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[目的]探讨盐酸二甲双胍缓释片对2型糖尿病病人的临床效果和安全性。[方法]以二甲双胍普通片为对照,对76例患者在2家医院进行了6周的随机对照试验研究。分别在基线和疗后6周,随访观测了血糖、血脂等糖尿病疗效相关指标。[结果]在控制了中心、基线水平的混杂后,利用线性回归模型进行非劣效性检验表明,各指标组间均有统计学意义(P≤0.05)。两组不良反应发生率差异无统计学意义(P﹥0.05)。[结论]盐酸二甲双胍缓释片在疗效可以认为非劣于普通片,安全性上和普通片相当,但由于剂型优势,其依从性要高于普通片,因此具有较强的临床推广价值。同时探索了一条在临床研究中利用线性回归模型,通过SAS软件包进行统计学检验的途径,并为类似问题的解决提供了理论参考。
[Objective] To investigate the clinical effect and safety of metformin hydrochloride sustained-release tablets on type 2 diabetic patients. [Methods] With metformin as a control, 76 patients were randomized into two hospitals for 6 weeks. At baseline and 6 weeks after treatment, follow-up observation of blood glucose, blood lipids and other indicators of the efficacy of diabetes. [Results] After controlling the center and baseline levels, the non-inferiority test using linear regression model showed that there was statistical significance between each index group (P≤0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). [Conclusion] Metformin Hydrochloride Sustained-release Tablets can be regarded as non-inferior to ordinary tablets in efficacy, and safety is comparable to that of ordinary tablets. However, its compliance is higher than that of ordinary tablets due to its advantages of dosage form, so it has strong clinical promotion value. At the same time, I explored a way of using the linear regression model in clinical research and the statistical test by SAS software package, and provided a theoretical reference for the solution of similar problems.