国产左旋甲状腺素钠临床试验研究  

Clinical trial of domestic levothyroxine sodium

作　　者：王坚[1] 王竹兰[1] 朱大龙[2] 田成功[2] 马建华[3] 齐绍康[3] 邓振霞 吴一玲 王晓[1] 王扬天[1] 赵明[1] 杜宏[1] 王燕燕[1] 张皖瑜[1] 

机构地区：[1]南京军区南京总医院,江苏南京210002 [2]南京市鼓楼医院,江苏南京210008 [3]南京市第一医院,江苏南京210001 [4]无锡市第一医院,江苏无锡214000

出　　处：《医学研究生学报》2001年第6期499-502,共4页Journal of Medical Postgraduates

摘　　要：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Objectives: To compare clinical effects and safety of domestic levothyroxine sodium (L T 4) made by Wujin Pharmaceutical Factory with those of imported L T 4 of Merck Company. Methods: One hundred and eighty three patients with primary hypothyroidism from 4 centers were included in this prospective, Controlled, randomized, parallel trial. All the patients in each center were randomly assigned to trial or control group. The daily dose was 50 μg initially and was added by 25 to 50 μg at intervals of 2 to 4 weeks according to laboratory test. All treatments were administered for 12 weeks. Results: The effects of both drugs to normalize measurements of thyroid function were comparable and not significantly different. The side effective incidences of both drugs were very low and almost the same. Conclusions: The domestic levothyroxine is identically effective and safe compared with import L T 4 for treatment of primary hypothyroidism.

关 键 词：左旋甲状腺素钠 原发性甲状腺功能减退症 临床试验 

分 类 号：R581.2[医药卫生—内分泌]