| 1 | Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy(STRATEGY):a multicenter,randomized,controlled,non-inferiority clinical trial显示文摘Despite the current guideline's recommendation of a timely stepwise intensification therapy,the 'clinical inertia',termed as the delayed treatment intensification,commonly exists in the real world,which may be partly due to the relatively little substantial evidence and no clear consensus regarding the efficacy and safety of triple oral agents in patients inadequately controlled with dual therapy.In this clinical trial performed in 237 centers in China,5,535 type 2 diabetic patients inadequately controlled by previous therapies were treated with a stable metformin/sitagliptin dual therapy for 20 weeks.The patients who did not reach the glycated hemoglobin A1c(HbA1c) goal were then further randomized into glimepiride,gliclazide,repaglinide,or acarbose group for an additional 24-week triple therapy.A mean HbAlc reduction of 0.85%was observed when sitagliptin was added to the patients inadequately controlled with metformin in 16 weeks.Further HbAlc reductions in the 24-week triple therapy stage were 0.65%in glimepiride group,0.70%in gliclazide group,0.61%in repaglinide group,and 0.45%in acarbose group.The non-inferiority criterion for primary hypotheses was met for gliclazide and repaglinide,but not for acarbose,compared with glimepiride,when added to metformin/sitagliptin dual therapy.The incidences of adverse events(AEs) were 29.2%in the dual therapy stage and30.3%in the triple therapy stage.Metformin/sitagliptin as baseline therapy,with the addition of a third oral antihyperglycemic agent,including glimepiride,gliclazide,repaglinide,or acarbose,was effective,safe and well-tolerated for achieving an HbAlc<7.0%goal in type 2 diabetic patients inadequately controlled with previous therapies.The timely augmentation of up to three oral antihyperglycemic agents is valid and of important clinical benefit to prevent patients from exposure to unnecessarily prolonged hyperglycemia. | Wen Xu Yiming Mu Jiajun Zhao Dalong Zhu Qiuhe Ji Zhiguang Zhou Bin Yao Anhua Mao Samuel S.Engel Bin Zhao Yan Bi Longyi Zeng Xingwu Ran Juming Lu Linong Ji Wenying Yang Weiping Jia Jianping Weng | 2017 | Science China(Life Sciences)2017，60，3： | 19 |
| 2 | 以二甲双胍和西格列汀为基础的三联降糖药物治疗的有效性和安全性:一项多中心、随机对照、非劣效临床研究(STRATEGY)显示文摘尽管目前指南推荐对糖尿病应该及时进行阶梯式强化治疗,但'临床惰性',即强化治疗的延迟在真实世界中仍普遍存在.这种情况出现的原因可能部分在于缺乏在二联治疗控制不佳的患者中添加第三联口服降糖药物治疗有效性及安全性的坚实证据及对此清晰的共识.本临床研究在中国237个研究中心进行,包括5535位既往治疗控制不佳的2型糖尿病患者.这些患者在接受稳定剂量的二甲双胍与西格列汀二联治疗20周后,糖化血红蛋白A1c(HbA1c)未达标的患者进一步随机接受格列美脲、格列齐特、瑞格列奈或阿卡波糖三联治疗24周.二甲双胍控制不佳的患者加用西格列汀治疗16周后,HbA1c平均下降0.85%.在24周的三联治疗阶段,HbA1c在各组分别进一步下降0.65%(格列美脲组),0.70%(格列齐特组),0.61%(瑞格列奈组)和0.45%(阿卡波糖组).二甲双胍/西格列汀二联治疗加用格列齐特或瑞格列奈治疗后,降糖疗效非劣效于加用格列美脲组的主要研究假设达到,但加用阿卡波糖组与加用格列美脲组相比未达到非劣效.不良事件(AE)的发生率在二联治疗阶段为29.2%,三联治疗阶段为30.3%.在既往降糖药物治疗不达标的患者中,以二甲双胍/西格列汀联合治疗为基础,加用包括格列美脲、格列齐特、瑞格列奈或阿卡波糖在内的第三联药物可使患者有效、安全达到HbA1c<7.0%的目标,且耐受性良好.及时启动二联及三联口服降糖药物治疗有效且有重要临床意义,可避免患者长期暴露于不必要的高血糖状态. | 许雯 母义明 赵家军 朱大龙 姬秋和 周智广 姚斌 毛安华 Samuel S.Engel 赵彬 毕艳 曾龙驿 冉兴无 陆菊明 纪立农 杨文英 贾伟平 翁建平 | 2017 | 中国科学:生命科学2017，47，3： | 11 |
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