A Monocenter, Randomized, Double Blind Pilot Study Comparing Doxycycline in Combination With Hydroxychloroquine Treatment Versus Doxycycline Monotherapy in Patients With Long-Term Complaints Attributed to Lyme Borreliosis.

The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are:
Does addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to treat Lyme borreliosis.
Participants will:
Take hydroxychloroquine or a placebo two times a day during 28 days. Visit the clinic 4 times in one year for checkups and tests.

开始日期2026-03-01

申办/合作机构

Radboud University Medical Center

NCT05842174

/ Not yet recruiting临床1/2期IIT

Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma Through Image-guided Locoregional Therapy

Trans-arterial chemoembolization (TACE) is the most commonly used therapy for patients with unresectable hepatocellular carcinoma (HCC). TACE is a minimally invasive procedure that involves placing a catheter into the artery in the liver that feeds the tumor, administering chemotherapeutics and then blocking the artery with embolics in order to kill tumor cells by depriving them of essential oxygen and nutrients. While TACE has a proven survival benefit, local recurrence is common, and long-term survival rates are poor. Prior studies demonstrate that HCC cells survive the oxygen and nutrient deprivation through autophagy, a process of cellular self-eating, to provide nutrients required for survival. The proposed project will leverage this dependency to develop a novel approach to TACE that integrates autophagy inhibition to improve therapeutic response by increasing tumor cell killing and enhancing anti-tumor immunity.

开始日期2026-02-01

申办/合作机构

VA Office of Research and Development

NCT06408298

/ Recruiting早期临床1期IIT

A Randomized, Placebo Controlled Proof of Principle (Window of Opportunity) Study of Hydroxychloroquine (HCQ) in Prostate Cancer Patients Undergoing Radical Prostatectomy

This is randomized, double blind, placebo controlled proof of principle (window of opportunity) study of oral hydroxychloroquine in patients with resectable localized prostate cancer. To determine the effects of hydroxychloroquine (HCQ) on markers of autophagy, such as p62, LC3-II and NBR-1 in prostate cancer tissue of patients with resectable localized prostate cancer who undergo radical prostatectomy. To monitor/observe the safety and tolerability of daily oral hydroxychloroquine in the pre and perioperative period in patients who undergo radical prostatectomy. To evaluate the concentration of hydroxychloroquine in normal and prostate tumor tissue and to correlate prostate tissue concentrations with the plasma concentrations in these patients. To perform tumor genomic analysis (for common somatic mutations) and to correlate the molecular response to HCQ and presence/absence of such mutations.

开始日期2026-01-06

申办/合作机构

Dartmouth-Hitchcock Medical Center

100 项与硫酸羟氯喹相关的临床结果

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100 项与硫酸羟氯喹相关的转化医学

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100 项与硫酸羟氯喹相关的专利（医药）

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11,736

项与硫酸羟氯喹相关的文献（医药）

2026-07-01·BIOMATERIALS

PANoptosis-triggering GA-based biomimetic nano-prodrug remodels the tumor microenvironment to enhance antitumor immunity

Article

作者: Zhang, Zhe ; Shen, Jianfeng ; Wu, Yijia ; Fang, Yan ; Lin, Yao ; Zheng, Guopei ; Yin, Yuping ; Li, Tianhao ; Li, Qian ; Shen, Feiyang

Gambogic acid (GA) exhibits potent antitumor effects through multiple synergistic mechanisms, making it a promising candidate for adjuvant therapy in refractory cancers. However, its clinical translation has been hindered by poor aqueous solubility, low bioavailability, and systemic toxicity. In this study, we develop a dual-responsive biomimetic nano-prodrug (CM@pGGH) that addresses these limitations and facilitates effective, tumor-targeted therapy. CM@pGGH is synthesized by conjugating GA and hydroxychloroquine (HCQ)-an FDA-approved antimalarial and immunomodulator-to polyglutamic acid (PGA) using disulfide and ester linkages, followed by incorporation of a hybrid membrane derived from tumor cell and macrophage. The dual linkages allow for tumor microenvironment-specific release of both drugs under reductive and acidic conditions. Additionally, the hybrid membrane provides tumor-homing capability and helps evade immune clearance. CM@pGGH induces PANoptosis, a recently characterized form of regulated cell death that integrates pyroptosis, apoptosis, and necroptosis, thereby activating multiple cytotoxic pathways. In vivo, CM@pGGH reprograms the tumor immune microenvironment by repolarizing tumor-associated macrophages to a pro-inflammatory M1 phenotype and promoting CD8⁺ T-cell infiltration, resulting in significant PANoptosis-driven immunogenic cell death (ICD) and sustained antitumor immunity. These findings highlight a dual-prodrug and immune-reprogramming strategy with potential for treating refractory cancers.

2026-04-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

Left ventricular global longitudinal strain impairment during long-term hydroxychloroquine exposure

Article

作者: Eicher, Jean Christophe ; Laurent, Gabriel ; Didier, Romain ; Bonnotte, Bernard ; Guenancia, Charles ; Muller, Géraldine ; Berthier, Sabine ; Collet, Evelyne ; Nivet, Martin ; Maillefert, Jean-Francis

AIMS:

Antimalarial-induced cardiomyopathy (AMIC) is a rare but severe and under-recognized condition. Although screening for ocular toxicity is recommended, this is not the case for cardiac damage. After observing three successive cases of AMIC, we aimed to study the association of chronic hydroxychloroquine (HCQ) intake on echocardiographic parameters in asymptomatic patients.

METHODS AND RESULTS:

After analyzing the characteristics of the 3 patients diagnosed with AMIC, we systematically investigated patients treated with HCQ and referred for routine transthoracic echocardiography between September 2017 and April 2025. Patients with known heart disease or decreased left ventricular ejection fraction (LVEF) were excluded. Patients were divided into tertiles of HCQ-exposure duration (ED). Eighty-two patients were included with a median HCQ-ED of 132 months (72-204) and a cumulative HCQ dose of 1414 g (864-2358). Global longitudinal strain (GLS) was significantly different among the three tertiles of HCQ-ED (p = 0.048) whereas there was no difference in LVEF, left ventricular mass or diastolic function. GLS values were significantly correlated with HCQ-ED (r = 0.395, p < 0.001) and HCQ cumulative dose (r = 0.402, p < 0.001). GLS remained significantly associated in multivariate linear regression analysis adjusted for age, female sex, creatinine and hypertension. A threshold of 1994 g had 78.6% sensitivity and 76.5% specificity for impaired GLS (> - 18%).

CONCLUSION:

This is the first study highlighting the association between long-term HCQ-ED and systolic dysfunction assessed by GLS in asymptomatic patients. Because of its poor prognosis, early detection of AMIC is necessary, and GLS could be an interesting tool in the screening strategy for the detection of pre-clinical alterations.

2026-03-01·JOURNAL OF ETHNOPHARMACOLOGY

Antimalarial potential and toxicity assessment of a polyherbal combination of Azadirachta indica A. Juss., Cymbopogon citratus (DC.) Stapf., and Psidium guajava L. in rodents

Article

作者: N'guessan, Jean David ; N'guessan, Benoit Banga ; Pereira, Dilson ; Azagoh-Kouadio, Richard ; Baidoo, Michael Frimpong ; Brou, Sygnoh Eve Pristile ; Ferrero-Gomez, Maria Lara ; Pakora, Gilles Alex ; Bohui, Gouegoui Serge-Pacôme ; Adima, Augustin Amissa ; Kouassi, Konan Aime Brice ; Agyemang, Alfred Ofori

ETHNOPHARMACOLOGICAL RELEVANCE:

Malaria continues to be a major public health burden in sub-Saharan Africa, particularly due to the emergence of drug-resistant Plasmodium strains and limited access to effective therapies. In African traditional medicine, Azadirachta indica A. Juss., Cymbopogon citratus (DC.) Stapf., and Psidium guajava L. are commonly used for managing malaria. However, their combined efficacy and safety as a standardized polyherbal preparation remain underexplored.

AIM OF THE STUDY:

This study evaluated the antimalarial efficacy and safety profile of a polyherbal formulation (Phymepalu Extract - PPE) prepared from A. indica, C. citratus, and P. guajava in rodent models.

MATERIALS AND METHODS:

The antimalarial activity of the PPE extract was assessed using a 4-day curative test in Plasmodium berghei-infected mice at doses of 30, 60, 90, and 120 mg/kg body weight. Hydroxychloroquine (25 mg/kg) was used as a positive control. Acute oral toxicity was evaluated in rats according to OECD Guideline 423, while subacute (28-day) and subchronic (90-day) toxicity studies followed OECD Guidelines 407 and 408, respectively. Toxicological evaluations included clinical signs, body weight, haematological and biochemical parameters, and histopathological analysis of key organs.

RESULTS:

The PPE extract exhibited dose-dependent antimalarial activity, with 90 mg/kg producing the highest parasitaemia inhibition (76 %), compared to 92 % with hydroxychloroquine. No mortality or signs of acute toxicity were observed at 5000 mg/kg. Repeated administration over 28 and 90 days did not result in significant changes in clinical, haematological, biochemical, or histopathological indices, indicating good tolerability.

CONCLUSION:

The PPE extract demonstrated significant antimalarial activity and an excellent safety profile in preclinical models, supporting its traditional use. These findings justify further investigations toward its development as a safe and effective phytotherapeutic agent for malaria.

762

项与硫酸羟氯喹相关的新闻（医药）

2026-02-26

·自免e声

类风湿关节炎相关研究最新进展分类汇总（2025年）

作者 |自免e声双螺旋小李特别说明 | 本文仅供医疗卫生等专业人士阅读类风湿关节炎（RA）是一种以全身性炎症为特征的慢性自身免疫性疾病，病变主要累及关节，亦可累及关节外脏器。其发病机制为多因素介导，仍需对其潜在作用机制开展深入研究。类风湿关节炎临床治疗的首要目标为实现疾病缓解或维持低疾病活动度，以此预防远期疾病相关的损害。2025年，类风湿关节炎的相关研究不断深入，新的治疗选择涌现，为患者带来了希望。现整理各领域的国内外研究，以飨读者。自免e声编辑部 PART 01 生物标志物一项纳入了2001例类风湿关节炎患者的研究发现，外周血生物标志物特征与类风湿关节炎相关间质性肺病存在关联，且能在临床风险因素基础上提升该并发症的识别。研究不仅证实了外周血生物标志物有望助力类风湿关节炎相关间质性肺病的风险分层，同时提示类风湿关节炎相关间质性肺病的发病机制涉及多种信号通路。[1] 四川华西医院的研究者对278例类风湿关节炎患者的纵向队列展开了血浆蛋白质组研究，发现疾病高风险人群与类风湿关节炎患者均存在特征性的血浆蛋白质组表达谱，且蛋白表达水平的改变与疾病活动度相关，为筛选类风湿关节炎发病及治疗应答的预测生物标志物提供了重要参考。[2] 欧洲抗风湿病联盟（EULAR）与美国风湿病学会（ACR）联合专家委员会对10个关节痛队列（含临床可疑关节痛和自身抗体阳性关节痛）的危险因素及结局数据展开了研究，制定了EULAR/ACR类风湿关节炎风险分层标准。该标准在有无影像学检测数据的情况下均适用。[3] PART 02 并发症一项研究基于TriNetX美国协作网络数据库，构建了一项模拟目标试验，评估了阿巴西普与利妥昔单抗治疗类风湿关节炎相关间质性肺病患者的有效性与安全性。分析显示，相较于利妥昔单抗，阿巴西普可显著降低患者的全因死亡风险，同时降低机械通气风险。后续仍需开展前瞻性随机对照试验，验证阿巴西普是否能真正带来生存获益。[4] 一项综述通过整合类风湿关节炎病理生理学与血栓-炎症领域的最新研究进展，系统阐述了类风湿关节炎与血栓之间的炎症关联机制，同时对当前及新兴的治疗方案进行了探讨与对比。[5] 一项研究基于UK Biobank队列，采用孟德尔随机化法评估了类风湿关节炎与心血管疾病及心血管影像学表型之间的观察性关联和因果关联。结果显示，排除共同危险因素的影响后，类风湿关节炎患者多种心血管疾病的现患风险和新发风险均显著升高，且研究证实类风湿关节炎与缺血性心脏病、急性心肌梗死及心律失常存在因果关联。[6] 一项研究证实，类风湿关节炎滑膜成纤维细胞在体内外均可影响血管生成过程，血管能抑素可改善类风湿关节炎滑膜成纤维细胞介导的病理性螺旋样血管形成。在重度联合免疫缺陷小鼠模型中，该调控过程由血管生成素2介导，且不依赖血管内皮生长因子A的调控，从分子水平阐释了其在类风湿关节炎核心病理生理过程中的重要作用。[7] 一项多中心回顾性研究纳入了由骨科专科医师确诊或通过法国药物警戒系统识别到的甲氨蝶呤诱导性骨病患者，甲氨蝶呤诱导性骨病虽罕见但危害性显著，在类风湿关节炎或银屑病关节炎的绝经后女性患者中尤为高发。通过磁共振成像或骨闪烁显像实现疾病早期诊断，并及时停用甲氨蝶呤是诊疗关键，停药可显著改善患者预后，预防后续骨折的发生。[8] PART 03 药物治疗一项研究分析了德国类风湿关节炎生物制剂与靶向改善病情抗风湿药长期治疗观察登记库（RABBIT）中的数据，观察到JAKi治疗对比bDMARD治疗的恶性肿瘤发病风险总体呈轻度升高，且在部分患者亚组中该风险更为显著。临床应用中，需谨慎权衡药物相关风险与类风湿关节炎病情控制不佳所带来的恶性肿瘤发病风险。[9] 一项日本的研究显示，JAKi治疗难治性类风湿关节炎患者的临床疗效与经1种bDMARD/JAKi治疗失败的患者、非难治性类风湿关节炎患者相比无显著差异。使用糖皮质激素、经多种bDMARD/JAKi治疗失败，是难治性类风湿关节炎患者的不良预后因素。[10] 山东大学齐鲁医院进行了一项Ⅲ期临床试验（NCT04333771）的事后分析，发现与安慰剂相比，艾玛昔替尼可显著降低患者的追加/升级用药需求，或有望减轻患者的治疗负担。但本研究为事后探索性分析，其研究结果仍需进一步验证。[11] 来自欧洲的研究团队探究了常规治疗组的两种非随机化治疗方案：1A组（甲氨蝶呤联合口服泼尼松龙组，覆盖瑞典、挪威、荷兰、冰岛）和1B组（三联药物甲氨蝶呤、柳氮磺吡啶、羟氯喹注射组，覆盖丹麦、芬兰）。结果显示，在未接受过治疗的早期类风湿关节炎患者中，相较于口服组，注射组在临床结局、患者治疗依从性、不良事件发生率方面表现更优，且糖皮质激素累积剂量更低，但影像学结局略差。[12] 一项Ⅱ期随机对照试验考察了羟氯喹（HCQ）的临床应用，在抗CCP抗体水平≥正常上限2倍的人群中，为期12个月的羟氯喹治疗未能预防受试者在36个月时发生临床型类风湿关节炎。[13] 来自法国的研究团队进行了一项双盲、双安慰剂随机对照试验，对比了氢化可的松替代方案与泼尼松逐渐减量方案，评估它们在低疾病活动度类风湿关节炎患者中成功停用糖皮质激素的效果。试验共随机纳入102例患者，平均年龄62.4岁，女性占比70.6%。分析结果显示，对于处于低疾病活动度的类风湿关节炎患者，采用氢化可的松替代方案停用糖皮质激素，其效果不优于泼尼松逐渐减量方案。[14] REGULATE-RA研究是一项正在开展的首次人体Ⅰ期开放标签研究，旨在评估靶向瓜氨酸化蛋白（Cit-P）的自体嵌合抗原受体调节性T细胞（CAR-Treg）疗法治疗难治性类风湿关节炎患者的安全性和耐受性，迄今显示出良好的安全性特征。[15] PART 04 饮食与疾病一项瑞典的巢式病例对照研究显示，红肉及加工肉类的高摄入量与血清阳性型类风湿关节炎发病风险升高相关，而增加蔬菜和水果的摄入量或可降低整体类风湿关节炎的发病风险。[16] 一项研究利用UK Biobank中188597例未患类风湿关节炎的受试者数据，以及Olink蛋白质组学技术分析，结果显示摄入ω-3多不饱和脂肪酸或有助于降低类风湿关节炎的发病风险，并为阐释ω-3多不饱和脂肪酸影响类风湿关节炎发病风险的作用机制提供了新的研究思路。[17] PART 05 共识国家区域诊疗中心中西医结合风湿病专科联盟发布了《类风湿关节炎中西医结合诊疗专家共识(2025版)》，覆盖类风湿关节炎中西医诊断标准、治疗目标与原则、疗效评估、中成药选择的原则、初治及持续缓解患者的中西医结合治疗、中医特色治疗、功能康复以及难治性类风湿关节炎的诊断与治疗等。[18] 泛美抗风湿联盟发布了《2025 PANLAR类风湿关节炎的管理建议》，制定了针对拉丁美洲地区类风湿关节炎药物治疗的循证诊疗建议。核心内容包括：尽早启动传统合成改善病情抗风湿药治疗（尤以甲氨蝶呤为首选）、对不耐受者改用胃肠外途径给药的甲氨蝶呤、谨慎使用糖皮质激素、生物或靶向合成改善病情抗风湿药治疗失败后更换作用机制药物、病情缓解后逐步减药，以及类风湿关节炎相关间质性肺病和血管炎的诊疗指导。[19] 中华中医药学会《类风湿关节炎病证结合诊疗指南》项目组遵循循证医学原则，通过文献检索客观评价中医病证结合诊治证据，并经专家充分讨论，修订、更新了2018年制定的《类风湿关节炎病证结合诊疗指南》中医证候诊断标准及治疗方案内容，形成了《类风湿关节炎病证结合诊疗指南（2025年）》，为类风湿关节炎的中医诊疗提供依据。[20] 参考资料 1.Wheeler, Austin M et al. “Peripheral Biomarker Signatures in Rheumatoid Arthritis-Associated Interstitial Lung Disease.” Arthritis & rheumatology (Hoboken, N.J.) vol. 77,8 (2025): 971-980. doi:10.1002/art.43149 2.He, Siyu et al. “A longitudinal cohort study uncovers plasma protein biomarkers predating clinical onset and treatment response of rheumatoid arthritis.” Nature communications vol. 16,1 6692. 21 Jul. 2025, doi:10.1038/s41467-025-62032-1 3.van Steenbergen, Hanna W et al. “EULAR/ACR risk stratification criteria for development of rheumatoid arthritis in the risk stage of arthralgia.” Annals of the rheumatic diseases vol. 84,9 (2025): 1445-1457. doi:10.1016/j.ard.2025.01.021 4.Shih, Po-Cheng et al. “Association of Abatacept With Lower Mortality Risk Compared to Rituximab in Rheumatoid Arthritis-Associated Interstitial Lung Disease: An Emulated Target Trial.” Arthritis & rheumatology (Hoboken, N.J.), 10.1002/art.43332. 22 Jul. 2025, doi:10.1002/art.43332 5.Adamantidi, Theodora et al. “The Inflammatory Link of Rheumatoid Arthritis and Thrombosis: Pathogenic Molecular Circuits and Treatment Approaches.” Current issues in molecular biology vol. 47,4 291. 18 Apr. 2025, doi:10.3390/cimb47040291 6.Salatzki, Janek et al. “Rheumatoid arthritis and cardiovascular disease associations in the UK Biobank.” BMC medicine vol. 23,1 605. 3 Nov. 2025, doi:10.1186/s12916-025-04431-1 7.Heck, Corinna et al. “Influence of canstatin on fibroblast-driven hypervascularisation in rheumatoid arthritis.” Annals of the rheumatic diseases vol. 84,12 (2025): 1968-1982. doi:10.1016/j.ard.2025.05.019 8.Liu, Huaxiang et al. “Ivarmacitinib reduces the need for adding/escalating medications in moderate-to-severe rheumatoid arthritis patients: a post hoc analysis from a phase III trial.” Frontiers in pharmacology vol. 16 1683508. 21 Nov. 2025, doi:10.3389/fphar.2025.1683508 9.Schaefer, Martin et al. “Comparative risk of incident malignancies in rheumatoid arthritis patients treated with Janus kinase inhibitors or bDMARDs: observational data from the German RABBIT register.” Annals of the rheumatic diseases vol. 84,11 (2025): 1779-1790. doi:10.1016/j.ard.2025.05.014 10.Anno, Shohei et al. “Efficacy and safety of Janus kinase inhibitors in patients with difficult-to-treat rheumatoid arthritis.” Modern rheumatology vol. 35,2 (2025): 225-233. doi:10.1093/mr/roae077 11.Liu, Huaxiang et al. “Ivarmacitinib reduces the need for adding/escalating medications in moderate-to-severe rheumatoid arthritis patients: a post hoc analysis from a phase III trial.” Frontiers in pharmacology vol. 16 1683508. 21 Nov. 2025, doi:10.3389/fphar.2025.1683508 12.Hetland, Merete Lund et al. “Treatment with methotrexate plus oral prednisolone versus triple therapy (methotrexate/sulfasalazine/hydroxychloroquine) plus intra-articular glucocorticoids in early rheumatoid arthritis: a prespecified nonrandomised subgroup analysis of clinical and radiographic data at 48 weeks from the NORD-STAR trial's conventional treatment arm.” Annals of the rheumatic diseases vol. 84,6 (2025): 937-948. doi:10.1016/j.ard.2025.03.002 13.Deane, Kevin D et al. “A phase 2 trial of hydroxychloroquine in individuals at risk for rheumatoid arthritis.” Arthritis & rheumatology (Hoboken, N.J.), 10.1002/art.43366. 29 Aug. 2025, doi:10.1002/art.43366 14.Ruyssen-Witrand, Adeline et al. “Comparison of two strategies of glucocorticoid withdrawal in patients with rheumatoid arthritis in low disease activity (STAR): a randomised, placebo- controlled, double-blind trial.” Annals of the rheumatic diseases vol. 84,1 (2025): 49-59. doi:10.1136/ard-2024-226620 15.Baxter, S. K., et al. "POS0034 REGULATE-RA: A Phase 1 Study of CAR-T Regulatory Cells Targeting Citrullinated Proteins in Refractory Rheumatoid Arthritis: Interim Safety and Tolerability." Annals of the Rheumatic Diseases 84 (2025): 348. 16.Bäcklund, Rebecka et al. “Quantified intakes of key diet components and the risk of developing rheumatoid arthritis: Results from a nested case-control study.” Annals of the rheumatic diseases vol. 84,11 (2025): 1791-1800. doi:10.1016/j.ard.2025.06.2123 17.Chen, Li et al. “Dietary Polyunsaturated Fatty Acid and the Risk of Rheumatoid Arthritis: Insights From Genetic Predisposition and Proteomics.” Arthritis & rheumatology (Hoboken, N.J.) vol. 77,11 (2025): 1475-1487. doi:10.1002/art.43229 18.国家中医药管理局区域中医(风湿病科)诊疗中心,国家区域诊疗中心中西医结合风湿病专科联盟,李娟,温鸿雁,戴冽,朱俊卿,陈世贤,王庆文.类风湿关节炎中西医结合诊疗专家共识(2025版).中华风湿病学杂志,2025,29(3):177-188. 19.Santos Moreno, Pedro et al. “Pan American League of Associations for Rheumatology recommendations for the management of rheumatoid arthritis.” The Lancet. Rheumatology vol. 8,1 (2026): e53-e65. doi:10.1016/S2665-9913(25)00259-0 20.姜泉, et al.类风湿关节炎病证结合诊疗指南（2025年）.中医杂志 66.17(2025):1842-1856.doi:10.13288/j.11-2166/r.2025.17.018. 免责声明：本微信文章中的信息仅供向医疗卫生专业人士传递专业信息，不可直接作为决策依据，发布方不对任何主体因使用本文内容而导致的任何损失承担责任。往期推荐 RECOMMEND JAK抑制剂怎么用更准？2025中国专家共识解读！乏力、血尿？警惕“沉默的ANCH相关性血管炎” 从诺贝尔医学奖看临床应用：皮肤局部免疫耐受的可塑性新机制如有会议直播/学术报道商务合作/原创投稿等需求请联系我们商务合作：姚女士 13752623793 原创投稿：yaohongli@methealth.cn 点分享点收藏点在看点点赞

2026-02-26

·觅健

泰它西普能让肿瘤缩小多少

泰它西普能让肿瘤缩小多少泰它西普（Telitacicept）目前未被批准用于肿瘤治疗，不存在"肿瘤缩小"的临床数据。该药是BLyS/APRIL双靶点融合蛋白，作用机制为抑制B细胞过度活化，适应证为系统性红斑狼疮（SLE）和IgA肾病。在自身免疫病领域，泰它西普的核心价值是降低致病性抗体水平而非实体瘤缩瘤。若患者存在自身免疫病合并肿瘤的情况，需由风湿免疫科与肿瘤科联合评估用药风险，不可自行用于抗肿瘤治疗。泰它西普有没有替代品存在替代方案，但需根据适应证分层讨论：系统性红斑狼疮：传统替代包括糖皮质激素（如泼尼松）、免疫抑制剂（如环磷酰胺、吗替麦考酚酯）及抗疟药（羟氯喹）。生物制剂领域，贝利尤单抗（Belimumab，BLyS单靶点）是泰它西普的直接竞品，两者机制相似但泰它西普为双靶点。若泰它西普疗效不足或耐受性差，可切换至贝利尤单抗，但需重新评估用药周期与感染风险。IgA肾病：替代方案包括RAS抑制剂（如缬沙坦）、SGLT2抑制剂（如达格列净）及布地奈德肠溶胶囊（Nefecon）。泰它西普作为生物制剂，通常用于尿蛋白>1g/天且进展风险高的患者，非一线首选。经济性替代：泰它西普年治疗费用约6-8万元（医保报销前），贝利尤单抗年费用相近。传统免疫抑制剂年费用可低至数千元，但副作用谱差异显著。泰它西普可以停服几天吗不建议自行停服，漏服处理需区分场景：单次漏服：若延迟未超过48小时，应尽快补注；若超过48小时，跳过该次，按原计划下次用药，禁止双倍剂量注射。计划性暂停：围手术期或严重感染时，需由医生评估暂停时机。通常建议重大手术前1-2周停药，术后感染控制后恢复。SLE患者停药超过2周可能诱发疾病活动。长期停药风险：泰它西普半衰期约10-13天，但B细胞功能恢复需更长时间。突然停药可能导致抗体水平反弹，引发狼疮复发或IgA肾病蛋白尿回升。任何超过7天的用药中断均需主治医生知情。

2026-02-25

·今日头条

泰它西普治疗IgA肾病的临床探索：疗效、个体化应用与联合策略

编者按随着对IgA肾病发病机制的深入研究，针对B细胞活化因子（BLyS）和增殖诱导配体（APRIL）的双重抑制治疗，已成为极具前景的治疗新方向。泰它西普（Telitacicept）作为全球首个同类靶向生物制剂，通过同时阻断BLyS和APRIL，旨在从源头减少致病性Gd-IgA1的产生。在第23届亚太肾脏病学大会（APCN 2025）上，多项临床研究壁报展示了泰它西普在IgA肾病治疗中的真实世界应用数据与创新联合方案，为该病的个体化精准治疗提供了新的重要证据。本文旨在综合其中三项关键研究（摘要号C0468、C0480、C0499），对其临床疗效、安全性及治疗策略进行梳理与解析。一、泰它西普单药治疗的初步疗效与安全性评估来自中国哈尔滨医科大学附属第二医院的研究（摘要C0468）[1]报告了一项小型真实世界研究，初步评估了泰它西普在14例蛋白尿＞2 g/d的活检证实IgA肾病患者中的疗效与安全性。所有患者接受泰它西普160 mg/周皮下注射，同时接受优化的支持治疗（ACEI/ARB），为期至少6个月。未同时使用激素或其他免疫抑制剂。研究结果：蛋白尿显著降低：泰它西普治疗4周时，患者24小时尿蛋白定量平均值即从基线时的4.27±2.63 g/d显著下降至2.61±1.92 g/d；治疗24周时进一步降至1.28±0.75 g/d，降幅显著（P=0.002）。血尿改善：尿红细胞计数从基线时的（57.11±101.18）/HPF，降至4周时的（20.74±31.83）/HPF（P=0.01），治疗24周时降至（5.53±7.33）/HPF（P=0.002）。血清白蛋白升高：治疗4周时，平均血清白蛋白水平从基线时的38.92±5.03 g/L升至43.25±4.40 g/L（P=0.01），治疗24周时，升至47.29±8.17 g/L（P=0.002）。肾功能稳定：治疗期间，患者平均血肌酐和估算肾小球滤过率（eGFR）保持稳定，无显著波动。安全性良好：所有14例患者在24周随访期间，均未报告感染、注射部位过敏反应等不良反应，亦无疾病复发。所有IgA患者在泰它西普治疗期间均未使用皮质类固醇或免疫抑制剂结论该研究表明，对于IgA肾病患者，在不联合激素或传统免疫抑制剂的情况下，泰它西普治疗能有效降低尿蛋白和血尿，提升血清白蛋白水平，且具有较高的安全性，为IgA肾病患者提供了一种新的治疗选择。二、泰它西普为合并糖尿病的IgA肾病患者提供“无激素”治疗新选择对于IgA肾病患者，传统治疗方案（无论是否联合免疫抑制剂）均会增加感染、骨质疏松及糖代谢紊乱的风险。来自中南大学湘雅医院的一例病例报告（摘要C0480）[2]则关注了IgA肾病治疗中的特殊困境——合并糖尿病患者因激素治疗可能导致的血糖控制恶化。该报告展示了一例49岁、糖尿病史超过10年且合并并发症（糖尿病视网膜病变和周围神经病变）的男性患者。病例特点与挑战：患者表现为大量蛋白尿，24小时尿蛋白排泄量（24h UPE）达9 g。初始临床诊断为糖尿病肾病。采用足量肾素-血管紧张素系统（RAS）抑制剂、钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂和非甾体MRA进行初始治疗，未能降低蛋白尿（24h UPE增至29 g）。肾活检确诊为IgA肾病（Lee分级：Ⅲ级，牛津分型：M1E1S1T0C1）。为避免糖皮质激素诱导的高血糖，治疗团队选择了泰它西普单药治疗。治疗方案与结果：治疗：起始予泰它西普240 mg/周皮下注射，后逐渐减量至160 mg/周维持。每月监测蛋白尿、血清白蛋白及安全性标志物。疗效：经过9个月治疗，患者24h UPE从29 g大幅降至0.75 g，血清白蛋白从24.1 g/L恢复正常，升至42.4 g/L。安全性：治疗期间IgG水平保持正常，未发生感染、血细胞减少或血糖恶化。图1. 治疗期间血清白蛋白、肌酐和24小时尿蛋白的变化启示该病例表明，对于合并糖尿病、不适合或不愿接受糖皮质激素治疗的IgA肾病患者，泰它西普治疗具有双重优势：能显著降低蛋白尿水平，同时损害血糖控制或增加感染风险，体现了其作为“激素节省”策略的潜力，为这类高风险人群提供了重要的治疗新路径。未来，有必要进一步开展随机试验以验证其作为激素替代药物在这一高风险人群中的作用。三、泰它西普联合靶向回肠布地奈德治疗晚期难治性IgA肾病取得突破来自南方医科大学珠江医院的一例创新性联合治疗报告（摘要C0499）[3]尤其引人注目。该病例探索了针对IgA肾病发病中“肠道黏膜免疫源”和“全身B细胞活化”双重机制的联合阻断策略。病例背景：患者为60岁男性，活检证实为IgA肾病（牛津分型：M1E0S1T1C0，LeeⅣ级），已进展至慢性肾脏病（CKD）4期。基线（2023年8月）血清肌酐为278 μmol/L，24小时尿蛋白4742 mg。曲折的治疗历程与联合方案的提出：初始（羟氯喹+沙库巴曲缬沙坦）治疗（2023年8月）及后续的加强治疗（加用泰它西普160 mg/周+达格列净）和挽救治疗（非奈利酮）（2024年2月）均未能有效控制疾病进展。鉴于患者病情顽固，治疗团队创新性地采用了“泰它西普（80 mg/周）+靶向回肠布地奈德（Nefecon，16 mg/d）”的双靶点联合方案（2024年10月）（图2）。卓越的联合治疗效果：联合治疗9个月后（至2025年6月）：蛋白尿近乎完全缓解： 24小时尿蛋白下降93.8%，从4742 mg/d降至294 mg/d。肾功能显著逆转：血肌酐下降20.3%（从300 μmol/L降至239 μmol/L），eGFR提升超过30%。安全性良好：未出现感染、高钾血症或肝毒性等不良反应。图2. 治疗历程结论与展望该病例首次证实，针对晚期、难治性IgA肾病，联合靶向肠道黏膜免疫（耐赋康）和全身B细胞活化（泰它西普）的双重机制治疗，能实现近乎完全的蛋白尿缓解和显著的肾功能改善。这一成功案例为高危、进展性IgA肾病的治疗提供了全新的、强有力的联合策略思路，亟待前瞻性研究的进一步验证。总结 APCN 2025上披露的这三项关于泰它西普的研究，从不同维度丰富了我们对这一新型生物制剂在IgA肾病治疗中应用的认识：摘要C0468初步验证了其单药治疗的有效性与安全性；摘要C0480凸显了其在特殊人群（如合并糖尿病）中作为激素替代方案的独特价值；而摘要C0499则开创性地展示了基于疾病机制的多靶点联合治疗的巨大潜力，为攻克晚期难治性IgA肾病带来了曙光。随着更多临床数据的积累和治疗方案的优化，泰它西普有望在IgA肾病的个体化、精准化治疗格局中扮演越来越重要的角色。参考文献 [1] weishiyao, et al. Real-world Study: Efficacy and Safety of Telitacicept in IgA Nephropathy without Hormones or immunosuppressants. Poster No.：C0468. 23rd Asian Pacific Congress of Nephrology. Dec 5-7, 2025. [2]Qiongjing Yuan, et al. Clinical Efficacy of Telitacicept in the Treatment of IgA Nephropathy complicated by Diabetes Mellitus: A Case Report. Poster No.：C0480. 23rd Asian Pacific Congress of Nephrology. Dec 5-7, 2025. [3]Tingting Guo, et al. Rapid Renal Recovery with Telitacicept and Nefecon Combination in Advanced IgA Nephropathy: A Case Report. Poster No.：C0499. 23rd Asian Pacific Congress of Nephrology. Dec 5-7, 2025.

100 项与硫酸羟氯喹相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02114	硫酸羟氯喹	P01BA02	DB01611

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
盘状红斑狼疮	美国	Novitium Pharma LLC	2022-01-14
疟疾	美国	Novitium Pharma LLC	2022-01-14
皮肤红斑狼疮	日本	Sanofi KK	2015-07-03
急性疟疾	美国	Advanz Pharma Corp. Ltd.	1955-04-18
类风湿关节炎	美国	Advanz Pharma Corp. Ltd.	1955-04-18
系统性红斑狼疮	美国	Advanz Pharma Corp. Ltd.	1955-04-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床3期	美国	Novartis Pharmaceuticals Corp.	2020-05-01
原发性干燥综合征	临床3期	法国	Sanofi	2008-03-01
转移性胰腺癌	临床2期	爱尔兰	Novartis AG	2023-05-31
胰腺腺癌	临床2期	美国	West Virginia University Hospitals, Inc.	2020-02-04
转移性透明细胞性肾细胞癌	临床2期	美国	Abramson Cancer Center	2011-09-01
转移性胰腺腺癌	临床1期	美国	Novartis Pharmaceuticals Corp.	2019-01-18
不能切除性胰腺癌	临床1期	美国	Novartis Pharmaceuticals Corp.	2019-01-18
绒毛膜羊膜炎	临床前	-	-	2025-11-17
乳腺癌	临床前	美国	Berry Consultants LLC	2025-09-02
乳腺癌	临床前	美国	University of Pennsylvania	2025-09-02

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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


NCT04524702 (CTgov)	临床2期	转移性胰腺腺癌 \| 晚期胰腺腺癌	10	Hydroxychloroquine+Nab-paclitaxel+Gemcitabine+Paricalcitol	築獵窪獵蓋艱壓選積憲 = 鏇憲艱襯憲鹽醖齋築鹹構製觸簾醖淵餘壓膚夢 (獵構鬱廠壓製餘鹽糧築, 糧網構鹽網鑰齋夢觸艱 ~ 衊獵鹹鹽構選顧製願簾) 更多	-	2026-01-23
NCT04303507 (COPCOV, Pubmed \| Trials)	临床3期	新型冠状病毒感染	76	Hydroxychloroquine or Chloroquine	積鑰廠醖鏇餘網願壓積(鹽鹹壓構鏇獵壓齋壓鹽) = 襯廠鑰膚製遞獵餘築糧廠顧艱遞鹽積製願衊繭 (夢積簾選範觸鬱獵獵選, 42.0)	积极	2025-12-16
NCT03032406 (CLEVER, SABCS2025)	临床2期	乳腺癌 ER+ \| HER2+ \| CK	51	Hydroxychloroquine (HCQ)	繭獵簾醖齋齋淵淵衊築(淵鏇遞選糧繭網鏇壓壓) = 廠憲齋積糧艱艱淵齋鬱夢糧製淵選窪壓鹹衊壓 (簾簾衊範襯獵構願鹽鬱 ) 更多	积极	2025-12-11
				Everolimus (EVE)	-
ACR2025	N/A	免疫性血小板减少症 \| 系统性红斑狼疮	29	Hydroxychloroquine (HCQ) monotherapy	蓋艱範齋膚築糧鏇觸獵(簾觸繭製構窪膚範獵夢) = 糧夢憲膚醖鹽構膚餘網醖襯衊廠餘膚範壓艱製 (選鬱築壓鬱繭鹽積糧鑰 ) 更多	积极	2025-10-24
NCT02603146 (ACR2025)	临床2期	类风湿关节炎	144	Hydroxychloroquine	鏇襯淵顧簾蓋艱鏇網顧(壓衊窪積網製齋繭淵壓) = Results for IA were similar. 繭艱製顧廠顧窪簾構獵 (窪壓鬱製憲顧艱鬱衊壓 ) 更多	不佳	2025-10-24
				Placebo
NCT03032406 (CLEVER, Pubmed \| Nat Med)	临床2期	乳腺癌	51	Hydroxychloroquine (HCQ)	顧憲簾簾鏇願鬱膚選衊(願範網鬱襯遞構膚製鑰) = 構鹽積艱獵衊夢鬱鏇簾壓獵選憲顧鏇鏇範繭齋 (觸觸觸夢廠餘觸製鏇積 )	积极	2025-10-01
				Everolimus (EVE)	顧憲簾簾鏇願鬱膚選衊(願範網鬱襯遞構膚製鑰) = 鹽構簾簾遞艱淵範繭願壓獵選憲顧鏇鏇範繭齋 (觸觸觸夢廠餘觸製鏇積 )
EURETINA2025	N/A	视网膜疾患	368	Hydroxychloroquine (HCQ) (Definite/Probable HCQ Retinopathy)	範鏇選鑰鬱廠糧醖築網(鹽淵網膚淵夢觸積積餘) = 簾憲鬱範鬱遞構鹹鏇壓構觸膚繭顧餘餘膚選齋 (獵蓋壓壓淵廠憲齋廠餘 ) 更多	积极	2025-09-04
				Hydroxychloroquine (HCQ) (No Retinopathy)	範鏇選鑰鬱廠糧醖築網(鹽淵網膚淵夢觸積積餘) = 齋積膚衊醖鬱醖鏇鹽繭構觸膚繭顧餘餘膚選齋 (獵蓋壓壓淵廠憲齋廠餘 ) 更多
NCT02603146 (Pubmed \| Arthritis Rheumatol)	临床2期	类风湿关节炎	144	Hydroxychloroquine	餘壓鏇鑰鏇壓觸衊範糧(襯製膚範鹽糧憲憲構艱) = 廠製齋餘獵鹽衊廠獵壓築淵齋鹽鹽餘淵糧衊積 (壓選糧簾膚積夢憲鹽鹽 )	不佳	2025-08-29
				Placebo	餘壓鏇鑰鏇壓觸衊範糧(襯製膚範鹽糧憲憲構艱) = 簾鹽顧選襯衊鹹夢鏇遞築淵齋鹽鹽餘淵糧衊積 (壓選糧簾膚積夢憲鹽鹽 )
NCT03030118 (SMILE, CTgov)	临床2期	系统性红斑狼疮	187	Hydroxychloroquine (Hydroxychloroquine)	築鏇鹽蓋糧願衊顧廠製 = 選夢遞蓋廠繭製淵遞選簾顧網壓壓醖簾鬱壓齋 (醖獵鑰壓鹹艱積糧醖獵, 築憲壓憲蓋壓鏇襯艱淵 ~ 壓顧製醖鹽製網繭繭膚) 更多	-	2025-08-29
				Placebo Oral Capsule (Placebo Oral Capsule)	築鏇鹽蓋糧願衊顧廠製 = 鏇鑰鏇築觸齋窪鑰餘鹽簾顧網壓壓醖簾鬱壓齋 (醖獵鑰壓鹹艱積糧醖獵, 醖繭蓋獵衊膚獵觸積蓋 ~ 簾蓋獵醖蓋廠製餘遞觸) 更多
EULAR2025	N/A	银屑病关节炎	13,710	Hydroxychloroquine (HCQ) users	鏇獵簾齋遞壓齋廠糧醖(淵廠醖鑰淵壓繭願鏇蓋): RR = 0.833 (95.0% CI, 0.7 ~ 0.992), P-Value = 0.04 更多	积极	2025-06-11
				Non-HCQ users