Reduction of thyroid nodule volume by levothyroxine and iodine alone and in combination: a randomized, placebo-controlled trial.
Reduction of thyroid nodule volume by levothyroxine and iodine alone and in combination: a randomized, placebo-controlled trial.
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DOI：
10.1210/jc.2011-0356
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发表时间：
2011-09
期刊：
影响因子：
--
通讯作者：
LISA Investigators
中科院分区：
文献类型：
--
作者：
Grussendorf M;Reiners C;Paschke R;Wegscheider K;LISA Investigators
结节性甲状腺肿在世界范围内很常见，但在治疗方法上仍存在争议。这项研究的目的是测量(非抑制性)T4、碘或两者的组合治疗与安慰剂相比对甲状腺结节和甲状腺体积的影响。这是一项在德国结节性甲状腺肿患者中进行的多中心、随机、双盲试验[LISA(Lisa(Lisa(Left-othyrosin and Iodo in der StrumaTreatie Als Mono-oooder KombinationsTreatment)试验)]。这项研究是在大学医院和地区医院的门诊以及私人诊所进行的。1,024名年龄在18-65岁、有一个或多个甲状腺结节(最小直径10 mm)的甲状腺功能正常的患者参加了这项研究。干预措施包括安慰剂、碘(I)、T4或T4+I，为期1年。T4剂量被调整为0.2-0.8亩/升的TSH目标范围。主要终点是超声测量的所有结节体积缩小的百分比，主要次要终点是甲状腺肿体积的变化。与安慰剂组相比，T4+I组结节体积缩小−为17.3%[95%可信区间−24.8/−9.0%，P<；0.001]，−7.3%(95%可信区间−15.0/+1.2%，P=0.201)，I组−4.0%(95%CI−11.4/+4.2%，P=0.328)。直接比较，T4+I组明显优于T4组(P=0.018)或I组(P=0.003)。甲状腺体积缩小分别为−7.9%(95%CI−11.8/−3.9%，P<；0.001)、−5.2%(95%CI−8.7/−1.6%，P=0.024)和−2.5%(95%CI−6.2/+1.4%，P=0.207)。T4+I组明显优于I组(P=0.034)，但不优于T4组(P=0.190)。在碘供应充足的地区，与单独或安慰剂相比，使用不完全抑制促甲状腺激素的I和T4联合治疗一年可进一步减少甲状腺结节的体积。
Nodular goiter is common worldwide, but there is still debate over the medical treatment. The objective of the study was the measurement of the effect of a treatment with (nonsuppressive) T4, iodine, or a combination of both compared with placebo on volume of thyroid nodules and thyroid. This was a multicenter, randomized, double-blind trial in patients with nodular goiter in Germany [LISA (Levothyroxin und Iodid in der Strumatherapie Als Mono-oder Kombinationstherapie) trial]. The study was conducted in outpatient clinics in university hospitals and regional hospitals and private practices. One thousand twenty-four consecutively screened and centrally randomized euthyroid patients aged 18–65 yr with one or more thyroid nodules (minimal diameter 10 mm) participated in the study. Intervention included placebo, iodine (I), T4, or T4+I for 1 yr. T4 doses were adapted for a TSH target range of 0.2–0.8 mU/liter. The primary end point was percent volume reduction of all nodules measured by ultrasound, and the main secondary end point was a change in goiter volume. Nodule volume reductions were −17.3% [95% confidence interval (CI) −24.8/−9.0%, P < 0.001] in the T4+I group, −7.3% (95% CI −15.0/+1.2%, P = 0.201) in the T4 group, and −4.0% (95% CI −11.4/+4.2%, P = 0.328) in the I group as compared with placebo. In direct comparison, the T4+I therapy was significantly superior to T4 (P = 0.018) or I (P = 0.003). Thyroid volume reductions were −7.9% (95% CI −11.8/−3.9%, P < 0.001), −5.2% (95% CI −8.7/−1.6%, P = 0.024) and −2.5% (95% CI −6.2/+1.4%, P = 0.207), respectively. The T4+I therapy was significantly superior to I (P = 0.034) but not to T4 (P = 0.190). In a region with a sufficient iodine supply, a 1-yr therapy with a combination of I and T4 with incomplete suppression of thyrotropin reduced thyroid nodule volume further than either component alone or placebo.
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影响因子：
--
作者：
Grussendorf, M;Vaupel, R;Wegscheider, K
通讯作者：
Wegscheider, K
影响因子：
5.4
作者：
Mainini, E;Martinelli, I;Mazzi, C
通讯作者：
Mazzi, C
影响因子：
5.8
作者：
Papini, E;Petrucci, L;Pacella, CM
通讯作者：
Pacella, CM
DOI：
10.1016/s0889-8529(02)00010-5
发表时间：
2002-09-01
影响因子：
4.5
作者：
Richter, B;Neises, G;Clar, C
通讯作者：
Clar, C
影响因子：
6.6
作者：
Caldwell, Kathleen L.;Makhmudov, Amir;Wang, Richard Y.
通讯作者：
Wang, Richard Y.