A Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

开始日期2023-05-22

申办/合作机构

Cali Pharmaceuticals LLC

NCT05602844 / Active, not recruitingN/AIIT

Randomised Controlled Trial Comparing the Outcome of the 3D-Printed Patient-Specific-Instrument Assisted Lapidus Fusion vs Conventional Lapidus Fusion for Surgical Correction of Hallux Valgus Deformity

RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.

开始日期2023-04-01

申办/合作机构

香港中文大学

NCT05773846 / Completed临床3期

A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia. The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours. This is A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

开始日期2023-03-13

申办/合作机构

PainReform Ltd.

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100 项与拇囊炎相关的临床结果

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100 项与拇囊炎相关的转化医学

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0 项与拇囊炎相关的专利（医药）

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项与拇囊炎相关的文献（医药）

2024-07-28·Cureus

Estimation of the Radiographic Parameters for Hallux Valgus From Photography of the Feet Using a Deep Convolutional Neural Network

Article

作者: Akagi, Ryuichiro ; Yamaguchi, Satoshi ; Kimura, Seiji ; Sasho, Takahisa ; Inoue, Kana ; Orita, Sumihisa ; Maki, Satoshi ; Ohtori, Seiji

BACKGROUNDHallux valgus (HV), also known as bunion deformity, is one of the most common forefoot deformities. Early diagnosis and proper evaluation of HV are important because timely management can improve symptoms and quality of life. Here, we propose a deep learning estimation for the radiographic measurement of HV based on a regression network where the input to the algorithm is digital photographs of the forefoot, and the radiographic measurement of HV is computed as output directly. The purpose of our study was to estimate the radiographic parameters of HV using deep learning, to classify the severity by grade, and to assess the agreement of the predicted measurement with the actual radiographic measurement.METHODSThere were 131 patients enrolled in this study. A total of 248 radiographs and 337 photographs of the feet were acquired. Radiographic parameters, including the HV angle (HVA), M1-M2 angle, and M1-M5 angle, were measured. We constructed a convolutional neural network using Xception and made the classification model into the regression model. Then, we fine-tuned the model using images of the feet and the radiographic parameters. The coefficient of determination (R²) and root mean squared error (RMSE), as well as Cohen's kappa coefficient, were calculated to evaluate the performance of the model.RESULTSThe radiographic parameters, including the HVA, M1-M2 angle, and M1-M5 angle, were predicted with a coefficient of determination (R²)=0.684, root mean squared error (RMSE)=7.91; R²=0.573, RMSE=3.29; R²=0.381, RMSE=5.80, respectively.CONCLUSIONThe present study demonstrated that our model could predict the radiographic parameters of HV from photography. Moreover, the agreement between the expected and actual grade of HV was substantial. This study shows a potential application of a convolutional neural network for the screening of HV.

2024-07-01·Foot & Ankle Orthopaedics

Minimally Invasive Surgery For Management of Bunionette Deformity (Tailor’s Bunion) Using Fifth Metatarsal Osteotomies: A Systematic Review and Meta-Analysis

Article

作者: Alkhalfan, Yousif ; Lewis, Thomas L. ; Ray, Robbie ; Lam, Peter

Background: There has been increasing interest in the use of percutaneous or minimally invasive osteotomy techniques for bunionette correction. The aim of this systematic review was to investigate the clinical and radiographic outcomes following percutaneous or minimally invasive surgery for bunionette deformity correction. Methods: A systematic review following PRISMA guidelines was undertaken. All clinical studies published in MEDLINE, Embase, PubMed, and the Cochrane Library Database from inception until December 2023 reporting on the use of percutaneous or minimally invasive osteotomy techniques for bunionette deformity correction were included. The primary outcome was radiographic deformity correction. A meta-analysis of clinical and radiographic outcomes was performed to assess the mean difference following surgery. Risk of bias was assessed using the ROBINS-I tool. Results: A total of 942 potential studies were identified, of which 18 were included encompassing 714 feet in 580 patients. There were no comparative studies identified. The majority of studies (n = 14/18) used an unfixed distal osteotomy technique. All studies showed a statistically significant improvement in clinical outcomes (American Orthopaedic Foot & Ankle Society ankle-hindfoot score and visual analog scale for pain) and radiologic outcomes (fourth-fifth intermetatarsal angle and fifth metatarsophalangeal angle). Complication rates ranged from 0% to 21.4%. The nonunion rate was 0% to 5.6%. Overall risk of bias was low to moderate. The most common complication was development of a hypertrophic callus that tended to resorb over time without needing further surgical intervention. Conclusion: The results of this systematic review must be considered in light of the methodologic limitations of the studies analyzed—including additional procedures performed at the same time as the bunionette correction, lack of comparative studies, and heterogeneity of the case series included. Despite these limitations, our review suggests that percutaneous techniques for bunionette deformity correction are generally clinically safe and associated with improvement in radiographic alignment and patient-reported outcome measures.

2024-06-01·Foot and Ankle Surgery

Long-term outcomes of first metatarsophalangeal hemiarthroplasty for hallux rigidus

Article

作者: Gursoy, Safa ; Caglar, Ceyhun ; Akcaalan, Serhat ; Akkaya, Mustafa ; Kavaklilar, Abdurrahim ; Simsek, Mehmet Emin

Hallux rigidus (HR) is arthritis of the first metatarsophalangeal joint.First metatarsophalangeal joint hemiarthroplasty surgery is one of the treatment options for end stage hallux rigidus.The aim of this study is to evaluate the long-term outcomes of hemiarthroplasty of the first MTPJ with a metallic implant in patients with end-stage HR. Patients who underwent hemiarthroplasty surgery with the diagnosis of HR were included in the study. Self-Administered Foot Evaluation Questionnaire (SAFE-Q) and Foot and Ankle Disability Index (FADI) scores were used in pre-operative and post-operative final follow-ups to evaluate the clinical status of the patients. Post-operative 1st metatarsophalangeal joint range of motion was measured and recorded separately for each patient. The intra-hospital and follow-up complications and revision surgeries of the patients were recorded. Thirty-five patients with a mean follow-up of 8.1 years were included in the study. There was a statistically significant positive change in both FADI and SAFE-Q scores compared to the pre-operative process(p = 0.0001). The average dorsiflexion angle at the final follow-up was 22.0 ± 8.2. Thus, it was determined that the 5-year and 8-year survival rates of patients in this study were 97.1% and 87.8%, respectively. In conclusion, the long-term results show that the use of hemiarthroplasty in the treatment of end-stage HR leads to high patient satisfaction, increased range of motion and a high survival rate.

项与拇囊炎相关的新闻（医药）

2024-10-22

·BioSpace

Treace to Report Third Quarter 2024 Financial Results on November 5, 2024

PONTE VEDRA, Fla., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty ® and Adductoplasty ® Procedures, today announced that it will release financial results for the third quarter of 2024 after the close of trading on Tuesday, November 5, 2024. Company management will host a conference call to discuss financial results beginning at 4:30 pm ET. Investors interested in listening to the conference call may do so by registering . Once registered, participants will receive dial-in numbers and a unique pin to join the call and ask questions. A live and archived webcast of the event will be available on the Company’s investor relations website at . About Treace Medical Concepts Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 67 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patented the Lapiplasty® 3D Bunion Correction® System – a combination of instruments, implants, and surgical methods designed to surgically correct all three planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. To further support the needs of bunion patients, Treace has introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of the midfoot as well as its Hammertoe PEEK Fixation System designed to address hammertoe, claw toe and mallet toe deformities. The Company continues to expand its footprint in the foot and ankle market with the introduction of its SpeedPlate™ Rapid Compression Implants, an innovative fixation platform with broad versatility across Lapiplasty® and Adductoplasty® procedures, as well as other common bone fusion procedures of the foot. For more information, please visit . To learn more about Treace, connect with us on LinkedIn , X , Facebook and Instagram . Contacts : Treace Medical Concepts Mark L. Hair Chief Financial Officer mhair@treace.net (904) 373-5940 Investors : Gilmartin Group Vivian Cervantes IR@treace.net

财报

2024-10-21

·药明康德

20多年来首款！潜在重磅药物3期临床结果公布；2.25亿美元助力潜在“first-in-class”疗法开发……

▎药明康德内容团队编辑推动潜在“first-in-class”疗法开发，新锐完成2.25亿美元B轮融资 Seaport Therapeutics今日宣布完成了超额认购的2.25亿美元B轮融资。公司将利用这笔资金推进其临床阶段的创新药物管线，并进一步提升Glyph技术平台的能力。 Glyph是Seaport的专有技术平台，利用淋巴系统来增强药物的口服给药能力。通过Glyph平台，药物如同膳食脂肪一样通过肠道淋巴系统吸收并运输到血液循环中。旨在提高药物的口服生物利用度，避免首过效应，并减少肝酶升高、肝毒性和其他副作用，从而推动那些因这些限制而受阻的临床活性药物。其管线中进展最快的候选药物是SPT-300，一种口服孕烷醇酮的前药，正在2b期临床试验中用于治疗伴或不伴焦虑困扰的抑郁症。孕烷醇酮是一种内源性神经类固醇，具有临床验证的快速抗抑郁和抗焦虑活性，SPT-300以口服形式保留了这种活性。此外，Seaport公司的管线中还包括潜在数十年来首个具有新作用机制的广泛性焦虑障碍治疗药物SPT-320，以及潜在“first-in-class”疗法SP-348。 3.6亿美元，Angelini Pharma合作开发阿尔茨海默病潜在“first-in-class”疗法 Angelini Pharma公司与Cureverse今日宣布，双方签署了一项关于Cureverse创新脑健康候选药物CV-01的全球独家选择权协议。根据协议条款，Angelini Pharma将负责CV-01的所有开发工作，并有权获得该化合物的全球独家开发和商业化许可（不包括韩国和大中华区）。 CV-01是一种潜在“first-in-class”在研化合物，能够激活由核因子红细胞2相关因子2（Nrf2）调控的保护性通路，具有精准控制神经炎症的作用，可作为一种在多种脑健康疾病（包括癫痫）中改变疾病进程的药物。CV-01目前正在韩国进行1期临床试验，用于治疗阿尔茨海默病。 Cureverse将获得一笔预付款，并有资格根据预定的开发和商业里程碑获得高达约3.6亿美元的额外付款。 20多年来首款！Vertex潜在重磅药物3期临床结果公布日前，Vertex Pharmaceuticals公司在美国麻醉师协会（ASA）年会上，展示了其在研口服高选择性NaV1.8疼痛信号抑制剂suzetrigine用于治疗中重度急性疼痛的关键性3期临床试验数据。 Suzetrigine是一种口服选择性NaV1.8抑制剂，与其它NaV离子通道相比，它对NaV1.8具有高度选择性。NaV1.8是在外周神经系统的痛觉信号传导中起到关键性作用的电压门控钠通道。它是经过遗传学验证的疼痛治疗靶点。Vertex的策略是通过选择性抑制NaV1.8，开发新的药物类型。与阿片类药物相比，它们可能在提供更好镇痛效果的同时，避免上瘾等副作用。数据显示，在接受腹部整形手术（abdominoplasty）患者中进行的3期临床试验中，suzetrigine达到试验的主要终点，与安慰剂相比，药物组患者48小时内疼痛强度差异的时间加权总和评分（SPID48）显著降低，SPID48的平均差异为48.4（95% CI：33.6，63.1；P<0.0001）。此外，患者在手术48小时后的数值疼痛评分量表（NPRS）评分与基线相比也显著降低。而在接受拇囊炎切除手术（bunionectomy）的患者中，该疗法也达到主要终点，SPID48的平均差异为29.3（95% CI：14.0，44.6；P=0.0002）。 ▲Suzetrigine在两项3期临床试验中达到主要终点（图片来源：Vertex官网） Suzetrigine的新药申请已经获得FDA的优先审评资格，此前的新闻稿指出，suzetrigine可能成为二十多年来首个用于治疗急性疼痛的新机制药物。此外，该公司持续推进suzetrigine用于外周神经性疼痛（PNP）的临床开发项目，并已启动针对疼痛性糖尿病外周神经病变（DPN）患者的关键性3期临床试验。此外，Vertex预计将在2024年底公布suzetrigine用于治疗疼痛性腰骶神经根病（LSR）的2期临床研究结果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Seaport Therapeutics Closes $225 Million Oversubscribed Series B Financing Round. Retrieved October 21, 2024, from https://seaporttx.com/press-release/seaport-therapeutics-closes-225-million-oversubscribed-series-b-financing-round/ [2] Vertex to Present Phase 3 Data Highlighting Suzetrigine’s Potential as a First-in-Class, Highly Selective Pain Signal Inhibitor at the American Society of Anesthesiologists Annual Meeting. Retrieved October 21, 2024, from https://news.vrtx.com/news-releases/news-release-details/vertex-present-phase-3-data-highlighting-suzetrigines-potential [3] Angelini Pharma Enters Into An Exclusive Option Agreement With Cureverse to License Global Development and Commercialization Rights For A Novel and Innovative Clinical-Stage Brain Health Asset. Retrieved October 21, 2024, from https://www.globenewswire.com/news-release/2024/10/21/2965863/0/en/Angelini-Pharma-Enters-Into-An-Exclusive-Option-Agreement-With-Cureverse-to-License-Global-Development-and-Commercialization-Rights-For-A-Novel-and-Innovative-Clinical-Stage-Brain-.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期引进/卖出临床2期临床结果

2024-09-13

·药智网

国产非阿片类长效镇痛药「接连突围」

近期，科伦药业发布公告，其子公司湖南科伦制药的化学药品“布比卡因脂质体注射液”获得国家药监局批准上市（商品名布瑞科®），按照化药3类获批，视同通过仿制药质量和疗效一致性评价。科伦药业的布瑞科®是我国第二个上市的布比卡因脂质体注射液产品。恒瑞医药的布比卡因脂质体注射液仿制药（商品名：艾恒平）已于2022年11月获批，为全球首仿药，同时也为国内首个上市的长效术后镇痛药物。今年7月，艾恒平获FDA批准上市，成为全球首家在美国获得该品种仿制药批准的厂家。国产药企接连成功突围背后，是全球及中国在长效术后镇痛制剂领域不断增长的市场需求。中国术后疼痛发生率仍然较高术后疼痛（postoperative pain）指手术操作引起的急性创伤和内脏器官的损伤以及神经末梢周围炎性刺激引起的疼痛。术后疼痛自麻醉清醒后出现，疼痛高峰期为术后24至48小时，持续时间一般不超过3到7天。术后疼痛短期内会对病人的心血管功能、呼吸功能、神经内分泌及免疫和心理情绪等方面造成不利影响，如术后疼痛在急性期没有得到有效控制，将有可能发展为慢性术后疼痛，持续时间可达半年甚至数十年。术后疼痛管理是保证术后镇痛效果的重要环节。术后疼痛管理的目标包括在安全的前提下，持续、有效镇痛。目前虽然非药物治疗，如理疗、音乐、分散注意力等方法有不同的治疗效果的研究报道，但手术后急性疼痛治疗仍以药物治疗为主。当前临床术后镇痛使用的主要药物包括：阿片类镇痛药、非甾体类抗炎药和局部麻醉药。其中局部麻醉药通过局部神经阻滞发挥区域镇痛作用，相比其他类型镇痛药物全身系统性不良反应少，但往往作用时间和强度不够，神经阻滞持续时间通常少于8小时，而术后疼痛的管理通常需要数天，临床可应用非连续多次注射局部麻醉药、硬膜外腔或外周神经插入导管连续输注药物、一次性泵等方法实现持续数天的术后镇痛。持续局部麻醉药输注可有效控制疼痛并减少术后阿片类药物的使用，但需要相对昂贵的设备和连续监测，且长期留置导管易引起导管移位和并发症。频繁给药也会增加血药浓度波动、降低患者依从性，给患者造成疼痛和不方便、导致严重的副作用。尽管国内术后疼痛管理开展已有二十余年的历史，国内术后疼痛患者人群数量仍然较大。国家统计局数据显示：2022年，我国医疗卫生机构住院病人手术人次达到8271.75万人。而2023年一项对中国大陆百余医疗中心的横断面研究显示，手术后中重度疼痛的发生率达48.7%，包括32.2%的患者患有严重术后疼痛。这意味着国内不同程度的术后疼痛患者总数可能达到四千万人以上。布比卡因脂质体如何治疗术后疼痛？布比卡因（bupivacaine）是一种酰胺类的局部麻醉药，通过可逆地阻断快速电压门控钠离子通道来阻断神经脉冲的传递，从而达到镇痛效果。其盐酸盐即盐酸布比卡因早在1972年就已经在美国作为局部麻醉药上市，商品名包括Marcain、Marcaine（麻卡因）、Sensorcaine及Vivacaine，主要用于局部浸润麻醉、外周神经阻滞和椎管内阻滞。短效布比卡因制剂麻醉效果能维持3-6小时或更长时间，无法覆盖术后三至四天的疼痛高峰期。在此背景下，2011，FDA批准了Pacira BioSciences公司研制的布比卡因脂质体注射液用于直接注射至手术部位以帮助控制术后疼痛，商品名Exparel，是首个在美国上市的长效术后镇痛药物。2018年，FDA批准其扩大使用范围，包括围术期或术后通过肌间沟臂丛神经阻滞给药以产生手术后局部镇痛。公开数据显示，2023年Exparel全球销售额达到4.8亿美元，折合人民币约34亿，从2012年以来的复合增长率为40%，具体销售额趋势如下图。图1 2012-2023 Exparel全球销售规模及趋势数据来源：公开数据整理 Exparel在仅有两个适应症的情况下，产品销售额仍能接近5亿美元，原因主要在于产品独特的作用机制和高昂的价格。多囊脂质体(multivesicular liposomes,MVL)是以储库泡沫技术为基础的非同心脂质体，其内部由许多水性腔室以非同心圆的形式紧密填充构成，在注射部位能够蓄积形成药物储库，通过脂质腔室溶蚀实现药物缓释效果，各个水性腔室之间以脂质双分子层相隔，具有较高的药物包封率和回收率，可以用于小分子药物和蛋白、多肽等高分子药物的包封。多囊脂质体的囊泡较大，载药量大，包封率高，具有较好的生物相容性，目前用于开发长效缓释制剂。布比卡因脂质注射液通过多个囊泡结构的脂质体包裹药物缓释释放，不仅将镇痛效果延长至72小时，还可以减少布比卡因带来的副作用。长效镇痛制剂需要平衡药品的安全性与长效性、起效速度与起效平稳性。作为全球首个获批的长效局麻药，Exparel相关100多项临床试验涉及拇囊炎切除术、痔切除术、前列腺切除术、膝关节置换术、胸腔手术等的术中术后镇痛，以及儿科用药临床试验，临床结果支持Exparel应用于几乎所有手术的局部浸润麻醉以及术后镇痛；对不同手术，可避免使用或减少使用45%～78%阿片类药物；且与普通注射液相比能够在72小时内维持有效血药浓度的同时始终低于CNS毒性限度且没有药物突释行为，没有CNS不良反应病例报道。此外有研究显示布比卡因脂质体的血药浓度峰值低于盐酸布比卡因，或可一定程度上降低中枢及心脏相关毒性风险。 Exparel在美国的用药费用高昂，一瓶20毫升的Exparel售价约为376美元，而相同尺寸的盐酸布比卡因每瓶售价为38美元。未来长效术后镇痛制剂的发展方向长效术后镇痛制剂仍属于有待开拓的药物领域。在Exparel上市后，FDA相继批准上市了四款非阿片类术后长效镇痛药，均为布比卡因的改良制剂。表1 国外非阿片类术后长效镇痛药上市情况数据来源：药智数据、药智咨询整理改良型长效局部麻醉药已成为国内术后镇痛药的研发热点。目前恒瑞制药和科伦制药的布比卡因脂质体分别于2022年11月和2024年8月获批上市，另有2个布比卡因活性成分和5个罗哌卡因活性成分长效注射制剂药物进入申报或开展临床阶段。表2 国内长效术后镇痛药物在研品种（部分）数据来源：药智数据、药智咨询整理长效术后镇痛制剂这一品类仍有很大的发展空间，布比卡因脂质体作为长效术后镇痛制剂品类中上市的首个药物，相比原研药在美国的高昂用药费用，国产布比卡因脂质体注射液每支价格为382元，并且已成功通过国谈纳入医保药品目录。国内手术数量不断增长驱动布比卡因脂质体需求提升，新适应症的上市将持续推动这一品种的市场空间，且研发壁垒决定了其良好的竞争格局，具有可观的市场潜力。参考资料： 1.https://data.stats.gov.cn/easyquery.htm?cn=C01&zb=A0O0A&sj=2023 2.成人手术后疼痛处理专家共识 3.Liu,Y.,Xiao,S.,Yang,H.,Lv,X.,Hou,A.,Ma,Y.,Jiang,Y.,Duan,C.,Mi,W.,&CAPOPS Group(2023).Postoperative pain-related outcomes and perioperative pain management in China:a population-based study.The Lancet regional health.Western Pacific,39,100822.https://doi.org/10.1016/j.lanwpc.2023.100822 4.Chaurasiya A,Gorajiya A,Panchal K,Katke S,Singh AK.A review on multivesicular liposomes for pharmaceutical applications:preparation,characterization,and translational challenges.Drug Deliv Transl Res.2022 Jul;12(7):1569-1587.doi:10.1007/s13346-021-01060-y.Epub 2021 Oct 1.PMID:34599471. 声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 斯科尔转载开白 | 马老师 18996384680（同微信）如需定制医药咨询服务，请扫描下方二维码咨询！阅读原文，是受欢迎的文章哦

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