甘精胰岛素联合阿卡波糖治疗2型糖尿病临床疗效观察

目的探讨甘精胰岛素联合阿卡波糖治疗2型糖尿病患者的临床疗效及安全性。方法将确诊的116例2型糖尿病患者随机分为观察组和对照组,各58例,对照组采用预混胰岛素(诺和灵30R)治疗,观察组采用甘精胰岛素联合阿卡波糖治疗,疗程12周,观察两组患者的空腹血糖(FBG)、餐后2 h血糖(2hBG)、糖化血红蛋白(HbA1c)、体质量指数(BMI)、血糖达标时间、低血糖事件发生率、胰岛素用量等指标。结果治疗12周后,两组患者FBG、2hBG、HbA1c指标均较治疗前显著改善(P<0.05),FBG、2hBG、HbA1c各指标组间比较,差异有统计学意义(P<0.05);两组患者胰岛素日用量、低血糖发生率比较,差异有统计学意义(P<0.05)。结论甘精胰岛素联合阿卡波糖治疗2型糖尿病疗效好,低血糖发生率低,且可减少胰岛素用量,临床效果显著。     

Comparison of Acarbose and Gliclazide as First-line Agents in Patients with Type 2 Diabetes

Summary

Aim: To compare the effect of acarbose and gliclazide on clinical findings, biochemical parameters and safety in type 2 diabetic patients insufficiently controlled with medical nutrition therapy (MNT).

Methods: Seventy-two patients (age 35–70 years, BMI ≤ 35 kg/m²), who had not taken any oral antidiabetic drug previously, were randomised into two groups after a four-week placebo period, and treated for 24 weeks with acarbose (100 mg two to three times daily) and gliclazide (40–80 mg twice daily). The study was open and 57 patients (33 males and 24 females) completed it. MNT was provided for each patient based on personal requirements as defined by a dietitian. The effect of treatment was evaluated by fasting and postprandial (PP) metabolic parameters (blood glucose, insulin and C peptide levels), HbA1C and plasma lipid levels. In addition, side-effects were recorded and clinical examinations performed.

Results: Both drugs were effective in reducing of HbA1C, fasting and PP blood glucose levels. However, PP serum insulin levels in the gliclazide group increased more than those in the group treated with acarbose (p = 0.007). Moreover, a small weight reduction was obtained with acarbose treatment but not with gliclazide. Lipid levels were favourably affected by both drugs. Total cholesterol levels decreased in both groups, the decrease only reaching significance in the acarbose group (p = 0.013). However, serum levels of LDL cholesterol decreased in both groups (acarbose and gliclazide, p = 0.033 and p = 0.023, respectively), but the ratio of HDL to LDL cholesterol increased in the acarbose group only (p = 0.045). Both treatments were generally well tolerated. Common complaints in the acarbose group were flatulence and meteorism (29.6%). However, 10.0% of the patients in the gliclazide group reported at least one mild hypoglycaemic episode.

Conclusions: The results of the study demonstrate that acarbose and gliclazide were reasonably effective in improving metabolic control in patients insufficiently controlled with diet alone, and both treatments were well tolerated. Because of its effects on weight reduction and PP hyperinsulinaemia, acarbose may be preferred as a firstline drug, particularly in the treatment of overweight type 2 diabetic patients.     

Metabolic effect of repaglinide or acarbose when added to a double oral antidiabetic treatment with sulphonylureas and metformin: a double-blind,cross-over,clinical trial

ABSTRACT

Objective: To compare the metabolic effects of acarbose and repaglinide in type 2 diabetic patients who are being treated with a sulphonylurea–metformin combination therapy. The primary endpoint of the study was to evaluate which add-on treatment between acarbose and repaglinide is more efficacious in reducing PPG. The second endpoint was to evaluate which of these two treatment is more efficacious in the global management of glucose homeostasis in the enrolled patients.

Research design and methods: After a 4-week run-in period with a suplonylurea–metformin combination, 103 patients were randomised to receive in addition either repaglinide, up to 6?mg/day (2?mg three times a day) or acarbose, up to 300?mg/day (100?mg three times a day) with forced titration (independently of their glycaemic control, unless side-effects developed due to the drug dosage) for 15 weeks. The treatment was then crossed-over for further 12 weeks until the 27th week. We assessed body mass index (BMI), glycosylated haemoglobin (HbA_1c), fasting plasma glucoe (FPG), postprandial plasma glucose (PPG), fasting plasma insulin (FPI), postprandial plasma insulin (PPI), homeostatic model assesssment (HOMA) index, systolic blood pressure (SBP), diastolic blood pressure (DBP), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides (Tg), at baseline and at 1, 2, 15 and 27 weeks of treatment.

Results: Seven patients did not complete the study, comprising one patient who was lost to follow-up and a further six through side-effects (two in week 1, one in week 15 and three after cross-over) Side-effects were classified as nausea (one in acarbose group), gastrointestinal events (four in acarbose group), and hypoglycaemia (one in repaglinide group). After 15 weeks of therapy, the repaglinide-treated patients experienced a significant decrease in HbA_1c (?1.1%, p?<?0.05), FPG (?9.5%, p?<?0.05), and PPG (?14.9%, p?<?0.05), when compared to the baseline values. However, the same treatment was associated with a significant increase in body weight (+2.3%, p?<?0.05), BMI (+3.3%, p?<?0.05) and FPI (+22.5%, p?<?0.05); The increase was reversed during the cross-over phase. After 15 weeks of therapy, the acarbose-treated patients experienced a significant decrease in body weight (?1.9%, p?<?0.05), BMI (?4.1%, p?<?0.05), HbA_1c (?1.4%, p?<?0.05), FPG (?10.7%, p?<?0.05), PPG (?16.2%, p?<?0.05), FPI (?16.1%, p?<?0.05), PPI (?26.9%, p?<?0.05), HOMA index (?30.1%, p?<?0.05), when compared to the baseline values. All these changes were reversed during the cross-over study phase, except those relating to HbA_1c, FPG and PPG. The only changes that significantly differed when directly comparing acarbose- and repaglinide-treated patients were those relating to FPI (?16.1% vs. +22.5%, respectively, p?<?0.05) and HOMA index (?30.1% vs. +2.7%, p?<?0.05).

Conclusion: In addition from having a similar effect to repaglinide on PPG, acarbose appeared to have a more comprehensive positive effect on glucose metabolism compared to repaglinide in this relatively small sample of type 2 diabetic patients when used as add-on therapy to sulphonylureas and metformin.     

门冬胰岛素30联合拜糖平治疗初诊2型糖尿病临床分析

目的探讨门冬胰岛素30联合拜糖平治疗初诊2型糖尿病的临床疗效。方法100例初诊2型糖尿病患者随机分为观察组与对照组各50例。对照组给予门冬胰岛素30治疗,观察组给予门冬胰岛素30联合拜糖平治疗,比较两组血糖控制效果。结果治疗16周后,观察组空腹血糖（FPG）、餐后2h血糖（2hPG）比对照组降低更加明显（P〈0．05）,每日胰岛素用量比对照组更少。结论门冬胰岛素30联合拜糖平治疗初诊2型糖尿病可有效控制血糖,减少胰岛素用量。     

养阴汤联合阿卡波糖干预治疗阴虚内热型糖耐量低减的临床观察

目的观察养阴汤联合阿卡波糖干预治疗阴虚内热型糖耐量低减患者的临床疗效。方法选择2016年8月～2017年8月福建中医学院附属人民医院门诊及住院的糖耐量异常患者66例,随机分为养阴汤联合阿卡波糖治疗组和阿卡波糖对照组,疗程3个月,观察两组治疗前后临床症状、血糖、血脂水平的变化。结果治疗组与对照组治疗后的糖化血红蛋白水平、甘油三酯及低密度脂蛋白胆固醇、不良反应(腹胀、排气)比较,差异有统计学意义(P0.05)。结论养阴汤联合阿卡波糖较单用阿卡波糖治疗在降低糖化血红蛋白、调节脂代谢、改善临床症状方面具有优势。     

尼莫地平联合阿卡波糖治疗糖尿病周围神经病变的疗效及对炎症因子的影响

【摘要】 目的 探讨尼莫地平联合阿卡波糖治疗糖尿病周围神经病变的疗效及其对炎症因子的影响。 方法 选取2017年5月～2018年5月西安医学院临床医学院收治的100例糖尿病周围神经病变患者,随机分为研究组和对照组,每组各50例。两组患者均给予常规治疗,对照组在常规治疗基础上给予阿卡波糖50 mg/次,tid,po。研究组在对照组治疗基础上给予尼莫地平40 mg/次,tid,po。所有患者治疗时间均为1个月。治疗后评价临床疗效。比较两组治疗前后的Toronto评分、腓总神经及正中神经的运动传导速度（MCV）、感觉传导速度（SCV）。比较两组患者治疗前后的血清缺氧诱导因子-1α（HIF-1α）、血管内皮生长因子（VEGF）、游离脂肪酸（FFA）、肿瘤坏死因子（TNF-α）、脑源性神经营养因子（BDNF）、神经生长因子（NGF）、磷髓脂碱性蛋白（MBP）水平。 结果 研究组临床治疗总有效率明显高于对照组,差异有统计学意义（P＜0.01）。研究组治疗后Toronto评分明显低于治疗前及对照组治疗后,差异均有统计学意义（P＜0.01）。研究组治疗后的腓总神经和正中神经的MCV、SCV均明显高于治疗前及对照组,差异均有统计学意义（P＜0.01）。研究组治疗前后Toronto评分的差值,腓总神经和正中神经的MCV、SCV治疗前后的差值均明显高于对照组治疗前后的差值（P＜0.01）。研究组治疗后血清中HIF-1α、VEGF、FFA、TNF-α、MBP水平明显低于治疗前及对照组治疗后,BDNF、NGF水平均明显高于治疗前及对照组治疗后,差异有统计学意义（P＜0.01）。研究组治疗前后血清HIF-1α、VEGF、FFA、TNF-α、MBP、BDNF、NGF的差值明显高于对照组,差异有统计学意义（P＜0.01）。 结论 在使用阿卡波糖降糖药物的基础上加用尼莫地平,能够明显改善糖尿病周围神经病变,降低炎症水平,提高患者神经传导速度与血中神经营养因子水平。     

羟苯磺酸钙治疗非增生性糖尿病视网膜病变

目的 观察羟苯磺酸钙治疗非增生性糖尿病视网膜病变的临床疗效。方法 选择我院2018年1月至2020年4月收治的非增生性糖尿病视网膜病变(NPDR)患者64例,按照随机数字表法分为观察组和对照组,每组各32例,对照组患者给予基础治疗,观察组在基础治疗的同时给予羟苯磺酸钙治疗。评价两组患者在治疗后的临床疗效;检测两组患者在治疗前后血糖控制情况;检测两组患者治疗前后视力水平、微血管瘤数量、出血斑面积、黄斑厚度;观察两组患者不良反应发生情况。结果 (1)观察组总有效率为93.75%(30/32),明显高于对照组的71.88%(23/32)(P0.05);(2)治疗前后,两组患者空腹血糖、餐后2 h血糖及糖化血红蛋白水平比较,差异无统计学意义(P0.05);(3)治疗前,两组患者视力水平、微血管瘤数量、出血斑面积及黄斑厚度比较,差异无统计学意义(P0.05)。治疗后,两组患者视力水平、微血管瘤数量、出血斑面积及黄斑厚度较治疗前明显改善,且观察组视力水平高于对照组,微血管瘤数量、出血斑点面积、黄斑厚度少于对照组(P0.05);(4)两组患者不良反应发生率[15.62%(5/32) vs. 12.50%(4/32)]比较,差异无统计学意义(P0.05)。结论 羟苯磺酸钙能够改善非增生性糖尿病视网膜病变,提高临床疗效,值得推广应用。     

阿卡波糖联合二甲双胍治疗2型糖尿病伴高血脂症疗效的回顾性研究

摘 要 目的：分析阿卡波糖联合二甲双胍治疗2型糖尿病伴高血脂症的疗效。方法: 采用回顾性研究方法,收集本中心全科门诊2型糖尿病伴高血脂症患者2 000例,其中采用阿卡波糖单药治疗1 050例为对照组,采用阿卡波糖联合二甲双胍治疗的950例为联合组。比较治疗3个月后两组疗效和药品不良反应;以及治疗前后两组血糖、血脂指标变化。结果: 联合组总有效率为94.83%,显著高于对照组的72.38%(P<0.05)。治疗后,两组患者各项血糖指标均有明显下降(P<0.05),且联合组均低于对照组(P<0.05)。治疗后联合组患者各项血脂指标均有显著改善(P<0.05),且均明显优于对照组(P<0.05)。两组药品反应发生率差异无统计学意义(P>0.05)。结论:阿卡波糖联合二甲双胍治疗2型糖尿病伴高脂血症可显著改善患者血糖水平和血脂水平,临床疗效值得肯定。     

HPLC测定阿卡波糖胶囊的含量及有关物质

目的　建立测定阿卡波糖胶囊含量及有关物质的方法。方法　采用HPLC法 ,LichrospherNH2 色谱柱 (4 .6mm× 2 5 0mm ,5 μm) ,以乙腈 -磷酸盐缓冲液 (72∶2 8)为流动相 ,流速 1.3ml·min-1,检测波长 2 10nm。结果　阿卡波糖在浓度为 0 .6～1.2mg·ml-1范围内线性关系良好 (r=0 .9999) ,平均回收率为 10 0 .6 3% ,样品溶液在 2 4h内稳定 ,最低检测限为 0 .0 8μg。 结论　所用方法简便、重复性好 ,结果准确。