预约演示
更新于：2025-07-26
Sulodexide
舒洛地特
更新于：2025-07-26
概要
基本信息
原研机构 |
在研机构 |
权益机构- |
最高研发阶段临床3期 |
最高研发阶段(中国)撤市 |
特殊审评- |
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关联
47
项与 舒洛地特 相关的临床试验NCT07038707
Research on the Identification of Early Screening Markers for Herpes Zoster Neuralgia Based on Intestinal Flora Analysis
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.
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- |
NCT07084727
Retinal Biomarkers as a Tool for Early Detection of Endothelial Dysfunction in Women With Preeclampsia
Every pregnancy has a major impact on a woman's heart and blood vessels due to changes required by the body to maintain proper blood flow between mother and foetus. When the placenta does not work properly, preeclampsia can occur. An important first symptom is high blood pressure. Women who have experienced preeclampsia are at higher risk of developing blood pressure and heart problems later on. Therefore, it is very important to detect changes in the blood vessel system so that they can be treated promptly and correctly. We aim to do this by using a new, non-invasive eye test that examines the blood vessels of the retina.
开始日期2025-07-01 |
申办/合作机构- |
NCT06982196
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 |
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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370
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.
62
项与 舒洛地特 相关的新闻（医药）2025-07-08
传统的2D贴壁培养MSC在商业化生产有着放大局限性，特别是细胞数量要求达到109 cells以上时。此外2D贴壁培养中pH、Do等控制较差，需要频繁的传代消化易污染等均可能导致细胞生长较差。而3D微载体培养工艺可以有效地上述解决问题。但动态的3D培养环境更为复杂，需要研究者调节和优化工艺参数，维持良好的细胞生长环境，促进细胞贴壁，迁移和生长。今天总结出一些文献以及实际中3D微载体cytodex 1可供研究者优化的工艺参数，希望能为大家提供有效解决方法。Q1我该如何选择培养基？一般而言，使用DMEM+血清的方式即可满足MSC传代，扩增和生产所需，有部分研究和客户也会使用αMEM或者MEM+血清的方式进行培养，且部分研究中这二者的MSC增殖效果优于DMEM+血清[1]，您可先使用小的转瓶或T瓶进行培养基筛选测试以确定平台MSC中表现最优的培养基。但如果您需要收集外泌体（或者有无血清工艺需求），可使用无血清培养基进行培养。血清中含有外泌体，如使用含血清工艺培养MSC且收集外泌体，会对目标外泌体纯化造成一定干扰。Q2微载体的推荐使用量多少？一般来说，MSC的推荐初始使用微载体使用量在2~5 g/L，您可以初期使用2 ~3 g/L的cytodex 1，后期细胞数量不断增加，可补充额外的微载体提供更多的贴壁界面，利于细胞迁移和增殖。如在Ferrari等人的研究中[2]，day4时分别向两个转瓶中额外加入1.2 g/L的全新微载体和已接种过细胞后消化的旧微载体，静止24 h后开启搅拌。白色marker组中添加新微载体的转瓶中细胞在15天培养中细胞总数维持稳定，不加微载体和加入旧微载体的转瓶在后期细胞数量逐步减少。图1：MSC在转瓶中的生长曲线Q3接种阶段细胞接种密度多少？常规MSC接种密度在0.4~0.8 E4 cell/cm2，此处的面积是计培养体积中所有微载体能提供的表面积，1 g干重的cytodex 1的表面积在4,400 cm2。如果微载体使用量2 g/ L，培养体积3 L，培养体积中所有微载体能提供的表面积：2*3*4400=26,400 cm2。当然，接种密度不是一个绝对值，如您使用高密度灌流工艺（如8~12 g/L cytodex 1的使用量）或者尝试高接种，接种密度可以提高至E5~E6 cell/cm2级别[3]。Q4转速如何设置？转瓶或者罐体当中以能使微载体全部悬浮起来为基准，后期细胞密度上来后可微微提高转速。转速的设定值既要考虑剪切力损伤，又要考虑好的混合。可以参考雷诺数Re、剪切力shear stress、K length等公式进行定性计算[4] [5]：表1：计算公式Q5接种时怎么让细胞贴的更好一些？小体积中一般直接接种后搅拌即可，当如果为了细胞更好贴壁或极少情况下平台MSC贴壁性能较差，可采用间歇搅拌——静置——搅拌的方式使MSC在最初的阶段粘附在微载体表面，可参考Tavares等人的研究[6]。图2：MSC间歇搅拌方式Q6消化细胞，细胞贴的太牢，怎么办？确保DPBS充分润洗微载体，排除DPBS，加入胰酶可采用间歇式搅拌或开启较低转速保证胰酶与微载体充分接触，同时机械搅拌可以加速细胞从微载体上解离，获得更多细胞[7]。图3：机械搅拌加速细胞消化曲线微载体培养MSC中有较多需要优化和注意的工艺操作点，在实际项目实践中需要一一攻破。如您有MSC任意产物的微载体、培养基、血清、填料、滤器需求或工艺问题欢迎扫描下方二维码Cytiva将为您提供专业技术和样品支持经核实意向用户可获得定制蓝牙音响一个！参考文献1.Different culture media affect growth characteristics, surface marker distribution and chondrogenic differentiation of human bone marrow-derived mesenchymal stromal cells2. Limiting Cell Aggregation During Mesenchymal Stem Cell Expansion on Microcarriers3.Large-Scale Expansion of Human Mesenchymal Stem Cells4.Advances in cell culture: anchorage dependence5.Characterization of agitation environments in 250 ml spinner vessel, 3 L, and 20 L reactor vessels used for animal cell microcarrier culture6.Dualproductionofhumanmesenchymalstromalcellsandderivedextracellularvesiclesinadissolvablemicrocarrier-basedstirredculturesystem 7.Process intensification for Peste des Petites Ruminants Virus vaccine production本期关键词：#Cytiva细胞培养 #HyClone
临床1期
2025-07-03
点击“蓝字”关注我们脑血管疾病作为全球致死致残重要病因之一，其防治策略优化始终是临床研究焦点。近日Stroke杂志刊载了多项该领域的研究成果，从病理机制探索到临床干预策略优化，为脑血管病全周期管理提供重要启示。这些研究聚焦于脑血管损伤的早期预警标志物与干预窗口，强调了多维度评估、精准化干预的重要性，对构建脑血管病防控体系具有重要指导意义。本刊特此报道，以飨读者。家族性高胆固醇血症作为脑小血管病的独立危险因素研究背景家族性高胆固醇血症（FH）的特征是自出生起低密度脂蛋白胆固醇（LDL-C）水平升高。然而，FH与包括脑小血管病（CSVD）在内的脑血管疾病之间的关联仍存在争议。为探究FH与CSVD的关联，本研究比较了FH患者与对照参与者之间CSVD神经影像学表现的患病率和严重程度。研究方法研究纳入了2006年11月至2021年4月期间就诊并接受脑部磁共振成像（MRI）检查的FH患者，以及2000年12月至2010年12月期间自愿接受脑部MRI作为体检的对照参与者。研究调查了FH患者和对照参与者中CSVD神经影像学表现的患病率和严重程度，并采用多变量逻辑回归和类泊松回归分析确定了CSVD发展的潜在危险因素。研究结果及结论研究共纳入151例FH患者和3172例对照参与者。结果显示，FH是腔隙性梗死患病和腔隙数量增加的独立危险因素。此外，FH还是脑微出血患病和脑微出血数量增加的独立危险因素。FH与腔隙性梗死和脑微出血的关联表明，应对FH患者进行常规脑部影像学检查，以预防症状性卒中的发生。血脑屏障破坏预测蛛网膜下腔出血预后不良：一项动态对比增强磁共振成像研究研究背景自发性动脉瘤性蛛网膜下腔出血早期即可引发血脑屏障通透性功能障碍，但其临床意义及潜在机制仍不明确。研究旨在评估早期脑损伤期末通过动态对比增强磁共振成像（DCE-MRI）量化的血脑屏障破坏程度、循环神经炎症介质水平与长期临床预后之间的关联。研究方法研究者分析了蛛网膜下腔出血患者的前瞻性队列数据，所有患者在临床发病后中位时间4天（四分位距2~6天）接受DCE-MRI检查。通过渗透性图谱获取全脑、灰质和白质的K-trans值，作为血脑屏障通透性增高的量化指标。同时采集血液样本，使用多重酶联免疫吸附试验检测包括白细胞介素8（IL-8）和血小板衍生生长因子（PDGF）在内的循环神经炎症分子水平。临床预后不良定义为90天时改良Rankin量表评分>2分。采用单变量及多变量回归模型分析K-trans值、神经炎症介质与临床预后之间的关联。研究结果及结论在初步筛选的153例患者中，最终纳入96例。调整后的线性回归分析显示，较高的K-trans值与IL-8（P=0.001）和PDGF（P=0.018）水平升高显著相关。单因素分析表明，预后不良患者的白质K-trans值显著高于预后良好患者。在调整年龄、高血压、脑实质血肿、动脉瘤大小及MRI检查时间等因素后，K-trans值每增加一个四分位距，预后不良风险则独立增加（P=0.003）。血脑屏障通透性增高与循环神经炎症介质水平升高及3个月时临床预后不良相关。研究支持白质通透性改变可作为蛛网膜下腔出血的潜在生物标志物及治疗靶点。隐性脑血管疾病与需医疗干预的跌倒之间的关联研究背景隐性脑血管疾病对普通人群跌倒的影响尚不明确。研究旨在确定在临床神经影像学检查中偶然发现的隐性脑血管疾病后，首次跌倒发生的时间。研究方法这项纵向队列研究分析了50岁以上患者的计算机断层扫描（CT）和磁共振成像（MRI）数据，排除了既往有卒中或痴呆病史的患者。研究通过自然语言处理技术从影像学报告中提取偶发性隐性脑梗死（CBI）和白质高信号/低衰减（WMH）的证据，并使用Cox比例风险回归模型分析CBI和WMH与需医疗干预的跌倒之间的关联。研究结果及结论研究纳入241,050例患者，平均年龄64.9岁（标准差10.42岁），女性占61.3%。在平均3.04年的随访期间，31.1%的患者检测到隐性脑血管疾病，21.2%的患者发生跌倒记录。CT及MRI结果均显示，同时存在CBI和WMH的患者跌倒发生率最高，且WMH严重程度与跌倒风险呈剂量依赖性增加。在接受神经影像学检查的大规模人群中，CBI和WMH均独立与跌倒风险增加相关。无论通过CT还是MRI评估，WMH严重程度均与跌倒风险呈渐进式关联。脑出血急性期后出院去向与主要心血管不良事件的关系研究背景目前缺乏评估脑出血幸存者中与医疗系统相关的因素对主要心血管不良事件（MACE）影响的研究。研究旨在比较不同急性期后护理场所（住院康复机构[IRF]、家庭或专业护理机构[SNF]）对MACE发生率的差异。研究方法研究纳入2016年4月至2018年12月期间出院至家庭、IRF或SNF的成年脑出血幸存者。通过多变量逻辑回归模型，评估出院去向（IRF vs. 家庭；IRF vs. SNF）与1年内MACE的关联。研究结果及结论研究纳入58,591例脑出血患者，其中17,647例脑出血幸存者出院至家庭（46.4%）、IRF（25.5%）或SNF（28.1%）。1年内，1,302例（7.4%）患者发生MACE，其中脑出血复发率为2.5%，急性缺血性卒中3.2%，急性心肌梗死0.6%，血管性死亡1.3%，全因死亡率3.5%。在完全调整模型中，出院至IRF的患者MACE发生概率显著低于出院至家庭，且出院去向与年龄存在显著交互作用（P=0.047）。分层分析显示，仅<65岁患者中，IRF出院（vs.家庭）与MACE显著相关，而≥65岁患者中无此关联。此外，IRF与SNF相比，脑出血复发、血管性死亡及全因死亡率均显著降低。总之，与SNF和家庭护理相比，IRF护理与MACE发生概率降低相关。未来研究需进一步明确IRF护理中具体改善预后的关键因素。资料来源：（上下滑动可查看）1.Hiroaki Murata, et al.Familial Hypercholesterolemia, as an Independent Risk of Cerebral Small Vessel Disease. Stroke,Originally Published 26 June 2025.2.Laura Llull, et al. Blood-Brain Barrier Disruption Predicts Poor Outcome in Subarachnoid Hemorrhage: A Dynamic Contrast–Enhanced MRI Study. Stroke, Originally Published 25 June 2025.3.Úna Clancy, et al. Association of Covert Cerebrovascular Disease With Falls Requiring Medical Attention. Stroke, Originally Published 27 June 2025.4.Abdulaziz T. Bako, Postacute Discharge Destination and Major Adverse Cardiovascular Events Among Patients With Intracerebral Hemorrhage.troke, Originally Published 26 June 2025.声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际循环》编辑部）
临床研究
2025-07-02
·生物谷
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
100 项与 舒洛地特 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 动脉粥样硬化 | 中国 | 2003-08-15 | |
| 糖尿病并发症 | 中国 | 2003-08-15 | |
| 血栓形成 | 中国 | 2003-08-15 |
未上市
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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 | 2023-06-01 | |
| 新冠肺炎后遗症 | 临床3期 | 墨西哥 | 2023-06-01 | |
| 慢性静脉功能不全 | 临床3期 | 捷克 | 2021-11-25 | |
| 静脉血管疾病 | 临床3期 | 捷克 | 2021-11-25 | |
| 冠心病 | 临床3期 | 突尼斯 | 2019-01-31 | |
| 间歇性跛行 | 临床3期 | 突尼斯 | 2019-01-31 | |
| 外周动脉闭塞性疾病 | 临床3期 | 突尼斯 | 2019-01-31 | |
| 静脉功能不全 | 临床3期 | 波兰 | 2016-09-03 | |
| 慢性肾病 | 临床3期 | 菲律宾 | 2009-11-01 | |
| 2型糖尿病肾脏病 | 临床3期 | 澳大利亚 | 2007-04-01 |
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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 |
|---|
临床3期 | 1,056 | (Sulodexide) | 遞糧鹹範糧鬱艱築窪鏇 = 網鹹醖夢憲齋憲鑰餘遞 範糧網積襯願獵鹽鑰積 (壓艱鏇遞積鏇壓觸醖齋, 簾鹽鑰鹽獵鏇膚蓋鏇遞 ~ 網壓繭艱蓋構範遞壓積) 更多 | - | 2018-03-23 | ||
Placebo (Placebo) | 遞糧鹹範糧鬱艱築窪鏇 = 製鑰壓膚鹽築簾餘遞鑰 範糧網積襯願獵鹽鑰積 (壓艱鏇遞積鏇壓觸醖齋, 獵淵衊窪網夢餘顧顧築 ~ 鏇糧鑰鑰廠鹽窪觸窪鬱) 更多 | ||||||
N/A | 94 | Sulodexidum 2 tb/day | 積窪夢壓鑰積鹹製願觸(艱築蓋鑰齋憲廠鬱膚簾) = 壓築艱鑰餘獵壓醖範齋 鬱廠淵壓願膚壓網繭鑰 (網夢網製築鏇製築構窪 ) | 积极 | 2016-10-01 | ||
临床2期 | 130 | 鹹鹹網製顧築鑰築膚繭(願壓膚壓願積製觸網衊) = 簾憲築鑰餘願繭壓鏇糧 鏇繭範醖廠鏇鹹憲醖艱 (構簾製憲網願繭艱鏇遞 ) | 积极 | 2015-06-01 | |||
Placebo | 鹹鹹網製顧築鑰築膚繭(願壓膚壓願積製觸網衊) = 壓繭網顧鹹繭齋鑰壓糧 鏇繭範醖廠鏇鹹憲醖艱 (構簾製憲網願繭艱鏇遞 ) | ||||||
临床3期 | 1,056 | 鹹選蓋鹹衊繭鹹壓鏇壓(範觸構構糧醖憲願網窪) = 鹹鹽構簾製餘選網衊襯 鹹蓋糧積鹽網繭夢獵糧 (艱製觸選窪夢襯網構獵 ) 更多 | 不佳 | 2011-11-01 | |||
Placebo | 鹹選蓋鹹衊繭鹹壓鏇壓(範觸構構糧醖憲願網窪) = 鑰窪衊齋願觸糧獵鑰壓 鹹蓋糧積鹽網繭夢獵糧 (艱製觸選窪夢襯網構獵 ) 更多 | ||||||
N/A | 20 | (Participants with type 2 diabetes) | 獵積鏇構獵齋醖餘廠遞(願醖壓襯壓鹹鹹簾簾窪) = 鏇觸襯觸糧襯糧製積觸 壓齋鬱範積蓋鹽獵齋獵 (鹹廠構網醖艱壓鏇膚繭 ) 更多 | - | 2010-12-01 | ||
(Controls) | 獵積鏇構獵齋醖餘廠遞(願醖壓襯壓鹹鹹簾簾窪) = 淵夢夢餘廠夢壓壓餘網 壓齋鬱範積蓋鹽獵齋獵 (鹹廠構網醖艱壓鏇膚繭 ) 更多 |
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