Lancet Diab & Endo:2型糖尿病初始治疗阿卡波糖不劣于二甲双胍(MARCH研究)

2013-10-22 MedSci MedSci原创

  中日友好医院内分泌科杨文英教授主持的一项研究显示,在中国新诊断的2型糖尿病患者中,阿卡波糖的疗效非劣于二甲双胍。该研究10月18日在线发表于The Lancet Diabetes & Endocrinology杂志,这是一项非劣效研究。    由于二甲双胍的疗效、 安全性和成本效益已被证实,因此目前多家指南将二甲双胍作为治疗2型糖尿病的唯一一线口服降

中日友好医院内分泌科杨文英教授主持的一项研究显示,在中国新诊断的2型糖尿病患者中,阿卡波糖的疗效非劣于二甲双胍。该研究10月18日在线发表于The Lancet Diabetes & Endocrinology 杂志,这是一项非劣效研究。


由于二甲双胍的疗效、 安全性和成本效益已被证实,因此目前多家指南将二甲双胍作为治疗2型糖尿病的唯一一线口服降糖药。然而,关于其在亚洲人群中使用的信息却很少。该研究的目的是将中国广泛使用的α-葡萄糖苷酶抑制剂阿卡波糖,与二甲双胍比较,确定其作为新诊断2型糖尿病初始治疗的疗效。

这是一个48周、随机、开放、非劣效性试验,共有中国的11家研究单位参与,入选了788位新诊断的2型糖尿病患者,平均HbA1c为7.5%。患者先经过4周的洗脱期,进行生活方式改善,然后被分配到二甲双胍或阿卡波糖单药治疗24周作为初始治疗,如果预定的血糖目标未达到,则再加用其他药物治疗24 周。这项研究在中国临床试验注册中心注册,注册号码为ChiCTR-TRC-08000231。
    
在788位患者中,784位患者开始了预定的药物治疗。结果显示,24周时,HbA1c下降幅度在阿卡波糖组为1.17%,在二甲双胍组为1.19%。 48周时,HbA1c下降幅度为1.11%(阿卡波糖)和1.12%(二甲双胍),差异为0.01%(95%CI 0.12到0.14,p=0.8999)。阿卡波糖组中有6位患者(共391位),二甲双胍组中有7位(共393位)发生严重不良事件,发生低血糖事件的 分别有2位和4位。
    
作者认为,这项研究提供了阿卡波糖疗效与二甲双胍相似的证据,因此为中国新诊断2型糖尿病患者的初始治疗提供了一种切实的选择。
    
在同时在线发表于该杂志的述评中,香港中文大学威尔士亲王医院内科及药物治疗学系马青云医生(英译)指出,这项研究为阿卡波糖与二甲双胍相比的疗效与收益提供了宝贵的信息,为制定2型糖尿病的循证和人群特异性治疗指南作出了贡献,迈出了重要的一步。
    
当然,MedSci也认为,在亚洲人群中,高纤维素饮食前提下,阿卡波糖可能有助于抑制餐后血糖的上升,对于始发糖尿病,或糖尿病前期可能具有较好的作用。当然,阿卡波糖能否抑制,甚至逆转胰岛素抵抗,还有待观察。另外,MARCH研究在亚洲人群中能获得较好的疗效(实际上很多临床医生也喜欢使用阿卡波糖),但在欧美人群中可能未必能获益,不同区域人群的饮食习惯存在较大的差异。同时,这是一项开放研究,因此很难避免可能出现的偏倚,因此,对于结果的解读仍然需要持谨慎态度。而且,MARCH研究是为期48周的研究,未来这批患者可能需要继续随访观察,MARCH后效应仍然不容忽视,仍然需要评价两种药物长期使用给患者带来的获益与风险,期待后续更长时间的观察和研究。

    
原始出处:
    
1. Acarbose compared with metformin as initial therapy in patients with newly diagnosed type 2 diabetes: an open-label, non-inferiority randomised trial. Wenying Yang et al. The Lancet Diabetes & Endocrinology 18 October 2013(Article in Press DOI: 10.1016/S2213-8587(13)70021-4)

2. Acarbose: an alternative to metformin for first-line treatment in type 2 diabetes? Ronald CW Ma. The Lancet Diabetes & Endocrinology 18 October 2013(Article in Press DOI: 10.1016/S2213-8587(13)70107-4)

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    2014-06-11 howi
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    2013-10-22 lovetcm

    MARCH研究做得不错,不过可能只合适亚洲人群。

    0

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EASD 2013:糖尿病病程长的肥胖患者抑郁风险高

2型糖尿病患者中抑郁症非常常见,人儿不同的研究显示2型糖尿病患者抑郁症危险因素不同。需要系统性的多因素分析研究糖尿病患者所有影响抑郁的尺度因素。为了寻找中国2型糖尿病患者抑郁的危险因素,来自东南大学中大医院孙子林教授及其团队进行了一项研究,该研究发现应给予肥胖和糖尿病足病患者的抑郁症状更多关注,特别是糖尿病病程长的女性患者。该研究结果发表在2013年EASD会议上。【原文下载】 该研究中,从20

Diabetes Care:基线HbA1c和β-细胞功能可预测T2DM

糖耐量受损(IGT)个体发生2型糖尿病(T2DM)的风险较高。为了检查可预测T2DM发生的基线特征,来自德克萨斯糖尿病研究所的Defronzo博士等进行了一项研究。结果表明,基线时仅HbA1c和β-细胞功能能够预测糖尿病的发生。研究结果发表于2013年9月23日的美国《糖尿病治疗》(Diabetes Care)杂志上。【原文下载】 研究对象为228名ACT NOW研究中经安慰剂治疗的高危IGT受

Nat Commun:研究发现蛋白Ecscr与代谢疾病有关

本期Nature Communications上发表的一篇论文报告说,蛋白Ecscr的删除增强胰岛素敏感性,防止采用高脂肪饮食的小鼠患肥胖症。这项工作表明,这一蛋白的失活对于2-型糖尿病及与肥胖相关的代谢疾病的控制可能具有治疗潜力。 胰岛素抗性与肥胖密切相关,是2-型糖尿病的最早症状之一。内皮细胞(ECs)已知与胰岛素抗性的产生有关,而现在Koji Ikeda及同事发现,Ecscr(一种调控EC

陆树良:重视糖尿病皮肤组织的“隐形损害”

在近日召开的2013年中国糖尿病足及相关疾病论坛上,上海交通大学医学院附属瑞金医院上海市烧伤研究所陆树良教授发表了题为《糖尿病皮肤组织的“隐形损害”现象》的报告。 糖尿病皮肤组织损伤在未损伤、组织结构完整性未遭到破坏的情况下,已经存在着组织学和细胞生物学行为的改变,我们将这一糖尿病皮肤的异常改变称为“隐性损害”。这一“隐形损害”现象可能是糖尿病皮肤易损或创面形成后难以