摘要

Experimental studies have suggested that dipeptidyl peptidase-4 (DPP-4) inhibitors provide cardiovascular protective effects. We performed a randomized study to evaluate the effects of sitagliptin added on to the conventional therapy compared with conventional therapy alone (diet, exercise, and/or drugs, except for incretin-related agents) on the intima-media thickness (IMT) of the carotid artery, a surrogate marker for the evaluation of atherosclerotic cardiovascular disease, in people with type 2 diabetes mellitus (T2DM).We used a multicenter PROBE (prospective, randomized, open label, blinded endpoint) design. Individuals aged ≥30 y with T2DM (6.2% ≤ HbA1c < 9.4%) were randomly allocated to receive either sitagliptin (25 to 100 mg/d) or conventional therapy. Carotid ultrasound was performed at participating medical centers, and all parameters were measured in a core laboratory. Of the 463 enrolled participants with T2DM, 442 were included in the primary analysis (sitagliptin group, 222; conventional therapy group, 220). Estimated mean (± standard error) common carotid artery IMT at 24 mo of follow-up in the sitagliptin and conventional therapy groups was 0.827 ± 0.007 mm and 0.837 ± 0.007 mm, respectively, with a mean difference of -0.009 mm (97.2% CI -0.028 to 0.011, p = 0.309). HbA1c level at 24 mo was significantly lower with sitagliptin than with conventional therapy (6.56% ± 0.05% versus 6.72% ± 0.05%, p = 0.008; group mean difference -0.159, 95% CI -0.278 to -0.041). Episodes of serious hypoglycemia were recorded only in the conventional therapy group, and the rate of other adverse events was not different between the two groups. As it was not a placebo-controlled trial and carotid IMT was measured as a surrogate marker of atherosclerosis, there were some limitations of interpretation.In the PROLOGUE study, there was no evidence that treatment with sitagliptin had an additional effect on the progression of carotid IMT in participants with T2DM beyond that achieved with conventional treatment.University Hospital Medical Information Network Clinical Trials Registry UMIN000004490.

译文

实验研究表明二肽基 peptidase-4 (DPP-4) 抑制剂具有心血管保护作用。我们进行了一项随机研究,以评估在常规治疗中添加西格列汀与单独常规治疗 (饮食、锻炼和/或药物,除了肠促胰岛素相关药物) 相比的效果颈动脉内中膜厚度 (IMT),评价动脉粥样硬化性心血管疾病的替代标志物,在 2 型糖尿病患者中。我们使用了多中心探针 (前瞻性、随机、开放标签、盲终点) 设计。年龄 ≥ 30 岁的 2 型糖尿病患者 (6.2% ≤ HbA1c <9.4%) 被随机分配接受西格列汀 (25 ~ 100 mg/d) 或常规治疗。在参与的医疗中心进行颈动脉超声检查,并在核心实验室测量所有参数。在 463 名登记的 2 型糖尿病参与者中,442 人被纳入主要分析 (西格列汀组,222; 常规治疗组,220)。在西格列汀和常规治疗组中,随访 24 个月时颈总动脉 IMT 的估计平均值 (± 标准误差) 分别为 0.827 ± 0.007毫米和 0.837 ± 0.007毫米, 平均差异为-0.009毫米 (97.2% CI-0.028 至 0.011,p = 0.309)。西格列汀在 24 个月的 HbA1c 水平明显低于常规治疗 (6.56% ± 0.05% 对 6.72% ± 0.05%,p = 0.008; 组平均差异-0.159, 95% CI-0.278 至-0.041)。仅在常规治疗组中记录严重低血糖发作,其他不良事件发生率在两组之间无差异。由于这不是一个安慰剂对照试验,并且颈动脉内膜厚度被测量为动脉粥样硬化的替代指标,解释有一些局限性。在序言研究中,没有证据表明西格列汀治疗对 2 型糖尿病参与者的颈动脉 IMT 的进展有超出常规治疗的额外影响。大学医院医学信息网络临床试验登记 umin000004490。

Sitagliptin

内分泌 内分泌 治疗药物
概述  :  

西格列汀是一种口服药物,可降低2型糖尿病患者的血糖水平。西格列汀被认为是除饮食和运动降糖以外的辅助手段。西格列汀不宜用于1型糖尿病患者或用于治疗糖尿病酮症酸中毒,因为在这些情况下无效。西格列汀尚未在有胰腺炎史的患者中研究,尚不清楚有胰腺炎病史的患者在使用西格列汀时是否有增加罹患胰腺炎的风险。不良反应①上市后已有急性胰腺炎的报道,包括致命性和非致命性出血性或坏死性胰腺炎。如果怀疑是胰腺炎,请立即停用西格列汀。②上市后有急性肾功能衰竭的报告,对于中度或重度肾功能不全的患者以及ESRD患者,建议调

Sitagliptin  

释    义   西格列汀(糖尿病类治疗药物名称)

例    句   Conclusion The sitagliptin can improve the insulin resistance situation in type 2 diabetes patients. 结论西格列汀可改善2型糖尿病患者胰岛素抵抗水平。

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