The LISA Trial - A randomized, double-blind, placebo-controlled FourArm study of 1,000 patients with nodular goiter in Germany. Study design and first results of feasibility
The LISA Trial - A randomized, double-blind, placebo-controlled FourArm study of 1,000 patients with nodular goiter in Germany. Study design and first results of feasibility
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DOI：
10.1007/s00063-005-1074-5
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发表时间：
2005-09-15
影响因子：
--
通讯作者：
Wegscheider, K
中科院分区：
文献类型：
--
作者：
Grussendorf, M;Vaupel, R;Wegscheider, K
LISATrial——一项在德国对 1,000 名结节性甲状腺肿患者进行的随机、双盲、安慰剂对照四组研究。研究设计和可行性的初步结果。背景：尽管左旋甲状腺素是德国最常用的处方药物，但其对结节性甲状腺肿的治疗效果从未在随机、双盲试验中进行过足够有力的研究。因此，2004 年 5 月，德国启动了一项 TSH 适应（TSH：促甲状腺激素）、随机、双盲、安慰剂对照四组（安慰剂 [P] 对比左旋甲状腺素 [T] 对比碘 [1] 对比左旋甲状腺素 + 碘 [TI]）多中心研究（LISA 研究）。 患者和方法：根据之前的回顾性和前瞻性研究，计算得出：每组 250 名患者即可获得足够的统计功效 (> 80%)。该试验的主要终点是超声测量的所有结节总体积的一年变化。次要标准是甲状腺肿的体积、结节的数量和结节的回声结构。虽然该研究严格保持双盲，但 T 组和 TI 组的左旋甲状腺素剂量根据 3 个月的 TSH 测量结果进行一次调整（目标范围 0.2-0.8 mU/l）。 结果：到目前为止（开始后 1 年），已纳入 305 名患者。 TSH 适应可以在不影响研究双盲特性的情况下进行，并取得良好结果：约 90% 的患者达到了 TSH 目标范围。结论：预计 2007 年将得出非盲结果。
The LISATrial - a Randomized, Double-Blind, Placebo-Controlled Four-Arm Study of 1,000 Patients with Nodular Goiter in Germany. Study Design and First Results of Feasibility.Background: Although levothyroxine is the mostly prescribed medicament in Germany, its therapeutic effectiveness in nodular goiter was never studied in a randomized, double-blind trial with sufficient power. Thus, in May 2004 a TSH-adapted (TSH: thyroid-stimulating hormone), randomized, double-blind, placebo-controlled four-arm (placebo [P] vs. levothyroxine [T] vs. iodine [1] vs. levothyroxine + iodine [TI]) multicenter study was started in Germany (LISA study).Patients and Methods: Based on former retrospective and prospective studies, it was calculated that a sufficient statistical power (> 80%) would be achieved with 250 patients in each arm. The primary endpoint of the trial is the 1-year change of ultrasonographically measured total volume of all nodules. Secondary criteria are volume of goiter, number of nodules, and echogenic structure of nodules. While the study is kept strictly double-blind, the dose of levothyroxine in the T and TI groups is adapted once according to 3-month TSH measurements (target range 0.2-0.8 mU/l).Results: Up to now (1 year after beginning), 305 patients have been included. TSH adaptation could be performed without compromising the double-blind character of the study with good results: about 90% of the patients reached the TSH target range.Conclusion: Unblinded results are to be expected in 2007.