胰岛素:系统回顾的长效胰岛素类似物。

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王F, Carabino JM,范盖拉CM

胰岛素:系统回顾的长效胰岛素类似物。

其他。2003年6月,25(6):1541 - 77,1539 - 40的讨论。

PubMed ID
12860485 (在PubMed
]
文摘

背景:胰岛素是第一个长效基础胰岛素类似物显示皮下政府一旦成人每日睡前1型或2型糖尿病和儿科患者年龄> = 6年1型糖尿病。它在结构上不同于本土人类胰岛素3氨基酸,结构修改提供行动的延迟性和一个常数,peakless效果的持续时间至少24小时。目的:本文的目的是帮助确定当前在胰岛素治疗检查所有可用的疗效和耐受性以来公布的数据引入到市场上。方法:相关英文文章被确定通过搜索MEDLINE, PubMed和EMBASE从1966年到2002年10月到2002年11月PREMED必威国际appLINE。是胰岛素必威国际app使用的搜索词,类似物,类似物,糖尿病,甘精,HOE901,锄头- 901、有效性、安全性,比较研究,治疗结果和案例报告。确定文章的引用列表寻找额外的相关出版物。必威国际app药代动力学和药效学数据进行了综述和总结。所有的大型临床试验患者(> = 100)评估胰岛素的疗效和耐受性1型或2型糖尿病患者中评估。研究的设计相比,主要和次要疗效参数(糖化血红蛋白(HbA (1 c)),空腹血浆葡萄糖(台塑)和/或空腹血糖(FBG)水平,低血糖的发生率),和耐受性评估。结果:14试验符合入选标准综述,其中7只以抽象的形式出版。 All were multicenter, randomized, open-label, parallel-group trials conducted in Europe or the United States, and ranged in duration from 4 to 52 weeks. They compared insulin glargine with neutral protamine Hagedorn (NPH) insulin given once or twice daily in >5000 patients with type 1 or type 2 diabetes, or in insulin-naive patients with type 2 diabetes that was poorly controlled by oral antidiabetic agents. Insulin doses were individually titrated to achieve a target FBG level < or =120 mg/dL (6.7 mmol/L). The studies were typically statistically underpowered to detect a significant difference in HbA(1c) between treatment groups; only 3 trials were of an adequate size to have 90% statistical power to detect a mean 0.5% difference in HbA(1c). Furthermore, analysis of the data from these trials was associated with a number of methodologic problems relating to inconsistencies in reporting. Given these limitations, the available data suggest that insulin glargine treatment produces statistically significant reductions in FPG or FBG levels at end point both compared with baseline and compared with NPH insulin (P < 0.001) without achieving overall significant improvements in HbA(1c) values. However, a recent abstract of a small 52-week trial in patients with type 1 diabetes reported a 0.4% additional decrease in HbA(1c) with insulin glargine treatment compared with NPH insulin. Patients have reported greater treatment satisfaction with insulin glargine compared with NPH insulin. The findings varied regarding weight gain, overall incidence of hypoglycemia, and incidence of nocturnal hypoglycemia. Currently, the cost of insulin glargine is twice that of NPH insulin on a per-unit basis. CONCLUSIONS: As a basal insulin replacement, insulin glargine administered once daily demonstrates a steady time-action profile over 24 hours without a pronounced peak. Based on the evidence from published clinical trials, insulin glargine appears to have equal clinical efficacy to NPH insulin, produces similar reductions in HbA(1c), and is associated with lower FPG and FBG levels and a consistent and significant reduction in the incidence of nocturnal hypoglycemia in patients with type 2 diabetes.

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