Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. And to prospectively collect biological samples to find molecular markers for early diagnosis of pancreatic cancer.
Study design: This is a real world, multicenter, prospective, observational cohort study.

开始日期2024-12-01

申办/合作机构

北京协和医院

[+2]

NCT06583109 / Not yet recruitingN/AIIT

Establishment and Application of Prediction Model of Treatment Efficacy for Age-related Macular Degeneration Based on Multi-source Imaging Modalities

Age-related macular degeneration (AMD) is one of the main causes of blindness in the elderly population. Intraocular injection of anti-VEGF drugs for neovascular AMD (nAMD) is the main treatment method at present. However, patients have different responses to anti-VEGF therapy, and some patients do not respond well to short - and long-term treatment.
In this study, a retrospective study was adopted to collate and analyze the clinical data and imaging data of nAMD in the past, and to extract the imaging features from the multimodal modalities before and after treatment for deep learning, and to evaluate and quantify the clinical features, and to construct two multi-source feature models for predicting the short-term and long-term prognosis of nAMD patients. By verifying the accuracy of the model to predict the curative effect, the classification efficiency of the above characteristic models was compared, and the optimal model was selected. Its clinical application value was evaluated by calibration curve and decision curve. In addition, patients with poor treatment response in the study cohort were retrospectively analyzed, and the efficacy and safety of the combination of other treatment options in the actual clinic were analyzed. The purpose of this study is to provide scientific basis for early prediction, dynamic monitoring and optimization of overall treatment strategies for nAMD.

开始日期2024-10-01

申办/合作机构

北京医院

ChiCTR2400090479 / SuspendedN/AIIT

The application research of heparin-binding protein combined with procalcitonin (HBP/PCT) in acute infectious diseases.

开始日期2024-09-30

申办/合作机构

北京医院

100 项与北京医院相关的临床结果

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0 项与北京医院相关的专利（医药）

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233

项与北京医院相关的文献（医药）

2023-10-01·International journal of radiation oncology, biology, physics

Cost-Effectiveness of Short-Course Radiotherapy Based Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer in China.

Article

作者: Wei, L ; Zhu, Y ; Zhu, S ; Chen, W ; Cheng, G ; Wang, W ; Cai, Y ; Zhang, K ; Liu, S ; Wang, J ; Zhang, H ; Gao, Y ; Li, N ; Li, Y ; Li, G ; Wang, X ; Yang, J ; Tang, Y ; Jin, J ; Zhang, W

PURPOSE/OBJECTIVE(S)The phase III STELLAR (NCT02533271) trial demonstrated that four cycles of chemotherapy after short-course radiotherapy (SCRT-TNT) were not inferior to the standard care of long-course concurrent radiotherapy (LCRT) in patients with locally advanced rectal cancer (LARC). This study assessed the cost-effectiveness of SCRT-TNT versus LCRT in locally advanced rectal cancer in China on the basis of the STELLAR trial.MATERIALS/METHODSA Markov model was used to synthesize the healthcare costs and benefits of LARC patients based on results from the STELLAR trial. The model assumes that LARC who meet the inclusion criteria of the STELLAR trial experience four possible states: No Evidence of Disease (NED), locally recurrence, distant metastases, or any death from rectal cancer or other unrelated causes, where local recurrence continues to be classified as resectable and unresectable. The transition status period is 3 month, and 5 years is used to calculate direct medical costs and health benefits. The probabilities of states transition after SCRT-TNT or LCRT were derived from the results of the STELLAR trial and previous published article (Table.1). Costs were evaluated from the Chinese payer's perspective reported in early 2022 US dollars (US$1 = 6.78 Chinese Yuan). Sensitivity analyses were performed for key variables. Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio and net monetary benefits. Effectiveness was defined as quality-adjusted life-years (QALYs). Willingness-to-pay (WTP) threshold was set at $43500/QALY. Data were collected from October 3, 2020, to September 20, 2021, and analyzed from November 15, 2020, to October 25, 2021.RESULTSDuring the 5-year horizon, for the base case scenario, SCRT-TNT incurred a lower total cost and higher QALYs compared with LCCRT. The total cost was $65767 and QALYs were 1.77 for SCRT-TNT; for LCCRT, the total cost was $72802 and QALYs were 1.64. This resulted in an ICER of -$ 55470.69 per QALY. Therefore, SCRT-TNT was a cost-saving and dominating treatment strategy compared with LCRT. Sensitivity analysis showed that ICERs were most sensitive to the parameters of distant metastases risk after treatment.CONCLUSIONSCRT-TNT in locally advanced rectal cancer can be a cost-effective alternative to LCRT in China, and should be considered in appropriately selected patients.

2022-06-01·Journal of Clinical Oncology

Biweekly mXELIRI versus FOLFIRI in combination with bevacizumab as the first-line treatment for metastatic colorectal cancer (EXIST): A multicenter, randomized, open-label, phase 2 study.

作者: Zhang, Yan ; Chen, Xiaobing ; Zhang, Wen ; Xiong, Feng ; Wei, Deng ; Bai, Chunmei ; Cheng, Jianping ; Shi, Shengbin ; Zhao, Yun-Bo ; Li, Sheng ; Zhou, Jianfeng ; Zhu, Chunrong ; Zhu, Liangjun ; Jiang, Zhichao ; SUN, Yongkun ; Wu, Rong ; Niu, Zuoxing ; Zhou, Ai-Ping ; Huang, Yingying

3594 Background: Irinotecan and fluorouracil are the most effective drugs in the treatment of metastatic colorectal cancer (mCRC). But XELIRI (irinotecan plus capecitabine) has not been recommended in the 1st-L setting due to the toxicity in the Western countries. While, modified 3-weekly XELIRI has been proved to be effective and safe in the 2nd-L therapy in Asian mCRC patients. Therefore, this study aimed to assess the efficacy and safety of biweekly mXELIRI with reduced dose of irinotecan in the 1st-L treatment of mCRC. Methods: This was a randomized, open-label, non-inferiority study undertaken at 11 hospitals in China. Eligible patients were aged ≥18 years with unresectable metastatic histologically diagnosed colorectal adenocarcinoma; had an ECOG of 0 or 1 and at least one measurable disease according to the RECIST v 1.1 without any systemic chemotherapy for metastatic disease. Patients were randomly assigned (1:1) stratified by the location of primary tumor (left or right site) to receive 9 cycles of mXELIRI + bevacizumab (Bev) (irinotecan 150mg/m2 D1, capecitabine 1000mg/m2 bid D1-10, Bev 5mg/kg D1, Q2W) or FOLFIRI + Bev (irinotecan 180mg/m2 D1, CF 400mg/m2 D1, 5-Fu 400mg/m2 bolus D1, 5-Fu 2400mg/m2 civ 46h D1, Bev 5mg/kg D1, Q2W) followed by maintenance treatments with capecitabine + Bev or 5-FU + CF + Bev. The primary endpoint was 12-month progression-free survival (PFS) rate. The secondary endpoints included objective response rate (ORR), PFS, overall survival (OS) and safety. Results: From May, 2018 to Apr, 2021, 264 pts were randomized (mXELIRI + Bev 132; FOLFIRI + Bev 132). The median age was 61 (29-80) years old. 62.5% of the patients were men. With a median follow-up of 17.1 months, the 12-month PFS rates were 43.9% vs. 28.8% in the mXELIRI + Bev and FOLFIRI + Bev groups, respectively. The HR was 0.72 (95%CI 0.51 -1.02) which didn’t cross the predefined non-inferiority margin of 1.18 (upper bound < 1.18). The median PFS were 10.5 months vs. 9.6 months (p = 0.056, HR 0.74, 95%CI 0.55-1.01). The median OS was still not mature. The ORR were 51.5% vs. 47.0% (p = 0.460), respectively. The incidence of treatment related adverse events (TRAEs) between these two groups were similar. The most common TRAEs were neutropenia (mXELIRI + Bev vs. FOLFIRI + Bev: 51.8% vs. 57.0%), leukopenia (43.9% vs. 55.3%), anemia (54.4% vs. 45.6%), nausea (31.6% vs. 40.4%), ALT/AST increased (22.8% vs. 23.7%), diarrhea (21.1% vs. 16.7%), fatigue (20.2% vs. 23.7%), vomiting (17.5% vs. 20.2%) and hyperbilirubinemia (14.9% vs. 17.5%). No treatment- related deaths were reported. Conclusions: Biweekly mXELIRI with reduced dose of irinotecan plus bevacizumab was noninferior to the standard dose of FOLFIRI + Bev in PFS, with similar safety profile in the patients with untreated mCRC. Clinical trial number: NCT04247984. Research Sponsor: No Clinical trial information: NCT04247984.

2022-06-01·Journal of Clinical Oncology

Molecular features differences between patients with BRAF mutant melanoma and thyroid cancer.

作者: Yuan, Mingming ; Huang, Yingying ; Zhou, Ledu ; Fang, Tongdi ; Zhao, Yun-Bo ; Xia, Xuefeng ; Xiao, Liang ; Ye, Ke ; Long, Guo

e15128 Background: The efficacy of BRAF inhibitors varies extremely among patients with different cancers, such as malignant melanoma (MM) and differentiated thyroid carcinoma (TC) (constituting > 95% of thyroid cancer). This study aims to investigate molecular biomarkers that may explain the efficacy difference of BRAF inhibitors in patients with MM and TC. Methods: Tumor tissue and paired peripheral blood samples from patients with MM and TC were sent for matched tumor-normal next-generation sequencing of 1021 cancer-related genes. MM and TC patients harboring known BRAF activating mutations were retrospectively recruited in this study. Concomitant mutations, tumor mutation burden (TMB) and other mutational features were compared between these two populations. Results: A total of 69 patients with MM and 315 patients with TC were included. The total and median number of mutations in these two groups were 503/6 and 605/1, respectively. Correspondingly, TMB was higher in MM compared with TC (median: 2.88 muts/Mb vs. 0.69 muts/Mb, p = 0.0002). Compared with TC, more copy number variants (CNV) (total number: 142 vs 5, p < 0.001) and less single nucleotide variants (total number: 353 vs 569, p < 0.001) were identified in MM. Most BRAF mutations in MM were located on V600, and other mutations including D594A/G/N, K483E/Q and K601E were identified. In TC, nearly all mutations were BRAF V600E. Excluding CNV and structural variants, the mutation frequency of 28 genes in MM was higher than TC. Pathway enrichment analysis suggested that 9 out of 28 genes (APC, ARID1B, ARID2, CDKN2A, CTNNB1, EGFR, PTEN, TERT, TP53) were significantly enriched on the hepatocellular carcinoma signaling. TERT, CDKN2A and PTEN were frequently mutated in MM, which may contribute to the efficacy difference of BRAF inhibitors in patients with MM and TC. Conclusions: This study found specific molecular features may explaining the efficacy difference of BRAF inhibitors in MM and TC, which requires further validation in patients treated with BRAF inhibitors.

项与北京医院相关的新闻（医药）

2024-10-30

·美通社

立现清晰侧颜革新耀目启航艾尔建美学旗下乔雅登®朔颜®中国上市

成都 2024年10月30日 /美通社/ -- 全球医美生物制药领域的领导企业艾尔建美学宣布旗下含利多卡因注射用交联透明质酸钠凝胶乔雅登 ® 朔颜 ® （Juvéderm ® VOLUX ® ）正式在中国上市。今日，乔雅登 ® 朔颜 ® 上市会以"解码轮廓，侧颜立现"为主题，诚邀国际及中国医疗美学专家及行业权威人士，共话下面部美学认知与治疗方案及面部年轻化领域的革新思路。作为一款专为下面部轮廓精雕而设计的透明质酸产品，乔雅登 ® 朔颜 ® 用于面部骨膜上注射，以改善中度下颌后缩患者的下颌轮廓。临床研究表明，乔雅登 ® 朔颜 ® 能维持长达18-24个月 [1],[2] 清晰利落的下颌线条。同时，乔雅登 ® 朔颜 ® 含利多卡因，可以减少治疗过程中患者的疼痛，提升治疗舒适度。艾尔建美学中国总经理丘汉华表示："乔雅登 ® 朔颜 ® 获批及上市再次印证了艾尔建美学在产品布局上的深度与前瞻性。自2015年登陆中国市场以来，乔雅登 ® 家族不仅通过技术迭代不断激发新的求美需求，同时通过持续引入全球前沿创新产品，针对医美需求者最为关注的面部细分部位，打造高品质的医生培训体系和专业诊疗方案。作为医美行业始终的革新者，我们将继续以‘敬畏医疗本质，恪守循证原则'的态度矢志创新，为中国医美行业发展注入新的动力。" 研究表明，下颌骨是面部美学的重要组成部分，对整体面貌起到协调美观的重要作用。下面部的形态最富有变化，最能体现个性，同时是定义男性与女性面部特征的关键。随着衰老进程，下颌骨吸收变化导致下面部失去结构支撑，出现衰老迹象。 [3],[4],[5],[6] 因此，下面部对于抗衰以及面部美学风格的塑造具有重要意义。此次，全球顶级整形美容专家、面部注射领域开拓者 Dr. Mauricio de Maio 特地莅临上市会现场，解读乔雅登 ® 朔颜 ® 轮廓密码——MD Codes™ 7&9-Point ∑hape™，及全球前沿的专属治疗方案。全面理解面部结构对于提升面部形态至关重要。作为MD Codes™体系下的轮廓治疗方案， 7&9-Point ∑hape™旨在构建中面部基础，同时塑造下面部轮廓。 [7],[8] 为了使医美需求者获得更加满意的治疗效果，Dr. Mauricio de Maio 提出了适合人们求美需要的情绪美学密码治疗方案，简称MD Codes™。MD Codes™不只是专注于个别治疗部位，更强调治疗的情绪动机，能够协助医生判断面部治疗部位与不同情绪特质的关联，确定合适的注射点位，满足医美需求者治疗后期望，呈现出自然外观的治疗效果。与会专家纷纷表示，体系完整、具有可重现性并且不断更新迭代的注射技术体系和相关培训，对于医美需求者当下治疗的满意度以及长期、安全、可持续的治疗旅程都具有重要意义。雕刻立体侧颜，创领行业新趋一项纳入800例不同年龄、性别的中国人群研究显示，约有60%至80%中国人群具有下颏短小、下颌后缩等问题，严重程度随年龄增长而增加。 [9],[10] 中国整形美容协会面部年轻化分会会长、爱思特医疗美容集团总院长李勤教授表示：" 亚洲地区的医美需求者对下颌和下颏区域的治疗需求高；同时，下颌、下颏的治疗需求复杂，医生需要谨慎选择具备理想特性的医美产品，包括强支撑能力、抗变形和抗位移能力，以及自然融合度高、安全可靠等。乔雅登 ® 家族丰富的产品组合以及朔颜 ® 强大的产品力，将成为医生能够实现三维全面部美学治疗的基础和保证。" 《中国人群面部年轻化透明质酸填充剂应用指南》指出，下颏和下颌的老化特征包括容量缺失和轮廓模糊，建议使用高弹性模量、中到高内聚力的透明质酸填充剂，在骨膜上或皮下注射，以重塑下颏轮廓和下颌缘线条。上海上实医疗美容医院副院长方建蔺表示："当前中国市场缺乏能够塑造从下颏到下颌线整体轮廓的塑形产品，乔雅登 ® 朔颜 ® 的上市恰逢其时，其定制化的弹性模量和内聚力配比符合下颌区域治疗需求。我们期待乔雅登 ® 品牌作为全球品类领导者能够更进一步，树立行业新的治疗标杆并助力实现患者多元化的治疗目标。" 目前，玻尿酸已经成为面部填充和塑形的主流产品之一。产自法国Pringy工厂的乔雅登 ® 朔颜 ® 使用特有的Vycross ® 交联技术，是乔雅登 ® Vycross ® 系列中透明质酸浓度、弹性模量和内聚力最高的产品。中国注册研究*临床数据显示，使用乔雅登 ® 朔颜 ® 治疗6个月后，下颌部位整体美观改善的满意度高达95.0%以上；在治疗后12个月，医美需求者仍然维持较高的满意度。数据充分证明了乔雅登 ® 朔颜 ® 在改善和塑造下颌线条方面的治疗效果。乔雅登 ® 家族目前已有6款产品（乔雅登雅致 ® 、乔雅登极致 ® 、丰颜 ® 、缇颜 ® 、质颜 ® 和乔雅登 ® 朔颜 ® ）进入中国市场，涵盖面颊部、鼻唇沟、唇部、鼻部、下颌轮廓等多个部位的治疗，配置不同的理化特性，实现分层分部位定制化解决方案。 1. Ogilvie Petal. Aesthet Surg J. 2020;40:NP499–510. 2. Allergan Aesthetics. Unpublished Data. INT-VOX-2150005. Juvéderm® VOLUX: Final Clinical Evaluation Report 2019. Apr 2021. 3. 吴敏娟,等.下颌骨的生长发育及下面部衰老后的变化[J].中国美容医学,2007,(09):1302-1304. 4. Ozturk C N, et al. Dentition, bone loss, and the aging of the mandible[J]. Aesthetic surgery journal, 2013, 33(7): 967-974. 5. 张陈平. 下颌骨重建术[J]. 口腔颌面外科杂志,2005,15(3):215-218. 6. 恒敏,等. 上下颌骨位置改变对上气道的影响[J]. 口腔颌面外科杂志,2007,17(1):94-97. 7. de Maio M. Facial Plast Surg 2022;38(2):102–10. doi: 10.1055/s-0041-1741499; 2. de Maio M. Aesthetic Plast Surg 2021;45:690–709. doi: 10.1007/s00266-020-01762-7. 8. de Maio M. Facial Plast Surg 2022;38(2):102–10. doi: 10.1055/s-0041-1741499; 2. de Maio M. Aesthetic Plast Surg 2021;45:690–709. doi: 10.1007/s00266-020-01762-7. 9. Hsieh D M Y, et al. Chin microgenia: an anthropometric analysis on the prevalence and severity in a Chinese population[J]. Dermatologic Surgery, 2022, 48(5): 516-522. 10. 2020 BONE CLONES, INC. Human Male and Female Skulls: African, Asian, and European:https://boneclones.com/product/human-male-and-female-skulls-african-asian-and-european-COMP-120-SET 2. Racial Determination using *参与该产品中国临床试验的机构包括北京大学国际医院整形美容外科、北京医院整形外科、华中科技大学同济医学院附属协和医院整形外科、南京大学医学院附属鼓楼医院/南京鼓楼医院烧伤整形外科、南方医科大学南方医院整形美容外科、上海第九人民医院/上海交通大学医学院附属第九人民医院整形外科、中国医学科学院整形外科医院整形外科（排名不分先后，按拼音首字母排序） ### 关于艾尔建美学艾尔建美学是一家艾伯维旗下的公司，致力于研发、生产和销售一系列领先的美学品牌和产品，覆盖面部美学、身体塑形、整形、皮肤护理等领域。艾尔建美学拥有独立的研发部门，专注于推进美学领域的突破创新，提供全面、科学的美学产品。如需更多信息，请登录： https://www.allerganaesthetics.cn/ 。

上市批准申请上市

2024-10-10

·信达生物

【学术前沿】郭立新教授介绍玛仕度肽与度拉糖肽的头对头降糖研究

转载自：医学界内分泌频道玛仕度肽作为目前全球研究进展最快的胰高糖素样肽-1（GLP-1）/胰高血糖素（GCG）双受体激动剂周制剂，其2型糖尿病（T2DM）III期注册临床研究DREAMS-2的结果在近期召开的第60届欧洲糖尿病研究协会（EASD）年会上以最新突破性摘要（LBA）形式进行口头报告（LBA OP-16），成为EASD大会上众多学术成果中的重要中国声音（注：本届EASD大会共接收摘要1064篇，评选出LBA 38篇，共有4项中国研究荣登LBA榜单，将中国声音展现于世界舞台）。DREAMS-2结果的首次亮相引起全球糖尿病领域专家学者们的广泛和重点关注。 DREAMS-2主要研究者，北京医院国家老年医学中心郭立新教授： DREAMS-2主要研究者北京医院郭立新教授： DREAMS-2主要研究者，北京医院郭立新教授表示：“DREAMS-2研究是评估玛仕度肽与度拉糖肽在T2DM患者中有效性和安全性的研究，研究纳入的患者是既往接受二甲双胍联合或不联合钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）或磺酰脲类药物血糖控制不佳的成人T2DM患者。研究取得了非常好的临床效果，结果显示，每周一次应用玛仕度肽，其4mg和6mg剂量均可显著降低糖化血红蛋白（HbA1c），优效于度拉糖肽1.5mg组，且HbA1c<7.0%以及HbA1c≤6.5%的受试者比例显著高于度拉糖肽1.5mg组。安全性方面，使用玛仕度肽消化道不良反应较小，安全性良好。在研究过程中，很多生活方式干预或口服降糖药物血糖控制不佳的患者纷纷表示在使用玛仕度肽后血糖和体重均得到了有效的控制。因此，在T2DM或既往使用口服降糖药物血糖未达标的T2DM患者中，玛仕度肽具有良好的临床应用效果。” “此外，肥胖是全社会面临的一个重要健康问题。中国肥胖人群的绝对人口数量在全球范围内最多，以腹型肥胖为主[1]。随着国家卫生健康委发布了为期三年的‘体重管理年’活动，更彰显了体重管理在代谢疾病管理中的重要性。研究结果表明，玛仕度肽在减重方面也有着良好的疗效且优效于度拉糖肽。玛仕度肽有望明年在华上市，获批降糖和减重双适应症。在此背景下，我们预计玛仕度肽具有临床应用优势，前景良好。” 那么，DREAMS-2研究具体表现如何呢？下面就请跟随本文，一同走进DREAMS-2研究吧！ DREAMS-2（NCT05606913）是一项在既往接受二甲双胍联合或不联合SGLT2i或磺酰脲类药物血糖控制不佳的成人T2DM患者中，评估玛仕度肽相对于度拉糖肽的疗效和安全性的随机、开放性、为期28周的III期临床研究。研究共纳入731例T2DM患者[平均糖化血红蛋白（HbA1c）8.22%；中位糖尿病病程4.0年；平均体重76.95kg；平均体重指数（BMI）：27.91kg/m2]，以1:1:1的比例随机接受玛仕度肽4mg（N = 242）、玛仕度肽6mg（N = 244）或度拉糖肽1.5mg（N = 245）每周一次皮下给药，治疗28周。首要终点为第28周时玛仕度肽4mg和6mg组与度拉糖肽1.5mg组相比HbA1c相对于基线的变化。研究结果显示，基于疗效估计目标，第28周时，玛仕度肽4mg组和6mg组HbA1c较基线平均降幅分别为1.69%和1.73%，均优效于度拉糖肽1.5mg组（1.38%）（P值均＜0.01）（图1）。图1 治疗28周时各组HbA1c变化情况来自ANCOVA（TPE）或MMRM（疗效被估量）分析。mITT人群。数据为LS均值，误差线代表SE。††P < 0.01，†††P < 0.0001，与度拉糖肽1.5mg相比的优效性，控制 I 类错误。ANCOVA = 协方差分析；LS = 最小二乘；mITT = 改良的意向治疗；MMRM = 重复测量混合模型；SE = 标准误；TPE = 治疗-政策被估量。 ●HbA1c达标患者比例显著更高研究结果显示，第28周时，玛仕度肽4mg或6mg组HbA1c<7.0%以及HbA1c≤6.5%的受试者比例显著高于度拉糖肽1.5mg组（图2）。图2 第28周达到HbA1c<7.0%及HbA1c<6.5%的受试者比例通过合并插补数据集中达到目标的受试者百分比计算百分比，mITT人群。 *标称P < 0.05，**标称P < 0.01，***标称P < 0.0001，与度拉糖肽1.5mg相比。†P < 0.05，††P < 0.01，对于相对于度拉糖肽1.5mg的优效性，控制 I 类错误。mITT = 调整意向治疗。 ●空腹血糖降低显著更多研究结果显示，基于疗效估计目标，第28周时，玛仕度肽4mg组和6mg组空腹血糖（FPG）水平较基线平均分别降低2.03mmol/L和2.19mmol/L，均优效于度拉糖肽1.5mg组（1.71mmol/L）（P值均＜0.05）（图3）。图3 治疗28周时各组FPG变化情况来自ANCOVA（TPE）或MMRM（疗效被估量）分析。mITT人群。数据为 LS 均值，误差线代表SE。*标称P < 0.05，**标称P < 0.01，与度拉糖肽1.5mg相比。ANCOVA = 协方差分析；FPG = 空腹血糖；LS = 最小二乘；mITT = 改良的意向治疗；MMRM = 重复测量混合模型；SE = 标准误；TPE = 治疗-政策被估量。 ●减重幅度和减重患者比例显著更大基于疗效估计目标，第28周时，玛仕度肽4mg组和6mg组的减重疗效呈剂量依赖性，体重较基线平均降幅分别为7.13%和9.24%，均优效于度拉糖肽1.5mg组（2.86%）（P值均＜0.0001）（图4）。与度拉糖肽1.5mg组相比，第28周时玛仕度肽组达到体重减轻≥5%和≥10%的患者更多。此外，在第28周时HbA1c<7.0%且体重减轻≥5%的受试者比例方面，玛仕度肽4mg和6mg均优于度拉糖肽（P值均<0.0001）。图4 治疗28周时各组体重变化情况通过合并插补数据集中达到目标的受试者百分比计算百分比，mITT人群。***标称P < 0.0001，与度拉糖肽1.5mg相比。†††P < 0.0001，与度拉糖肽1.5mg相比的优效性，控制 I 类错误。mITT = 调整意向治疗。 DREAMS-2研究过程中，观察到玛仕度肽的耐受性良好，治疗中导致治疗中止的不良事件（TEAE）发生率较低。最常报告的胃肠道不良事件为腹泻、恶心和呕吐。 DREAMS-2研究表明，在口服降糖药控制不佳的中国T2DM患者中，玛仕度肽4mg和6mg治疗28周后，表现出良好的降糖和减重疗效，且均优于度拉糖肽1.5mg。该结果支持了玛仕度肽在口服降糖药物疗效不佳的T2DM患者中的临床应用价值。玛仕度肽有望明年在华上市，获批降糖和减重双适应症。相信玛仕度肽在中国超重/肥胖及T2DM患者中具有良好的临床应用前景。专家简介郭立新教授 ●医学博士、二级教授、主任医师 ●北京医院内分泌科首席专家，博士研究生导师，博士后导师 ●中华医学会糖尿病学分会候任主任委员 ●北京医师协会内分泌分会会长 ●北京医学会常务理事 ●北京医学会糖尿病学分会名誉主任委员参考文献： [1]. Xiong-Fei Pan, et al. Epidemiology and determinants of obesity in China. The Lancet Diabetes and Endocrinology VOLUME 9, ISSUE 6, P373-392, JUNE 01, 2021. 本文旨在为医疗卫生专业人士传递更多医学信息，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，信达不推荐任何未获批的药品/适应症使用。

临床结果临床3期临床2期突破性疗法

2024-09-26

·李氏大药厂

公益直播 | 9月29日(周日）2024年全国痤疮诊疗新进展学术研讨会

为深入贯彻党的二十大精神，落实实施健康中国战略要求，进一步加强和提升我国皮肤病防治事业，拓展和深化皮肤病规范化诊疗工作，以“搭建交流合作平台，促进医师规范化诊疗”为宗旨，聚焦目前皮肤病诊疗的热点及难点，把脉新时期发展大势，助力广大医师服务能力提升，北京整合医学学会将于9月29日晚19:00-21:00举行“2024年全国痤疮诊疗新进展学术研讨会”。李氏大药厂控股有限公司（简称“李氏大药厂”或“集团”，股份编号：00950）邀请您参加本次会议公益直播。北京医院常建民教授和上海交通大学医学院附属仁济医院鞠强教授共同担任会议主席，13位全国各省皮肤领域专家齐聚线上，共话痤疮治疗新篇章。欢迎各位老师扫描下方二维码，在线观看会议直播，共享学术盛宴！关于李氏大药厂 - 亞太地區最具創新力的上市企業 - 李氏大药厂控股有限公司（简称“李氏大药厂”或“集团”, 股份编号: 00950）成立于1994年，是一家结合了研发驱动和市场导向的生物医药集团公司，总部位于香港。李氏大药厂于2002年7月在香港联合交易所（简称：“港交所”）创业板上市，并于2010年5月成功转至港交所主板上市。李氏大药厂在中国大陆拥有两大综合性生产研发基地，即：兆科合肥基地（位于安徽省合肥市高新区）和兆科广州基地（位于广东省广州市南沙区），目前员工总数超过1100人。李氏大药厂立足中国大陆，放眼国际，通过坚实和稳固的投入建设，全面覆盖整合了药物研发、临床研究、药政注册、生产制造、销售与市场推广等各个环节。集团集中于心血管科、妇科与产科、儿科、罕见病、肿瘤科、皮肤科、精神科等多个重要疾病领域开发不同阶段的专利新药和高端仿制药。李氏大药厂与20余家国际公司建立了广泛的合作关系，目前在中国大陆、香港、澳门及台湾地区推广及销售25种包含专利新药、仿制药物及授权引进的国外已上市进口药品。李氏大药厂现有超过40个处于不同开发阶段的产品，既有自主研发产品，也有通过来自美国、欧洲及日本等公司通过授权引进进行研发、生产以及商业化的产品。李氏大药厂的使命是通过提供治疗各种疾病的创新产品，以改善患者健康及提高生活质量，成为亚洲一家成功的生物医药集团。下滑查看更多免责声明：本公众号发布或转载企业宣传资讯，仅供读者参考之用，并不构成收购、购买或认购依据，并不构成任何个人化的投资劝诱或建议。因本公布全部或任何部分内容而产生或因倚赖该等内容而引致的任何损失不承担任何责任。企业文化公共关系部出品图片来源：妇儿皮肤产品事业部排版：樊扬波校对：刘瑛审核：潘甫孟与“李”同行招商热线 020-39062882

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