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目的 :比较研究武进制药厂生产的左旋甲状腺素钠片 (国产L T4 )与德国默克公司生产的优甲乐同类产品治疗原发性甲状腺功能减退症的临床疗效和安全性。 方法 :采用多中心、随机、对照研究 ,其中试验组 91例 ,对照组 92例 ,初始剂量均为 5 0 μg/d ,每 2 4周增加 2 5 5 0 μg/d ,疗程为 12周 ,主要根据用药前后甲状腺功能检测指标值的变化进行疗效评估。 结果 :试验药与对照药有效率均为 10 0 %,显效率试验药为 86 .81%,对照药为92 .39%,组间比较差异不显著 ,不良反应发生率两组均为 1.1%。 结论 :左旋甲状腺素钠片临床疗效和安全性与进口同类产品一致
OBJECTIVE: To compare the clinical efficacy and safety of levothyroxine sodium tablets (domestic L T4) produced by Wujin Pharmaceutical Factory and the similar products of Euthyrox in Merck to treat primary hypothyroidism. METHODS: A multicenter, randomized, controlled trial was conducted in which 91 patients in the trial group and 92 in the control group received an initial dose of 50 μg / d, an increase of 2550 μg / d every 24 weeks for 12 weeks, Mainly based on the thyroid function test before and after the index changes in the value of efficacy evaluation. Results: The effective rates of test drug and control drug were both 100%, 86.81% for markedly effective drug and 92.39% for reference drug. There was no significant difference between the two groups and the incidence of adverse reactions were both 1.1% . Conclusion: The clinical efficacy and safety of L-thyroxine sodium tablets are the same as that of imported similar products