Use of insulin glargine during pregnancy: a case-control pilot study

OBJECTIVE: To determine whether the use of insulin glargine during pregnancy is associated with an increase in the incidence of fetal macrosomia or adverse neonatal outcome. DESIGN: A matched case-control study. SETTING: Women's Centre, John Radcliffe Hospital, Oxford, UK. SAMPLE: Sixty-four pregnant women treated with insulin during their pregnancies, 20 with type I diabetes and 44 with gestational diabetes. METHODS: Two groups of women were compared in matched pairs. A study group of 32 pregnant women with diabetes treated with insulin glargine during their pregnancy and a control group of 32 pregnant women treated with an intermediate-acting human insulin (isophane or insulin zinc suspension) and matched for weight at booking, height, gestation at delivery, parity, fetal sex, duration of insulin use in pregnancy and glycaemic control during the third trimester of pregnancy (glycosylated haemoglobin [HbA(1c)] concentration and mean blood glucose concentration). MAIN OUTCOME MEASURES: Birthweight, centile birthweight, the incidence of fetal macrosomia (birthweight > 90th percentile) and neonatal morbidity in the two study groups. RESULTS: There was no significant difference between the birthweight or centile birthweight of babies born to the women treated with insulin glargine during pregnancy and that of the babies born to those in the control group treated with intermediate-acting human insulin. The overall incidence of fetal macrosomia was 12/32 (37.5%) in the insulin glargine group and 13/32 (40.6%) in the control group. There was no significant difference in neonatal morbidity between the groups. CONCLUSIONS: The results of this pilot study indicate that insulin glargine treatment during pregnancy does not appear to be associated with increased fetal macrosomia or neonatal morbidity.     

高健美延缓衰老的临床研究

目的 观察增龄对人血清中甲状腺激素（ＴＨ）、胰岛素样生长因子－１（ＩＧＦ－１）及脱氢表雄酮（ＤＨＥＡ）变化及用高健美治疗老年人后甲状腺功能（甲功）、ＩＧＦ－１、ＤＨＥＡ和肾虚衰老症状的改变。方法 从健康体检的人群中,选择５０例属于肾虚衰老的老年人作为治疗组,选择老年前期及青壮年期各３０例作为对照组,分别检测甲功（ＴＴ３、ＴＴ４、ＦＴ３、ＦＴ４）,ＩＧＦ－１、ＤＨＥＡ、肝功能及心电图;对治疗组用小剂     

甘精胰岛素联合口服降糖药治疗2型糖尿病磺脲类继发性失效临床观察

目的：探讨甘精胰岛素联合口服降糖药物（拜糖苹或二甲双胍）治疗继发性磺脲类药物失效的2型糖尿病的短期疗效。方法：46例继发性磺脲类药物失效的2型糖尿病患者随机分成两组，A组使用甘精胰岛素加拜糖苹或二甲双胍，B组使用中效胰岛素加拜糖苹或二甲双胍。所有患者均于治疗前、治疗后12周测定空腹血糖（FBG）、餐后2h血糖（2hBG）、糖化血红蛋白（HbAte）。结果：两组治疗3个月后，FBG、2hBG、HbA。。均较治疗前明显降低，对于空腹血糖的控制A组明显优于B组，有统计学意义（P＜0．05），且A组低血糖发生率明显低于B组（P＜0．05）。结论：甘精胰岛素联合口服降糖药治疗继发性磺脲类药物失效的2型糖尿病患者，可以良好地控制高血糖，且低血糖发生率低，安全而有效。     

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。