Lancet:胖子的福音!新型胰高血糖素样肽-1类似物索马鲁肽可长期用于减肥

2018-08-17 MedSci MedSci原创

肥胖已成为主要的公共健康问题,急需新的药物来控制体重。现有研究人员对胰高血糖素样肽-1(GLP-1)类似物索马鲁肽对比利拉鲁肽和安慰剂在促进减肥方面的有效性和安全性进行评估。研究人员在8个国家的71个医疗点开展一随机化的双盲安慰剂和阳性对照的剂量梯度性的临床2期试验,招募年满18岁的无糖尿病的身体指数(BMI)≥30kg/m2的个体。将受试者按6:1随机分至每个阳性治疗组(索马鲁肽[0.05mg、

肥胖已成为主要的公共健康问题,急需新的药物来控制体重。现有研究人员对胰高血糖素样肽-1(GLP-1)类似物索马鲁肽对比利拉鲁肽和安慰剂在促进减肥方面的有效性和安全性进行评估。

研究人员在8个国家的71个医疗点开展一随机化的双盲安慰剂和阳性对照的剂量梯度性的临床2期试验,招募年满18岁的无糖尿病的身体指数(BMI)≥30kg/m2的个体。将受试者按6:1随机分至每个阳性治疗组(索马鲁肽[0.05mg、0.1mg、0.2mg、0.3mg或0.4mg,起始剂量0.05mg/日,每4周加量]或利拉鲁肽[3.0mg,起始剂量0.6mg/日,每周增加0.6mg])或安慰剂组。给药方式均为皮下注射,1/日。主要评估指标是52周时体重下降百分比。

2015年10月1日-2016年2月11日,共将957位受试者随机分组(每个实验组102-103人、对照组126人)。起始时,平均年龄47岁、体重111.5kg、BMI39.3kg/m2。52周时采集到891(93%)位受试者的体重数据。安慰剂组平均体重减轻-2.3%,索马鲁肽各剂量组的分别是-6.0%(0.05mg)、-8.6%(0.1mg)、-11.6%(0.2mg)-11.2%(0.3mg)和13.8%(0.4mg)。索马鲁肽各剂量组与安慰剂组均存在显著差异(校正前p≤0.0010,校正后p≤0.0055)。索马鲁肽0.2mg及以上剂量组相比利拉鲁肽,平均体重减轻比也均存在显著差异(-13.8%~-11.2% vs -7.8%)。安慰剂组有10%的受试者体重减轻10%及以上,而索马鲁肽0.1mg及以上剂量组体重减轻10%及以上的受试者比例高达37-65%。索马鲁肽各剂量组耐受性均良好,未引发新的安全性问题。最常见的副反应是剂量依赖性肠道反应,主要是恶心(既往GLP-1受体激动剂所有的)。

本研究表明长期应用索马鲁肽可有效减轻体重,并且耐受性良好,可考虑与饮食控制和体育活动联合采用。


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    2019-04-18 howi
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    2018-08-19 hbwxf
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    2018-08-18 owlhealth

    不错耶,学习了

    0

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    2018-08-17 CHANGE

    什么时候有懒人用的减肥神药?

    0

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