Herpes zoster (HZ), especially postherpetic neuralgia, is one of the most typical types of clinical neuralgia. The incidence rate of HZ in China is approximately 7.7%. Among them, 29.8% of HZ patients eventually develop PHN. About 20% of PHN patients suffer from severe neuralgia for more than one year, or even ten years. It is worth noting that patients with neuralgia are prone to comorbidities such as depression, anxiety and sleep disorders, which seriously affect their work efficiency and quality of life. This is a great torment to both the patients and their families, and it also imposes a heavy burden on the medical system.
Professor Xiao Lizu, a collaborator of our team, has discovered in clinical practice that spinal cord electrical stimulation for HZ patients can significantly reduce the risk of developing PHN. Other therapies for reducing the risk of PHN include multiple parvertebral injections of local anesthetics/steroids, which require patients to return for repeated visits. Although these intervention measures have good effects, they may bring additional economic burdens to patients, treatment side effects and prolong their hospital stays. Therefore, they are not suitable for all patients. From this perspective, our development of early screening methods and selective non-pharmacological intervention only for high-risk patients will improve the overall treatment status of HZ, effectively reduce the incidence of PHN, and alleviate the burden on medical insurance and the medical system at the same time.
This project aims to conduct the following research by analyzing the intestinal flora of patients: identifying biomarkers with the ability to predict the risk of PHN in patients, constructing a machine learning classifier for risk prediction, and developing an early screening kit based on this.
Furthermore, traditional studies mostly focus on a single pathological link and lack systematic multi-dimensional analysis. In recent years, the cerebral lymphatic system, as a key pathway for the clearance of metabolic wastes in the brain, has attracted widespread attention. Furthermore, the role of the gut-brain axis in pain regulation has gradually been recognized. Therefore, it is of great scientific significance to integrate and explore the pathological mechanism of PHN from three dimensions: the lymphatic system, neuroinflammation, and intestinal flora.
This project assumes that patients with PHN have a pathological triad of "lymphoid dysfunction - neuroinflammatory activation - intestinal flora imbalance". The specific manifestations are as follows: Impaired lymphoid clearance function (decreased DTI-ALPS index and increased free water), activated systemic inflammatory response (elevated TNF-α and IL-6), and disordered intestinal flora structure (decreased α diversity and increased opportunistic pathogenic bacteria). The three interact with each other and have a synergistic effect, jointly participating in the pathogenesis of PHN.The expected outcome of this project may provide new options for pain management of the large group of neuralgia patients, improve their quality of life, and has great practicality and practical value.

开始日期2025-07-01

申办/合作机构-

NCT06982196

/ Enrolling by invitation临床3期IIT

Multicenter, Randomized, Double-blinded，Controlled Clinical Study to Evaluate the Efficacy and Safety of Sulodexide in Controlling the Recurrence of Psoriasis

This is a multicenter, randomized, double-blinded，controlled clinical trial. The purpose of the study is to evaluate the efficacy and safety of Sulodexide versus placebo in preventing psoriasis recurrence in patients with plaque psoriasis who have discontinued biologic therapy after achieving clinical cure.

开始日期2025-04-20

申办/合作机构

西京医院第四军医大学

CTRI/2025/03/082526

/ Not yet recruiting临床4期IIT

Comparing the outcome of conventional suture ligation technique versus sutureless technique using bipolar diarthermy in thyroidectomy - A randomized controlled trial - NIL

开始日期2025-03-29

申办/合作机构-

100 项与舒洛地特相关的临床结果

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100 项与舒洛地特相关的转化医学

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100 项与舒洛地特相关的专利（医药）

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368

项与舒洛地特相关的文献（医药）

2025-09-01·Journal of Vascular Surgery-Venous and Lymphatic Disorders

The role of venoactive compounds in the treatment of chronic venous disease

Review

作者: Nicolaides, Andrew ; Gloviczki, Monika Lecomte ; Kakkos, Stavros K ; Chuback, John ; Urbanek, Tomasz

BACKGROUND:

Chronic venous disease (CVD) is a major global health issue, affecting millions of people and contributing to significant morbidity and economic strain. The condition's pathophysiology is complex, involving both mechanical and biochemical processes that lead to venous reflux, obstruction, and chronic inflammation. This review focuses on the role of venoactive compounds (VACs), also known as venoactive drugs in Europe and other parts of the world, in managing CVD. The aim was to review the scientific evidence and to define the role of VACs within the comprehensive treatment algorithm for CVD, alongside established and well adopted interventional therapies and noninterventional therapies such as compression.

METHODS:

The review of the scientific evidence was done on VACs mechanism of action and efficacy in alleviating CVD symptoms, reducing swelling or venous edema, and improving healing of venous leg ulcers. Whenever available, systematic reviews, meta-analyses and randomized controlled trials were used. The quality of evidence assessment followed the GRADE methodology from A (high), B (moderate), to C (low to very low) quality.

RESULTS:

Venoactive drugs or compounds share similar effects, such as sealing the endothelial barrier, enhancing lymphatic drainage, reducing edema, improving venous tone, inhibiting leukocyte adhesion to vein walls/valves and inflammatory mediator release, lowering blood viscosity, and promoting red blood cell flexibility. Scientific evidence on the VACs effectiveness on CVD symptoms (pain, cramps, and heaviness) and swelling or edema have shown some variability. Micronized purified flavonoid fraction (MPFF) and Ruscus extract combined with hesperidin methyl chalcone and ascorbic acid had the highest, mostly level A, quality of evidence. In venous leg ulcers, micronized purified flavonoid fraction, sulodexide, and pentoxifylline were the most effective adjunctive treatments, with evidence level A.

CONCLUSIONS:

The existing scientific evidence provides a strong rationale for incorporating VACs into a comprehensive treatment plan for CVD, alongside established interventional therapies and noninterventional approaches like compression, to optimize patient outcomes and improve quality of life.

2025-07-01·Journal of Vascular Surgery-Venous and Lymphatic Disorders

Utility of venoactive compounds in post-thrombotic syndrome: A systematic review

Review

作者: Raffetto, Joseph D ; Gloviczki, Peter ; Puggioni, Alessandra ; Stoughton, Julianne ; Gloviczki, Monika L

BACKGROUND:

Post-thrombotic syndrome (PTS) has been highly prevalent; over 50% of the patients develop PTS after lower extremity acute deep vein thrombosis. Venoactive compounds (VACs) have been recommended for decades for patients with chronic venous insufficiency, including PTS. The objective of our study was to perform a systematic review to determine the quality of evidence on the utility of VACs for both prevention and treatment of PTS.

METHODS:

A systematic review was conducted to search the literature between January 1, 1980, and July 14, 2023, for venoactive drugs or medications, deep vein thrombosis, and PTS using PubMed, MEDLINE, life science journals, and the Cochrane Library. Only randomized controlled trials (RCTs) published in English were included in this review. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the revised Cochrane risk-of-bias tool for RCTs were used.

RESULTS:

Ninety-four references were identified; 11 RCTs fulfilled the inclusion criteria. VACs administered were diosmin, hidrosmin/rutosides, micronized purified flavonoid fraction (MPFF), and sulodexide. The studies included a highly variable proportion of patients with PTS (8.6%-100%). Some older studies omitted details of the methodology. Two studies suggested benefit of diosmin and MPFF as adjunctive treatment to rivaroxaban in the prevention of PTS and showed low or unclear risk of bias. Evaluation of RCTs for the treatment of post-thrombotic chronic venous insufficiency found low or unclear risk of bias in 81.6% to 85.7%. All studies suggested that VACs were beneficial for PTS treatment; they improved venous symptoms, decreased edema, and helped heal venous ulcers.

CONCLUSIONS:

This systematic review found that VACs had at least moderate quality of evidence in improving venous symptoms, decreasing edema, and accelerating venous ulcer healing. Two pilot RCTs of higher quality suggested the usefulness of diosmin and MPFF as adjunctive treatment to rivaroxaban therapy to reduce the incidence of PTS and improve deep vein recanalization. Because most RCTs were published over two decades ago, and several lacked the required precision in reporting, new high-quality, low-bias RCTs are needed to assess the role of specific VACs for both prevention and treatment of PTS.

2025-06-03·Zhonghua yi xue za zhi

[A meta-analysis of efficacy and safety of sulodexide in the prevention and treatment of venous thromboembolism].

Article

作者: Zou, F K ; Qu, L F ; Jiang, Q J

Objective: To evaluate the efficacy and safety of sulodexide in preventing venous thromboembolism (VTE) in high-risk populations and reducing recurrence in established VTE patients. Methods: A literature search was conducted in databases including China National Knowledge Infrastructure, Wanfang Data, VIP Chinese Periodical Database, China Biology Medicine disc, PubMed, Embase, the Cochrane Library, and Web of Science to retrieve relevant literature on sulodexide in the treatment of VTE, with the retrieval time frame set from the establishment of the databases to April 2024. According to the inclusion and exclusion criteria, two researchers independently screened the literature and extracted the data. The Cochrane risk of bias tool or the Newcastle-Ottawa Scale was used to evaluate the quality of the included studies. Meta-analysis was performed using Revman5.4.1 software, with the RR value as the effect measure. The trial group comprised high-risk individuals or VTE patients treated with sulodexide, while the control group consisted of patients treated with other traditional anticoagulants or placebos. The outcome measures included the incidence and recurrence rate of VTE, the incidence of post-thrombotic syndrome (PTS), and the risk of bleeding, among others. Results: A total of 11 articles involving 11 studies and 3 364 patients were included according to the inclusion and exclusion criteria. For high-risk populations of VTE, prophylactic use of sulodexide was more effective than the control group in reducing the incidence of VTE in high-risk individuals [2.2% (3/138) vs 10.9% (15/138), RR=0.25, 95%CI: 0.09-0.72, P=0.010]. For VTE patients, sulodexide was more effective than control group in reducing the recurrence rate of VTE [5.6% (56/996) vs 9.7% (198/2 043), RR=0.59, 95%CI: 0.44-0.80, P<0.001]. There was no statistically significant difference in the incidence of PTS between patients treated with sulodexide and those treated with other traditional anticoagulants [14.0% (36/257) vs 16.6% (149/897), RR=0.86, 95%CI: 0.61-1.20, P=0.370]. Moreover, the incidence of bleeding events was lower in patients treated with sulodexide compared to those treated with other traditional anticoagulants [0.8% (2/251) vs 6.1% (40/656), RR=0.11, 95%CI: 0.03-0.37, P<0.001]. Conclusion: Sulodexide exhibits favorable efficacy and safety for VTE prevention in high-risk populations and recurrence reduction in VTE patients.

项与舒洛地特相关的新闻（医药）

2025-07-02

·生物谷

原来「伟哥」还有别的妙用！研究表明：西地那非不仅可以抗癌，还可以治疗阿尔兹海默症等，可谓是“小小神药”

提到蓝色小药片——“伟哥”（西地那非），大多数人会露出心领神会的微笑，第一反应都是它那些“不可描述”的功效。但最近，科学家们发现，这款“男性福音”可能要解锁一个让人意想不到的新技能，那就是「帮助免疫系统对抗肿瘤」！众所周知，“伟哥”是一种治疗男性勃起障碍的药物。但实际上，它最初被生产出来，是用于治疗心脏疾病的。而近日，它的用途得到了进一步的扩展。西湖大学相关研究团队在《Nature》杂志上发表了一项重要研究成果。该研究首次揭示了关键的抗原呈递细胞 —— 树突状细胞（DCs），它们从肿瘤向肿瘤引流淋巴结（tdLNs）迁移的能力会随着肿瘤的进展而逐步受到抑制。这种抑制作用削弱了树突状细胞对肿瘤特异性 T 细胞的致敏功能，进而导致进入肿瘤微环境的 T 细胞数量减少，最终引发免疫逃逸现象。然而，破解这一不利影响的关键在于我们熟知的 “蓝色小药片” 也就是西地那非，俗称 “伟哥”。从更通俗的角度来讲，我们身体内部存在着一支高度精密的 “抗癌部队”。在其中，DCs 扮演着至关重要的“侦察兵”角色。但在肿瘤不断发展的过程中，DCs会逐渐“走着走着，忘了自己要去哪、要干嘛”。这使得本应迅速赶来消灭肿瘤的 T 细胞大军无法及时获取准确的情报，从而为肿瘤的壮大提供了可乘之机。而咱“伟哥”的出现则宛如为 DCs 安装了一套精准的 GPS 导航系统，帮助它们重新校准方向，能够准确无误地向免疫系统传递肿瘤相关敌情！这样一来，免疫大军便能更精准地锁定肿瘤目标，并发起更为有效的攻击。听起来有点不可思议？那让我们一起看看“伟哥”究竟有没有描述的那么“多功能”吧！进展性肿瘤会导致“侦察兵”DCs集体迷路在本研究中，研究人员分析了32位胰腺癌、乳腺癌和肠癌患者的淋巴结，他们发现：三种肿瘤晚期患者的淋巴结中，成熟的树突状细胞（DCs）数量明显减少且分散。为了验证这个现象，研究人员构建了黑色素瘤和结肠癌小鼠模型，发现当肿瘤体积超过600立方毫米时，小鼠肿瘤引流淋巴结比例及DCs数量下降了2-3倍，而造成这一现象的原因就是——DCs迁移到肿瘤引流淋巴结的数量减少，从而导致了T细胞活化程度降低70%。此外，研究人员还开展了一项关键实验，即将 OT-I T 细胞过继转移到携带早期或晚期肿瘤的小鼠体内。实验结果显示，与早期肿瘤小鼠相比，晚期肿瘤小鼠中过继转移的 OT-I T 细胞的增殖能力明显减弱。这一发现进一步有力地印证了 DCs 如“侦察兵”般在机体免疫应答过程中发挥的重要先锋作用，即 DCs 能够准确地向免疫系统传递肿瘤相关抗原信息，从而启动 T 细胞介导的免疫反应，而其功能的受损会显著影响整个抗肿瘤免疫效应。图1：在肿瘤进展过程中，肿瘤引流淋巴结中的DCs表达下降CRISPR筛出“救星”——PDE5抑制剂为了找出原因，研究人员采用CRISPR基因编辑技术筛选出可能影响树突状细胞（DCs）迁移的基因。他们发现肿瘤微环境会通过激活PDE5基因及相关通路，显著抑制DCs向肿瘤引流淋巴结的迁移，具体而言：当PDE5活跃时，DCs就会被困在肿瘤中无法移动；而敲除PDE5后，DCs迁移能力就提升215倍（真是惊呆我了）！在动物实验中，特异性敲除DCs的PDE5基因可使肿瘤生长减缓40%。图2：DCs体内CRISPR筛选和验证这好巧不巧的：PDE5恰好正是“伟哥”的作用靶点。我们已知：PDE5的底物是cGMP，于是，研究人员便从cGMP角度入手。机制研究表明，cGMP通过激活RhoA-ROCK-肌球蛋白II信号通路，驱动树突状细胞（DCs）像阿米巴虫一样进行变形运动；而进展性肿瘤会通过降低一氧化氮水平，间接抑制sGC活性，使得GTP无法转化为cGMP，彻底切断cGMP的生成来源，最终导致DCs运动功能完全瘫痪。此外，PDE5也可通过分解残存的cGMP来进一步消耗cGMP，使得DCs迁移能力大幅度减弱，动力不足。图3：肿瘤如何抑制DC迁移运动“伟哥”的免疫调节潜力作用那按上面的逻辑，服用“伟哥”西地那非应当是可以起到抗癌作用的，这是真的吗？研究人员首先探讨了西地那非对于晚期肿瘤分离或衍生的小鼠骨髓树突状细胞（DCs）跟人DCs的影响，发现其治疗显著增加了DCs的迁移速度及持久性。接着，研究人员使用了多个小鼠同基因肿瘤模型，他们发现西地那非治疗能显著提升晚期肿瘤中淋巴结的DCs含量，其数量可恢复到早期肿瘤水平；而这些重新活跃的DCs能有效激活T细胞反应，增加了肿瘤T细胞的数量。机制研究表明西地那非的确是通过抑制PDE5发挥作用的。特别值得注意的是，研究者发现，西地那非与抗PD-1免疫治疗联合使用时效果更佳。图4：西地那非恢复DCs迁移并增强了基于DCs的抗肿瘤疗效那么，咱“伟哥”还有其他跨界“功能”嘛？“伟哥”的阿尔茨海默病防治作用《Nature aging》杂志研究表明：西地那非的使用与阿尔茨海默病风险下降69%显著相关。在这项研究中，研究人员致力于挖掘能够治疗阿尔茨海默病的“旧药”。对此，其利用一种计算方法整合了遗传学数据和其他生物学数据，构建了能展现阿尔茨海默病生物学特征的13个疾病“内表型模块”。接着，再将这些模块绘制成一个包含了351444种人类蛋白互作的大型网络，计算了1600种FDA批准药物的网络接近度分数，分数越高表示该药物在阿尔茨海默病相关模块中能与多种分子靶点进行物理相互作用。分析结果显示，西地那非是得分最高的药物之一，而且之前有临床前研究表明西地那非可以显著改善认知和记忆，这提示了该药或能影响阿尔茨海默病。研究团队进一步分析了美国723万人的保险理赔数据，发现开处方药西地那非与随访6年后阿尔茨海默病确诊风险降低69%有关。对潜在因素进行校准后，开处方药西地那非与男性随访6年后阿尔茨海默病确诊风险降低73%有关，与女性风险降低35%有关。与65-74岁年龄的人风险降低62%有关，与75岁及以上的人风险降低51%有关。图5：西地那非的使用可能降低阿尔兹海默症患病风险不仅如此，《Circulation Research》杂志的研究也表明西地那非在改善大脑血流方面同样表现出色，对血管性痴呆高风险患者的血管功能具有积极作用。在这项研究中，研究人员开展了一项名为OxHARP的精心设计的双盲、安慰剂对照的临床试验，该试验共有75名参与者，他们经历过轻微中风，并表现出轻度至中度的小血管疾病的迹象。每个参与者在三周的时间内随机接受西地那非、安慰剂和西洛他唑（一种抗血小板聚集和血管扩张的药物）。结果发现：西地那非可增加大脑大血管和小血管的血流量，降低大脑血管的阻力从而发挥改善血管功能，且其副作用较少。图6：研究流程图小结这颗小小的蓝色药丸，从最初研发出来的用于治疗心血管疾病，到成为“男性福音”，之后又能用于治疗阿尔兹海默症，现在又可能在抗癌战场上大显身手。可谓是用途广泛！但是，可别急着自行用药！这项研究目前还处在实验室阶段，距离临床应用还有很长的路要走！不可否认的是，这个脑洞大开的发现再次证明：在医学研究的道路上，有时候最意想不到的组合，反而能擦出最耀眼的火花~参考文献[1]Tang H, Wei Z, Zheng B, et al. Rescuing dendritic cell interstitial motility sustains antitumour immunity. Nature. Published online June 25, 2025. doi:10.1038/s41586-025-09202-9[2]Fang J, Zhang P, Zhou Y, et al. Endophenotype-based in silico network medicine discovery combined with insurance record data mining identifies sildenafil as a candidate drug for Alzheimer's disease [published correction appears in Nat Aging. 2023 Jul;3(7):908. doi: 10.1038/s43587-023-00396-z.]. Nat Aging. 2021;1(12):1175-1188. doi:10.1038/s43587-021-00138-z[3]Webb AJS, Birks JS, Feakins KA, et al. Cerebrovascular Effects of Sildenafil in Small Vessel Disease: The OxHARP Trial. Circ Res. 2024;135(2):320-331. doi:10.1161/CIRCRESAHA.124.324327撰稿｜M编辑 | lcc部分文字来源于网络，本文仅用于分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！精彩推荐：1、坐在地上，不扶任何东西你能站起来吗？最新25年随访研究：「地板坐立测试」能预测中老年男女因自然和心血管原因导致的过早死亡风险2、打耳洞也有代价？！研究揭示：穿耳洞后，其周围的微生物群落会发生显著变化，痤疮杆菌和表皮葡萄球菌开始竞争，或就导致了耳洞发“臭”3、「高蛋白低碳水」实则并不健康？最新研究：适度多吃蛋白质有益，但过度提升蛋白质比例（尤其替代碳水时）会加速衰老，显著缩短寿命4、你经历过鬼压床或睡觉时腿抽动吗？Science ：这些现象的关键或是大脑中的黑质网状部！其中GAD2神经元是运动与睡眠的共享开关5、每一口外卖、瓶装水都在伤肝、伤脑！多项研究：微塑料会影响血糖，损害多器官功能，引发肝中毒；且能侵入大脑，诱发帕金森病！点击下方「阅读原文」，前往生物谷官网查询更多生物相关资讯~

细胞疗法免疫疗法

2025-06-20

·药精通Bio

上海科技大学罗振革等构建人血管类器官和血管化脑类器官

OTC2025论坛深度聚焦类器官与疾病建模、新药发现/研发、3D细胞培养、类器官培养及质控。展位咨询请联系：王晨 180 1628 8769。脑类器官作为干细胞衍生的3D微组织，已被广泛用于模拟人类胎脑发育程序，重现发育性、精神性和退行性脑疾病。脑类器官的广泛应用提高了我们对人脑发育过程的理解。然而，神经血管系统的缺失严重限制了脑类器官的应用，因为血管系统在氧气供应、神经发生调节和功能应用中发挥着重要作用。血管起源于中胚层，通过血管生成和血管发生的连续过程发育，侵入神经上皮区域形成脑血管网络。自组织人血管类器官模型已被报道并应用于糖尿病血管病变研究。然而，由于脑血管和神经元来源于两个不同的胚层，生成血管化脑类器官一直是一个挑战。多项研究尝试在脑类器官中诱导血管结构，包括将脑类器官与内皮细胞或其祖细胞共培养。这些报告为该领域的进一步改进提供了各种思路。近期，上海科技大学罗振革等在Bio-Protocol期刊上发表了题为Generation of Human Blood Vessel and Vascularized Cerebral Organoids的研究论文，研究团队开发了一种脑特异性血管类器官的诱导方法，在成熟阶段用含有神经营养因子的培养基培养，以获得具有脑血管特征的血管类器官。虽然通过组装神经和间充质聚集体生成血管化神经类器官的方法已有报道，但该研究显示血管类器官中细胞类型更加丰富，包括融合血管化类器官中大量的小胶质细胞，能够更好地重现体内脑特征。图示描述：1) 血管类器官的成功构建与发育表征：研究建立了从人胚胎干细胞分化血管类器官的标准化流程。通过优化培养条件，包括使用特定的中胚层诱导培养基（含CHIR99021）、内皮诱导培养基（含VEGF、BMP4、bFGF）和内皮成熟培养基（含VEGF），成功构建了具有血管特征的类器官。血管类器官在培养过程中表现出明显的发育阶段性变化，从第4天开始形成圆形光滑的形态，到第12天后在Matrigel中显示出血管向外突出的特征性结构。定量分析显示类器官直径从第4天的约0.5mm逐渐增长到第25天的约2.2mm，表明其持续的生长发育能力。图1 实验流程示意图2) 血管类器官的细胞组成与标志物表达：免疫荧光染色结果显示，培养40天的血管类器官表达内皮细胞标志物CD31，形成了复杂的血管网络结构。通过Imaris三维重建技术清晰展示了类器官内部完整的血管结构。更重要的是，血管类器官中不仅含有内皮细胞，还诱导产生了大量的小胶质细胞，通过IBA1标志物染色可以观察到这些免疫细胞在第25天和第40天均有表达。这种多样化的细胞组成使得血管类器官能够更好地模拟体内脑血管的复杂微环境，为后续的血管化脑类器官构建奠定了基础。3) 脑类器官的独立培养体系建立：研究同时建立了脑类器官的培养体系，使用外胚层诱导培养基（含Dorsomorphine和A83-01）和神经上皮诱导培养基（含SB431542和LDN193189）进行分化。脑类器官在培养过程中表现出典型的神经发育特征，能够分化出多种神经细胞类型。通过对比培养，研究发现单独的脑类器官中小胶质细胞表达较少，这与体内发育过程中小胶质细胞主要来源于造血干细胞而非神经干细胞的事实相符。这一发现进一步证明了血管类器官在提供小胶质细胞方面的重要作用。图 2 通过细胞标志物染色对血管类器官（VOrs）和融合血管化脑类器官（fVOrs）进行鉴定4) 融合血管化脑类器官的成功构建：通过将两个血管类器官和一个神经上皮组织在第12天进行融合，成功构建了血管化脑类器官（fVBOr）。融合过程中，神经组织位于两个血管类器官的中间，三个组织在同一水平面上并位于Matrigel液滴的中心。融合后的类器官在40天的培养中表现出良好的血管侵入和神经血管相互作用。免疫染色结果显示，表达DCX的神经元被表达CD31的血管结构包围，表明神经和血管结构之间建立了有效连接。这种融合策略为研究神经血管相互作用提供了理想的体外模型。5) 神经血管相互作用与小胶质细胞侵入的验证：在融合血管化脑类器官中，小胶质细胞成功从血管类器官侵入到脑组织中，这一过程模拟了体内发育过程中小胶质细胞的迁移和定植。通过IBA1染色可以观察到，相比于单独的脑类器官，融合后的血管化脑类器官中小胶质细胞数量显著增加且分布更加广泛。这些小胶质细胞的成功整合表明该模型能够重现体内复杂的神经血管微环境，包括免疫细胞与神经细胞的相互作用。此外，血管结构在类器官中形成了完整的网络，为营养物质和氧气的供应提供了通道，更好地支持了神经细胞的生存和发育。图 3 在血管类器官（VOrs）和融合血管化脑类器官（fVOrs）中诱导产生的小胶质细胞全文总结：该研究成功建立了人血管类器官和血管化脑类器官的培养体系，为神经血管研究提供了重要的体外模型工具。该模型不仅能够重现血管和神经组织的基本结构特征，更重要的是实现了小胶质细胞等免疫细胞的整合，使其更接近体内真实的脑微环境。这一突破为研究神经发育、神经血管疾病机制以及药物筛选提供了新的平台。相比于传统的共培养方法，该融合策略能够产生更稳定、更复杂的血管化结构，为脑疾病建模和治疗策略开发提供了有力工具。该研究为推动神经血管相互作用的机制研究和神经系统疾病的精准医学发展具有重要意义。类器官时间类器官制作流程：该研究采用分步骤融合策略构建血管化脑类器官：1. 首先，将人胚胎干细胞用Accutase消化成单细胞，以7000-9000个细胞/孔的密度接种到Lipidure处理的V型96孔板中形成胚胎体。2. 血管类器官分化过程包括：第0-2天使用聚集培养基；第2-4天转换为中胚层诱导培养基（含6μM CHIR99021）；第4-7天使用内皮诱导培养基（含VEGF、BMP4、bFGF）；第7-12天采用内皮成熟培养基。脑类器官则使用外胚层诱导培养基和神经上皮诱导培养基进行分化。第12天时，将两个血管类器官和一个神经上皮组织以神经组织居中的方式包埋在25μL Matrigel中进行融合。融合组织在扩增培养基中培养4天后，转至成熟培养基并置于摇床上培养至第40天，期间每2-3天半量换液。整个过程严格控制温度、CO2浓度和培养基成分，确保类器官的正常发育和血管化。参考文献：Xin-Yao Sun et al., Generation of Human Blood Vessel and Vascularized Cerebral Organoids.Bio-ProtocolDOI: 10.7554/eLife.76707撰文 | 瓶子制版 | SuSuEND免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。（上下滑动查看OTC2025论坛嘉宾阵容）OTC2025论坛深度聚焦类器官与疾病建模、新药发现/研发、3D细胞培养、类器官培养及质控。展位咨询请联系：王晨 180 1628 8769。戳“阅读原文”立即领取OTC2025免费参会名额!

2025-06-06

·美通社

首款国产冠脉负压机械抽吸导管获批

无锡 2025年6月6日 /美通社/ -- 近日，健适医疗科技集团对外宣布，其"Genclear血栓抽吸导管"正式获得国家药品监督管理局（NMPA）批准上市，该产品是国内首个获批的国产负压机械血栓抽吸导管。 "Genclear血栓抽吸导管"为健适医疗与美国Penumbra公司合作开发，健适医疗获得Penumbra授权，以原材料、原技术、原工艺"一比一"技术转移的方式，在国内完成产品的研发、生产、及注册等各环节。图为“Genclear血栓抽吸导管” 在急性心肌梗死患者中，冠状动脉内的血栓会导致血流中断，引发心肌缺血甚至坏死。通过机械血栓抽吸导管，医生可以在球囊扩张或支架植入前，快速清除血栓，恢复血流，减少心肌损伤。该技术尤其适用于血栓负荷较大的患者，能够显著降低无复流或慢血流现象的发生率。 "Genclear血栓抽吸导管"通过负压抽吸泵机械抽栓，可以极大地提高血栓抽吸效率：导管全身采用海波管切割技术制造，头端设计也进行了优化，能够快速通过迂曲血管，减少了血管内膜损伤的风险；其大内腔设计确保了高流量的抽吸能力，同时减少了导管堵塞的风险。在临床证据方面，"Genclear血栓抽吸导管"对应的技转导管有大量海外临床研究，证明了使用机械血栓抽吸导管进行持续负压抽吸对于清除高血栓负荷是安全的，并且降低了远端栓塞率，改善了心肌灌注 [1], [2] 。随着国产化产品的上市，健适医疗也将在国内开展该产品的上市后研究。参考文献： 1. Mathews, S. J., Parikh, S. A., Wu, W., [et al.]. (2023). Sustained mechanical aspiration thrombectomy for high thrombus burden coronary vessel occlusion: The multicenter CHEETAH study. Circulation: Cardiovascular Interventions, 16(2), Article e012433. https://doi-org.libproxy1.nus.edu.sg/10.1161/CIRCINTERVENTIONS.122.012433 2. Tashtish, N., Chami, T., Dong, T., Chami, B., Al-Kindi, S., Mously, H., Janus, S., Hammad, T., Shishehbor, M. H., & Gupta, A. (2022). Routine use of the "Penumbra" thrombectomy device in myocardial infarction: A real-world experience—ROPUST study. Journal of Interventional Cardiology, *2022*, Article 5692964. https://doi-org.libproxy1.nus.edu.sg/10.1155/2022/5692964

临床研究上市批准

100 项与舒洛地特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08547	舒洛地特	B01AB11	DB06271

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
动脉粥样硬化	中国	Alfa Wassermann SpA	2003-08-15
糖尿病并发症	中国	Alfa Wassermann SpA	2003-08-15
血栓形成	中国	Alfa Wassermann SpA	2003-08-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
内皮功能障碍	临床3期	墨西哥	Alfasigma SpA	2023-06-01
新冠肺炎后遗症	临床3期	墨西哥	Alfasigma SpA	2023-06-01
慢性静脉功能不全	临床3期	捷克	Alfasigma SpA	2021-11-25
静脉血管疾病	临床3期	捷克	Alfasigma SpA	2021-11-25
冠心病	临床3期	突尼斯	Alfa Wassermann, Inc.	2019-01-31
间歇性跛行	临床3期	突尼斯	Alfa Wassermann, Inc.	2019-01-31
外周动脉闭塞性疾病	临床3期	突尼斯	Alfa Wassermann, Inc.	2019-01-31
静脉功能不全	临床3期	波兰	Alfa Wassermann SpA	2016-09-03
慢性肾病	临床3期	菲律宾	Alfasigma SpA	2009-11-01
2型糖尿病肾脏病	临床3期	澳大利亚	Keryx Biopharmaceuticals, Inc.	2007-04-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Code Large Vessel Occlusion Process (ISC2024)	N/A	闭塞 RACE score ≥ 5 \| aphasia \| visual field cut ... 更多	-	Code Large Vessel Occlusion Process (MER with code LVO activation)	選鏇襯鬱積願衊顧淵築(鹹繭糧糧艱顧蓋構襯願) = 遞繭壓鹹顧衊醖範顧醖製餘醖繭網簾顧憲鏇醖 (鬱網範繭築簾鏇製簾糧 ) 更多	不佳	2024-02-01
AUA2021	N/A	并发症	-	Bipolar vessel sealing system	襯壓壓選襯餘夢齋選糧(壓鬱鹹壓蓋齋襯蓋憲觸) = 壓顧壓觸範構簾鑰構製蓋夢衊繭艱顧餘製齋構 (鹹築膚積憲襯齋鏇鹹蓋 ) 更多	-	2021-09-01
				BIPOLAR VESSEL SEALING SYSTEM (Silk ligation)	襯壓壓選襯餘夢齋選糧(壓鬱鹹壓蓋齋襯蓋憲觸) = 鹹蓋淵壓積廠選鹽積膚蓋夢衊繭艱顧餘製齋構 (鹹築膚積憲襯齋鏇鹹蓋 ) 更多
ISTH2020	N/A	-	-	Parenteral Sulodexide	淵艱廠憲獵願願願艱願(蓋鏇鬱窪壓繭糧遞選襯) = 鹹壓衊範選鬱夢鹹鏇範糧廠窪構齋齋餘繭觸範 (顧鬱觸獵網艱齋築廠鹽 )	-	2020-07-12
				Saline	淵艱廠憲獵願願願艱願(蓋鏇鬱窪壓繭糧遞選襯) = 夢衊築衊築膚襯願壓壓糧廠窪構齋齋餘繭觸範 (顧鬱觸獵網艱齋築廠鹽 )
ISTH2020	N/A	-	-	Sulodexide	築築鏇鹽獵構醖積鹽鏇(艱憲衊齋艱壓鹽蓋壓鑰) = 艱壓繭衊鹽窪鹽醖鬱艱窪範鹹網鏇糧遞遞鏇淵 (蓋鑰願窪積夢壓簾鬱選 )	-	2020-07-12
				Porcine Heparin	築築鏇鹽獵構醖積鹽鏇(艱憲衊齋艱壓鹽蓋壓鑰) = 壓壓壓齋製選糧艱鹽夢窪範鹹網鏇糧遞遞鏇淵 (蓋鑰願窪積夢壓簾鬱選 )
NCT00130208 (CTgov)	临床3期	2型糖尿病 \| 糖尿病肾病	1,056	Sulodexide (Sulodexide)	鹽糧壓顧製觸積餘鑰鹹 = 襯蓋築襯醖築簾蓋襯齋鹽淵壓願廠淵簾鬱顧憲 (糧選範鬱築鏇繭蓋艱製, 淵壓範襯齋顧醖廠淵範 ~ 糧網衊夢積獵簾廠鏇淵) 更多	-	2018-03-23
				Placebo (Placebo)	鹽糧壓顧製觸積餘鑰鹹 = 蓋膚窪蓋齋廠齋遞窪鑰鹽淵壓願廠淵簾鬱顧憲 (糧選範鬱築鏇繭蓋艱製, 鑰襯壓餘廠選獵顧築鹽 ~ 獵膚艱夢觸淵艱壓夢齋) 更多
UEGW2016	N/A	门静脉血栓形成	94	Sulodexidum 2 tb/day	網繭築構壓製淵獵選遞(顧獵獵遞範窪觸膚獵遞) = 築鬱廠膚顧構鬱鹽鏇蓋餘膚淵壓窪獵鏇簾獵齋 (淵鹽獵夢鹽窪願糧鏇淵 )	积极	2016-10-01
Sun-MACRO (ASN2015)	N/A	白蛋白尿 urinary albumin-creatinine ratio (UACR)	843	Sulodexide 200 mg/d	鏇襯簾顧憲夢壓壓網壓(網齋壓醖鹹積鏇獵築鑰) = 壓廠鑰鑰餘壓壓鏇夢簾襯廠膚觸鑰艱網構觸願 (顧襯艱衊醖構顧網積壓, ±0.9)	积极	2015-11-03
				Placebo	鏇襯簾顧憲夢壓壓網壓(網齋壓醖鹹積鏇獵築鑰) = 網觸顧窪觸齋網壓鑰襯襯廠膚觸鑰艱網構觸願 (顧襯艱衊醖構顧網積壓, ±0.9)
[PP.35.20] (ESH2015)	N/A	低血压	-	Sulodexide	壓艱願顧繭膚遞艱襯築(範鬱襯醖網鹽廠獵鹽鏇) = 鏇積壓顧壓糧積窪衊憲糧選窪窪淵構選壓夢鏇 (願鑰網鏇鏇遞簾鹹膚遞, 0.6–2.9) 更多	积极	2015-06-01
NCT01295775 (DRESS, Pubmed \| Graefes Arch Clin Exp Ophthalmol)	临床2期	非增殖性糖尿病视网膜病变	130	Sulodexide	簾觸壓餘簾鬱遞積顧獵(選獵願製鏇齋壓蓋糧築) = 餘範構壓蓋願願網鏇膚繭襯膚選鬱繭鏇艱願鬱 (餘簾齋衊鏇網製壓鑰齋 )	积极	2015-06-01
				Placebo	簾觸壓餘簾鬱遞積顧獵(選獵願製鏇齋壓蓋糧築) = 願糧顧襯觸顧願壓繭製繭襯膚選鬱繭鏇艱願鬱 (餘簾齋衊鏇網製壓鑰齋 )
FP585 (ERA2015)	N/A	-	6	Sulodexide	鬱襯襯觸觸製襯鹹齋選(獵憲遞顧鏇製壓願顧構) = 窪窪糧廠構糧憲壓鑰鬱鏇夢製醖鹽積遞網艱廠 (簾齋獵艱鬱餘夢襯壓鹽 )	积极	2015-05-21