[格列齐特普通片改为格列齐特缓释片治疗2型糠尿病的临床观察]格列齐特缓释片

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  [摘要] 目的:评价服用格列齐特缓释剂 (格列齐特释片30 mg片剂)治疗12周后,对2型糖尿病患者总体控制的有效性,并与普通剂型比较。方法:100例2型糖尿病患者随机分为两组治疗,一组为开始使用单纯格列齐特普通制剂,在观察开始时改为使用格列齐特缓释剂组,一组为普通剂型格列齐特组。治疗12周后以其两组的糖基化血红蛋白(HbA1c),空腹血浆葡萄糖各自的对比,评价服用格列齐特缓释片对2型糖尿病的有效性及对比普通制剂的优越性。同时通过对副作用,特别是低血糖的出现情况的统计,评价12周治疗对2型糖尿病病人的安全性与普通制剂的对比。结果:12周治疗后,100例患者使用格列齐特缓释剂后和之前使用普通剂型对比的血糖化血红蛋白水平非常接近,组间差异无统计学意义,表明临床疗效相当。两组血糖日均值也相近。两组经血糖监测观察到低血糖发作次数差异无统计学意义。患者依从性的对比,格列齐特缓释片优于达美康普通片,并且无病人因不良事件出观察。观察中无严重不良事件发生。结论:格列齐特缓释剂与普通剂的疗效相似且安全性更佳。
  [关键词] 达美康缓释片;2型糖尿病;疗效;安全性
  [中图分类号] R587.1 [文献标识码]B [文章编号]1674-4721(2009)02(a)-019-02
  
  Clinical observation of type 2 diabetes treatment by use of gliclazide modified release tablets instead of Gliclazide Ordinary Tablets
  WU Bang-tai, HOU Kai-jian
  (Department One of Internal Medicine, Hospital of Traditional Chinese Medicine of Shantou, Shantou515000,China)
  [Abstract] Objective: This thesis evaluates the effectiveness of general control of type 2 diabetes by taking Gliclazide Modified Release Tablets(30 mg per pill) for 12 weeks, compared with that of Gliclazide Ordinary Tablets. Mothods: 100 examples of type 2 diabetes were divided into 2 groups arbitrarily and received treatment. One group only took Gliclazide Ordinary Tablets at the beginning, but afterward change into using Gliclazide Modified Release Tablets. The other group was Gliclazide Ordinary Tablets users. After 12 weeks of treatment, the effectiveness and advantages of Gliclazide Modified Release Tablets to type 2 diabetes were evaluated refer to HbA1c and fasting blood-glucose. Meanwhile, the side-effect, especially the appearance of glucopenia, was taken statistics. And then the security of type 2 diabetes after 12 weeks of treatment was evaluated. Results: After 12 weeks of treatment, the HbA1c of the 100 examples who had used Gliclazide Modified Release Tablets was approaching to that of those who had used Gliclazide Ordinary Tablets, but there was no statistical significance in the disparities between the two groups, which indicated the clinical curative effect was closed. The blood sugar per day of the two groups was also closed. After blood sugar monitoring, the number of times of glucopenia attacks in the two groups were observed without statistical disparity. Compared to Gliclazide Ordinary Tablets, the patient"s compliance of Gliclazide Modified Release Tablets was superior, and the latter didn"t cause severe adverse incidents from observation. Conclusion: The curative effect of Gliclazide Modified Release Tablets is similar to that of Gliclazide Ordinary Tablets, but the security of the former one is better.
  [Key words] Gliclazide Modified Release Tablets;Type 2 diabetes;Curative effect;Security
  
  在国内完成的格列齐特缓释片注册后临床大研究结果显示,格列齐特缓释片能够有效改善2型糖尿病患者的血糖控制状况,治疗前后患者血糖水平和HbA1c水平均有显著下降,并具有良好的耐受性。由于独特的剂型设计,格列齐特缓释片能够作到真正意义的一天一次给药,大大地减少了药物的使用次数和剂量,并且其生物利用度高,其药代动力学曲线恰好与血糖水平昼夜波动相吻合,较好的耐受性,也使得低血糖发生率较近,特别对于老年人,合并慢性肾竭的患者,还可以改善治疗依从性,对长期控制血糖有益。
  本研究主要是从临床,从基层的角度,评价服用格列齐特缓释片(30 mg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,并与普通剂型的主要疗效和低血糖的几率作比较,现报道如下:
  
  1资料与方法
  
  1.1一般资料
  2006年4月~2006年9月,共作为观察对象的100例诊断为2型糖尿病的,并单纯使用格列齐特普通片的患者,其中男性50例,女性50例,年龄(54.0±3.6)岁,平均54.5岁,体重(52.0±4.1) kg,平均52 kg。平均病程8.4年。病例入选标准:根据美国糖尿病诊断协会(ADA)糖尿病诊断标准,未发现严重的急慢性并发症的患者。
  1.2用药立法
  原使用达美康普通片80 mg,口服,2 次/d。改为使用格列齐特缓释片60 mg,口服,1 次/d(早餐时),并维持原有的饮食及运动调节等生活方式无特殊改变。
  1.3检测手段
  12周观察期血糖的检测:所有患者均使用罗氏血糖仪,测试早餐前的空腹血糖及早餐后2 h的血糖为期1周,后改为1次/周,测试早餐前血糖及餐后2 h血糖。HbA1c的测试:观察开始时检测所有患者的HbA1c。
  1.4统计学方法
  所有两组数据相比较,均采用χ2检验。
  
  2结果
  
  2.1普通制剂和缓释片治疗12周的的血糖及糖基化血红蛋白指标的对比
  结果见表1。
  
  以上两组数据对比,P均>0.05,普通制剂及缓释片使用对比,患者血糖无明显差别。
  2.2平均依从性
  从服药次数的角度来考虑依从性,格列齐特普通片及缓释片分别为83.1%和98.7%(P

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