磺酰脲类药物合用马来酸罗格列酮治疗2型糖尿病的有效性和安全性观察——随机、双盲、对照、平行、多中心临床试验被引量：36

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摘要背景本试验是中国患者在服用磺酰脲类药物的基础上,加服马来酸罗格列酮治疗2型糖尿病的首次大型临床试验。方法患者在服用磺酰脲类药物基础上,随机接受马来酸罗格列酮4mg(2mgbid)或8mg(4 mg bid)或安慰剂对照治疗24周。其中,34％患者合并使用格列苯脲,25％的患者合并使用格列吡嗪。治疗24周后,观察患者HbA_(1c)、空腹血浆血糖(FPC)和血浆胰岛素浓度的变化情况。结果530例患者随机进入治疗(平均年龄为59岁,其中45％患者为男性,55％患者为女性),105人进入磺酰脲类药物合用安慰剂组(安慰剂组),215人进入罗格列酮4mg合用磺酰脲类药物组(R4+su组),210人进入罗格列酮8mg合用磺酰脲类药物治疗组(R8+SU组)。与安慰剂组对照相比,R4+SU组和R8+SU组平均HbA_(1c)值分别下降1.04％和1.44％(均P<0.001),FPG分别下降1.2mmol/L和2.0mmol/L(均P<0.001)。R4+SU组和R8+SU组治疗24周后,血中胰岛素水平较基线值分别下降23.3pmol/L和30.4pmol/L(均P<0.001)。尽管本试验入选人群中56％患者基线时的肝炎血清学检查结果为阳性,但试验中无明显肝毒性反应。血常规、血生化及心电图各项观察指标均无明显改变。结论罗格列酮合用磺酰脲类药物能明显改善中国2型糖尿病患者的血糖控制水平。乙型和丙型肝炎血清学阳性的患者。

作者朱禧星潘长玉李光伟史虹莉田慧杨文英姜晶孙晓春 C.DAVIES 王梅周永浩

机构地区上海复旦大学附属华山医院北京中国人民解放军总医院北京中日友好医院 GlaxSmithKline Asia-Pacific and China Singapore GlaxSmithKline Asia-Pacific and China Singapore GlaxSmithKline

出处《中华内分泌代谢杂志》 CAS CSCD 北大核心 2003年第3期U001-U006,共6页 Chinese Journal of Endocrinology and Metabolism

关键词 2型糖尿病磺酰脲类药物马来酸罗格列酮治疗临床试验

分类号 R587.1 [医药卫生—内分泌] R977.15 [医药卫生—药品]

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