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ADA:新诊断2型糖尿病患者宜初始接受三联治疗

2013-06-27 伊文 EGMN

  美国糖尿病学会(ADA)2013年会上报告的一项为期2年的随机试验证实,新诊断2型糖尿病患者初始即接受二甲双胍、吡格列酮及艾塞那肽三联治疗,优于指南推荐的二甲双胍、磺酰脲类及基础胰岛素序贯添加治疗。   德克萨斯大学医学部的Muhammad A. Abdul-Ghani博士报告称,与常规治疗组患者相比,三联治疗组患者的糖化血红蛋白A1c(HbA1c)下降幅度更大、

  美国糖尿病学会(ADA)2013年会上报告的一项为期2年的随机试验证实,新诊断2型糖尿病患者初始即接受二甲双胍、吡格列酮及艾塞那肽三联治疗,优于指南推荐的二甲双胍、磺酰脲类及基础胰岛素序贯添加治疗。

  德克萨斯大学医学部的Muhammad A. Abdul-Ghani博士报告称,与常规治疗组患者相比,三联治疗组患者的糖化血红蛋白A1c(HbA1c)下降幅度更大、持续时间更长,并且低血糖风险更低。此外,三联治疗组患者的体重有所减轻,而常规治疗组患者则出现了体重增加。

  Abdul-Ghani博士指出,初始三联治疗效果与安全性俱佳的研究结果表明,胰岛素抵抗和β细胞进行性衰竭是引起高血糖和2型糖尿病的关键代谢缺陷,针对这2个靶点的治疗策略优于仅专注于降低血糖。“这项研究带给我们的关键信息是,当你治疗2型糖尿病患者时,应当治疗的是病——糖尿病,而不是高血糖症状。”

  这项开放标记研究纳入了155例近期被诊断为2型糖尿病的患者,其平均年龄为47岁,平均体重指数为30.5 kg/m2,平均基线HbA1c为8.6%。三联治疗组患者初始接受二甲双胍1,000 mg/d+吡格列酮15 mg/d+艾塞那肽5 mcg、2次/d治疗。1个月后这3种药物的剂量均加倍。如果治疗3个月仍未达到HbA1c<6.5%的治疗目标,可将吡格列酮剂量增至45 mg/d。常规治疗组患者初始接受二甲双胍治疗,之后按需序贯添加吡格列酮和基础胰岛素,以使HbA1c降至6.5%以下。

  该研究的主要终点是2年时HbA1c组间差异。结果显示,三联治疗组的平均HbA1c由基线时的8.6%降至6%,显著优于常规治疗组(降至6.6%)。两组患者的中位HbA1c分别为5.8%和6.4%。三联治疗组有60%的患者HbA1c<6%,而这类患者在常规治疗组中仅占27%。两组分别有92%和72%的患者达到了ADA提出的HbA1c<7%的治疗目标。

  受试者每3个月到医院接受1次随访。治疗失败定义为连续2次随访测得的HbA1c均高于6.5%,结果三联治疗组和常规治疗组分别有17%和42%的患者治疗失败。

  尽管三联治疗组的平均HbA1c比常规治疗组低0.5%,但在2年研究过程中,三联治疗组发生的低血糖却更少:15% vs. 46%。三联治疗组患者的体重平均降低了1.2 kg,而常规治疗组患者平均增重4.1 kg。

  多变量回归分析显示,三联治疗与治疗失败风险降低84%有关。年龄较大也是一项保护性因素:从40岁开始,年龄每增加10岁,治疗失败风险即降低64%。“我们尚不清楚年龄与治疗失败风险的关联机制,或许是由于老年人的治疗依从性更好,也可能与糖尿病的病理生理学机制有关。”

  研究者之所以在将二甲双胍选入三联治疗,是因为该药可纠正肝脏内的胰岛素抵抗;选择吡格列酮是由于该药可纠正脂肪细胞和肌肉中的胰岛素抵抗,并能保存β细胞功能;艾塞那肽的入选是因为它能增强β细胞功能。

  与会者的质疑和研究者的答复

  这项研究并未使在场的所有人信服,一些与会者指出,尽管这项研究试图推翻基于指南的临床实践,但仅从单中心招募不足200例患者显然力度不够。

  Abdul-Ghani博士在接受采访时表示,他与同事正在争取开展一项更大规模的多中心随访研究,微血管并发症将是这项研究的主要终点。“每种新方法在刚问世时都会引起争议。但是,假如我们观察到的HbA1c差异能够维持超过24个月,就可能引起微血管并发症风险的显著降低。那样一来,初始三联治疗将会改变2型糖尿病治疗的游戏规则。”

  Abdul-Ghani博士还补充道,尽管缺乏有关视网膜病变和其他微血管并发症减少的数据,他仍然强烈建议临床医生对新诊断2型糖尿病患者采取初始三联治疗。“我们的数据太有力了:在不增加风险的同时可以带来如此之多的益处。”他指出,二甲双胍和吡格列酮均有廉价的仿制药可供选用,在有多种GLP-1激动剂正处于研发通道中的情况下,相对较老、需每日给药2次的艾塞那肽的价格还可能进一步下降。

  这项研究由美国糖尿病学会资助,并获得了Amylin制药和武田制药的支持。Abdul-Ghani博士报告称无相关利益冲突。



    

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    2013-07-24 rgjl
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    2013-06-29 般若傻瓜
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