格列齐特片(Ⅱ)含量测定检验方法的改进

目的:改进格列齐特片(Ⅱ)含量测定方法。方法:改变供试品溶液的浓度和溶剂,使主成分能充分溶解。结果:改进后的供试品溶液溶解性好,回收率高,测定结果更为可靠。结论:改进方法操作简便,测定结果准确可靠。     

Effect of middle-term gliclazide treatment on insulin secretion in non-insulin dependent diabetics

Summary

Insulin secretion was studied in 12 non-insulin dependent diabetics during middle-term administration of the sulphonylurea gliclazide. Blood sugar, C-peptide and glucagon were also estimated during the intravenous glucose tolerance and arginine tests performed before and after therapy. After 3 months of gliclazide/therapy (240?mg/day) in addition to a low carbohydrate diet, the intravenous glucose tolerance test showed a significant reduction in blood sugar levels and in the partial and total areas under the blood sugar curve, as well as an improvement in early insulin secretion, characterized by a significant increase in plasma C-peptide at 4, 10 and 20 minutes. Plasma glucagon levels were not affected by the sulphonylurea therapy. In the arginine test, blood sugar levels were lower at the end of the treatment period; plasma insulin, C-peptide and glucagon did not change significantly. In this study, plasma C-peptide has proved to be a better indicator of stimulated insulin secretion than plasma insulin levels. The scarcity of hypo-glycaemic episodes during therapy with gliclazide may be related to the selective stimulation of early insulin secretion by this drug.     

地特胰岛素联合格列齐特缓释片治疗老年2型糖尿病的疗效及安全性

目的:探讨地特胰岛素联用格列齐特缓释片治疗老年2型糖尿病患者的疗效及安全性。方法:68例经口服降糖药血糖控制不理想的2型糖尿病患者随机分为地特胰岛素治疗组(ID组)和中性鱼精蛋白锌胰岛素NPH组,予睡前皮下注射胰岛素联合口服格列齐特缓释片治疗12周,比较两组的疗效及安全性。结果:治疗后两组血糖、糖化血红蛋白(HbAlc)均明显下降,C肽水平均明显升高(P<0.05);但ID组低血糖事件及体重增加明显少于NPH组,且C肽水平也高于NPH组(P<0.05)。结论:地特胰岛素联用格列齐特缓释片治疗老年2型糖尿病的方案安全有效。     

格列齐特对老年糖尿病患者冠状动脉血流储备变化的初步观察

目的　观察老年糖尿病患者冠状动脉血流储备 (coronaryflowreserve ,CFR)的变化及格列齐特治疗对糖尿病患者CFR的影响。　方法　选取 2 5例 2型糖尿病患者 ,将格列齐特治疗前患者血糖、糖化血红蛋白A1c、血脂、内皮素 1水平及CFR(应用彩色多普勒超声仪检测 )结果与 2 8例健康老年人作对照 ,并将治疗前、后的各项指标进行比较。　结果　格列齐特治疗 6个月后 ,患者的空腹血糖、早餐后 2h血糖、糖化血红蛋白A1c及内皮素 1水平较治疗前显著下降 (均为P <0 0 1) ,甘油三酯水平下降 (P <0 0 5 ) ,CFR从治疗前的 2 31± 0 4 9上升到 3 2 9± 0 4 2 (P <0 0 1)。结论　应用格列齐特治疗可改善老年糖尿病患者的CFR。     

格列齐特缓释剂治疗2型糖尿病患者的疗效和安全性评价

目的 评价服用格列齐特缓释片(达美康缓释剂30mg片剂)治疗12周后,对2型糖尿病患者总体控制的有效性及安全性,并与普通剂型比较。方法 159例2型糖尿病患者随机分配到格列齐特缓释剂和普通剂型组进行治疗。治疗12周后以血糖化血红蛋白,空腹血浆葡萄糖和胰岛素水平,评价服用格列齐特缓释片对2型糖尿病的有效性。同时通过对不良事件、主要体征、心电图以及临床实验室指标的分析,评价12周治疗对2型糖尿病病人的安全性。结果 12周治疗后,格列齐特缓释剂组和普通剂型组血糖化血红蛋白水平非常接近,组间差异无统计学意义(P=0．66),可信区间很窄(-0．15; 0．24％),表明临床疗效相当。两组24h血糖曲线下面积,血糖日均值和空腹血清胰岛素水平也相近。两组经血糖监测观察到低血糖发作次数无统计学差异。所有不良事件中,仅3次为中度,其余均为轻度。无病人因不良事件退出研究。研究中无严重不良事件发生。结论格列齐特缓释剂与普通剂型的疗效和安全性相似。     

格列齐特缓释片与格列美脲片治疗2型糖尿病疗效与安全性的临床探讨

目的比较格列齐特缓释片与格列美脲片治疗2型糖尿病的疗效与安全性。方法选择2018年1—12月在解放军总医院京东医疗区门诊就诊的2型糖尿病患者86例,随机分为格列齐特组(43例)和格列美脲组(43例),分别给与格列齐特缓释片和格列美脲片进行治疗,观察12周。结果格列齐特缓释片和格列美脲片均可明显降低2型糖尿病患者的空腹血糖、餐后2 h血糖及糖化血红蛋白,差异有统计学意义(P<0.001),且两组间降糖有效率差异无统计学意义(P>0.05)。两组均无明显临床低血糖发生,不良反应发生率差异无统计学意义(χ²=0.138,P>0.05)。结论格列齐特缓释片和格列美脲片是安全有效的磺脲类降糖药物,患者依从性良好。     

磺酰脲类药物受体1基因多态性与格列齐特疗效的研究

应用Taqman-PCR技术观察磺酰脲类药物受体1基因33外显子（TCC→GCC,S1369A）多态性与格列齐特降糖疗效的关系。发现G等位基因携带者较TT基因型者HbA1c下降显著。     

Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes

Aims/hypothesis The aim of this analysis was to examine the long-term effects of pioglitazone or gliclazide addition to failing metformin monotherapy and pioglitazone or metformin addition to failing sulphonylurea monotherapy in patients with type 2 diabetes.Methods Two 2-year, randomised, multicentre trials were performed in patients with inadequately controlled type 2 diabetes (HbA₁c 7.5–11% inclusive), who were receiving either metformin or a sulphonylurea at 50% of the maximum recommended dose or at the maximum tolerated dose. In the first study, patients on metformin received add-on therapy with pioglitazone (15–45 mg/day, n=317) or gliclazide (80–320 mg/day, n=313). In the second study, patients on sulphonylurea therapy were randomised to receive add-on therapy with either pioglitazone (15–45 mg/day, n=319) or metformin (850–2,550 mg/day, n=320). HbA₁c, fasting plasma glucose, insulin and lipids were investigated.Results At week 104, the mean reduction from baseline in HbA₁c was 0.89% for pioglitazone and 0.77% for gliclazide addition to metformin (p=0.200). There was a statistically significant between-group difference for the change in mean fasting plasma glucose at week 104 (–1.8 mmol/l for pioglitazone vs –1.1 mmol/l for gliclazide, p<0.001). There were no significant differences in changes from baseline in glycaemic parameters for pioglitazone compared with metformin addition to sulphonylurea therapy. Whether added to metformin or sulphonylurea, pioglitazone caused significantly greater decreases in triglycerides and significantly greater increases in HDL cholesterol than the comparator regimens (p0.001). There were decreases in LDL cholesterol in the comparator groups and these were significantly different from the small changes observed with pioglitazone (p<0.001). All treatment regimens were well tolerated. There were weight increases of 2.5 kg and 3.7 kg in the pioglitazone and 1.2 kg in the gliclazide add-on groups, and there was a mean decrease of 1.7 kg in the metformin add-on group.Conclusions/interpretation As add-on therapy to existing sulphonylurea or metformin therapy, pioglitazone improved glycaemic control and this improvement was sustained over 2 years. Furthermore, there were potential benefits in terms of improvements in specific lipid abnormalities. This could offer an advantage over the addition of other oral agents in the long-term treatment of diabetes.     

格列齐特联合阿卡波糖治疗老年2型糖尿病的效果探讨

目的探讨对格列齐特联合阿卡波糖治疗老年2型糖尿病效果。方法抽取该院2013年2月—2014年4月收治的80例老年2型糖尿病患者,随机分组后对比格列齐特联合阿卡波糖治疗（观察组,n=40例）与格列齐特单独治疗（对照组,n=40例）的效果。结果两组各指标均明显降低,观察组2hPBG、HbAlc均明显低于对照组。结论格列齐特联合阿卡波糖治疗老年2型糖尿病疗效显著。     

Advanced and multifaceted stability profiling of the first-line antidiabetic drugs metformin,gliclazide and glipizide under various controlled stress conditions

The antidiabetic drugs metformin, gliclazide and glipizide have been widely used and studied in terms of pharmacological and antidiabetic effects, and their individual stability has been studied in the literature. However, the drugs’ combined stability profiling remains poorly understood, and hence the aim of this study was to investigate the collective stability profiling of different combinations at various controlled conditions. Degradation assessments were carried out on metformin, glipizide and gliclazide by applying a stability-indicating HPLC method that was developed and validated in accordance with ICH guidelines. Glipizide, gliclazide, metformin and the binary mixtures (metformin/glipizide and metformin/gliclazide) were subjected to different forced degradation conditions and were detected at 227 nm by an isocratic separation on an Alltima CN column (250 mm × 4.6 mm × 5µ) utilizing a mobile phase that consists of 20 mM ammonium formate buffer (pH 3.5) and acetonitrile at a ratio of (45:55, v/v). The method is linear (R² = 0.9999) at the concentration range 2.5–150 µg/ml for metformin and 1.25–150 µg/ml for sulfonylureas respectively and offers a specific and sensitive tool for their determination in <10 min chromatographic run. All drug peaks were sharp and well separated. Stress degradation revealed that metformin has a remarkable sensitivity to alkaline stress, glipizide was more sensitive to thermal degradation while gliclazide exhibited almost full degradation in acidic, alkaline and oxidative stress conditions.