Early Vessel Recoil Following Below-the-knee (BTK) Artery Treatment With the Spur Peripheral Retrievable Scaffold System in Specific Patient Populations With Chronic Limb-threatening Ischemia (CLTI) - The DEEPER CHALLENGE Single Center Prospective Study

Chronic limb threatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD) and is characterized by ischemic rest pain, non-healing wounds, or ischemic gangrene. High-risk PAD populations including patients with end-stage renal disease and or diabetes also experience worse outcomes with significantly increased rates of amputation and mortality.
Although some patients with PAD are best treated with a combination of medical management, exercise and lifestyle modification, revascularization is indicated in those with advanced stages of disease and particularly in the presence of CLTI. Revascularization of below-the-knee (BTK) arteries is required for most patients suffering from CLTI, but treatment faces numerous challenges comprising calcification, small vessel size, long-lesion length and early elastic recoil. With regard to these challenges, numerous innovative techniques and devices have been developed within the past decades to optimize endovascular treatment of BTK vessels.
The Spur Peripheral Retrievable Scaffold System (Spur) was developed to directly address many of these pitfalls of infrapopliteal arterial disease. The premise of the design of the Spur is to provide temporary mechanical scaffolding and to prepare the vessel for treatment with a drug-coated balloon (DCB) to enhance drug absorption by creating channels in the endothelium by the deployed Spur.
The objective of this study is to perform a prospective, single-center, single-arm, non-randomized study to evaluate acute vessel recoil following BTK treatment with the Spur Retrievable Scaffold System in combination with a commercially available DCB in specific patients populations. Specific patient populations that are selected to participate in this study are either at high risk to discover unfavorable outcomes with standard techniques due to a high complexity of lesions and/or patients that are not adequately mirrored in available studies. The patient cohorts that will be studied are diabetics and patients on hemodialysis (for at least 6 months). As women are commonly under-represented in comparable trials, this study requires at least 50% of women for each cohort.
The primary endpoint is vessel recoil within 15 minutes post treatment assessed with angiography. Secondary endpoints will be followed out to 12 months.

开始日期2026-03-01

申办/合作机构

Medizinische Universität Graz

[+1]

NCT07038707

/ Not yet recruitingN/AIIT

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.

开始日期2025-07-01

申办/合作机构-

NCT07084727

/ RecruitingN/AIIT

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-

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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313

项与舒洛地特相关的文献（医药）

2026-01-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Sulodexide can ameliorates renal interstitial fibrosis in adenine-induced kidney injury rats

Article

作者: Li, Wenbin ; Xing, Minghui ; Xu, Huiyan ; Wang, Qun ; Li, Lin ; Zhang, Yifei ; Liang, Liming ; Kong, Xianglei ; Xu, Shuqi

OBJECTIVE:

To investigate the effect and mechanisms of sulodexide(SDX) on adenine-induced kidney injury (KI) in rats.

METHODS:

Thirty female Sprague-Dawley rats were randomized into 3 groups: rats were fed on a normal diet (control group), rats received 0.75 % adenine diet for 4 weeks and 0.9 % saline intraperitoneally for 8 weeks (KI group) and rats received 0.75 % adenine diet for 4 weeks and sulodexide (15 mg/kg/day) intraperitoneally for 8 weeks (KI + SDX group). After the treatments of 8 weeks, the blood and kidney tissue specimens were obtained. Biochemical index and pathological staining were used to assess renal injury and fibrosis. Immunohistochemistry and Western blot were used to detect fibrosis-related proteins and signaling pathways.

RESULTS:

Compared with the control group, the KI group showed higher blood creatinine and urea nitrogen levels, lower total protein levels, and increased renal injury, with significantly higher expression of α-SMA (p < 0.01) and FN (p < 0.01) and increased expression of the Wnt/β-catenin signaling pathway proteins Wnt3a (p < 0.05) and β-catenin (p < 0.01). After sulodexide treatment, biochemical indexes and renal pathological manifestations were improved, and the expression of α-SMA (p < 0.01) and FN (p < 0.01) were significantly reduced, and the expression of Wnt/β-catenin signaling pathway proteins Wnt3a (p < 0.01) and β-catenin (p < 0.05) was decreased.

CONCLUSIONS:

The study demonstrated that SDX can delay renal interstitial fibrosis in adenine-induced kidney injury rats, which may be related to the inhibition of Wnt/β-catenin signaling pathway.

2025-12-19·Khirurgiia

Pharmacological support strategies following endovenous laser ablation in patients with varicose veins

Article

作者: Kamaev, A.A. ; Pshennikov, A.S. ; Suchkov, I.A. ; Kalinin, R.E.

Objective. To evaluate the impact of endovenous laser ablation (EVLA) combined with micronized purified flavonoid fraction (MPFF), sulodexide, and their combination on the dynamics of circulating biomarkers and quality of life in patients with varicose vein disease of the lower extremities. Material and methods. A prospective study included 173 patients who underwent EVLA. They were allocated into four groups: EVLA alone (n=44), EVLA+MPFF (n=43), EVLA+sulodexide (n=43), and EVLA+MPFF+sulodexide (n=43). MPFF was prescribed at 1000 mg/day and sulodexide at 500 LSU/day for two months. Serum levels of E-selectin, MCP-1, VEGF, MMP-2, and MMP-9 were measured using ELISA at baseline (V0), after 2 months (V2), and after 12 months (V3). Quality of life was assessed with validated questionnaires CIVIQ-20 and SF-36. Results. EVLA alone provided early improvements in quality of life and reductions in E-selectin and MCP-1, although the effect partially diminished by 12 months in patients with advanced disease. MPFF mainly reduced MCP-1 (213.8 → 115.5 pg/mL; p<0.001) and VEGF (109.6 → 52.6 pg/mL; p<0.001), particularly in patients with CEAP C2–C3. Sulodexide significantly decreased MMP-2 (517.8 → 250.8 ng/mL; p<0.001) and MMP-9 (19.4 → 9.9 ng/mL; p<0.001) in CEAP C4–C6, although the effect partly attenuated at 12 months. The most pronounced and sustained effect was observed in the combination group: E-selectin (60.1 → 43.1 ng/mL), MCP-1 (265.4 → 131.3 pg/mL), VEGF (188.7 → 87.1 pg/mL), MMP-2 (487.8 → 230.1 ng/mL), and MMP-9 (19.8 → 8.7 ng/mL) all significantly decreased (all p<0.001), while improvements in CIVIQ-20 and SF-36 were maintained throughout one year. Conclusion. EVLA provides clinical improvement and reductions in inflammatory biomarkers, but the effect is less durable in advanced disease. MPFF primarily modulates MCP-1 and VEGF, while sulodexide acts on MMP-2 and MMP-9. Their combination shows complementary pathogenetic mechanisms, yielding the most durable biochemical and clinical benefits, and may represent the optimal pharmacological support for EVLA in patients with severe chronic venous disease.

2025-10-01·JOURNAL OF CLINICAL LABORATORY ANALYSIS

Clinicopathological Characteristics and Prognosis of IgA Nephropathy Combined With Malignant Hypertension Kidney Injury

Article

作者: Yang, Wenzhuo ; Dai, Zefang ; Li, Zhijian ; Li, Jianbo ; Zhong, Zhong

ABSTRACT:

Background:

IgA nephropathy (IgAN), a major cause of primary glomerulonephritis, is closely associated with malignant hypertension (MHT). This study aimed to explore the clinicopathological characteristics and renal prognosis of patients with IgAN combined with malignant hypertension kidney injury (IgAN‐MHT) and investigate the associations of clinicopathological indicators with prognosis.

Methods:

In this single‐center retrospective cohort study, patients diagnosed with IgAN‐MHT through kidney biopsy between January 1, 2008, and June 30, 2023, in our hospital were enrolled. Cox regression models were used to assess the associations between clinical indicators and renal prognosis in IgAN‐MHT patients.

Results:

A total of 70 patients were included in the analysis of renal function improvement. During a median follow‐up time of 9.4 months, 26 patients (37.1%) achieved renal function improvement. Patients in the improved renal function group had higher hemoglobin levels ( p = 0.003), lower serum creatinine levels ( p = 0.006), a higher proportion of patients using sulodexide ( p = 0.018), and a lower proportion of glomerulosclerosis ( p < 0.001). Multivariable Cox regression analysis indicated that a higher proportion of glomerulosclerosis was independently associated with a lower likelihood of renal function improvement (HR = 0.97, 95% CI = 0.96–0.99, p = 0.003), while sulodexide administration was independently associated with a higher likelihood of improvement (HR = 2.75, 95% CI = 1.18–6.41, p = 0.019).

Conclusion:

This study revealed that in IgAN‐MHT patients, a higher proportion of glomerulosclerosis was independently associated with poorer renal outcomes, while the use of sulodexide showed a significant independent association with improved renal function.

180

项与舒洛地特相关的新闻（医药）

2026-04-17

·生物谷

产丁酸菌匮乏诱发慢性炎症导致慢病的病理机制以及补充产丁酸菌抗炎抗肿瘤的机理

产丁酸菌匮乏诱发慢性炎症导致慢病的病理机制以及补充产丁酸菌抗炎抗肿瘤的机理马曼茹1逄梦玉1鹿凤娇2江学良3 崔云龙4 1 医用微生态制品开发国家地方联合工程研究中心 2 医用微生态制品开发国家地方联合工程研究中心，清华大学医学院北京协和医学院 3 中国中西医结合学会炎症性肠病主任委员，《世界华人消化杂志》主编 4医用微生态制品开发国家地方联合工程研究中心主任，中国科促会微生态专委会副主任委员、《世界华人消化杂志》微生态专委会主任委员摘要：慢性低度炎症是多种慢性非传染性疾病与肿瘤发生发展的共同病理基础，常规抗炎治疗存在靶点单一、不良反应明显、难以从源头遏制等局限。肠道产丁酸菌作为维持微生态与免疫稳态的 “基石菌”，其丰度匮乏可通过肠屏障损伤、毒素易位、免疫紊乱等途径诱发并放大慢性炎症，进而驱动代谢病、自身免疫病、炎症性肠病及结直肠癌等疾病进程。本文系统综述产丁酸菌匮乏介导慢性炎症与慢病发生的级联病理机制，阐述补充产丁酸菌在修复肠屏障、调控免疫、遏制慢性炎症及阻断 “炎 - 癌转化” 中的分子机理，并结合临床研究总结其应用价值与前景，为慢性炎症相关疾病的微生态干预提供理论依据。关键词：产丁酸菌；丁酸；酪酸梭菌；酪酸；基石菌；慢性炎症；肠屏障；免疫调节；抗炎；抗肿瘤； 1 慢性炎症的巨大危害及常规治疗的局限性慢性低度炎症是一种持续、隐匿、全身性的低度炎症状态，与衰老、代谢紊乱、自身免疫及肿瘤发生高度相关，被视为多种慢病共同的病理土壤[1]。与急性炎症的防御性与自限性不同，慢性炎症以促炎因子持续释放、免疫细胞异常活化、组织反复损伤修复为特征，长期作用可诱发多器官结构与功能异常[2]。在肠道局部，慢性炎症是炎症性肠病（IBD）的核心特征，长期黏膜炎症显著提升结肠炎相关结直肠癌（CAC）的发病风险，炎症持续时间与癌变概率呈明显正相关[3, 4]。在全身层面，慢性炎症通过循环系统参与动脉粥样硬化、2 型糖尿病、非酒精性脂肪性肝病（NAFLD）、神经退行性疾病及自身免疫病等多种疾病[2, 5]。同时，慢性炎症可通过活性氧与活性氮造成 DNA 损伤、激活 NF-κB、STAT3 等促癌通路，营造免疫抑制微环境，直接推动 “炎 - 癌转化”[6, 7]。目前临床针对慢性炎症的治疗主要依赖非甾体抗炎药、糖皮质激素、免疫抑制剂及生物制剂等[8]。此类药物虽可短期缓解症状，但存在明显局限：第一，靶点单一，多作用于下游炎症因子，无法纠正肠屏障损伤、菌群紊乱等上游病因，易反复发作[2, 9]；第二，不良反应突出，长期使用可导致胃肠道损伤、肝肾功能异常、骨质疏松及继发感染[8]；第三，对肠源性慢性炎症效果有限，难以从源头阻断肠漏 - 全身炎症轴[2, 10]。因此，以肠道微生态为靶点的源头性抗炎策略，已成为慢病防治的重要方向[11, 12]。 2 基石菌 - 产丁酸菌匮乏诱发慢性炎症导致慢病的病理机制产丁酸菌是肠道核心 “基石菌”，主要包括酪酸梭菌、普拉梭菌、罗斯氏菌、柔嫩梭菌等，其代谢产物丁酸（又称酪酸）是结肠上皮细胞首要能量来源，也是维持肠屏障、菌群平衡与免疫稳态的关键分子[10, 13]。多项临床与基础研究证实，IBD、糖尿病、肥胖、动脉粥样硬化及结直肠癌患者肠道中产丁酸菌丰度显著下降，丁酸水平降低，且与疾病活动度呈负相关[2, 3, 14, 15]。产丁酸菌匮乏通过多级病理通路诱发慢性炎症并驱动慢病发生。 2.1 肠屏障损伤与肠漏：慢性炎症的启动环节丁酸可通过上调紧密连接蛋白 ZO-1、occludin、claudin-1 维持肠黏膜完整性[16, 17]。产丁酸菌匮乏导致丁酸生成不足，肠上皮细胞能量供应障碍，增殖修复能力下降，凋亡增加[10, 16]；同时杯状细胞分泌 Muc2 减少，黏液层变薄，致病菌黏附侵袭增强[17]。肠屏障通透性异常升高形成 “肠漏”，肠道脂多糖（LPS）、病原菌抗原等大量入血，引发代谢性内毒素血症，激活 TLR4-NF-κB 通路，启动全身低度炎症[2, 18]。 2.2 菌群失衡与致病菌过度增殖：炎症放大环路产丁酸菌可通过降低肠道 pH、生态占位、营养竞争抑制致病菌增殖[10, 18]。当其丰度下降，肠杆菌科、变形杆菌、具核梭杆菌等条件致病菌过度生长，进一步破坏肠屏障、刺激炎症因子释放，形成 “菌群失衡 — 肠漏 — 炎症加剧 — 菌群更失衡” 的恶性循环[9, 19]。普拉梭菌丰度降低还与 IBD 患者疲劳症状加重密切相关，提示产丁酸菌对全身炎症与生活质量的重要影响[20]。 2.3 免疫稳态破坏：慢性炎症持续的核心机制丁酸通过激活 GPR41/43、抑制组蛋白去乙酰化酶（HDAC）调控先天与适应性免疫[2, 16]。产丁酸菌匮乏可导致：①巨噬细胞向促炎 M1 型极化，抗炎 M2 型减少[5, 17]；②树突状细胞促炎因子分泌增加，免疫耐受降低[16]；③Treg 细胞分化受抑，Th17 细胞异常活化，Treg/Th17 平衡破坏，IL-17、IL-6、TNF-α 等持续升高[5, 21, 22]；④肠道 sIgA 分泌下降，黏膜防御能力减弱[10, 17]。免疫紊乱不仅加剧肠道炎症，还通过肠 - 关节轴、肠 - 肾轴、肠 - 脑轴诱发脊柱关节炎、肾病、多发性硬化与抑郁等[21-24]。 2.4 代谢紊乱与氧化应激：炎症 - 慢病的协同通路产丁酸菌 - 丁酸轴可调控 AMPK 通路改善胰岛素敏感性与脂质代谢[15, 25]。其匮乏导致胰岛素抵抗、脂肪组织炎症、肝脏脂质沉积，促进肥胖、糖尿病及 NAFLD 进展[15, 25]；同时慢性炎症诱发大量活性氧，加剧 DNA 损伤与基因组不稳定性，为肿瘤发生奠定基础[6, 7]。综上，产丁酸菌匮乏构成 “基石菌缺失→丁酸不足→肠漏→毒素易位→免疫失衡→慢性炎症→代谢紊乱→氧化应激→慢病 / 肿瘤” 的完整病理链条[2, 10, 13]。 3 补充基石菌 - 产丁酸菌消除炎症、遏制慢病以及抗肿瘤的机理外源性补充产丁酸菌（尤其是酪酸梭菌）可通过丁酸依赖与非丁酸依赖途径，从上游阻断肠源性炎症，实现系统性抗炎、慢病控制与抗肿瘤效应[10, 12, 17]。 3.1 修复肠屏障，从源头阻断炎症启动酪酸梭菌等产丁酸菌在肠道定植后持续产生丁酸，为肠上皮供能，促进黏膜修复与溃疡愈合[17, 26]；同时上调紧密连接蛋白，降低肠道通透性，减少 LPS 等易位[16, 17]；促进杯状细胞分泌黏液，增强黏膜防御[17]。肠屏障修复可显著降低全身内毒素水平，切断慢性炎症的始动因素[2, 18]。 3.2 重塑肠道菌群，抑制致病菌与炎症放大产丁酸菌可通过产酸降低肠道 pH、竞争黏附位点抑制致病菌增殖[10, 18]；同时促进双歧杆菌、乳酸菌等有益菌生长，恢复微生态平衡[26, 27]。菌群结构改善可减少炎症刺激，降低促炎因子水平，缓解肠道及全身慢性炎症[9, 26]。 3.3 系统性抗炎与免疫稳态重塑丁酸作为 HDAC 抑制剂与 GPR41/43 激动剂，可抑制 NF-κB、MAPK 等炎症通路，降低 IL-6、IL-1β、TNF-α 水平[2, 16]；促进巨噬细胞向 M2 型极化，增强 Treg 功能，恢复 Treg/Th17 平衡，抑制自身免疫异常激活[5, 21, 22]；同时提升 sIgA 分泌，增强黏膜免疫[10, 17]。酪酸梭菌还可通过激活 EGFR 通路减轻结肠炎症，体现非丁酸依赖的抗炎机制[26]。 3.4 阻断炎 - 癌转化，发挥直接与间接抗肿瘤作用慢性炎症是结直肠癌发生的重要驱动因素，补充产丁酸菌可从多层面抑制肿瘤[3, 4]： 1）抗炎抑突变：降低炎症相关氧化应激，减少 DNA 损伤，抑制 NF-κB/STAT3 促癌通路[6, 7]； 2）HDAC 抑制效应：上调 p21、p53 等抑癌基因，诱导肿瘤细胞周期阻滞与凋亡[2, 7]； 3）改善肿瘤免疫微环境：减少 MDSC、Treg 等免疫抑制细胞，激活 CD8⁺T 细胞与 NK 细胞[28, 29]； 4）增强免疫治疗疗效：酪酸梭菌可抑制 IL-6 介导的免疫抑制，提高抗 PD-1 抗体在结直肠癌中的治疗效果，将 “冷肿瘤” 转化为 “热肿瘤”[19, 28]； 5）临床预防作用：酪酸梭菌可降低结直肠腺瘤性息肉复发风险，实现癌前病变干预[30]。此外，产丁酸菌还可减轻化疗所致肠道损伤、菌群紊乱与炎症反应，改善肿瘤患者生活质量[7, 31]。 3.5 改善代谢紊乱，遏制多系统慢病进展通过肠 - 肝轴、肠 - 心轴、肠 - 脑轴等，产丁酸菌可改善胰岛素抵抗、降低血脂、减轻肝脏脂肪变性，延缓 NAFLD 向肝癌进展[15, 25]；缓解动脉粥样硬化相关血管炎症[2]；改善脊柱关节炎、肾病、抑郁等肠 - 器官轴相关疾病[21-24]。 4 产丁酸菌的临床价值及应用前景 4.1 临床应用疗效在肠道疾病方面，酪酸梭菌联合美沙拉嗪可显著提高溃疡性结肠炎缓解率，降低复发，卫生经济学效益良好[26]；对腹泻型肠易激综合征可改善腹痛、腹泻，调节肠道菌群[27]；对抗生素相关性腹泻、感染性腹泻亦有明确疗效[11, 12]。在肠外疾病方面，酪酸梭菌可通过肠 - 肾轴调节 Th17/Treg 平衡，减轻儿童原发性肾病综合征炎症[22]；改善实验性骨关节炎症状[11]；缓解多发性硬化相关神经炎症[23]；改善抑郁相关肠 - 脑轴紊乱[24]。在肿瘤领域，酪酸梭菌可降低结直肠癌前病变复发[30]，减轻术后化疗不良反应，改善免疫炎症指标[31]，并与免疫检查点抑制剂协同提高抗肿瘤效果[19, 28]。 4.2 临床应用优势产丁酸菌（如酪酸梭菌）为人体共生菌，安全性高，经特殊微囊包埋技术能耐受胃酸直达肠道，适合长期使用[11, 12, 17]；作用于炎症上游，实现多靶点、全身性调控，不同于对症治疗[2, 10]；可与常规药物、化疗、免疫治疗联用，达到增效减毒效果[7, 11, 31]。其中酪酸梭菌研究最为广泛，是国内外唯一获得药准字号的产丁酸基石菌，如我国自主创研的酪酸梭菌CGMCC0313-1菌株拥有中美双发明专利，其制剂已获得国药准字号-酪酸梭菌活菌胶囊（国药准字 S20040084）、酪酸梭菌活菌散（国药准字 S20040088）等已获批上市[32, 33]，主要应用于修复受损肠粘膜、恢复肠功能等，经多年临床应用印证，安全、有效、可靠[12, 34, 35]，为上述国际前沿新研究成果的转化提供了可能性。 4.3 应用前景与展望未来产丁酸菌可用于：①健康人群慢性炎症早期干预；②代谢病、自身免疫病等慢病长期管理；③结直肠癌癌前病变预防与术后辅助治疗；④与免疫治疗联合以克服耐药[19, 28, 30]。《中国微生态调节剂临床应用专家共识（2025 版）》已将产丁酸菌列为重要推荐菌株[11]，其在精准干预慢性炎症、预防慢病及肿瘤中具有广阔转化价值。结论慢性炎症是慢病与肿瘤的共同通路，而产丁酸菌匮乏是肠源性慢性炎症的核心始动因素。产丁酸菌作为肠道基石菌，通过丁酸介导肠屏障修复、菌群重塑与免疫调控，维持全身稳态；其缺乏可引发肠漏、免疫紊乱与持续低度炎症，最终促进多系统慢病及结直肠癌发生。补充酪酸梭菌等产丁酸菌可从源头遏制慢性炎症、阻断炎 - 癌转化、增强抗肿瘤免疫并改善多器官代谢紊乱，具备安全、多靶点、长效的特点，在慢性炎症相关疾病防治中具有重要临床价值与应用前景。参考文献 [1]BAECHLE J J, CHEN N, MAKHIJANI P, et al. 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Effect of Clostridium butyricum on High-Fat Diet-Induced Intestinal Inflammation and Production of Short-Chain Fatty Acids [J]. Digestive diseases and sciences, 2023, 68(6): 2427-40. [19]SEBASTIAN S A, KAIWAN O, CO E L, et al. Current Pharmacologic Options and Emerging Therapeutic Approaches for the Management of Ulcerative Colitis: A Narrative Review [J]. Spartan medical research journal, 2024, 9(3): 123397. [20]BERMúDEZ-SáNCHEZ S, BAGER P, DAHLERUP J F, et al. Thiamine-Reduced Fatigue in Quiescent Inflammatory Bowel Disease Is Linked to Faecalibacterium prausnitzii Abundance [J]. Gastro hep advances, 2025, 4(1): 100533. [21]MIN H K, NA H S, JHUN J, et al. Identification of gut dysbiosis in axial spondyloarthritis patients and improvement of experimental ankylosing spondyloarthritis by microbiome-derived butyrate with immune-modulating function [J]. Frontiers in immunology, 2023, 14: 1096565. [22]LI T, MA X, WANG T, et al. Clostridium butyricum inhibits the inflammation in children with primary nephrotic syndrome by regulating Th17/Tregs balance via gut-kidney axis [J]. BMC microbiology, 2024, 24(1): 97. [23]ORDOñEZ-RODRIGUEZ A, ROMAN P, RUEDA-RUZAFA L, et al. Changes in Gut Microbiota and Multiple Sclerosis: A Systematic Review [J]. International journal of environmental research and public health, 2023, 20(5). [24]WANG X, FANG Y, LIANG W, et al. Fusobacterium nucleatum facilitates anti-PD-1 therapy in microsatellite stable colorectal cancer [J]. Cancer cell, 2024, 42(10): 1729-46.e8. [25]LIN X, ZHANG J, CHU Y, et al. Berberine prevents NAFLD and HCC by modulating metabolic disorders [J]. Pharmacology & therapeutics, 2024, 254: 108593. [26]WU J, ZHOU B, PANG X, et al. Clostridium butyricum, a butyrate-producing potential probiotic, alleviates experimental colitis through epidermal growth factor receptor activation [J]. Food & function, 2022, 13(13): 7046-61. [27]CHANG S L, LIN Y Y, LIU S C, et al. Oral Administration of Clostridium butyricum GKB7 Ameliorates Signs of Osteoarthritis in Rats [J]. Cells, 2022, 11(14). [28]XIE M, YUAN K, ZHANG Y, et al. Tumor-resident probiotic Clostridium butyricum improves aPD-1 efficacy in colorectal cancer models by inhibiting IL-6-mediated immunosuppression [J]. Cancer cell, 2025, 43(10): 1885-901.e10. [29]WU G, XU T, ZHAO N, et al. A core microbiome signature as an indicator of health [J]. Cell, 2024, 187(23): 6550-65.e11. [30]WANG J W, HSU W H, YU F J, et al. Clostridium butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial [J]. Oncology research, 2025, 33(12): 3907-22. [31]王沁, 龚黎明, 郑惠.酪酸梭菌活菌片对结直肠癌术后FOLFOX4方案化疗肠道菌群平衡,毒副反应及免疫炎症指标的影响[J].世界华人消化杂志, 2021. [32]国家药品监督管理局.境内生产药品——国药准字S20040084 [Z]. 2004. [33]国家药品监督管理局.境内生产药品——国药准字S20040088 [Z]. 2004. [34]刘琳, 郑智俊, 秦环龙.酪酸梭菌的临床应用及其作用机制的研究进展[J].中国微生态学杂志, 2025, 37(11): 1343-8. [35]江学良, 张伟, 张玉琦,等.酪酸梭菌活菌胶囊联合美沙拉嗪治疗溃疡性结肠炎的疗效及卫生经济学评价[J].中国微生态学杂志, 2015, 27(11): 1291-4+9.

2026-04-16

·药明康德

“以光为刃”，当传统工艺无解，药明康德如何将新药化学合成的鸿沟化为坦途？

在新药研发道路上，有时候决定成败的往往不是宏大的叙事，而是一次关键化学中间体的高效合成。这类中间体如同精密的齿轮，其结构的细微偏差，都可能导致后续进程的停滞。在药明康德的众多客户里，许多重要合作常常始于一个看似微小却至关重要的化学工艺节点。故事要从一个棘手的分子骨架说起。某公司在推进一个极具潜力的分子项目时，被一个关键的“路障”卡住了。项目急需构建一个复杂而精确的三维分子骨架。这个骨架，是整个药物分子的“心脏”，它的形状、空间结构都必须分毫不差。因此，只有成功构建出正确立体构型的核心骨架，才能构建出具有生物活性的复杂分子，进而有望推进临床，拯救生命。然而，摆在他们面前的，是行业内传统分批工艺的“瓶颈”。传统分批工艺生产模式是将所有原料按顺序投入反应容器中，在设定好的温度、压力下搅拌、反应。待反应结束，再进行分离提纯，得到产物。在这个项目中，如果采用传统合成路线，需经过5步反应，效率较低。而且，最终得到的产物里，只有一半是符合要求的立体构型，整体收率也不高。更为棘手的是，传统分批工艺从实验室的克级探索放大到千克级生产时，横亘着一条难以逾越的“鸿沟”。这不是简单地把原料配方乘以1000就能解决的。规模放大后，反应体系的物理环境会发生变化，许多在烧瓶中运行良好的反应，一旦进入大釜，就可能面临效率下降、甚至失败风险。要解决这些挑战，就需要耗费更多时间和资源来重新摸索工艺条件。面对难题，该公司第一时间联系上药明康德研发化学服务部（Research Chemistry Services，RCS）。这种信任并非凭空而来。它是十多年间，在多个合作项目里，由药明康德一次次专业、高效的服务交付，一点一滴积累起来的。接到任务后，药明康德RCS团队迅速组建了由多个研发和生产基地专家构成的项目团队，一场与时间赛跑的技术攻坚就此拉开序幕。如何破解分批工艺收率低、顺反选择性差，以及难以放大的“死结”？团队的目光投向了光化学工艺技术。所谓光化学工艺，是利用特定波长的光能作为“精确的刻刀”，代替传统的热能或化学试剂，来精准切断或重组化学键，从而高效构建目标分子。这听起来似乎有些深奥，但光化学离我们的生活并不遥远，就像晾在阳台的彩色衣物，时间久了会慢慢褪色，其实是染料分子在太阳光的照射下发生了光化学反应；或是老式胶片相机按下快门的瞬间，胶片上的感光材料会因吸收光线而发生化学变化，最终定格下影像，也是光化学的典型应用。然而，当光化学技术应用于工业场景时，对设备、对人员的专业素养要求极高，它需要光能均匀、稳定地穿透反应体系，这在传统的反应釜中几乎无法实现。为此，项目团队引入了一套高效的技术“组合拳”。首先登场的是高通量实验（HTE），如果说分批工艺是在黑暗中一把把地尝试“钥匙”，那HTE就像同时启动了上百个微型“智能钥匙”，它能在极短时间内并行测试数百种反应条件——换一种光波长、试一种新催化剂、调一下浓度——过去需要几周甚至几个月的摸索，现在可将项目初期的摸索时间压缩到以天计，从而迅速锁定关键“配方”。但仅找到“配方”还不够，关键是如何让它稳定、高效地运转起来，并适用于规模放大。于是，流动化学技术便登场亮相。想象一下，不再让原料闷在反应容器里“不均匀光照”，而是将它们像输液一样，通过细细的管道持续泵入一个盘成线圈的透明“光隧道”。反应物一边匀速流动，一边接受管道外壁均匀的光照，真正实现了“边走边反应”。在这条精心设计的“光隧道”上，光照条件均匀稳定，反应路径精准可控。原本需要5步、多批次投放、多次分离、转移的复杂过程，如今像一条流水线，仅需1步连贯完成。结果是令人惊喜的——产物收率良好，顺式选择性极高。更难得的是，项目团队仅用了9个小时，就完成了100克以上规模的精准制备，这意味着该工艺路线已成功跨越实验室研究阶段，具备了直接为后续毒理研究、临床试验提供足量药物的能力，也为未来更大规模化生产奠定了坚实的技术基础。这种效率与质量的双重提升，使得原本预估需要4个多月的项目工期，被大幅缩短至仅10周。当项目团队将高质量的产物交付到客户手中时，客户的项目负责人难掩兴奋，高度赞赏道：“你们对光化学工艺的掌握和应用令人印象深刻，新的技术为我们打开了路线优化的大门，不仅提高了产量，也让规模放大成为可能。” 如今，这家客户仍有多个后续项目与药明康德持续合作。图片来源：123RF 这不仅是药明康德光化学平台一次高质量的服务交付，更是公司“让天下没有难做的药，难治的病”这一愿景在微观层面的生动注脚。这一成功的赋能案例，不仅彰显了药明康德在光化学领域的技术深度，更是公司全面化学能力的坚实印证，是公司CRDMO全球赋能平台在创新浪潮中的一个典型缩影。回首二十余载，药明康德构建的一体化、端到端CRDMO赋能平台，早已超越了单纯的技术叠加。公司将光化学、电化学、流动化学、酶催化等一系列创新技术融会贯通，以更好地赋能全球合作伙伴。因为，每一次分子的合成，背后都是满怀期待的科学家和客户，以及等待救治的患者。正是这份敬畏与担当，驱动公司支持全球数千家合作伙伴破解研发挑战，加速新药从分子走向临床的过程，让创新疗法突破瓶颈，推动更多新药、好药早日问世。 Light and Flow: How WuXi AppTec Bridges the Gap in Novel Drug Chemical Synthesis In the journey of new drug development, success or failure often hinges on the efficient synthesis of a single, critical chemical intermediate—far more than on grand narratives. Among WuXi AppTec’s many customers, numerous significant collaborations begin at what may seem like a minor but is in fact a pivotal point in the chemical process. The story starts with a challenging molecular scaffold. A company was advancing a highly promising molecule when it hit a critical roadblock. The project urgently required the construction of a complex and precise three-dimensional molecular scaffold. This scaffold was the “heart” of the drug molecule; its shape and spatial structure had to be flawless. Therefore, successfully constructing this core scaffold with correct stereo configuration was the only way to build a biologically active complex molecule, ultimately advancing it toward clinical trials and the potential to save lives. However, the team faced a bottleneck inherent to traditional batch processing. In traditional batch processing, all raw materials are sequentially added to a reaction vessel, stirred, and reacted under set temperature and pressure conditions. Once the reaction is complete, the product is isolated and purified. For this project, the conventional synthetic route would have required five reaction steps, resulting in low efficiency. Moreover, only about half of the final product possessed the required stereo configuration, and the overall yield was low. An even greater challenge was the significant gap between gram-scale laboratory exploration and kilogram-scale production using traditional batch methods. This scaling-up process is not a simple matter of multiplying the recipe by a factor of 1000. When a process is scaled up, the physical environment of the reaction system changes. Many reactions that work smoothly in a flask may face decreased efficiency or even fail when transferred to a large reactor. Overcoming these challenges would require substantial additional time and resources to re-optimize the process conditions. Faced with this challenge, the company immediately contacted WuXi AppTec’s Research Chemistry Services (RCS) team. This trust was not built overnight. It has been accumulated over more than a decade through multiple collaborative projects, earned through consistent delivery of professional and efficient services. Upon receiving the task, the RCS team quickly pulled together experts from multiple sites—kicking off a race against time to tackle the technical challenge. How could they solve the intertwined problems of low yield, poor cis-trans selectivity, and the difficulty of scaling up the batch process? The team’s focus turned to photochemistry. Photochemistry uses light energy of a specific wavelength as a “precision chisel,” replacing traditional thermal energy or chemical reagents to precisely break or reform chemical bonds, efficiently constructing the target molecule. While this might sound complex, photochemistry is not far from our daily lives. For example, colored clothes left to dry on a balcony slowly fade over time because the dye molecules undergo photochemical reactions under sunlight. Similarly, when a vintage film camera shutter clicks, the photosensitive material on the film absorbs light and undergoes a chemical change, capturing the image—a classic application of photochemistry. However, applying photochemistry in an industrial setting demands highly specialized equipment and expertise. It requires the light energy to penetrate the reaction system uniformly and stably, a feat nearly impossible in traditional reaction vessels. To address this, the project team implemented a powerful combination of technologies. The first was High-Throughput Experimentation (HTE). If batch processing is like trying keys one by one in the dark, HTE is like activating hundreds of miniature “smart keys” simultaneously. It allows hundreds of reaction conditions—varying the light wavelength, trying a new catalyst, adjusting the concentration—to be tested in parallel within a very short time. What used to take weeks or even months of exploration could now be compressed into days, enabling the team to rapidly lock in a critical “formula.” But finding the formula was only half the battle. The key was to make it run stably, efficiently, and in a scalable manner. This is where flow chemistry came into play. Imagine, instead of having the raw materials confined in a reactor with uneven light exposure, they were continuously pumped like an intravenous drip through a narrow tube coiled into a transparent “light tunnel.” As the reactants flowed at a constant rate, they received uniform illumination from the outside of the tube wall, truly achieving “reaction on the go.” Within this precisely engineered “light tunnel,” the light exposure was consistent and stable, and the reaction pathway was precisely controlled. The original complex process requiring five steps, multiple batch additions, and multiple separations and transfers was streamlined like an assembly line, completed in continuous flow in one step. The results were remarkable: excellent product yield, exceptionally high cis-selectivity, and precise preparation of over 100 grams in just nine hours. This demonstrated that the process had successfully crossed the laboratory research stage, enabling the possibility to directly supply sufficient quantity of the drug candidate for subsequent toxicology studies and clinical trials, and laying a solid technical foundation for future large-scale production. This dual improvement in efficiency and quality shortened the project timeline significantly, from an estimated over four months to just ten weeks. When the project team delivered the high-quality product to the client, the client’s project lead couldn’t hide their excitement. "The photochemical process had opened the door to route optimization for us, not only increasing yield but also making it possible to scale-up." Since then, this client has continued to collaborate with WuXi AppTec on multiple subsequent projects. Image source: 123RF This case represents more than just a high-quality service delivery by WuXi AppTec’s photochemistry platform; it is a tangible microcosm of the company’s vision: “Every drug can be made, and every disease can be treated.” This successful enabling story not only highlights WuXi AppTec’s technical depth in the field of photochemistry but also stands as a solid testament to its comprehensive chemistry capabilities, serving as a quintessential example of its global CRDMO enabling platform in action amidst a wave of innovation. Looking back over more than two decades, WuXi AppTec’s integrated, end-to-end CRDMO enabling platform has gone beyond a mere collection of technologies. The company has integrated and mastered a suite of innovative technologies—including photochemistry, electrochemistry, flow chemistry, enzymatic catalysis, and beyond—to better enable its global partners. Behind every synthesis of a molecule, what we see are scientists and clients full of anticipation, as well as patients waiting for treatment. It is this sense of respect and responsibility that drives the company to support thousands of customers worldwide in tackling R&D challenges, accelerating the journey of new drugs from molecule to clinical, breaking through bottlenecks in innovative therapies, and helping bring more new and better medicines to patients faster. 免责声明：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：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

诊断试剂

2026-04-16

·终身学习-星辰如梦

【药品分享】塞伐艾替尼片——口服、可逆、选择性酪氨酸激酶抑制剂（TKI）

塞伐艾替尼片（Sevabertinib，商品名：HYRNUO®）是拜耳公司研发的口服、可逆、选择性酪氨酸激酶抑制剂（TKI），主要用于治疗HER2（ERBB2）激活突变的晚期非小细胞肺癌（NSCLC）。基本信息通用名：塞伐艾替尼片（Sevabertinib）商品名：HYRNUO® 研发公司：拜耳（Bayer）药物类型：小分子靶向药，可逆性TKI 规格：10mg/片，120片/瓶。作用靶点：选择性抑制HER2（ERBB2）激酶结构域（TKD）激活突变（含外显子20插入），同时对突变型EGFR有高选择性。美国获批适应症：治疗经FDA批准检测证实为HER2（ERBB2）酪氨酸激酶域（TKD）激活突变阳性，且既往接受过全身性治疗的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者。用法用量推荐剂量：20mg，口服，每日2次（BID），随餐服用，直至疾病进展或出现不可耐受毒性。服用方式：整片吞服，不可切割、压碎或咀嚼。漏服/呕吐：漏服尽快补服（保证与下次服药间隔足够），不可加倍；呕吐后无需补服，按计划下次服药。剂量调整：根据不良反应分级，可依次减量至10mg BID、10mg QD；无法耐受则永久停药。核心临床数据（SOHO-1研究）总体人群（经治）：客观缓解率（ORR）71%，中位缓解持续时间（DoR）9.2个月。 HER2 YVMA突变亚组：ORR高达78%，中位无进展生存期（PFS）12.2 个月。脑转移患者：ORR 达78%，显示良好颅内活性。不良反应（≥20%）最常见：腹泻、皮疹、甲沟炎、口腔炎、恶心。重要警告：需警惕腹泻、肝毒性、间质性肺病（ILD）/ 肺炎、眼部毒性、胰腺酶升高、胚胎 - 胎儿毒性。药物相互作用避免与强效CYP3A抑制剂/诱导剂合用；合用时需调整剂量。塞伐艾替尼是弱至中度CYP3A抑制剂，可能升高CYP3A/P-gp底物血药浓度，增加不良反应风险。塞伐艾替尼vs同类HER2靶向药核心对比（非小细胞肺癌HER2突变，含20外显子插入）上市情况美国：2025年11月19日获FDA加速批准，用于既往接受过系统治疗、伴HER2 TKD激活突变的局部晚期/转移性非鳞状NSCLC成人患者。中国：尚未在中国上市。注册受理情况 2025 年 7 月：首次提交上市申请（二线治疗），获CDE优先审评。 2026年4月：一线治疗适应症（HER2激活突变晚期NSCLC）获CDE受理并拟优先审评。专利情况塞伐艾替尼（Sevabertinib，BAY2927088）的专利布局以核心化合物 + 用途为基础，辅以晶型、制剂专利，形成多层保护。化合物+医药用途专利（拜耳主导）国际PCT专利WO2020/216781于2020-04-16申请；中国同族专利CN107406417已授权；美国同族专利US10428063已授权。预计2040年4月（自申请日起 20年）到期。保护塞伐艾替尼化学结构（CAS：2521285-05-0），其药学上可接受的盐、水合物、溶剂化物，医药用途——治疗HER2/EGFR 突变相关肿瘤（含 NSCLC）。晶型与盐型专利国际PCT专利WO2026/047020于2025-08-28申请。保护特定晶型、水合物（如上市片剂所用晶型），可延长制剂与原料药的专利保护期。制剂与组合物专利国际PCT专利WO2026/047022于2025-08-28申请。保护口服片剂的处方、工艺、给药方案。可阻挡仿制药直接复制上市剂型。仿制药壁垒核心化合物专利2040年到期前，无法合法仿制原料药；晶型/制剂专利进一步延迟仿制药上市。竞品开发限制：其他药企开发同靶点、同结构药物将构成侵权；仅能通过全新结构、不同靶点或专利挑战进入市场。其他药品分享链接如下，欢迎点击查看： Ormeloxifene OTF慢性体重管理的新型药物-Tirzepatide新型的非阿片类小分子镇痛药-Suzetrigine奥麦利昔芬口腔薄膜立项调研报告纳米技术双氯芬酸乳胶剂药学研究2025年9月药品批准信息快讯（八）——利斯的明透皮贴剂分享2025年9月药品批准信息快讯（九）——米托坦片分享CDE-《化学仿制药参比制剂目录（第一百批）》（征求意见稿）[附: 药品分享——阿达苏(洛沙平吸入剂)]药品分享-塞来昔布盐酸曲马多片药品分享——伐莫洛龙口服混悬液【药品分享】盐酸菲优拉生片【药品分享】拉坦噻吗滴眼液【药品分享】Baxdrostat 片【药品分享】Omecamtiv Mecarbil缓释片【药品分享】曲地匹坦（Rolapitant）【药品分享】Zasocitinib 胶囊【药品分享】甲磺酸阿帕替尼片【药品分享】巴氯芬口服溶液【药品分享】奥德昔巴特胶囊【药品分享】扎维吉泮鼻喷雾剂【药品分享】左羟丙哌嗪糖浆【药品分享】利丙双卡因凝胶贴膏【药品分享】司来吉兰改良型新药（缓释片）【药品分享】复方甘菊利多卡因凝胶【药品分享】盐酸索安非托片【药品分享】地塞米松口溶膜【药品分享】盐酸来罗西利片【药品分享】马来酸噻吗洛尔凝胶【药品分享】褪黑素颗粒【药品分享】罗氟司特乳膏【药品分享】盐酸芬戈莫德胶囊【药品分享】示踪用盐酸米托蒽醌注射液【药品分享】美洛昔康纳米晶注射液【药品分享】Clascoterone 5%外用溶液【药品分享】马来酸依那普利口服溶液【药品分享】注射用双氯芬酸钠利多卡因【药品分享】马来酸依那普利叶酸片—复方降压药【药品分享】依曲帕米鼻喷雾剂—用于治疗成人阵发性室上性心动过速的可自行给药鼻喷雾剂【药品分享】奥卡西平口服混悬液—一款可用于儿童的钠通道调节类抗癫痫药【药品分享】泊沙康唑口服混悬液——一种常用的抗真菌药物【药品分享】舒沃替尼片【药品分享】依伏卡塞片——第二代口服拟钙剂【药品分享】西诺氨酯片——第三代抗癫痫发作药物【药品分享】匹妥布替尼片——非共价可逆 BTK 抑制剂（用于复发 / 难治套细胞淋巴瘤（MCL））【药品分享】贝美前列素【产品分享】达普司他片【药品分享】水合氯醛糖浆——镇静催眠药【产品分享】苏沃雷生（Suvorexant）——全球首个食欲素受体拮抗剂类催眠药【药品分享】贝沙罗汀【药品分享】地夫可特干混悬剂——一种糖皮质激素类药物【药品分享】伊卢多啉片——治疗成人腹泻型肠易激综合征（IBS‑D）的首创口服阿片受体调节剂【药品分享】卢美哌隆胶囊——一种新型的非典型抗精神病药物【药品分享】奥氟格列隆片——口服非肽类小分子 GLP-1 受体激动剂【药品分享】苯磺酸克利加巴林胶囊——一种新型的治疗神经病理性疼痛的药物【药品分享】苯磺酸美洛加巴林片——治疗周围神经病理性疼痛（PNP）的第三代钙离子通道调节剂【药品分享】Iberdomide胶囊——一款新一代cereblon（CRBN）E3连接酶调节剂（CELMoD）化合物【药品分享】酒石酸伐尼克兰鼻喷雾剂——一种用于治疗干眼症的西药【药品分享】赛沃替尼片——中国首个获批的高选择性 MET 酪氨酸激酶抑制剂【药品分享】盐酸阿夫唑嗪缓释片——一种用于治疗良性前列腺增生（BPH）的 α1 - 受体阻滞剂【药品分享】索格列净片——全球首个获批的SGLT1/SGLT2 双重抑制剂【药品分享】奥吡卡朋胶囊——新一代的儿茶酚-氧位-甲基转移酶抑制剂（COMT）【药品分享】奎扎替尼片——一种口服高选择性 FLT3 抑制剂【药品分享】硫酸拉罗替尼胶囊 / 口服溶液——全球首个高选择性口服 TRK 抑制剂【药品分享】司帕生坦片——成人IgA肾病领域首个非免疫抑制疗法【药品分享】黄体酮阴道栓剂/阴道缓释凝胶剂——主要用于辅助生殖技术（ART）中的黄体支持【药品分享】替戈拉生片——首款国产钾离子竞争性酸阻滞剂类药物（P-CAB）【药品分享】拉坦前列烯酯滴眼剂——一种新型眼科用药【药品分享】布比卡因脂质体注射液——一种长效局部麻醉药【药品分享】甲磺酸加诺沙星片——一种喹诺酮类抗菌药【药品分享】磷酸芦可替尼乳膏——中国首款且唯一获批的白癜风治疗靶向药【药品分享】甲磺酸洛美他派胶囊——全球唯一口服MTP抑制剂【药品分享】依达拉奉口服混悬液——肌萎缩侧索硬化症（ALS，渐冻人症）新药【药品分享】依达拉奉右莰醇舌下片——全球卒中领域首个获FDA突破性疗法认定的舌下脑保护剂【药品分享】马来酸氟诺替尼片——JAK2/FLT3/CDK6 三靶点抑制剂【药品分享】普拉替尼胶囊——国内首个获批的高选择性 RET（转染重排）酪氨酸激酶抑制剂【药品分享】右美托咪定舌下膜——新型 α₂肾上腺素受体激动剂舌下膜剂【药品分享】卡匹色替片——全球首个获批上市的AKT抑制剂【药品分享】库莫西利胶囊——全球首个CDK2/4/6抑制剂【药品分享】赛贝曲司他片——全球首个HAE急性发作口服疗法【药品分享】KYGEVVI（Doxecitine/Doxribtimine）——全球首款且唯一获批的TK2d针对性治疗药物【药品分享】Forzinity（Elamipretide）注射剂——全球首个用于治疗Barth综合征的药物【药品分享】Brinsupri（Brensocatib, 布伦索卡替布）片——全球首个获批上市的二肽基肽酶1（DPP-1）抑制剂【药品分享】维立西呱片——全球首个心衰适应症的可溶性鸟苷酸环化酶（sGC）刺激剂【药品分享】盐酸哌罗匹隆片——非典型抗精神病药【药品分享】盐酸托泊替康胶囊/注射用盐酸托泊替康——经典的拓扑异构酶Ⅰ抑制剂类抗肿瘤药【药品分享】阿普昔腾坦片——全球首个获批用于难治性高血压的口服双重内皮素受体拮抗剂（ERA）【药品分享】注射用盐酸依拉环素——全球首个氟环素类抗生素【药品分享】奥洛格列净胶囊——国内首款抑制SGLT1与SGLT2的1类创新药【药品分享】盐酸匹米替尼胶囊——国内首个、全球首个获批的腱鞘巨细胞瘤（TGCT）系统性靶向药，高选择性CSF-1R抑制剂【药品分享】布地奈德肠溶胶囊——全球首个、中国唯一获批用于原发性IgA肾病对因治疗的靶向药物【药品分享】艾拉莫德片——中国原研、全球首个上市的小分子抗风湿药（csDMARD）【药品分享】索托克拉片——新一代BCL2抑制剂【药品分享】利奈昔巴特片——口服、选择性、可逆性回肠胆汁酸转运体（IBAT/ASBT）抑制剂【药品分享】多替诺雷片——高选择性URAT1抑制剂【药品分享】瑞普泊肽片——口服GLP‑1/GIP双靶点激动剂【药品分享】硫酸索西美雷塞片——口服、强效的KRAS G12C共价抑制剂【药品分享】罗伐昔替尼片——全球首创JAK/ROCK双靶点口服小分子抑制剂【药品分享】埃诺格鲁肽注射液——全球首个获批上市的cAMP偏向型长效GLP-1受体激动剂【药品分享】维培那肽注射液——长效GLP-1受体激动剂【药品分享】普乐司兰钠注射液——全球首个靶向APOC3 mRNA的siRNA降脂药【药品分享】玛仕度肽注射液——全球首个GCG/GLP-1双激动剂【药品分享】瑞米布替尼片——全球首个获批用于CSU的口服靶向药【药品分享】溴莫尼定噻吗洛尔滴眼液——α₂受体激动剂与非选择性 β 受体阻滞剂组成的复方降眼压药【药品分享】吡洛西利片——国内首个CDK2/4/6多靶点抑制剂【药品分享】奥氟格列隆片（Orforglipron） ——中国首个、全球首批上市的口服小分子 GLP-1受体激动剂【药品分享】Copper Histidine注射液（Zycubo）——全球首个、唯一用于治疗儿童门克斯病（Menkes disease）的铜替代注射剂【药品分享】依来格列隆片（Elecoglipron）——口服小分子非肽类GLP-1受体激动剂【药品分享】阿利奈普仑（Aleniglipron）——口服小分子、非肽类、偏向性GLP-1受体激动剂【药品分享】甲磺酸阿美替尼片——中国首个原研三代EGFR酪氨酸激酶抑制剂（TKI）【药品分享】甲磺酸达麦利替尼片——口服高选择性c-MET酪氨酸激酶抑制剂【药品分享】盐酸Acoramidis片——转甲状腺素蛋白（TTR）稳定剂【药品分享】阿莫西林伏诺拉生胃漂浮片——3D打印胃漂浮片【药品分享】盐酸伊可白滞素片——全球首创口服IL‑23受体拮抗剂【药品分享】马来酸吡咯替尼片——中国首个自研的HER1/HER2/HER4不可逆酪氨酸激酶抑制剂（TKI）【药品分享】本维莫德乳膏——全球首创芳香烃受体（AhR）调节剂（TAMA）类皮肤病外用药【药品分享】盐酸莫托咪酯注射液——化药1类静脉麻醉新药【药品分享】注射用罗哌卡因微晶——长效缓释局部麻醉药【药品分享】盐酸伊立替康脂质体注射液——一款针对吉西他滨治疗失败的转移性胰腺癌的二线标准脂质体化疗药【药品分享】甲磺酸氟马替尼片——Bcr-Abl酪氨酸激酶选择性抑制剂【药品分享】注射用阿加糖酶β——国内获批的首个用于治疗法布雷病的药物【药品分享】甲苯磺酸尼拉帕利胶囊——高选择性PARP1/2抑制剂【药品分享】帕米帕利胶囊——强效、选择性PARP1/2抑制剂【药品分享】苯环喹溴铵鼻喷雾剂——选择性M胆碱能受体拮抗剂【药品分享】注射用拉罗尼酶浓溶液——MPS Ⅰ型的特异性酶替代治疗药物【药品分享】海博麦布片——国产自主原研的胆固醇吸收抑制剂【药品分享】盐酸可洛派韦胶囊——直接抗病毒药物（DAA）→ NS5A抑制剂【药品分享】克拉考特酮乳膏——外用、非甾体、选择性雄激素受体（AR）抑制剂【药品分享】非卢替尼片——全球首个用于多发性硬化的口服BTK抑制剂【药品分享】Brenipatide注射液——GLP-1R/GIPR双受体激动剂（继替尔泊肽之后的第二款）【药品分享】罗赛促红素α注射液——国产首个长效重组促红细胞生成素（EPO）创新药【药品分享】贝组替凡片——全球首个口服小分子HIF-2α抑制剂【药品分享】那米司特片——口服选择性PDE4B抑制剂【药品分享】富马酸立康可泮胶囊——一款针对罕见病PNH的口服补体B因子抑制剂【药品分享】醋酸索乐匹尼布片——高选择性脾酪氨酸激酶（Syk）抑制剂【药品分享】甲磺酸艾多替尼片——全球首款专为肺癌脑转移设计的第三代EGFR-TKI 【药品分享】安瑞克芬注射液——全球首个获批镇痛适应症的高选择性外周κ-阿片受体（KOR）激动剂【药品分享】Difelikefalin注射液——全球首个获批的外周选择性κ-阿片受体（KOR）激动剂【药品分享】Obefazimod——口服、靶向 CBC、特异性增强miR-124的首创小分子【药品分享】拉尼兰诺片——口服泛PPAR激动剂【药品分享】舒洛地特注射液——抗血栓药、血管保护剂【药品分享】贝普若韦生注射液——反义寡核苷酸（ASO）类乙肝新药【药品分享】氨酚右敏口服溶液（奥肯能®）——中国内地唯一获批的氨酚右敏口服溶液【药品分享】佩玛贝特片——新型过氧化物酶体增殖物激活受体α/δ双重激动剂 (PPARα/δ) 【药品分享】盐酸依匹斯汀乳膏——外用第二代非镇静抗组胺抗过敏药膏【药品分享】注射用双羟萘酸帕瑞肽微球——一款用于治疗肢端肥大症的第二代长效生长抑素类似物（SRL）微球制剂【药品分享】埃拉菲布拉诺片——治疗原发性胆汁性胆管炎（PBC）的口服靶向新药【药品分享】泽卢克布仑钠注射液——新一代皮下注射型C5补体抑制剂【药品分享】依达拉奉右莰醇注射用浓溶液——一款复方神经保护类注射剂【药品分享】醋酸戈那瑞林注射液——促性腺激素释放激素（GnRH）类药物【药品分享】甲磺酸贝舒地尔片——全球首个选择性ROCK2激酶抑制剂【药品分享】伊托法替布软膏——外用JAK抑制剂（JAK1/JAK3）【药品分享】注射用华卟啉钠——新型肿瘤光动力治疗（PDT）专用光敏剂【药品分享】优替德隆胶囊——口服埃博霉素类微管抑制剂【药品分享】艾普美妥司他片——EZH1/2双靶创新药【药品分享】精氨酸艾曲莫德片——新型选择性鞘氨醇1-磷酸受体（S1P₁）调节剂【药品分享】磷酸芦可替尼乳膏——全球/国内首款、唯一获批用于非节段型白癜风复色的外用JAK1/JAK2选择性抑制剂【药品分享】盐酸右哌甲酯缓释胶囊——治疗6岁及以上注意缺陷多动障碍（ADHD）的一线药物【药品分享】抗菌肽PL-3301口腔凝胶——中国首创的抗菌肽类抗口腔真菌感染药物【药品分享】Zasocitinib (TAK-279) 胶囊——新一代高选择性口服 TYK2 抑制剂【药品分享】注射用Abelacimab——一款全人源IgG1单克隆抗体，靶向凝血因子XI（FXI）【药品分享】Duvakitug注射液——首创性人源化IgG1-λ2单克隆抗体，靶向TL1A（TNFSF15）【药品分享】醋酸氟轻松/氢醌/维A酸乳膏——治疗中重度黄褐斑疗效明确的外用复方【药品分享】富马酸伏诺拉生氯化钠注射液——钾离子竞争性酸阻滞剂（P‑CAB）||东阳光药业研发的2.2,2.4类改良新型新药【药品分享】盐酸阿曲生坦片——诺华研发的高选择性内皮素 A（ETA）受体拮抗剂||中国首个获批用于IgA 肾病的非免疫性口服靶向药【药品分享】RGT-274-CR胶囊——上海齐鲁锐格医药研发的口服小分子GLP-1受体激动剂【药品分享】酒石酸西尼必利片——高选择性5-HT₄受体激动剂类胃肠动力药【药品分享】石杉碱甲控释片——采用双相控释/渗透泵技术的2.2类改良型新药免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。

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,

后查看更多信息

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	2021-06-08
静脉血管疾病	临床3期	捷克	Alfasigma SpA	2021-06-08
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
复发性深静脉血栓形成	临床3期	捷克	Alfa Wassermann SpA	2010-08-20
静脉血栓栓塞	临床3期	捷克	Alfa Wassermann SpA	2010-08-20

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临床结果

适应症

分期

评价

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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


NCT00130208 (CTgov)	临床3期	2型糖尿病 \| 糖尿病肾病	1,056	Sulodexide (Sulodexide)	鑰壓蓋淵網觸鏇齋糧窪 = 鹽夢糧壓範餘壓壓願選鬱鬱齋蓋膚憲願糧積壓 (簾壓網鏇選製蓋蓋廠襯, 選糧醖憲構夢齋膚齋淵 ~ 膚繭憲選簾衊網觸淵網) 更多	-	2018-03-23
				Placebo (Placebo)	鑰壓蓋淵網觸鏇齋糧窪 = 衊鏇鑰衊積膚獵鬱齋襯鬱鬱齋蓋膚憲願糧積壓 (簾壓網鏇選製蓋蓋廠襯, 選襯範淵選觸齋艱觸夢 ~ 鹹壓鑰積選餘選選觸顧) 更多
UEGW2016	N/A	门静脉血栓形成	94	Sulodexidum 2 tb/day	壓積繭醖糧簾淵鏇簾鑰(選糧築糧夢觸餘網範遞) = 醖襯窪餘艱蓋餘壓蓋艱衊獵壓鏇夢窪鏇構衊蓋 (餘醖積願餘廠憲鹹餘鏇 )	积极	2016-10-01
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	築構繭衊艱範夢積鹹鑰(蓋積廠顧遞襯製鏇構壓) = 淵鹽憲窪鹹製觸顧廠獵蓋齋範窪憲膚餘範餘獵 (鏇構遞窪艱構鏇觸衊鹹 )	积极	2015-06-01
				Placebo	築構繭衊艱範夢積鹹鑰(蓋積廠顧遞襯製鏇構壓) = 壓艱選衊鹽廠艱範積襯蓋齋範窪憲膚餘範餘獵 (鏇構遞窪艱構鏇觸衊鹹 )
NCT00130208 (Pubmed \| Am J Kidney Dis)	临床3期	2型糖尿病肾脏病	1,056	Sulodexide	餘願製膚觸窪製選範餘(範鏇壓壓鹹積獵艱鏇鑰) = 蓋製鬱夢憲顧窪衊鏇觸製積構廠遞襯鹽鬱構觸 (簾淵繭膚鏇衊餘襯網醖 ) 更多	不佳	2011-11-01
				Placebo	餘願製膚觸窪製選範餘(範鏇壓壓鹹積獵艱鏇鑰) = 醖餘窪觸顧醖製鏇範築製積構廠遞襯鹽鬱構觸 (簾淵繭膚鏇衊餘襯網醖 ) 更多
ISRCTN82695186 (NTR780/ISRCTN82695186, Pubmed \| Diabetologia)	N/A	2型糖尿病	20	sulodexide (Participants with type 2 diabetes)	艱膚糧夢繭鹹積鹹淵憲(壓糧壓範廠醖醖願遞餘) = 糧範醖蓋顧鬱衊構遞觸膚廠蓋範壓壓製鑰齋廠 (餘淵網憲鹹襯顧衊築襯 ) 更多	-	2010-12-01
				sulodexide (Controls)	艱膚糧夢繭鹹積鹹淵憲(壓糧壓範廠醖醖願遞餘) = 醖鹽鏇鏇衊膚簾齋觸壓膚廠蓋範壓壓製鑰齋廠 (餘淵網憲鹹襯顧衊築襯 ) 更多