甘精胰岛素300 U/ml与100 U/ml治疗中国2型糖尿病患者疗效和安全性的比较

目的比较甘精胰岛素300 U/ml(Gla-300)与100 U/ml(Gla-100)治疗非胰岛素类降糖药血糖控制不佳中国T2DM患者的疗效和安全性。方法本研究为EDITION AP(NCT02855684)中国亚组分析,在这项开放标签、随机对照的临床试验中,非Ins类降糖药物血糖控制不佳的474例中国T2DM患者按2:1比例随机予Gla-300(n=315)或Gla-100(n=159)治疗,观察两组26周时的疗效和安全性指标。结果两组自基线至治疗26周时HbA1c降幅的最小二乘均值差为0.05%,达到非劣效性评估终点。26周治疗期间,Gla-300组发生至少1次重度和/或证实夜间低血糖患者比例低于Gla-100组(31.5%vs 42.0%,P=0.03)。两组其余疗效和安全性指标差异无统计学意义。结论Gla-300治疗26周降低HbA1c效果与Gla-100相似,发生夜间低血糖风险更低。     

Optimum management of type 2 diabetes – timely introduction, optimization and intensification of basal insulin

The natural progression of type 2 diabetes mellitus (T2DM) requires continuing medical care, early insulin intensification and patient self-management education to reduce the risk of long-term complications, including microvascular and macrovascular complications. However, too few people are on insulin, and all too commonly have poor glycaemic control. This paradigm significantly increases the risk for long-term complications. It is becoming increasingly apparent that the early introduction of basal insulin, such as insulin glargine, is essential to provide clinically important improvements in glycaemic control. In this review, we discuss the rationale for the earlier insulinization in T2DM in order to reach and maintain treatment targets and to provide further support for the recent American Diabetes Association and European Association for the Study of Diabetes consensus statement.     

Perinatal outcomes associated with the use of glargine during pregnancy

Aims Insulin glargine (IG), with its non‐peaking action profile, might be useful in diabetic pregnancy. However, data on its safety are limited and its use during pregnancy is not recommended. This study focused on the effects of IG on perinatal outcome, particularly to estimate the rate of congenital anomalies and birthweight. Methods This retrospective study included women with pre‐gestational diabetes who used IG before (at least 1 month) and during pregnancy. For all women we recorded data regarding maternal glycaemic control and pregnancy outcome. We also compared women treated with IG throughout pregnancy and women who stopped taking IG at an earlier stage. Results From 27 centres, 107 Type 1 diabetic pregnancies were identified. IG was started 10.3 ± 6.9 months before conception and in 57.4% of cases was stopped during the first trimester; 42.6% of women continued using it until the end of pregnancy. There were six abortions (four spontaneous and two induced) and five newborns (4.9%) with congenital anomalies. Glycaemic control, birthweight and the prevalence of macrosomia and neonatal morbidity were similar in women who used IG for the full term compared with those who stopped IG earlier during pregnancy. Conclusions This study, although limited, suggests that IG is safe and effective; the rate of congenital malformations was within the range expected for diabetic pregnancies treated with more traditional forms of insulin. IG used throughout pregnancy did not seem to influence birthweight or increase adverse outcomes.     

阿卡波糖联合甘精胰岛素治疗2型糖尿病效果的Meta分析

目的:系统评价阿卡波糖联合甘精胰岛素治疗2型糖尿病的效果。方法:系统检索PubMed、EMbase、Web of Science、中国知网、万方、维普、中国生物医学文献数据库中关于使用阿卡波糖联合甘精胰岛素治疗2型糖尿病病人的随机对照试验,检索时间为建库至2020年4月1日。按照纳入及排除标准筛选文献、提取资料并评价纳入文献的方法学质量。采用RevMan 5.3进行Meta分析。结果:共纳入21项研究,Meta分析结果显示:阿卡波糖联合甘精胰岛素可以降低2型糖尿病病人空腹血糖[MD=-0.98,95%CI(-1.27,-0.70),P<0.00001]、餐后2 h血糖[MD=-1.10,95%CI(-1.47,-0.72),P<0.00001]及糖化血红蛋白[SMD=-0.97,95%CI(-1.30,-0.65),P<0.00001]。结论:现有证据表明阿卡波糖联合甘精胰岛素可降低2型糖尿病病人空腹血糖、餐后2 h血糖及糖化血红蛋白。     

黄葵胶囊联合甘精胰岛素治疗糖尿病肾病的疗效

目的：探讨黄葵胶囊联合甘精胰岛素治疗糖尿病肾病的疗效及对患者血尿素氮、血肌酐和尿白蛋白排泄率水平的影响。方法：选取糖尿病肾病患者76例为研究对象,采用抽签方式分为对照组和治疗组,各38例。对照组给予甘精胰岛素治疗,治疗组在对照组基础上口服黄葵胶囊治疗,对比两组临床疗效,治疗前后血糖、肾功能水平和不良反应发生情况。结果：治疗组治疗总有效率明显高于对照组（P＜0.05）;两组空腹血糖、餐后2 h血糖和糖化血红蛋白水平较治疗前显著降低,且治疗组降低程度显著大于对照组（P＜0.05）;两组血尿素氮、血肌酐和尿白蛋白排泄率水平较治疗前明显降低,且治疗组降低程度大于对照组（P＜0.05）;两组不良反应发生情况比较,差异无统计学意义（P＞0.05）。结论：采用黄葵胶囊联合甘精胰岛素治疗糖尿病肾病患者效果显著,能够较好维持患者血糖水平,改善患者肾功能。     

甘精胰岛素治疗糖尿病的卫生经济学评价

糖尿病及其慢性并发症不仅严重影响患者的健康,同时给患者、社会和政府都带来巨大的经济负担。甘精胰岛素是胰岛素的类似物,可以使患者在获得较好血糖控制的同时较少发生低血糖反应,但其价格相对较高。本文总结了有关甘精胰岛素治疗的药品经济学评价结果。研究显示,与中效胰岛素或者其他常用治疗方案相比,甘精胰岛素治疗的患者可因低血糖反应减少和相关住院减少等原因降低部分近期治疗成本,长期治疗因慢性并发症减少而具有较高的成本—效益比。     

甘精胰岛素对体外培养的人脂肪细胞脂肪因子分泌及脂质合成与分解的影响

目的 探讨甘精胰岛素对体外培养的人脂肪细胞脂肪因子分泌及脂质合成与分解的影响.方法 原代培养人皮下前脂肪细胞,采用不同浓度的甘精胰岛素（20、200、500、1 000、1 500nmol/L）干预其分化过程,酶联免疫吸附法检测分化过程中肿瘤坏死因子α（TNF-α）、瘦素、脂联素、视黄醇结合蛋白4（RBP4）的分泌情况,比色法检测细胞内甘油三酯（TG）合成及培养基中甘油的释放量,实时定量聚合酶链反应（RT-PCR）检测脂肪分化标志基因：过氧化物酶体增殖物活化受体γ（PPAR-γ）、CCAAT促进结合蛋白α（C/EBPα）以及脂联素、RBP4、脂质代谢基因脂肪细胞脂肪酸结合蛋白（aP2）、激素敏感性酯酶（LPL）转录情况.组内比较采用配对t检验,组间比较采用.结果（1）人脂肪组织可分离出前脂肪细胞,并诱导分化为成熟的脂肪细胞,随着细胞的分化成熟,TNF-α、瘦素、脂联素、RBP4的分泌逐渐增加.（2）随着细胞的分化,细胞内TG含量逐渐增加,分化第15天时达峰值[（12.16±0.19）比（0.02 ±0.00） mmol·L-1·g-1,t=11.20,P＜0.001];培养基中甘油含量与甘精胰岛素浓度呈正相关,1 500比500nmol/L组增高[21 d：（961±15）比（611±10） μmol/L,t =3.70,P＜0.01],与分化时间无关.（3）RT-PCR结果：PPAR-γ、C/EBPα、脂联素、RBP4、aP2、LPL基因转录水平随着分化时间的延长逐渐增加,在第15 ～21天达峰值,与分化前比较,差异均有统计学意义（均P＜0.01）.结论 甘精胰岛素可诱导体外培养的人前脂肪细胞的分化,促进多种脂肪细胞因子的分泌,中低浓度促进脂质合成,高浓度可诱导脂质分解.