acemetacin(19)是另一种强效非甾体抗炎药物，由吲哚-3-乙酸衍生而来(图12)。它主要通过酯分解代谢为吲哚美辛。 Etodolac(20)是一种非甾体抗炎药，具有消炎、镇痛和解热作用(图13a)。以前被认为是一种非选择性COX抑制剂，但现在被认为对COX-2的选择性是COX-1的5-50倍。 Carprofen(21)是兽医用作缓解老年犬关节炎症状的辅助疗法的一种非甾体抗炎药，人们认为卡洛芬(21)的作用机制是抑制环氧化酶的活性。帕金森病的药物 Cabergoline(22)是一种长效多巴胺受体激动剂，与D2受体有很强的亲和力，用于治疗高催乳素血症和帕金森综合症(图14a)。 Lisuride(23)可能是某些血清素受体的激动剂,也可能是多巴胺D1受体的拮抗剂。可降低催乳素水平，适量服用可阻止偏头痛，从药理上讲，(23)是还是一种帕金森氏症药物。治疗子宫脱垂的药物甲基麦角新碱(26)是一种麦角生物碱，临床上用于预防和治疗产后和流产后出血(图17)。这种药物与多巴胺D1受体结合，作为一种拮抗剂发挥作用，可增强平滑肌的张力、节奏和节律性收缩的幅度。治疗精神疾病的药物 sertindole（27）是一种抗精神分裂症药物，也是一种苯基吲哚衍生物。临床试验证实，(27)对低水平的多巴胺D2占位具有疗效。治疗神经系统疾病的药物吲哚洛尔(28)是一种非选择性β肾上腺素受体拮抗剂，用于治疗心房颤动、水肿、高血压和室性心动过速。卡维地洛(29)通过阻断β肾上腺素受体防止运动引起的心动过速，它对α-1肾上腺素能受体的作用可使血管平滑肌放松，从而降低外周血管阻力和血压。尼麦角林(30)是一种半合成麦角衍生物，可用于治疗认知功能障碍。这种药剂作为一种选择性α-1A肾上腺素能受体抑制剂用于临床(图20)。治疗生殖系统疾病的药物麦角新碱(32)是一种麦角生物碱，可用于控制妇女的产后和流产后出血。结构与活性关系明确的药物 Tezacaftor(41)属于用于治疗囊性纤维化(CFTR)增效剂。美国食品及药物管理局批准该药与ivacaftor联合用于治疗囊性纤维化(图28a)。该药物可在2至4小时内达到血浆浓度峰值。 2015年2月23日，FDA批准口服去乙酰化酶(DAC)抑制剂Panobinostat(42)用于治疗多发性骨髓瘤(图29a)。(42)在体外与人体血浆蛋白的结合率约为90%,这与其浓度无关。其吲哚环可以通过与Asn645的氢键相互作用为SAR创造一个稳定的框架(图29b)。结构与活性关系不完全明确的药物 Metergoline(52)是一种麦角衍生物，用于治疗女性高催乳素闭经症(图39)。通过靶向钠通道而非5HT受体来抑制钠通道的活性，从而导致泌乳素分泌减少。 Lurbinectedin(53)是一种抗癌天然产物。该药物在化疗中用于治疗转移性小细胞肺癌。Lurbinectedin(53)在临床试验中的治疗反应率和持续时间在2020年获得了加速批准。总体而言，在FDA批准的药物中，含有吲哚环的药物数量在不断增加。在药物分子中引入吲哚砌块也已成为药物化学和药物设计中的一种常见策略。现有的含吲哚药物因其特殊的结构，在抗癌、抗炎和抗病毒等方面具有显著的临床价值。参考文献：DOI: 10.1039/d3md00677h 内容来源于网络，如有侵权，请联系删除。

上市批准放射疗法

2024-02-18

·药智网

“全球药企一哥”的新下注方向

GLP-1领域的无敌之姿，也让礼来和诺和诺德登上了全球前二大市值药企，两者市值分别为7189.2亿美元、5493.95亿美元。更可怕的地方在于，“礼诺”正在不断的迭代和丰富自己的GLP-1布局，举措不仅包括广开新适应症、开发双&三靶点更强效果的分子、开发不同剂型的GLP-1药物及BD组合疗法伙伴。在投资者对于GLP-1资产市值上限和空间踌躇之时，新的减重伴生投资机会又在哪里？近期以来，礼来通过以19.25亿美元收购Versanis、投资BioAge Labs并计划联用其核心产品开展二期临床这两个动作，揭示了“全球药企一哥”全新的代谢领域下注方向：降脂增肌。01循环减重危害引发的全新需求众所周知，GLP-1减重药最大的软肋是“停药反弹”和“需长期服药”，对于利用GLP-1药物“循环减重”或者“间歇性用药”的患者人群十分不友好。对于GLP-1药物停药反弹想再次减重的患者来说，减重时除了失去脂肪还失去了肌肉，而体重反弹时他们恢复的只是脂肪；长此以往，“循环减肥”将渐进的改变这类人群的身体构成，身体的脂肪含量会越来越高，肌肉将越来越少。正因GLP-1类药物存在这类局限性，如何更高质量的减肥成了时下的热门研发领域。那么，肌肉流失的危害有多大？肌肉组织不仅支撑人类个体的日常运动，还起到帮助人体吸收营养物质并代谢掉体内的废物等功能。肌肉流失除了带来日常活动及体运动能力的下降，还会来带代谢改变、骨质疏松风险增加和免疫功能下降等危害。上述危害可能代表增加各类疾病的患病的风险，仅以肌肉的承重能力对应潜在疾病而言，当肌肉流失严重时，可能会发生如子宫脱垂、直肠脱垂等疾病，若流失的是心脏肌肉，还可能出现心肺功能减弱、心肺衰竭等危急情况。02百花齐放趋势的增肌减脂靶点降脂增肌作为新一代减肥药物或伴侣的研发方向，全球在研的靶点并不在少数，包括肌肉生长抑制素、雄激素受体调节剂、代谢调控加速器等，本文重点聚焦礼来系已经重点下注肌肉生长抑制素和艾帕素领域（ActRII受体和apelin受体靶点）。肌肉生长抑制素（MSTN）是一种限制骨骼肌然蛋白质（ActRII是MSTN主要受体），部分研究表明：其较高活性能够抑制骨骼肌的增长（研究表明敲除MSTN基因的小鼠肌肉质量增加25-30%），过去一直是神经肌肉疾病中治疗脊髓性肌萎缩症（SMA）的重要研究方向。图片来源：太平洋证券近年来，MSTN抑制剂的研发正好与目前减重药物的缺陷形成“互补”的曙光。一方面，MSTN抑制剂可能影响代谢过程，有助于调节能量平衡和代谢；另一方面，MSTN抑制剂对增加肌肉质量可能有帮助，可增加能量消耗进而有助于减少人体脂肪，达到此消彼长的目的。艾帕素（Apelin）是一种因运动而释放分泌的多肽，它通过与骨骼肌、心脏、和中枢神经系统的相互作用调节新陈代谢，调节新陈代谢并促进肌肉再生。BioAge的研究显示，人的一生中，总体Apelin水平会逐渐下降，而Apelin水平较高的人具有更强的身体功能和更长的寿命。从全球相关靶点研发进度看，MSTN抑制剂有较多临床在研产品，但核心适应症以肌肉萎缩相关适应症为主；而Apelin受体激动剂全球进入临床阶段的分子较少，BioAge的Azelapra进度领先。靶向肌肉生长抑制素疗法不完全统计图片来源：吉满生物礼来收购的Versanis靶向ActRII受体抑制剂Bimagrumab已经收获了非常积极的数据。据Versanis早前公布的48周二期临床针对2型糖尿病的超重或肥胖患者数据显示，相比安慰剂，尽管Bimagrumab治疗组的体重虽只下降了6.5%，造成患者约22%脂肪含量的丢失，并且增加4.5%的无脂体重。更重要的是，相比一般的GLP-1药物，Bimagrumab治疗组患者停止治疗12周内并未观察到体重的增加。而另一边礼来投资的BioAge，在一项227名65岁及以上的老年人的早期临床试验表明：Apelin受体激动剂Azelaprag可预防老年人的肌肉萎缩。从Bimagrumab到Azelaprag两款产品布局，我们可以看到礼来迭代、揽全的多点出击思维，但前者为单抗，后者为小分子，也考虑到了未来患者的依从性需求。03国产分子的机会相对于火热的减重，降脂增肌这样新兴而差异化的领域在国内显得更加的“先进而有价值”。目前从全球来看，ActRII和apelin两个靶点的竞争格局十分良好，尽管前者在研相关药物较多，但适应症以血液病、肺动脉高压、癌症为主，表现形式以ActRIIA/B融合蛋白为主；真正进入临床研究的、有计划以肥胖为适应症的ActRII抗体，仅有Versanis/礼来的Bimagrumab和来凯医药的LAE102；后者而言，前面提到BioAge的Azelapra可能是唯一一个进入临床的apelin激动剂。图片来源：太平洋证券对于国内Biotech来凯医药而言（不止于某家公司，而是针对ActRII靶点开发后来者），LAE102是存在较大突围机会的，原因有几个：1）礼来收购的Bimagrumab原研为诺华公司，原本针对一种罕见的肌肉萎缩疾病（散发性包涵体肌炎）治疗的中后期临床失败，转而进行减重适应症的研究（后Versanis从诺华手中收购）。也就是说，原本该药物并非以减重适应症为前期研发导向，后来me better分子有很大优化空间；2）Bimagrumab在安全性上也有优化空间，诺华2021年在JAMA发表的Bimagrumab临床数据显示：其核心不良事件是轻度腹泻(41%vs 11%)和肌肉痉挛(41%vs 3%)，尤其是首次给药后腹泻频率最高，后逐渐减少。3）另外针来凯医药的LAE102，其创始人吕博为Bimagrumab的共同发明者，可能对该靶点有更深的理解，或者对改良该靶点的管线有更强的优势。除了来凯医药之外，翰森药业也留意到了激活素（ActRII）受体靶点带来的广谱疾病治疗的机会。2021年12月翰森药业以2000万美金加高达1.705亿美元里程碑从Keros引入KER-050，该产品是一种“工程化的配体捕获体”，由经修饰的TGF-β受体（即激活素受体IIA型）配体结合区域与人源抗体的Fc区域融合而成，用于治疗骨髓增生异常综合征（MDS）和骨髓纤维化患者血细胞减少等领域患者。对于国内的创新药企业来说，减重药“伴侣”管线是能够获得MNC补全代谢领域布局的热门方向，也是全新的方向，存在巨大的机会。结语：华创医药从基于肌肉萎缩的抗衰治疗需求、消费者对于塑型的医美需求等分析指出，增肌本身便是有望和减肥相媲美的巨大蓝海市场；而从现已发现的ActRII、apelin等靶点潜力来看，随着癌症、肌肉萎缩疾病、肺动脉高压和代谢等适应症治疗潜力的逐步兑现，上述的展望并非是一句空话。来源 | 瞪羚社（药智网获取授权转载）撰稿 | Kris.责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 张武龙 13368443108（同微信）阅读原文，是昨天最受欢迎的文章哦

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