相关实验视频

Updated: Jan 16, 2026

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

对不受控制的CRSwNP进行抗TSLP单克隆抗体:DUBHE随机临床试验

Mu Xian^1,2,3, Feng Lan^1,2,3, Bing Yan^1,2,3

¹Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.

Nature communications

|September 29, 2025

概括

这项研究表明,CM326是一种胸膜 stromal lymphopoietin (TSLP) 抑制剂,在患有带鼻息肉的eosinophilic慢性鼻炎 (ECRSwNP) 的患者中有效降低鼻息肉大小. 较高的TSLP基线水平预测了更好的治疗反应.

科学领域:

免疫学免疫学免疫学
耳鼻喉科耳鼻喉科耳鼻喉科
临床药理学临床药理学

背景情况:

带鼻息肉的慢性鼻炎 (CRSwNP) 是一种复杂的炎症上呼吸道疾病.
胸膜 stromal lymphopoietin (TSLP) 是一种关键的细胞因子,涉及到驱动CRSwNP病变的2型炎症.
准TSLP为CRSwNP提供了一个潜在的治疗策略,特别是对eosinophilic表型.

研究的目的:

评估CM326的安全性和有效性,一种针对TSLP的单克隆抗体,在不受控制的CRSwNP的患者中.
评估CM326对CRSwNP患者鼻息肉大小 (NPS) 和相关生物标志物的影响.
为了确定CM326治疗反应的潜在预测标记.

主要方法:

一个阶段1b/2a,随机,双盲,安慰剂受控试验,涉及84名患有不受控制的CRSwNP的患者.
患者每隔2周或4周接受CM326 (220毫克) 或安慰剂,持续16周,随后延长开放标签治疗期.
主要终点包括16周的安全性和NPS的变化,这些都是在埃索诺菲尔CRSwNP (ECRSwNP) 患者身上.

主要成果:

每隔2周 (Q2W) 服用CM326的ECRSwNP患者在16周与安慰剂相比,显著改善了NPS (平均差异:-1.2;P=0.04).
用CM326 Q2W治疗导致了外周血液和组织中异氨基细胞的数量以及血IL-5和IL-13水平的降低.
后期分析表明,在基线TSLP>330 fg/mL的患者中,CM326 Q2W显著减少了NPS (平均差异与安慰剂相比:-1.75;P=0.01).

结论:

CM326耐受性很好,并且在未经控制的ECRSwNP.NP患者中改善NPS的疗效得到证明.
这项研究表明,CM326 Q2W是ECRSwNP的一种有前途的治疗选择.
血TSLP基线水平为330 fg/mL,可以作为CM326治疗疗效的预测生物标志物.

更多相关视频

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

Protocol for Repetitive Transcranial Magnetic Stimulation with Symptom Provocation to Treat Obsessive-compulsive Disorder

Protocol for Repetitive Transcranial Magnetic Stimulation with Symptom Provocation to Treat Obsessive-compulsive Disorder

Published on: November 25, 2025

相关概念视频

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF

Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...

Drugs for Treatment of Diarrhea-Predominant IBS

Drugs for Treatment of Diarrhea-Predominant IBS

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...

Drugs for Treatment of Constipation-Predominant IBS

Drugs for Treatment of Constipation-Predominant IBS

Pharmacological therapies for IBS-C are designed to alleviate abdominal discomfort and enhance bowel function. In patients with IBS-C, fiber supplements may help soften stools and decrease straining, but may also lead to increased gas production and bloating. Osmotic laxatives like milk of magnesia are frequently used to soften stools and increase stool frequency in IBS-C patients. In addition, two drugs approved for use in severe IBS-C adult cases are linaclotide (Linzess) and lubiprostone...