A comparative evaluation of scalp block using 0.5% bupivacaine with dexamethasone versus 0.5% bupivacaine alone for attenuating postoperative pain in patients undergoing supratentotial craniotomy under general anaesthesia - Nil

开始日期2025-05-02

申办/合作机构

Sardar Patel Medical College

CTRI/2024/08/072668

/ Not yet recruitingN/A

Assessment of gastric residual volume using ultrasonography in diabetic and non-diabetic patients undergoing elective surgery: an observational study - nil

开始日期2024-08-30

申办/合作机构

Sardar Patel Medical College

CTRI/2023/12/060658

/ Not yet recruiting临床2/3期

TO STUDY THE EFFECT OFINTRAOPERATIVE INTRAVENOUSLIGNOCAINE INFUSION ON HEMODYNAMICRESPONSES AND POST OPERATIVEANALGESIA IN PATIENT UNDERGOINGLAPAROSCOPIC CHOLECYSTECTECTOMY - NIL

开始日期2024-01-15

申办/合作机构

Sardar Patel Medical College

100 项与 Sardar Patel Medical College 相关的临床结果

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0 项与 Sardar Patel Medical College 相关的专利（医药）

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355

项与 Sardar Patel Medical College 相关的文献（医药）

2025-07-01·International Journal of Stroke

Indian Trial of Tranexamic acid in Spontaneous Intracerebral Hemorrhage study protocol

Article

作者: Das, Dwijen ; Nambiar, Vivek ; Huilgol, Rahul ; Jain, Agam ; Sharma, Dinesh ; Chaturvedi, Monali ; Sarmah, Binod ; Parthasarathy, Rajsrinivas ; Karadan, Ummer ; Borah, NC ; Das, Rupjyoti ; Jha, Menka ; Iype, Thomas ; KS, Arya Devi ; Yerasu, Muralidhar Reddy ; Kulkarni, Girish Baburao ; Arora, Deepti ; Alapatt, Paul J ; Upputuri, Aruna K ; Sharma, Meenakshi ; Menon, Deepak ; Kempegowda, Madhusudhan ; Zirpe, Kapil ; Raju, Pheba S ; Chander, Praveen ; Narayan, Sunil ; Ramakrishnan, TCR ; Dhankhar, Kailash ; Sylaja, PN ; Sharma, Sudheer ; Kumaravelu, S ; Akhtar, Saleem ; Saravanan, Sankaralingam ; Sundarachary, Nagarjunakonda V ; Pamidimukkala, Vijaya ; Bal, Deepti ; Naik, Karkal R ; Bhoi, Sanjeev ; Singh, Sulena ; Maheshwari, Siddarth ; Dhasan, Aneesh ; Sahonta, Rajeshwar ; Sharma, Ashish ; Khurana, Dheeraj ; Kalita, Naurima ; Basumatary, Lakshya J ; Ramrakhiani, Neetu ; Mittal, Gaurav ; Jaiswal, Shyam K ; Desai, Soaham ; Sarma, P Sankara ; Dhamija, Rajinder K ; Chakraborty, Uddalak ; Wagh, Satish ; Puri, Inder ; Bhatia, Rohit ; Thakkar, Vicky ; Raja, Pritam ; Saroja, Aralikatte Onkarappa ; Benny, Rajesh ; Johnson, Jacob ; Verma, Shweta Jain ; Adhikari, Sweekriti ; Gurav, Sushma ; Sharma, Praveen Kumar ; Roy, Jayanta ; Ray, Biman Kanti ; Bhutani, Neeraj ; Ray, Sucharita ; Aaron, Sanjith ; P, Chithra ; Pradeep Kumar, VG ; Pandian, Jeyaraj Durai ; Menon, Girish ; Pathak, Abhishek ; Gorthi, Sankar Prasad ; Dhaliwal, Rupinder S ; Doshi, Darshan ; Phillips, Atul ; Chaudhary, Vikram

Rationale::

Early mortality in intracerebral hemorrhage (ICH) is due to hematoma volume (HV) expansion, and there are no effective treatments available other than reduction in blood pressure. Tranexamic acid (TXA) a hemostatic drug that is widely available and safe can be a cost-effective treatment for ICH, if proven efficacious.

Hypothesis::

Administration of TXA in ICH patients when given within 4.5 h of symptom onset will reduce early mortality at 30 days.

Design::

Indian Trial of Tranexamic acid in Spontaneous Intracerebral Haemorrhage (INTRINSIC trial) is a multicenter, randomized, open-label, trial enrolling patients aged more than 18 years presenting with non-traumatic ICH within 4.5 h of symptom onset or when last seen well. Study participants received 2 g of TXA administered within 45 min while control group received standard of care. Intensive blood pressure reduction as per INTERACT 2 protocol is followed is done in both groups. Study plans to recruit 3400 patients. Primary outcome is mortality at day 30. Secondary outcomes are radiological reduction in HV at 24 h from baseline, neurological impairment at day 7 or earlier (if discharged), and assessments of dependency and quality of life at day 90.

Summary::

If proven to be beneficial, TXA will have a major impact on medical management of ICH.

Trial registration::

Clinical Trial Registry India (CTRI/2023/03/050224) and Clinical Trials.gov (NCT05836831).

2025-07-01·Lung India

Risk factors for asthma across India: Results from global asthma network (GAN) phase I study

Article

作者: Mangal, Daya K. ; Sukumaran, Thevaruparambil U. ; Awasthi, Shally ; Sharma, Arvind K. ; Sinha, Sanjeev ; Mahesh, Padukuduru Anand ; Kochar, Sanjay K. ; Ghoshal, Aloke G. ; Salvi, Sundeep ; Barne, Monica ; Singh, Nishtha ; Mishra, Akash ; Mohammed, Sabir ; Singh, Virendra ; Singh, Sheetu ; Singh, Meenu ; Singh, Udaiveer ; Kabra, Sushil K.

Introduction::

This study aimed to assess the risk factors and triggers predisposing to asthma in Indian children and adults.

Methods::

The Global Asthma Network Phase I study was a multicentre, international, school, and questionnaire-based cross-sectional study conducted across the world with nine centers in India from 2017-18, the current study being analysis of the Indian data.

Results::

There were 20084 children, 25887 adolescents, and 81296 adults from 9 sites across India. The adjusted odds ratio (AOR) and 95% confidence interval (CI) for atopic factors were as follows: parental history of asthma in adults (AOR 2.88, CI 2.21–3.75), hay fever in children (AOR 2.05, CI 1.62–2.58), and hay fever in adolescents (AOR 1.65, CI 1.40–1.94). Environmental triggers such as exposure to damp spots in the home (AOR1.28, CI 1.05–1.55), antibiotics consumption (AOR 1.80, CI 1.30–2.51), paracetamol taken during pregnancy (AOR 1.23, CI1.02–1.49), and laying on a woollen blanket in the first year of life (AOR 1.67, CI1.34–2.03) were the risk factors predisposing to current wheeze in the children. Risk factors for current wheeze in the adolescents included passage of trucks in front of the house (AOR 1.20, CI 1.04–1.39), and pet animal exposure (AOR 1.32, CI 1.14–1.53); and in the adults included damp spots in houses (AOR 1.61, CI 1.47–1.77), and the use of coal or kerosene or cow dung as a cooking fuel (AOR 1.48, CI 1.28–1.71). Personal factors such as the history of pneumonia in the children (AOR 1.71, CI 1.36-2.15); wheezing after exercise (AOR 1.45, CI 1.23–1.69), hospitalization in the past year (AOR 2.85, CI 2.61–3.59) and caesarean birth (AOR 1.28, CI 1.07–1.53) in the adolescents were associated with current wheeze. India-specific triggers included consumption of bananas (AOR 1.34, CI 1.10–1.63), curd (AOR 1.49, CI 1.23–1.82), packed crunchies (AOR 1.23, CI 1.03–1.48), ice-creams (AOR 1.31, CI1.12–1.53) in adolescents and use of mosquito repellents in adults (AOR 1.11, CI 1.01–1.22).

Conclusion::

The study identifies genetic, environmental, personal health, and dietary risk factors for asthma in India, underscoring the need for public health measures to improve air quality, promote dietary awareness, and reduce indoor hazards.

2025-04-13·Cureus Journal of Medical Science

Role of Renal Resistive Index as an Early Marker of Diabetic Nephropathy in Children With Type 1 Diabetes Mellitus

Article

作者: Sengar, G S ; Choudhary, Preeti ; Rani, Meenakashi

Objective Diabetic nephropathy (DN) is the most common microvascular complication in type 1 diabetes mellitus (T1DM). The study aimed to assess the role of renal resistive index (RRI) in early detection of DN in children with T1DM. Methods This study was conducted on 122 children with T1DM. The following parameters were studied: age, gender of patients, duration of diabetes, number of diabetic ketoacidosis (DKA) episodes, serum creatinine, serum urea, urine albumin excretion (UAE), glycated hemoglobin (HBA1c) and mean RRI of both kidneys. Results The study included 60 (49%) males and 62 (51%) females; with male to female ratio 0.96:1; their mean ages were 9.5 ± 2.89 years (range, 5-14) years and mean disease duration was 3.7 ± 1.6 years (range, 2-10) years; mean value of HBA1c was 11.69 ± 2.1 and 88.5% (108) of cases with T1DM in our study were normoalbuminuric and only 11.4% (14) of cases had albuminuria. The RRI >=0.7 (indicative of DN) was found in 12.2% (15) cases of T1DM in our study. Risk factors significantly associated with DN were age of children (older ages more affected), longer duration of disease, and higher total cholesterol and triglycerides levels. The cases of T1DM with UAE >30 mg/24 hours as well as RRI >=0.7 had significantly higher mean blood urea and serum creatinine levels indicating renal involvement. Conclusion RRI values significantly correlates with renal UAE. RRI abnormality occurs even before the level of UAE reaches the cut-off value of early diagnosis of DN. Hence, RRI (>=0.7) can be used as an early indicator of DN.

项与 Sardar Patel Medical College 相关的新闻（医药）

2025-04-03

·美通社

司美格鲁肽2.4mg可降低超重或肥胖且已确诊心血管疾病患者的总体心血管事件负担

司美格鲁肽 2.4mg （商品名：诺和盈 ® ）可使超重或肥胖且已确诊心血管疾病（ CVD ）但无糖尿病的患者总体心血管事件发生风险降低 22% 。 1 肥胖症可直接导致心血管疾病发病率、死亡率和卒中风险上升，其中约三分之二的与肥胖相关的死亡与心血管疾病相关。 2,3 此次分析基于 SELECT 研究的结果， SELECT 是首个验证肥胖症治疗药物可改善心血管结局的试验。 4 北京 2025年4月3日 /美通社/ -- SELECT试验的最新二次分析结果显示，与安慰剂相比，司美格鲁肽2.4mg（诺和盈 ® ）在超重或肥胖且已确诊心血管疾病但无糖尿病的患者中，可显著降低总体心血管事件负担。 1 这些数据结果在第74届美国心脏病学会科学年会暨博览会（ACC 2025，3月29日至31日在伊利诺伊州芝加哥市举行）上公布。这些结果为SELECT心血管结局试验的现有证据提供了补充，并进一步提供了在首次发生心血管事件后使用司美格鲁肽2.4mg获益的相关数据。 1 这些研究结果具有重要意义。大多数心血管结局试验的主要分析通常仅评估首次心血管事件，而肥胖症患者是心血管疾病高风险群体，可能会在一定时间内经历多次心血管事件。因此，仅分析首次心血管事件无法完全反映肥胖症对健康的长期负担及患者面临的损伤或过早死亡风险。 1,5 在SELECT试验的此项预设二次分析中，与安慰剂相比，司美格鲁肽2.4mg可使主要不良心血管事件（MACE）的首次发生风险降低20%（HR: 0.80; 95% CI 0.73–0.87; P<0.001），并使总体（首次及后续）心血管事件发生风险降低22%（MR: 0.78; 95% CI 0.70–0.86; P<0.001）。[*] 1 此外，与安慰剂相比，司美格鲁肽2.4mg可使总体心脏病发作风险降低31%（MR 0.69; 95% CI 0.58–0.82; P<0.001），总体冠状动脉血管重建风险降低26%（MR: 0.74; 95% CI 0.65–0.84; P<0.001），共同推动了总体心血管事件风险下降。 1 此项分析共纳入17,604名受试者，平均随访时间39.8个月，共计发生3,031例心血管事件，其中，1,947例（64%）为首次事件，1,084例（36%）为后续事件。 1 在首次心血管事件中，冠状动脉血管重建的比例为27.2%，心脏病发作的比例26.2%；而在后续心血管事件中，冠状动脉血管重建的比例为72.9%，心脏病发作为10.3%。 1 总体而言，SELECT研究的最新次要分析结果表明，在超重或肥胖且已确诊心血管疾病但无糖尿病的患者中，司美格鲁肽2.4mg显著降低了首次、后续及总体心血管事件风险。 1 这进一步印证了司美格鲁肽2.4mg在已证实的健康获益外，还具有降低心血管风险的潜力。 4,6-16 关于肥胖症与心血管疾病肥胖症是一种慢性疾病，可直接导致心血管发病率、死亡率及住院风险增加， 17,18 肥胖相关的死亡有三分之二与心血管疾病相关。 2,3 肥胖还与高血压、慢性肾病和炎症等多种风险因素有关。 19 对于已患有心血管疾病的超重或肥胖患者而言，及时的干预至关重要，以降低包括心脏病发作和卒中在内的MACE的残余风险。 5 尽管治疗手段不断进步，但针对肥胖相关疾病的有效治疗方案仍存在巨大的未被满足的需求。 20 关于 SELECT 研究 SELECT是一项国际性随机、双盲、平行分组、安慰剂对照试验，旨在评估司美格鲁肽2.4mg和安慰剂结合标准治疗在超重或肥胖且已确诊心血管疾病但无糖尿病病史的人群中预防MACE的有效性。 9 被纳入试验的人群年龄≥45岁、BMI≥27 kg/m 2 ，最长随访时间达到5年。 9 SELECT试验的主要目标是证实与安慰剂相比，司美格鲁肽2.4mg在降低3点MACE（包括心血管死亡、非致死性心脏病发作（心肌梗死）或非致死性卒中）发生率方面的优效性。 4 关键的次要目标是比较司美格鲁肽2.4mg相较于安慰剂在死亡率、心力衰竭、心血管风险因素（包括糖代谢、体重和肾功能）方面的疗效 4 。 SELECT研究于2018年启动，共招募了17,604名成人受试者，在41个国家和地区的800多个研究中心开展了研究。 SELECT研究的主要研究结果已于2023年11月在美国心脏协会科学年会上公布，并发表于《新英格兰医学杂志》（NEJM）。 4 迄今为止，SELECT研究已衍生出多个数据集和次要分析，相关研究结果已在多个心血管、肾脏及代谢疾病相关的科学大会上发布，相关成果也已发表于众多权威医学期刊 4,10-16 。参考文献 1. Lincoff, MA, Colhoun HM, Emerson S. (2025) Effect of the GLP-1 receptor agonist semaglutide on total cardiovascular events in patients with cardiovascular disease and overweight or obesity but no diabetes in the SELECT trial. Presented at ACC 2025, Chicago, United States. 2. Collaborators GBDO, Afshin A, Forouzanfar MH, et al. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017; 377:13-27. 3. Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, et al. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014; 5:444-470. 4. Lincoff MA, Brown-Frandson K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389:2221-2232. 5. Koskinas KC, Van Craenenbroeck EM, Antoniades C et al. Obesity and cardiovascular disease: an ESC clinical consensus statement. European Heart Journal. 2024;45(38):4063–4098. 6. Kosiborod MN, Abildstrom SZ, Borlaug BA, et al. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2023; 389:1069-1084. 7. Kosiborod MN, Petrie MC, Borlaug BA, et al. Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes. N Engl J Med. 2024; 390:1394-1407. 8. Bliddal H, Bays H, Czernichow S, et al. Once-weekly semaglutide in people with obesity and knee osteoarthritis. N J Engl J Med. 2024:391(17):1573-1583. 9. Lingvay I, Brown-Frandsen K, Colhoun HM, et al. Semaglutide for cardiovascular event reduction in people with overweight or obesity: SELECT study baseline characteristics. Obesity (Silver Spring). 2023; 31:111-122. 10. Deanfield JE, Verma S, Scirica BM, et al. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial. Lancet. 2024;404(10458). 11. Ryan DH, Lingvay I, Deanfield JE, et al. Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial. Nat Med. 2024;30:2049–2057. 12. Scirica BM, Lincoff AM, Lingvay I, et al. The effect of semaglutide on mortality and COVID-19–related deaths: an analysis from the SELECT trial. J Am Coll Cardiol. 2024;84(10):1350–1359. 13. Kahn SE, Deanfield JE, Jeppesen OK, et al. Effect of semaglutide on regression and progression of glycemia in people with overweight or obesity but without diabetes in the SELECT trial. Diabetes Care. 2024;47(8):1350–1359. 14. Kosiborod MN, Deanfield JE, Pratley RE, et al. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024;404(10456):949-961. 15. Colhoun HM, Lingvay I, Brown PM, et al. Long-term kidney outcomes of semaglutide in obesity and cardiovascular disease in the SELECT trial. Nat Med. 2024;30:2058–2066. 16. Nicholls SJ, Ryan DH, Deanfield JE, et al. Semaglutide reduces hospital admissions in patients with obesity or overweight and established CVD. Presented at ObesityWeek® 2024, San Antonio, USA, November 3, 2024. 17. Haidar A, Horwich T. Obesity, Cardiorespiratory Fitness, and Cardiovascular Disease. Curr Cardiol Rep. 2023;25:1565–1571. 18. Zizza C et al. Length of Hospital Stays Among Obese Individuals. Am J Public Health. 2004;94:1587–1591; 3. 19. Powell-Wiley TM, Poirier P, Burke LE, et al. Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021;143:e984-e1010. 20. Rigopoulos AG, Bakogiannis C, de Vecchis R, et al. Acute heart failure: An unmet medical need. Herz. 2019; 44:53-55. [*]研究所定义的"扩大的MACE综合结局"包括心血管死亡、心脏病发作、卒中、冠状动脉血管重建或因不稳定型心绞痛住院。关于诺和诺德诺和诺德公司成立于1923年，是一家全球领先的生物制药公司，总部位于丹麦。立足于在糖尿病领域的百年传承，我们的使命是驱动改变，携手战胜严重慢性疾病。为达成这一目标，我们引领科研突破，扩大公司药物可及性，并致力于预防及最终治愈疾病。诺和诺德在全球80个国家和地区拥有约7.63万名员工，向全球约170个国家和地区提供产品和服务。诺和诺德中国官方网站： http:\/\/www.novonordisk.com.cn 免责声明本新闻稿仅用于传递相关前沿科学信息和市场资讯。本新闻稿不构成对任何药物或治疗方案的推荐、推广或广告。读者不应参考、依据或依赖本新闻稿的任何内容，作出购买、使用任何药物或治疗方案的任何决定。如读者有药物或治疗方面的问题，请咨询医疗卫生专业人士。本新闻稿含有关于诺和诺德产品的前瞻性信息，包括但不限于其潜在益处、研发进展、商业化进程、市场竞争情况等。这些信息涉及到重大的不确定性。仅依赖此信息进行解读、判断和推测可能导致实际结果与此信息所表达或暗示的结果有实质性的差异。请读者充分知悉上述不确定性以及由此可能导致的风险。本新闻稿中所含信息的原始信息来自于诺和诺德，该等信息的有效性仅截至其发布日期。诺和诺德无义务就由于新信息、未来事件、事件进展或其他原因产生的任何变化对相关信息进行更新。对于因使用、依赖本新闻稿中包含的任何信息或任何信息遗漏而直接或间接产生的任何损失，诺和诺德不承担任何责任。在转发、使用或以其它方式处理本新闻稿中的信息前，相关行为人应负责确保其行为符合所有相关国家或司法管辖区的任何适用法律、法规和监管要求。任何由于引用、转载、编辑或通过其它方式使用本新闻稿中所含信息而产生的一切直接或间接的后果，均由相关行为人自行承担全部责任，诺和诺德不对此承担任何责任。建议相关行为人在转发、使用或以其它方式处理本新闻稿中的信息前审慎评估风险，必要时请咨询专业法律人士的意见。特此声明。

临床结果临床研究

2025-03-31

·医学新视点

近30%糖尿病患者有这个并发症！《柳叶刀》：司美格鲁肽再添新效，带来多重改善

▎药明康德内容团队编辑外周动脉疾病（PAD）预计影响全球超2.3亿人，最常见于下肢动脉。外周动脉疾病也是糖尿病的常见并发症。相关研究指出，住院外周动脉疾病患者中约1/3患有糖尿病，糖尿病患者中合并外周动脉疾病者的比例高达20%~28%。合并下肢动脉疾病的糖尿病患者临床表现通常不典型，若得不到及时诊断和治疗，预后往往不佳。因此，糖尿病患者应重视下肢动脉疾病的防治。正在美国芝加哥火热进行的2025年美国心脏病学会年会（ACC.25）上发布了STRIDE试验结果，表明司美格鲁肽可显著改善糖尿病合并外周动脉疾病患者步行距离和生活质量。研究结果同步发表于《柳叶刀》（The Lancet）。该研究第一作者兼通讯作者，来自科罗拉多大学的Marc P Bona教授表示：“对于患有外周疾病和2型糖尿病的患者而言，司美格鲁肽是一种有效的治疗方式，其具有心脏代谢、心血管和肾脏方面的益处，有助于改善患者症状、器官功能和生活质量”。截图来源：The LancetSTRIDE是一项双盲、随机、安慰剂对照研究，在全球20个国家和地区的112家医学中心开展。研究纳入2型糖尿病合并外周动脉疾病、伴有间歇性跛行（可行走200米）、踝肱指数≤0.9（评价外周动脉疾病的首选检查项目，正常参考值为0.9~1.3）或趾肱指数≤0.7（评估真实动脉灌注的首选指标，通常认为≥0.7正常）成人患者792例。研究人员以1：1的比例随机将患者分配接受司美格鲁肽（396例，1.0 mg，每周一次，皮下注射）或安慰剂（396例），持续治疗52周。主要研究终点为治疗第52周时，在跑步机上测定的最大步行距离与基线的比值。结果显示，司美格鲁肽组和安慰剂组第52周时中位最大步行距离与基线的比值分别为1.21和1.08[治疗比（ETR）=1.13，95%CI：1.06~1.21，P=0.0004），提示在一年的治疗时间内司美格鲁肽组获得了13%的统计学意义改善，相比于安慰剂组，司美格鲁肽组中位改善距离绝对值为26.4米，平均改善距离绝对值为40米。▲司美格鲁肽组（红色）和安慰剂组（蓝色）第52周中位最大步行距离与基线比值（图片来源：参考文献[1]）次要终点方面，司美格鲁肽组表现仍优于安慰剂组：▲两组次要结局指标对比（内容来源：参考文献[1]；图表制作：药明康德内容团队）安全性方面，司美格鲁肽组和安慰剂组分别有1%（6起）和2%（9起）可能与治疗相关的严重不良事件发生，最常见的为严重胃肠道不良反应。无一例与治疗相关的死亡病例。考虑到本次研究参与者中，59%的患者体重指数＜30 kg/m2，中位值为28.6 kg/m2（这一比例显著低于其他司美格鲁肽相关研究），Marc P Bona教授指出：“患者体重指数较低，研究结果与体重减轻之间的关系也比较弱。因此，我们未来需要开展更多的研究来明确患者从治疗中获益的具体发生机制。此外，使用司美格鲁肽的患者踝肱指数有所升高，这提示司美格鲁肽具有直接的血管效应作用，但这也引发我们更深层次的思考，那就是，仅有外周动脉疾病，无2型糖尿病的患者是否也能从治疗中获益？这有待进一步的探索和分析”。点击文末“阅读原文/Read more”，即可访问The Lancet官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1] Marc P Bonaca, Andrei-Mircea Catarig, Kim Houlind, et al. Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial. Published March 29, 2025. The Lancet. DOI: 10.1016/S0140-6736(25)00509-4[2] STRIDE and SOUL: Semaglutide Improves PAD Outcomes; Oral Formulation Effective. Retired Mar 29, 2025. From https://www.acc.org/Latest-in-Cardiology/Journal-Scans/2025/03/24/16/30/sat-130pm-stride-soul-acc-2025[3] Ozempic® (semaglutide) injection 1 mg showed improved functional outcomes and health-related quality of life in Phase 3 STRIDE trial in adults with type 2 diabetes and peripheral artery disease (PAD) presented at ACC 2025. Retired Mar 29, 2025. From https://www.prnewswire.com/news-releases/ozempic-semaglutide-injection-1-mg-showed-improved-functional-outcomes-and-health-related-quality-of-life-in-phase-3-stride-trial-in-adults-with-type-2-diabetes-and-peripheral-artery-disease-pad-presented-at-acc-2025-302414859.html[4]刘浩, 董智慧, 符伟国.糖尿病下肢动脉疾病的诊治进展 [J] . 中华糖尿病杂志, 2024, 16(1) : 43-47. DOI: 10.3760/cma.j.cn115791-20230919-00175.[5]《多学科合作下糖尿病足防治专家共识(2020版)》编写组. 多学科合作下糖尿病足防治专家共识(2020版)全版 [J] . 中华烧伤杂志, 2020, 36(8) : E01-E52. DOI: 10.3760/cma.j.cn501120-20200217-01000.免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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：本文来自药明康德内容团队，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「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床结果抗体药物偶联物

2024-11-06

·药明康德

诺和诺德重磅疗法3期试验积极，明年将再递交监管申请

▎药明康德内容团队编辑今日，诺和诺德（Novo Nordisk）在其第三季度的财报当中宣布其重磅疗法Ozempic（semaglutide，司美格鲁肽）用于治疗患有外周动脉疾病（PAD）的2型糖尿病患者的3b期试验达到主要终点。根据此积极结果，诺和诺德预计将于2025年上半年在美国和欧盟递交Ozempic扩展适应症的监管申请。 2024年9月，诺和诺德成功完成了STRIDE临床3b期试验。这是一项为期52周的试验，比较了1.0 mg司美格鲁肽与安慰剂作为标准护理的辅助疗法，在患有2型糖尿病和间歇性跛行（活动时腿部肌肉疼痛）的PAD患者中的效果。分析显示，试验达成主要终点，在试验52周时，司美格鲁肽与安慰剂相比患者在最大步行距离上显著提升达13%，该结果具有临床意义。此外，在司美格鲁肽组中，最大步行距离与基线相较增加了21%，而安慰剂组仅增加了8%。试验中，司美格鲁肽的安全性和耐受性与先前的试验结果一致。 Ozempic是一种GLP-1受体激动剂，它能够刺激胰岛素的生成。该疗法每周一次的注射剂型在2017年获得FDA批准治疗2型糖尿病。并在2020年1月再获FDA批准，用于降低2型糖尿病和已知心脏病成人患者的主要不良心血管事件（MACE）风险，如心脏病发作、中风或死亡。近年，许多研究指出Ozempic的主要疗效成分司美格鲁肽具有治疗多项代谢相关适应症的潜力。除了FDA在2021年6月批准其用于治疗普通肥胖患者（商品名：Wegovy）外，今年7月一项发表在《柳叶刀》旗下医学期刊eClinicalMedicine上的研究显示，Ozempic的使用与痴呆症和尼古丁滥用风险降低相关。分析显示，与DDP-4抑制剂相比，接受Ozempic治疗的患者痴呆症风险降低48%（HR=0.52，95% CI：0.40-0.68）。在尼古丁滥用方面，接受Ozempic治疗的患者与接受胰岛素分泌刺激药物治疗的患者相比，风险降低28%（HR=0.72，95% CI：0.61-0.85）。此外，FLOW临床3期试验结果显示，Ozempic可使患有慢性肾病（CKD）和2型糖尿病的患者发生重大心血管事件的风险降低18%，因任何原因死亡的风险降低20%。该试验详细结果在今年5月同时发布于顶尖医学期刊《新英格兰医学杂志》当中。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Novo Nordisk's sales increased by 23% in Danish kroner and by 24% at constant exchange rates to DKK 204.7 billion in the first nine months of 2024. Retrieved November 6, 2024 from https://ml-eu.globenewswire.com/Resource/Download/74140056-5832-4a59-af10-e7defd8936b7 [2] Novo unveils new cardiometabolic data as it reports solid third-quarter profits. Retrieved November 6, 2024 from https://endpts.com/novo-unveils-new-cardiometabolic-data-as-it-reports-solid-third-quarter-profits/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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：本文来自药明康德内容团队，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

临床3期财报临床结果

100 项与 Sardar Patel Medical College 相关的药物交易

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100 项与 Sardar Patel Medical College 相关的转化医学

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