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随机临床试验结果的概括性,用于控制由腹手术引起的糖尿病
Edward H Livingston1, Hila Zelicha1, Erik P Dutson1
1From the Department of Surgery, UCLA School of Medicine, Los Angeles, CA.
概括
大多数为控制糖尿病而接受减肥手术的患者获得的结果与临床试验中的结果相似. 这项研究表明,关于减肥手术和糖尿病的随机对照试验 (RCT) 的结果很好地概括到现实世界患者群体.
科学领域:
- 代谢手术 代谢手术
- 糖尿病管理 糖尿病管理
- 临床试验的外部有效性
背景情况:
- 随机对照试验 (RCT) 对临床治疗证据至关重要,但可能缺乏现实世界的概括性.
- 随机试验中的参与者特征可能不代表接受治疗的更广泛的患者群体.
- 评估RCT结果对不同患者群体的概括性至关重要.
研究的目的:
- 评估减肥外科手术RCTs关于糖尿病控制的外部有效性.
- 为了比较经过袖子胃切除术的患者的结果与重量减肥手术RCT (STAMPEDE,DSS) 的结果.
主要方法:
- 对比了UCLA袖子胃切除术患者的基线特征,体重变化和糖尿病控制,其中包括STAMPEDE和DSS RCT参与者.
- 分析了符合和不符合RCT资格标准的UCLA患者的结果.
主要成果:
- 在UCLA患者中,只有很小一部分 (17%的STAMPEDE,7.5%的DSS) 符合RCT资格标准,通常是由于年龄,BMI或HbA1c水平.
- 美国加州大学洛杉矶分校的患者体重减轻略低,但糖尿病控制能力与RCT参与者相比相当.
- 不符合RCT条件的患者表现出与符合条件的患者相似的长期糖尿病控制.
结论:
- 尽管主要RCT的资格率较低,但当代队列中的大多数减肥手术患者取得了类似的糖尿病控制结果.
- 结果表明,STAMPEDE和DSSRCT的糖尿病结局可以将其推广到大多数接受糖尿病管理减肥手术的患者中.
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