你在哪里?治疗糖尿病神经病变:续集
Yigit Can Guldiken1, Ayesha Malik2, Ioannis N Petropoulos3
1Department of Neurology, Kocaeli University Research and Application Hospital, İzmit/Kocaeli, Turkey.
Expert review of neurotherapeutics
|August 21, 2023
概括
糖尿病外围神经病 (DPN) 临床试验应优先考虑小纤维功能和先进的成像,而不是传统的神经传导和症状. 这确保了更好的药物开发和DPN患者的治疗结果.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 糖尿病神经病学研究研究 糖尿病神经病学研究
背景情况:
- 糖尿病外围神经病变 (DPN) 诊断和治疗试验主要依赖于症状和神经传导研究.
- 小神经纤维 (Aδ和C) 对疼痛,皮肤血流和糖尿病足至关重要,但在DPN试验中经常被忽视.
- 目前对传统终点的依赖可能会阻碍开发有效的DPN疗法.
研究的目的:
- 挑战食品和药物管理局 (FDA) 坚持将症状/信号和神经传导作为DPN临床试验中主要终点的理由.
- 倡导重新评估关于DPN疗法的合适初级终点的证据.
- 提高制药公司获得新型DPN治疗批准的机会.
主要方法:
- 对DPN临床试验终点选择当前实践的审查.
- 分析小神经纤维在DPN病原和并发症中的作用.
- 评估用于DPN评估的先进诊断技术.
主要成果:
- 传统的终点,如症状和神经传导研究,可能无法完全捕捉疾病的复杂性或治疗反应.
- 诸如定量感官测试,皮内神经纤维密度和角膜共焦显微镜等先进方法作为主要终点未得到充分利用.
- 美国食品和药物管理局目前对终点的立场可能基于"意见",而不是全面的证据,可能会阻碍药物批准.
结论:
- 对DPN的临床试验应纳入能够更好地反映小纤维参与和疾病进展的终点.
- 对DPN试验终点的FDA指南进行重新评估是必要的,以包括更敏感和更具体的措施.
- 采用先进技术作为主要终点可以加速批准有效的DPN疗法,使患者受益.
相关概念视频
Diabetes: Management and Pharmacotherapy
310
The therapy for diabetes aims to alleviate hyperglycemia-related symptoms, prevent acute metabolic decompensation, and reduce chronic end-organ complications. Glycemic control is evaluated through short-term (self-monitoring, continuous glucose monitoring) and long-term (A1c, fructosamine) metrics, enabling near real-time tracking of blood glucose levels and reflecting glycemic control over specific time frames.
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
310
Peripheral Artery Disease IV: Nursing Management
12
The nursing management of a patient with peripheral artery disease (PAD) begins with a thorough assessment of the patient’s health history and clinical manifestations.AssessmentHealth History: Evaluate the patient’s history of hypertension, hyperlipidemia, family history of cardiovascular issues, and lifestyle factors such as dietary patterns, smoking, and physical activity.Physical Examination:Assess the affected extremity for decreased or absent peripheral pulses,...
12
Peripheral Artery Disease III: Interprofessional Care
11
Peripheral Artery Disease (PAD) is characterized by narrowed arteries that diminish blood flow to the extremities. Effective management of PAD requires an interprofessional approach involving various healthcare professionals. The critical aspects of interprofessional care for PAD patients focus on risk factor modification, drug therapy, exercise therapy, nutrition therapy, critical limb ischemia care, and interventional radiology and surgical procedures.The primary treatment goal for PAD...
11
Diabetes Mellitus: Overview and Type I Subtype
2.8K
Diabetes mellitus is a chronic metabolic disorder characterized by high blood glucose levels due to inadequate insulin production, insulin resistance, or both. The condition affects millions worldwide and can significantly impact their health and quality of life.
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
2.8K
Peripheral Artery Disease V: Postoperative Nursing Management
12
During the postoperative period, it is crucial to focus on maintaining circulation, identifying and managing potential complications, and planning for discharge.Nursing AssessmentVital signs monitoring: Regularly monitor vital signs, including blood pressure, heart rate, respiratory rate, and temperature, to detect early signs of complications such as bleeding and infection.Circulation assessment: Monitor pulses, perform Doppler assessments, and check capillary refill, color, temperature, and...
12
Diabetes: Symptoms, Diagnosis, and Complications
588
For most patients, experiencing several weeks of polyuria, polydipsia, fatigue, and significant weight loss may indicate the presence of diabetes. Furthermore, adults displaying the phenotypic appearance of type 2 diabetes (particularly those who are obese and not initially insulin-requiring), may have islet cell autoantibodies, suggesting autoimmune-mediated β cell destruction and a diagnosis of latent autoimmune diabetes of adults (LADA). The categorization of glucose homeostasis is...
588


