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更新于：2026-02-27
Sulodexide
舒洛地特
更新于：2026-02-27
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
49
项与 舒洛地特 相关的临床试验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- |
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- |
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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309
项与 舒洛地特 相关的文献（医药）2026-01-01·EUROPEAN JOURNAL OF PHARMACOLOGY
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.
2026-01-01·Dermatitis
Letter:
Urticarial Vasculitis Triggered by Sulodexide in an Elderly Patient with Renal Impairment: A Case Report
Letter
作者: Slim, Raoudha ; Ben Salem, Chaker ; Bouraoui, Hajer ; Boukadida, Raja ; Derbel, Souha ; Sriha, Badreddine ; Fathallah, Neila ; Mrabet, Sanda
2025-12-19·Khirurgiia
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.
143
项与 舒洛地特 相关的新闻（医药）2026-02-27
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通信作者：陈凛教授
执笔者：李力教授（左），宁宁教授（右）
【引用本文】中国抗癌协会胃癌专业委员会，中国医师协会外科医师分会上消化道外科医师专家工作组，中国老年保健协会消化系统疾病诊疗分会，等. 胃癌肝转移诊断与综合治疗中国专家共识（2026版）[J]. 中国实用外科杂志,2026,46(2):153-161.
DOI:10.19538/j.cjps.issn1005-2208.2026.02.01
胃癌肝转移诊断与综合治疗中国专家共识（2026版）
中国抗癌协会胃癌专业委员会
中国医师协会外科医师分会上消化道外科医师专家工作组
中国老年保健协会消化系统疾病诊疗分会
中国研究型医院学会消化道肿瘤专业委员会
中国实用外科杂志,2026,46(2):153-161
DOI:10.19538/j.cjps.issn1005-2208.2026.02.01
基金项目：国家自然科学基金项目（No. 81972790）
通信作者：陈凛，E-mail：chenlinbj@vip.sina.com
我国为胃癌高负担国家，其发病总数占全球比例>40%，且>1/4的病人在初诊时已存在远处转移［1-2］。肝脏作为胃癌血行转移最常累及的靶器官，胃癌肝转移的总体发生率为9.9%~18.7%［3-4］，病人中位发病年龄为62岁，男女发病比例约为4∶1［5］。胃癌肝转移病人的整体预后不佳，中位生存时间仅12个月，5年生存率<20%［6］。手术是重要的治疗手段，原发灶与转移灶均实现根治性切除的病人，其5年生存率可提高至23.8%~25.0%［7-9］。近年来，以多学科综合治疗协作组（multidisciplinary team，MDT）为核心的综合治疗模式已成为胃癌肝转移诊治的关键策略，推动其诊疗流程向个体化、规范化方向发展，但在具体治疗方案的制定与选择上仍存在诸多争议。为进一步提高我国胃癌肝转移诊断和综合治疗水平，中国研究型医院学会消化道肿瘤专业委员会、中国医师协会外科医师分会上消化道外科医师专家工作组、中国抗癌协会胃癌专业委员会联合中华医学会外科学分会胃肠外科学组于2019年整合国内部分专家意见制定了《胃癌肝转移诊断与综合治疗中国专家共识(2019版)》（简称2019版共识）［10］。2024年，基于全国多中心回顾性队列研究（RECORD研究）结果［11-13］及其他循证医学证据，共识内容进行了系统修订与更新［14］。为及时整合国内外先进经验和近期研究进展，中国抗癌协会胃癌专业委员会、中国医师协会外科医师分会上消化道外科医师专家工作组、中国老年保健协会消化系统疾病诊疗分会联合中国研究型医院学会消化道肿瘤专业委员会，组织本领域部分专家再次修订并形成《胃癌肝转移诊断与综合治疗中国专家共识（2026版）》（简称本共识）。本共识重点完善了胃癌肝转移的病理特征、诊断标准、MDT应用价值及各分型个体化治疗策略等重要内容。
本共识采用德尔菲（Delphi）专家咨询法，通过多轮匿名问卷、结构化意见反馈及专家集体研讨的方式，系统整合多学科专家的临床实践经验与最新循证医学证据；所有推荐意见均依据推荐意见分级的评估、制定与评价（grading of recommendations assessment，development and evaluation，GRADE）系统对证据级别与推荐强度进行规范界定，见表1［15-16］。依据专家赞同率将推荐程度划分为高（≥90%）、中（75%～<90%）、低（50%～<75%）3个等级，以保障共识内容兼具科学权威性与临床实践适用性。
1 |胃癌肝转移病理特征
胃癌肝转移灶的病理类型通常与胃原发灶一致，以腺癌为主，其他罕见类型还包括腺鳞癌、髓样癌、肝样腺癌、鳞状细胞癌、神经内分泌肿瘤以及未分化癌。Lauren分型进一步将腺癌分为弥漫型、肠型和混合型［17］。除原发灶特征外，肝转移灶的部位、数量及大小也是影响预后的重要因素，尤其对于孤立性肝转移病人，积极的局部干预往往能够为其带来更为显著的临床获益［7, 9, 18-19］。
根据肝转移灶出现时间的不同，可将胃癌肝转移分为同时性胃癌肝转移（胃癌确诊同时或术后<6个月出现肝转移灶）和异时性胃癌肝转移（胃癌确诊或术后>6个月出现肝转移灶）；其中同时性胃癌肝转移病人约占所有病人的80%，异时性肝转移发现的中位间隔时间约14个月。多项研究结果表明，同时性胃癌肝转移病人的总体生存期劣于异时性病人［7-9］。
2 |胃癌肝转移诊断
2.1 影像学检查 腹部增强磁共振（MRI）和（或）超声造影是明确肝脏转移瘤的必要手段。MRI可以明确转移灶大小、数目、位置及周围毗邻关系，而采用肝细胞特异性造影剂的MRI检查，在检测肝脏微小转移灶（最大径<1 cm)方面具有较高的敏感度［20-21］。术中肝脏超声或超声造影检查有助于发现术前影像学检查未能检出的隐匿转移灶［22］。正电子发射断层扫描（PET）-CT能够评估病人的全身情况，提示肝外转移灶，在术前分期、术后复发与转移的监测方面具有重要意义。此外，肝转移灶18F-氟代脱氧葡萄糖（18F-FDG）代谢值的改变不仅可在化疗早期阶段（2周）识别治疗应答病例，也可作为判断病人预后的指标［23］。
推荐意见1：建议胃癌肝转移病人行腹部增强MRI和（或）肝脏超声造影以明确肝转移情况，PET-CT检查不作为常规推荐手段，可根据病情需要酌情选用。（证据级别：2b）
专家赞同率：94.3%（33/35）；推荐度：高。
2.2 诊断性腹腔镜探查 在胃癌肝转移病人初始治疗前，行诊断性腹腔镜探查联合腹腔灌洗液细胞学检查，有助于排除影像学检查或肉眼无法识别的肝转移灶或腹膜播散种植转移，进一步明确胃癌肝转移的临床分型，以利于制定后续治疗及复查方案［24］。
推荐意见2：拟行初始治疗前的胃癌肝转移病人，推荐行诊断性腹腔镜探查及腹腔脱落细胞学检查，有助于进一步明确胃癌肝转移的临床分型。（证据级别：2c）
专家赞同率：80.0%（28/35）；推荐度：中。
2.3 病理学检查 对于胃癌肝转移的病人，胃原发灶除常规诊断所需的病理形态学检查外，还应增做免疫组化、分子检测等必要项目，如人表皮生长因子受体2（HER2）［25］、程序性死亡受体-1（PD-1）/程序性死亡受体配体-1（PD-L1）［26］、微卫星不稳定性（MSI）/错配修复蛋白（MMR）［27］、Claudin 18.2［28］、肿瘤突变负荷（TMB）［29］、EB病毒（EBV）状态［30］、神经营养酪氨酸受体激酶（NTRK）基因融合［31］、成纤维细胞生长因子受体2b（FGFR2b）［32］、c-酪氨酸蛋白激酶（c-MET）检测［33］等，有条件的病人可考虑进行二代基因测序（next-generation sequencing，NGS）检测，以指导基于分子标记物的精准治疗。
此外，基于循环肿瘤DNA（circulating tumor DNA，ctDNA）的微小残留病灶（minimal residual disease，MRD）动态监测，可有效预测病人复发风险及生存结局；尤其对于治疗后达到病理学完全缓解（pathological complete response，pCR）或无疾病证据（no evidence of disease，NED）状态的胃癌肝转移病人，MRD状态可为预后分层及后续治疗策略的制定提供关键参考［34-35］。肝转移灶的经皮穿刺活检为诊断转移的金标准，但该检查为有创操作，存在出血、针道转移等潜在风险，其实施需综合评估病人全身状况及穿刺获益情况，且建议在MDT团队（尤其需包括穿刺操作医师）充分参与评估后进行。
推荐意见3：胃癌原发灶应常规行病理形态学检查、免疫组化及分子病理检测；如临床需要，推荐对肝脏转移灶行活组织穿刺病理学检查，并同步完成病理学及分子病理检测。（证据级别：1a）
专家赞同率：100%（35/35）；推荐度：高。
2.4 血清学检查 胃癌肝转移病人术前血清肿瘤标记物癌胚抗原（CEA）、CA19-9、CA72-4、CA125、甲胎蛋白（AFP）升高提示复发率高和预后不良［36-37］。部分复发的病人血清肿瘤标记物指标升高要早于影像学诊断2~3个月出现［38］。
推荐意见4：胃癌肝转移病人应常规检测血清肿瘤标记物CEA、CA19-9、CA72-4、CA125、AFP等，并在后续随访中定期复查。（证据级别：2a）
专家赞同率：100%（35/35）；推荐度：高。
3 |胃癌肝转移临床分型
2019版共识首次提出并建立了全新的胃癌肝转移临床分型体系——胃癌肝转移中国专家共识分型（Chinese Consensus Classification for Gastric Cancer Liver Metastasis，C-GCLM），见图1。该分型系统的临床有效性与对预后的指导价值，已在后续开展的全国多中心RECORD研究中得到充分验证，并在2024版共识中沿用［12］；本共识在此基础上进一步补充并更新了肝脏储备功能评估的具体实施方法及术中重要血管结构的保留原则。见表2［39-43］。
4 |MDT模式在胃癌肝转移中的价值
MDT模式需贯穿胃癌肝转移病人的诊疗全程［44］。由MDT专家团队讨论其诊断、临床分型、治疗方案选择、疗效评估及随访流程，制定个体化方案［45］。MDT专家团队至少应由以下科室人员组成：普通外科（胃肠外科、肝脏外科）、 肿瘤内科、消化内科、放疗科、介入科、影像科及病理科等，必要时可增加超声科、营养科、重症医学科、麻醉科、手术室、心理科等。本共识对MDT模式在胃癌肝转移中的应用与价值有以下推荐意见。
（1）对于原发灶和转移灶初始均具备R0切除条件者，可选择术前系统治疗、同期切除原发灶、转移灶和（或）联合射频消融（radiofrequency ablation，RFA）、微波消融（microwave ablation，MWA）及立体定向放射治疗（stereotactic body radiationtherapy，SBRT）等局部治疗手段，以期达到R0切除或NED状态，其围手术期系统治疗策略应依据MDT综合评估结果制定。
（2）对于原发灶或转移灶其一暂不具备R0切除条件者，推荐优先实施术前系统治疗并动态评估疗效；若治疗后转化为原发灶与转移灶均具备R0切除条件，建议行手术治疗；若仍有一方暂不具备R0切除条件，则再次纳入MDT诊疗评估流程。对于肝转移灶始终无法达到NED状态的病人，需由MDT全面评估肿瘤负荷及病人整体状况，明确原发灶是否需行切除治疗。
（3）对于原发灶与转移灶均不具备R0切除条件者，推荐以全身系统治疗为核心的综合治疗方案，治疗期间定期行MDT评估。
（4）对于不伴有原发灶复发的异时性肝转移和肝内复发病人，经MDT综合评估后，推荐优先实施术前系统治疗；或根据肝转移灶R0切除的可能性及肝脏功能储备情况，选择手术切除或其他局部物理治疗方式［46］。
（5）对于全身状况欠佳、难以耐受高强度治疗的病人，推荐采用单药化疗（可联合免疫类药物）、减量两药方案或最佳支持治疗，以控制疾病进展、提高生活质量并最大限度延长生存周期；若后续全身情况改善，可再行MDT讨论评估后续治疗。
（6）对于合并出血、穿孔、梗阻等情况的病人，根据病人全身情况，可行局部姑息性手术治疗。
（7）对于联合肝外转移等情况复杂的病人，根据MDT讨论结果制定具体计划。
5 |胃癌肝转移初次诊疗流程图
图2为基于C-GCLM制定的胃癌肝转移诊疗流程图。
6 |不同临床分型胃癌肝转移综合治疗
胃癌肝转移的多学科综合治疗主要包括系统治疗（化疗药物、分子靶向药物、抗体偶联药物和免疫检查点抑制剂等）、手术切除、放射治疗、射频消融及动脉介入栓塞化疗等局部治疗手段。
6.1 系统治疗原则 近年来，随着Checkmate649［47］，Orient-16［48］，Keynote859［49］，Rationale-305［50］，Gemstone303［51］，Compassion15［52］等关于免疫检查点抑制剂在晚期胃癌领域关键临床试验结果的公布，以PD-1/PD-L1为主的免疫抑制剂联合化疗成为晚期胃癌主流的治疗策略，这也为胃癌肝转移病人的治疗提供了重要的选择。对于胃癌肝转移病人的系统治疗，应依据分子分型制定个体化策略：（1）对于无免疫治疗禁忌证的胃癌肝转移病人，推荐采用化疗联合免疫治疗方案：①对PD-L1联合阳性评分（combined positive score，CPS）≥5分的病人，建议化疗联合PD-1抑制剂、PD-L1抑制剂（如舒格利单抗）或PD-1/细胞毒性T淋巴细胞相关蛋白4（cytotoxic T-lymphocyte-associated protein 4，CTLA-4）双特异性抗体（如卡度尼利单抗）。②对于PD-L1 CPS＜5分或表达状态未明的病人，则优先推荐PD-1/CTLA-4双特异性抗体卡度尼利单抗［52］。（2）HER2阳性（IHC 3+或IHC 2+及荧光原位杂交检测阳性）病人，推荐联合曲妥珠单抗治疗或抗体药物偶联物（ADC）药物［53-54］。（3）Claudin18.2高表达（IHC 2+~3+，阳性细胞比例≥75%）病人，建议加用佐妥昔单抗［55-56］。（4）dMMR/MSI-H病人，推荐采用双免疫联合治疗（纳武利尤单抗+伊匹木单抗）、免疫检查点抑制剂单药治疗或免疫联合化疗等策略［47, 57-58］。（5）罕见病理学类型（如腺鳞癌、肝样腺癌、神经内分泌肿瘤等）的肝转移病人，推荐经由MDT讨论依据其分子特征及临床生物学行为制定个体化方案。上述系统治疗原则具体方案选择参照相关指南。若转化治疗成功且达到手术标准，推荐术前系统治疗时限原则上≤6～8个周期。
6.2 不同临床分型治疗策略
6.2.1 Ⅰ型：可切除型 Ⅰ型病人占胃癌肝转移总体病人的20%左右［8］。经MDT综合评估，胃原发灶和肝转移灶均可手术切除，可选择术前系统治疗（具体方案参照本共识“6.1 系统治疗原则”）或直接手术。
胃原发灶手术切除标准为胃癌根治术+D2淋巴结清扫。肝转移灶手术切除标准为R0切除。肝转移灶切除范围：（1）保证切缘阴性的局部转移灶肝切除术。（2）肝区、段切除术。（3）半肝切除术。（4）联合肝区、段切除术。肝切除过程中需确保保留≥1根主要肝静脉，且剩余功能性肝体积需满足同时性切除≥40%、异时性切除≥30%的标准。手术技术方法：开放、腹腔镜或机器人辅助手术。RFA和MWA作为手术切除的重要补充手段，对肝脏转移灶可实现有效毁损，既可联合手术治疗也能单独应用［59-60］。消融方式的选择需综合转移灶大小、位置、毗邻解剖结构及操作者临床经验。术后推荐每2~3个月进行1次评估［61］。
推荐意见5：C-GCLM Ⅰ型病人建议行术前系统治疗，在评估原发灶和（或）转移灶能达到R0根治切除或损毁治疗时，应积极考虑外科或肝脏局部损毁治疗。（证据级别：2b）
专家赞同率：97.1%（34/35）；推荐度：高。
6.2.2 Ⅱ型：潜在可切除型 Ⅱ型病人占胃癌肝转移总体病人的25%左右［8］，其治疗应以MDT指导下的全身系统治疗为基础，积极争取转化为可手术根治状态。在肝脏局部化疗方面，肝动脉化疗栓塞术（transarterial chemoembolization，TACE）［5, 61-62］和肝动脉灌注化疗（hepatic arterial infusion chemotherapy，HAIC）［63-64］在提高肝脏局部药物浓度的同时不增加全身毒副反应，既可用于术前系统治疗也可用于术后防止肝内复发。SBRT和调强放射治疗（intensity-modulated radiation therapy，IMRT）技术，可精准处理特殊位置（如肝门区、包绕大血管）的转移灶，尤其适用于最大直径<5 cm的肝脏转移灶。此外，HAIC、TACE和经动脉放射栓塞（transarterial radioembolization，TARE）等局部治疗手段均可与全身系统性治疗联合应用，不仅有助于提高肿瘤客观缓解率和手术转化率，还可进一步延长病人生存时间，故也可作为初始不可切除病人的挽救性治疗选择［65］。对于全身情况不能耐受或拒绝手术的异时性肝转移和（或）肝内复发者，RFA和MWA可多次反复使用［66-67］。经皮冷冻消融术［68］、质子射线治疗［69］及高强度聚焦超声［70］等局部物理疗法也逐步应用到胃癌肝转移的治疗中，并取得了初步成果。
推荐意见6：C-GCLM Ⅱ型胃癌肝转移病人推荐进行全身系统治疗，仅在具备R0切除可能时，推荐手术治疗。对于始终无法达到NED状态的肝转移灶病人，应由MDT全面评估肿瘤负荷及病人整体情况，以确定原发灶是否应予切除。（证据级别：2b）
专家赞同率：94.3%（33/35）；推荐度：高。
6.2.3 Ⅲ型：不可切除型 Ⅲ型病人占胃癌肝转移总体病人的55%左右［8］，其治疗应基于分子病理检测结果及病人一般状况，以MDT意见为指导，贯彻分层、精准的治疗策略。该类病人虽经转化治疗后获得R0切除概率较低，但仍有部分病人可以转化成功。推荐在MDT模式下制定整体治疗计划，给予病人及家属充分的人文关怀与正向引导，鼓励病人积极参与临床试验。
对于全身状况良好、能够耐受化疗的Ⅲ型胃癌肝转移病人，推荐选择晚期胃癌一线标准治疗（具体参照本共识“6.1 系统治疗原则”）或参与临床试验，可选试验方案包括ADC药物［71-72］、FGFR2b靶向药物［73］、MET靶向药物、嵌合抗原受体T细胞（CAR-T）［74-75］等。此外，胸腺法新作为免疫调节剂，通过促进T细胞成熟与分化增强机体抗肿瘤免疫应答［76］，热休克蛋白gp96-多肽复合物，能够激发病人体内肿瘤细胞抗原的特异性细胞免疫应答［77］。因此，在胃癌肝转移综合治疗中，二者均可作为辅助治疗手段，用以改善病人免疫功能状态、增强整体抗肿瘤效应。对于肝转移灶负荷较高或伴有肝主导性疾病者，可在一线治疗有效的基础上联合局部处理，如TACE、HAIC或SBRT，以期最大程度减轻肿瘤负荷、延长药物有效时间［78］。当出现穿孔、梗阻、出血等并发症时，可行姑息手术以缓解症状。对于肿瘤所致的狭窄、持续性出血，能够安全地进行胃切除时可行姑息性胃切除，若存在困难或危险时应行胃空肠吻合或空肠造口等短路手术。
推荐意见7：C-GCLM Ⅲ型病人推荐在MDT指导下实施治疗，并基于分子检测结果进行分层管理，强调一线精准选药、后线积极参与临床试验，局部治疗作为系统治疗的有效补充。如出现并发症，应酌情尽快行手术治疗，除此之外，不建议行减瘤手术。（证据级别：2b）
专家赞同率：100%（35/35）；推荐度：高。
7 |胃癌肝转移随访
随访检查项目及间隔时间见表3。
参考文献
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（2025-12-20收稿）
（来源：中国实用外科杂志）
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2026-02-26
·动脉网
Medical News 医学新闻: A major new scientific review has carefully examined two leading injectable treatments for diabetic macular edema, a serious eye complication of diabetes that can result in permanent vision loss. The study compares aflibercept and brolucizumab, two anti-VEGF medications that reduce retinal swelling and help protect sight.. ：一项重要的新科学综述仔细审查了两种治疗糖尿病性黄斑水肿的主要注射药物，糖尿病性黄斑水肿是糖尿病的一种严重眼部并发症，可能导致永久性视力丧失。该研究比较了阿柏西普和布罗鲁珠单抗，这两种抗VEGF药物能够减轻视网膜肿胀并帮助保护视力。A comprehensive 2026 review compares two leading injectable therapies for diabetic macular edema, highlighting 2026年的一项全面审查比较了两种领先的糖尿病性黄斑水肿注射疗法，重点介绍了differences in durability and safety. 耐用性和安全性方面的差异。The research was conducted by experts from the “Carol Davila” University of Medicine and Pharmacy Bucharest, the Emergency University Hospital Bucharest, the “Vasile Goldis” Western University of Arad, and the “Lucian Blaga” University of Sibiu in Romania. Their comprehensive analysis offers valuable insights for ophthalmologists and patients managing diabetic retinal disease.. 该研究由布加勒斯特“卡罗尔·达维拉”医药大学、布加勒斯特急诊大学医院、阿拉德“瓦西里·戈迪斯”西部大学和罗马尼亚锡比乌“卢西安·布拉加”大学的专家进行。他们的综合分析为眼科医生和管理糖尿病视网膜病变的患者提供了宝贵的见解。Understanding Diabetic Macular Edema 了解糖尿病性黄斑水肿Diabetic macular edema, commonly referred to as DME, develops when prolonged high blood sugar damages the tiny blood vessels in the retina. These weakened vessels begin to leak fluid into the macula, the central region of the retina responsible for detailed vision. As fluid accumulates, the retina thickens, leading to blurred or distorted sight.. 糖尿病性黄斑水肿，常称为DME，是由于长期高血糖损害视网膜中的微小血管而引发的。这些受损的血管开始向黄斑渗漏液体，黄斑是视网膜中负责清晰视力的中心区域。随着液体积聚，视网膜变厚，导致视力模糊或扭曲。A protein called vascular endothelial growth factor, or VEGF, plays a central role in this process. VEGF increases blood vessel leakage and abnormal growth. Anti-VEGF medications are designed to block this protein, thereby reducing swelling and stabilizing vision. 一种叫做血管内皮生长因子（VEGF）的蛋白质在这一过程中起核心作用。VEGF会增加血管渗漏和异常生长。抗VEGF药物旨在阻断这种蛋白质，从而减少肿胀并稳定视力。How Aflibercept and Brolucizumab Differ 阿柏西普和布罗鲁珠单抗的区别Aflibercept is a fusion protein that blocks multiple growth factors, including VEGF-A, VEGF-B, and placental growth factor. It has been widely used for many years and is supported by extensive long-term safety and efficacy data. 阿柏西普是一种融合蛋白，能够阻断多种生长因子，包括VEGF-A、VEGF-B和胎盘生长因子。它已被广泛使用多年，并拥有大量长期安全性和有效性数据的支持。Brolucizumab, in contrast, is a smaller antibody fragment. Its compact structure allows a higher molar dose to be delivered into the eye, which may lead to stronger and longer-lasting VEGF suppression. This molecular design has raised interest in its potential to extend injection intervals and reduce treatment burden.. 相比之下，布罗鲁珠单抗是一种更小的抗体片段。其紧凑的结构允许更高摩尔剂量被递送到眼中，这可能导致更强和更持久的VEGF抑制。这种分子设计引起了人们对其延长注射间隔和减轻治疗负担潜力的兴趣。This 这Medical News 医学新闻report emphasizes that although both drugs target VEGF, their structural differences influence their durability and safety profiles. 报告强调，尽管这两种药物都针对VEGF，但它们的结构差异会影响其持久性和安全性。Evidence from Major Clinical Trials 主要临床试验的证据 Landmark trials such as VIVID and VISTA demonstrated that aflibercept significantly improved best-corrected visual acuity and reduced retinal thickness in patients with center-involving DME. These improvements were sustained over long-term follow-up periods of up to three years. VIVID 和 VISTA 等具有里程碑意义的试验表明，阿柏西普显著提高了中心受累 DME 患者的最佳矫正视力，并减少了视网膜厚度。这些改善在长达三年的长期随访中得以持续。 Meanwhile, the KESTREL and KITE trials showed that brolucizumab achieved vision gains that were non-inferior to aflibercept. In several analyses, brolucizumab produced numerically greater reductions in central retinal thickness. A considerable proportion of patients maintained disease cont 同时，KESTREL 和 KITE 试验表明，brolucizumab 实现的视力增益不低于 aflibercept。在多项分析中，brolucizumab 在中央视网膜厚度方面实现了数值上更大的减少。相当一部分患者维持了疾病控制。rol on 12-week dosing intervals after the initial treatment phase, suggesting a potential reduction in injection frequency. 在初始治疗阶段后，使用12周的给药间隔，这表明注射频率可能会减少。Real-world observational studies further confirmed that both medications can improve or stabilize vision. In patients who switched to brolucizumab due to persistent swelling despite other treatments, significant anatomical improvements were observed in some cases. 现实世界的观察性研究进一步证实，这两种药物均可改善或稳定视力。在因其他治疗仍存在持续肿胀而改用布罗鲁珠单抗的患者中，部分病例观察到了显著的解剖学改善。Safety Profiles Require Careful Consideration 安全性概况需要仔细考虑Aflibercept has demonstrated a well-established and predictable safety profile over years of use. Reported side effects are generally mild and consistent with intravitreal injection procedures. 阿柏西普在多年的使用中已展现出稳定且可预测的安全性。报告的副作用通常较轻，且与玻璃体内注射程序一致。Brolucizumab, however, has been associated with a higher incidence of intraocular inflammation, including retinal vasculitis and, rarely, retinal vascular occlusion. Although these events are uncommon, they can be serious and require prompt treatment. The review notes that inflammatory events appear less frequent in diabetic macular edema than in some other retinal diseases, yet careful monitoring remains essential.. 然而，Brolucizumab 与较高的眼内炎症发生率相关，包括视网膜血管炎，且罕见情况下会出现视网膜血管阻塞。尽管这些事件并不常见，但可能很严重，需要及时治疗。该综述指出，相较于其他一些视网膜疾病，在糖尿病性黄斑水肿中炎症事件的发生频率似乎较低，但仍需谨慎监测。Treatment Burden and Long-Term Management 治疗负担与长期管理DME is a chronic disease requiring repeated injections and ongoing monitoring. Frequent clinic visits can create logistical and financial challenges. Brolucizumab’s potential for longer dosing intervals may benefit selected patients who struggle with frequent appointments. However, safety considerations must be weighed against convenience.. DME是一种需要反复注射和持续监测的慢性疾病。频繁的门诊就诊可能会带来后勤和经济上的挑战。Brolucizumab延长给药间隔的潜力可能使难以频繁就诊的特定患者受益。然而，必须在安全性与便利性之间进行权衡。Both drugs are high-cost biologic therapies, and long-term affordability and access remain important considerations in many healthcare systems. 这两种药物都是高成本的生物疗法，长期的可负担性和可及性在许多医疗系统中仍然是重要的考虑因素。Final Conclusions 最终结论The review concludes that both aflibercept and brolucizumab are effective and valuable options for treating diabetic macular edema. Aflibercept continues to serve as a reliable first-line therapy due to its strong evidence base and established safety record. Brolucizumab offers promising durability and potent anatomical effects, but its use requires careful patient selection and vigilant follow-up due to inflammatory risks. 综上所述，阿柏西普和布罗鲁珠单抗都是治疗糖尿病性黄斑水肿的有效且有价值的选项。由于其强大的证据基础和可靠的安全记录，阿柏西普仍然是值得信赖的一线疗法。布罗鲁珠单抗在持久性和解剖学效果方面表现出良好的潜力，但由于存在炎症风险，其使用需要谨慎选择患者并密切随访。Ultimately, individualized treatment strategies that consider disease severity, prior response, patient lifestyle, and risk tolerance are essential for achieving optimal long-term visual outcomes in patients with diabetic retinal disease.. 最终，考虑疾病严重程度、先前的治疗反应、患者生活方式和风险承受能力的个体化治疗策略，对于实现糖尿病视网膜病患者的最佳长期视力结果至关重要。The study findings were published in the peer reviewed journal: Biomedicines. 研究结果发表在同行评审期刊《生物医学》上。https://www.mdpi.com/2227-9059/14/3/501 https://www.mdpi.com/2227-9059/14/3/501For the latest Diabetic Macular Edema, keep on logging to Thailand 对于最新的糖尿病性黄斑水肿，继续登录到泰国。Medical News 医学新闻. 。Read Also: 另请阅读：https://www.thailandmedical.news/articles/ophthalmology-(eye-diseases) https://www.thailandmedical.news/articles/ophthalmology-(eye-diseases)https://www.thailandmedical.news/articles/diabetes https://www.thailandmedical.news/articles/diabeteshttps://www.thailandmedical.news/articles/med-news https://www.thailandmedical.news/articles/med-news
2026-02-25
老年神经疾病精准治疗与功能评估
晏宁
【关键词】 精准医学；卒中；阿尔茨海默病；帕金森病；生物学标记；功能评估
[DOI] 10.3969/j.issn.1009-0126.2025.12.001
正文：
随着全球人口结构不可逆转地走向老龄化，老年神经疾病已成为影响公共健康的重大威胁。据《2021年全球疾病负担研究》系统分析显示，影响神经系统的疾病是全球导致失能调整生命年（disabilityadjustedlifeyears，DALY）的首要原因，其中脑卒中、阿尔茨海默病（Alzheimer’sdisease，AD）及其他痴呆症、帕金森病（Parkinson’sdisease，PD）等老年期高发疾病贡献了主要部分[1]。
中国作为世界上老年人口最多的国家，截至2023年，65岁及以上人口占比已达15.3%，数量接近2.2亿。与此相应，根据《2021年全球疾病负担研究》中国专刊数据，神经系统疾病已成为中国人群死亡的第三大原因和DALY的第五大原因，其中AD和其他痴呆症是增长最快的疾病负担之一，1990至2021年，其DALY增长了约两倍，凸显了我国在该领域面临的严峻形势[2]。最新模型研究预测，到2050年，全球PD患病率将比2015年翻倍，中国的患病人数将位居世界首位[3]。更加不利的是，中国脑卒中发病率和死亡率也持续居高不下[4]。由此可见，PD、AD和脑卒中共同构成的疾病负担成为我国老龄化社会面临的重大挑战[5]。
在此背景下，精准医学的理念与实践为摆脱上述困境提供了新的契机。其核心在于，依据个体在遗传、生物标志物、神经影像、临床表现及环境暴露等方面的特征，实现对疾病的精准分型、预后预测、治疗选择及预防干预[6]。
1 主要疾病的精准诊断和治疗的现状和趋势
1.1 AD AD已从病理诊断迈入到精准诊疗的新时代。在诊断方面生物标志物扮演了决定性角色。近年来，血液生物标志物的发展尤为迅猛，结合β淀粉样蛋白（β-amyloidpeptide，Aβ）-正电子发射断层扫描（positronemissiontomography，PET）和tau-PET显像技术，这使得在活体中就能对AD病理进行定性甚至定量评估。血浆磷酸化tau蛋白（phosphorylatedtauprotein，P-tau）217、p-tau181、p-tau231以及Aβ42/Aβ40比值等检测，展现出与脑脊液和PET高度相关的性能，提示大规模筛查和早期诊断已成为可能[7-9]。例如，研究发现血液p-tau217能有效鉴别AD与其他神经退行性疾病，并在临床前阶段即出现变化[8]。一项在初级保健机构中使用自测数字认知评估结合血液生物标志物的研究，展示了新技术在社区早期筛查AD的巨大潜力。因此，最新的诊断标准已将脑脊液Aβ42、Aβ42/Aβ40比值、p-tau、总tau蛋白检测，以及Aβ-PET和tau-PET显像技术纳入其中[10]。基因诊断在早发性或家族性AD中具有明确价值，最新的《认知障碍疾病基因诊断策略中国专家共识（2025版）》为临床实践提供了指导[11]。
在治疗方面，靶向Aβ的免疫治疗是近年来最大的突破。仑卡奈单抗和多奈单抗等药物能够显著清除脑内Aβ斑块，并在早期AD患者中证实可延缓认知和功能衰退27%~35%。这标志着AD已进入“疾病修饰治疗”时代。然而，这些治疗对中晚期患者效果不佳，且存在淀粉样蛋白相关影像学异常等不良反应的风险，凸显了精准选择患者（生物标志物确认Aβ病理阳性）和用药时机（疾病早期）的极端重要性[10]。此外，针对tau蛋白、神经炎症（小胶质细胞机制、先天免疫）以及多种病理并存的联合治疗策略正在探索中[10，12]。对疾病异质性的深入理解，特别是AD患者精神行为症状的神经病理基础研究，有望在未来针对特定症状群（如过度活跃、精神病性症状）的精准治疗提供靶点[13]。生活方式干预（如地中海饮食、长期锻炼）和共病管理（如糖尿病药物二甲双胍）也被证实可通过多途径降低AD风险，是精准预防的重要组成部分[14]。
1.2 PD PD的精准诊断正在从基于临床症状的表型分型，向基于病理机制、遗传背景和脑网络异常的分子亚型深化[15-16]。例如：α-突触核蛋白编码基因（α-synuclein，SNCA）变异影响运动表型；富亮氨酸重复激酶2（leucinerichrepeatkinase2，LRRK2）基因变异表现为姿势不稳步态障碍；E3泛素化连接酶、PTEN诱导假定激酶1和PD相关去糖化酶基因变异常见于早发型PD，病程进展缓慢，且对左旋多巴治疗反应良好。MTOR基因变异的PD患者更容易出现运动障碍，但表现出相对较轻的运动症状[17]。还有葡萄糖脑苷酯酶（glucoserebrosidase，GBA）基因、SNCA变异、载脂蛋白Eε4等位基因等与睡眠障碍、认知障碍等非运动症状表型有关[15]。
此外，全基因组研究揭示，PD患者所携带某些基因如ADAMTS19等，在遗传网络中风险变异负担的增加会导致α-突触核蛋白稳态途径的失调，从而导致病理蛋白出现。这为理解疾病的散发性提供了新的视角。旨在实现病理的确诊的生物标志物检测方面，α-突触核蛋白的实时诱导转化分析、皮肤或结肠活检检测磷酸化α-突触核蛋白，以及潜在的血液或脑脊液标志物，也是当前研究的热点[15，18]。神经影像，如多巴胺转运体PET，可用于辅助诊断和评估黑质纹状体通路完整性。功能磁共振研究发现，早期PD患者不同认知表型（如执行功能受损）与特定脑网络（如默认网络、突显网络）的功能连接改变密切相关，这为在诊断初期即实现PD认知障碍亚型分型提供了客观影像学依据[19]。
精准治疗的趋势体现在：第一，药物治疗的个体化。根据患者的年龄、症状类型、并发症风险等因素，选择初始药物（左旋多巴、多巴胺受体激动剂、单胺氧化酶B抑制剂等），并利用药效基因组学预测不良反应（如左旋多巴导致的运动障碍）[20]。第二，脑深部电刺激等高级疗法的精准应用。脑深部电刺激(deepbrainstimulation，DBS)对纹状体或苍白球的靶点选择，需基于患者的症状谱（震颤优势型vs姿势不稳/步态障碍型）、认知情绪状态等进行综合决策[16]。当前强调的是一种高度个体化的方法，即“4W”原则：何种患者（Whichpatient）、何时介入（When）、何种靶点（Whichtarget）、何种技术（Withwhichtechnology），以确保最佳疗效与安全性[16]。长期随访数据显示，精心筛选的患者在接受DBS后5年仍能维持显著的运动症状改善[21]。第三，针对特定病理机制的疾病修饰治疗探索。对于GBA、LRRK2等基因的靶向治疗药物正在临床试验中，旨在延缓或阻止疾病进展[15]。
功能评估方面，除了统一的PD评定量表，可穿戴设备能够客观、连续地监测运动症状（如震颤、运动迟缓、步态）和症状波动，为实现基于客观数据的个体化药物和DBS参数调整提供了可能，形成了“评估-治疗-再评估”的优化闭环。
1.3 脑卒中 脑卒中的精准医学贯穿预防、急性期治疗、二级预防和康复全过程。全球疾病负担研究再次证实了高血压、高体质量指数、高空腹血糖、环境污染等是可干预的脑卒中主要风险因素。在此基础上，新兴的综合评价指标，如联合三酰甘油-葡萄糖指数与衰弱指数，显示出对心血管病和脑卒中潜在风险的优越预测价值，为精准识别高危人群并实施早期干预提供了新工具[22]。
急性期，基于影像学的精准评估是关键。多模态CT或MRI（包括灌注成像）能够精确界定缺血半暗带，为静脉溶栓和血管内取栓治疗提供个体化决策依据，最大化疗效并降低出血风险[23]。对于取栓治疗，评估侧支循环、血栓成分等，有助于预测再通成功率和临床结局。
二级预防的精准化体现在病因分型指导下的针对性策略。例如，对于心房颤动导致的心源性脑卒中，新型口服抗凝药的应用需要根据患者的脑卒中与出血风险进行平衡。对于颅内外动脉狭窄，血管内支架置入或颈动脉内膜剥脱术的决策需基于狭窄程度、症状以及脑血流储备能力等综合评估。遗传和分子研究也开始揭示脑卒中风险和治疗反应的个体差异，例如与胰岛素抵抗相关的遗传评分可能与神经结局相关[24]。
康复期，精准康复是未来方向。利用功能磁共振、弥散张量成像等技术评估大脑结构和功能连接的重构潜力，结合临床特征和生物标志物，可以预测患者的运动、语言和认知功能的恢复轨迹，从而制定个体化的康复方案[23]。机器人辅助训练、经颅磁刺激等神经调控技术，其靶点选择和参数设置也趋向于基于个体脑网络特征的精准化。此过程中的功能恢复评估，同样需要从简单的量表，向基于传感器技术的客观、定量化测量转变，以精准指导康复方案的调整。
2 未来的发展方向和机遇挑战
老年神经疾病精准诊疗与功能评估的未来发展，充满机遇，也面临严峻挑战。
2.1 发展方向与机遇
2.1.1 生物标志物体系的整合与标准化 未来研究将致力于发现和验证更灵敏、更特异的生物标志物（特别是血液来源），并建立涵盖Aβ、tau、α-突触核蛋白、神经炎症、血管损伤等多病理的生物标志物组合。推动这些标志物检测技术的标准化和降低成本，是实现临床广泛转化的关键[7，9]。
2.1.2 人工智能与多组学数据融合 人工智能和机器学习算法能够高效处理海量的多模态数据，包括基因组、蛋白质组、代谢组、影像组和临床数据，从而发现新的疾病亚型、识别复杂的生物标志物模式、构建高精度的诊断和预后预测模型[25]。
2.1.3 功能评估的客观化与生态化 开发基于可穿戴传感器、计算机化认知测试和虚拟现实技术的功能评估工具，实现从“诊所内评估”向“真实世界功能”的转变，更灵敏地捕捉治疗干预带来的细微变化，更全面地反映患者的生活质量。
2.1.4 跨学科协作与主方案临床试验 借鉴肿瘤学的经验，建立神经疾病的“主方案平台”，在同一研究框架下同时测试多种靶向不同生物学亚型的治疗药物，可极大提高新药研发效率[3]。这需要神经科、精神科、影像科、生物信息学、数据科学等多学科的紧密协作[6]。
2.1.5 精准预防与早期干预 基于遗传风险、血液生物标志物和数字认知筛查，识别高危人群，并结合可改变的危险因素（如血压、血糖、饮食、运动、社交），开展针对性的、个性化的预防干预实施性研究，将防控关口前移[26]。
2.2 面临的挑战
2.2.1 技术壁垒与复杂性 老年神经疾病常存在多病理共存，大脑老化本身带来的复杂性，使得生物学分型和生物标志物解读异常困难。多组学数据的整合与分析对计算能力和生物信息学对从业者的跨专业知识和科学素养的要求极高。
2.2.2 临床转化与可及性 许多前沿的精准诊断技术（如PET、部分血液标志物检测）成本高昂，且在基层医疗机构难以普及。如何将研究成果转化为普惠、可及的临床实践是一大挑战。
2.2.3 伦理及隐私与社会公平 遗传信息和生物标志物的使用涉及隐私保护和伦理问题。精准医疗可能加剧医疗资源分配的不平等，需要政策引导以确保其公平性。
2.2.4 证据积累与法规适应 精准医疗策略，特别是基于人工智能的模型和组合生物标志物，需要大规模前瞻性队列研究来验证其有效性和成本效益。监管审批路径也需要适应这种个体化、动态发展的治疗模式。
3 讨论与展望
在精准医学的宏大叙事下，我们在拥抱其带来的革命性机遇的同时，也必须清醒地审视其内在的张力与未来的航向。
首先，精准医学在中国的落地，必须探索一条具有本土特色的道路。中国的优势在于庞大的患者基数、强有力的国家科研组织能力以及正在快速发展的数字技术生态。挑战则在于医疗资源分布不均和卫生经济学压力。因此，中国的精准医学发展路径，应是“顶天立地”的：具体而言，“顶天”可依托我国已有的大型自然人群队列（如中国慢性病前瞻性研究）与国家级脑库资源，深度挖掘中国人群特异的遗传背景、环境暴露与疾病特征。“立地”则关键在于赋能基层，例如，将经过验证的数字认知筛查工具与可穿戴设备整合进社区卫生服务中心的年度老年体检包，并建立与区域医疗中心的双向转诊与数据共享绿色通道，从而将“筛-诊-管”的链条前移并贯通。
其次，我们必须重新定义“功能评估”在精准医学中的核心地位。医学的本质是为人民服务。精准医学若只关注生物学指标而忽视患者的功能状态和生活质量，将是片面的。未来的趋势是构建一个“生物标志物指导治疗，功能评估验证疗效”的闭环。数字化功能评估——通过智能手机应用程序、可穿戴传感器和远程监测平台——能够无缝、客观、高频地采集患者在真实世界中的认知、运动、睡眠及日常活动数据[27]。这些连续性的“数字生物标志物”不仅能更灵敏地捕捉疾病进展和治疗反应，其本身所反映的“数字表型”也能反过来为精准分型提供补充。这个闭环使得诊疗决策从基于“单次就诊的快照”转变为基于“长期动态的电影”，真正实现以患者价值为中心的个体化医疗。然而，在将这些“数字生物标志物”广泛应用之前，我们必须解决其标准化与临床验证的问题。这包括确立其相对于金标准评估的信度与效度，界定不同疾病、不同干预措施下的“最小临床重要差异”，并确保算法在不同人群和设备间的普适性与稳健性。
4 结论
我们正处在一个老年神经疾病诊疗模式发生革命性变革的时代。精准医学通过深化对疾病生物学本质的理解，为实现疾病的早期诊断、个体化治疗和精准预防带来了前所未有的机遇。整合多模态数据、构建以数字化功能评估为核心的动态优化闭环，是推动这一领域持续发展的关键。尽管前路挑战重重，但坚定不移地迈向精准医学，必将为全球数亿罹患神经疾病的老年人及其家庭，带来延缓疾病、改善生活质量的希望之光。
利益冲突 作者声明不存在利益冲突
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（选自中华老年心脑血管病杂志2025年12月第27卷第12期）
END
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临床研究
100 项与 舒洛地特 相关的药物交易
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研发状态
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10 条最早获批的记录, 后查看更多信息
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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 |
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10 条进展最快的记录, 后查看更多信息
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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 | 意大利 | 2021-02-19 | |
| 静脉血管疾病 | 临床3期 | 意大利 | 2021-02-19 | |
| 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 | |
| 肺栓塞 | 临床3期 | 葡萄牙 | 2010-09-30 | |
| 复发性深静脉血栓形成 | 临床3期 | 波兰 | 2010-07-20 |
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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) | 選製製襯製艱壓糧構繭 = 壓鬱網鹽積鏇衊積醖鬱 觸網糧襯觸鬱鑰壓獵觸 (觸觸積艱鏇夢壓餘夢觸, 糧鬱鏇壓獵醖鹹積網膚 ~ 製衊構簾醖襯構窪襯衊) 更多 | - | 2018-03-23 | ||
Placebo (Placebo) | 選製製襯製艱壓糧構繭 = 觸簾鹹鹽鏇繭願選範蓋 觸網糧襯觸鬱鑰壓獵觸 (觸觸積艱鏇夢壓餘夢觸, 範遞觸繭糧衊齋齋憲夢 ~ 簾夢壓鏇淵顧選製鏇餘) 更多 | ||||||
N/A | 94 | Sulodexidum 2 tb/day | 鑰繭鏇襯網繭廠齋遞鏇(窪構鏇範製壓憲廠獵醖) = 夢顧積憲積簾遞鏇艱築 鬱觸艱簾鏇顧鏇網繭願 (網艱獵觸膚醖鹹鑰齋積 ) | 积极 | 2016-10-01 | ||
临床2期 | 130 | 餘鹹遞顧艱糧鹽夢獵夢(壓壓繭網廠淵遞製廠顧) = 齋觸遞獵網餘遞鬱製鑰 蓋窪積簾窪網獵憲餘鹽 (廠鏇餘繭積鏇窪壓遞壓 ) | 积极 | 2015-06-01 | |||
Placebo | 餘鹹遞顧艱糧鹽夢獵夢(壓壓繭網廠淵遞製廠顧) = 醖壓襯艱遞繭淵壓淵觸 蓋窪積簾窪網獵憲餘鹽 (廠鏇餘繭積鏇窪壓遞壓 ) | ||||||
临床3期 | 1,056 | 糧淵鹽遞願觸網築簾範(膚淵觸網製衊鏇鏇壓鬱) = 鹹繭蓋醖鏇衊淵夢願艱 膚鹽繭衊選壓簾製遞衊 (鬱顧廠簾簾淵築築醖遞 ) 更多 | 不佳 | 2011-11-01 | |||
Placebo | 糧淵鹽遞願觸網築簾範(膚淵觸網製衊鏇鏇壓鬱) = 鑰觸齋鑰鑰膚廠蓋艱繭 膚鹽繭衊選壓簾製遞衊 (鬱顧廠簾簾淵築築醖遞 ) 更多 | ||||||
N/A | 20 | (Participants with type 2 diabetes) | 簾範鑰廠積蓋夢築蓋鏇(襯積膚鑰遞夢顧膚醖網) = 選獵廠淵積顧範齋糧淵 構糧餘齋鬱夢衊鹽壓蓋 (蓋窪鬱艱範衊壓製築顧 ) 更多 | - | 2010-12-01 | ||
(Controls) | 簾範鑰廠積蓋夢築蓋鏇(襯積膚鑰遞夢顧膚醖網) = 膚鏇繭構壓鑰鹹鏇夢壓 構糧餘齋鬱夢衊鹽壓蓋 (蓋窪鬱艱範衊壓製築顧 ) 更多 |
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