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甲巯咪唑低日剂量(15毫克/天)每日一次与每日分次给药在格雷夫斯甲亢诱导甲状腺功能正常化中的疗效:一项随机对照研究

Efficacy of Once Daily versus Divided Daily Administration of Low Daily Dosage (15 mg/Day) of Methimazole in the Induction of Euthyroidism in Graves' Hyperthyroidism: A Randomized Controlled Study.

作者信息

Sriussadaporn Sutin, Pumchumpol Wanwaroon, Lertwattanarak Raweewan, Kunavisarut Tada

机构信息

Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Int J Endocrinol. 2017;2017:2619695. doi: 10.1155/2017/2619695. Epub 2017 Dec 18.

Abstract

BACKGROUND

Previous studies used unequal or high daily dosages of methimazole (MMI) to compare the efficacy of once daily dose regimen (OD-MMI) with that of divided daily doses regimen (DD-MMI) in inducing euthyroidism.

OBJECTIVES

To compare the efficacy of OD-MMI to that of DD-MMI using low daily dosage of MMI in inducing euthyroidism.

METHODS

Fifty patients with clinically nonsevere Graves' hyperthyroidism were randomized to be treated with 15 mg/day OD-MMI or 15 mg/day DD-MMI.

RESULTS

21 cases (84%) in OD-MMI and 23 cases (92%) in DD-MMI were eligible for analyses. During the treatment, there was no difference in baseline characteristics, serum FT3 and FT4 reductions, and cumulative rate of achieving euthyroidism (4.8% versus 4.3%, 28.6% versus 34.8%, 71.4% versus 82.6%, and 85.7% versus 87.0% at 2, 4, 8, and 12 weeks, resp.) between both regimens. Hypothyroidism developed in DD-MMI significantly more than in OD-MMI (17.4% versus 0%, < 0.05).

CONCLUSIONS

Treatment with MMI at a low daily dosage of 15 mg/day OD-MMI is as effective as DD-MMI in the reduction of serum thyroid hormone levels and induction of euthyroidism. The OD-MMI regimen is preferable to the DD-MMI regimen in the treatment of clinically nonsevere Graves' hyperthyroidism. This trial is registered with Thai Clinical Trials Registry: TCTR20170529001.

摘要

背景

既往研究使用不等量或高剂量的甲巯咪唑(MMI)来比较每日一次剂量方案(OD-MMI)与每日分次剂量方案(DD-MMI)在诱导甲状腺功能正常方面的疗效。

目的

使用低剂量的MMI比较OD-MMI与DD-MMI在诱导甲状腺功能正常方面的疗效。

方法

50例临床症状不严重的格雷夫斯甲亢患者被随机分为接受15mg/天的OD-MMI治疗或15mg/天的DD-MMI治疗。

结果

OD-MMI组21例(84%)和DD-MMI组23例(92%)符合分析条件。治疗期间,两组在基线特征、血清FT3和FT4降低情况以及实现甲状腺功能正常的累积率(分别在2、4、8和12周时为4.8%对4.3%、28.6%对34.8%、71.4%对82.6%以及85.7%对87.0%)方面无差异。DD-MMI组发生甲状腺功能减退的情况显著多于OD-MMI组(17.4%对0%,P<0.05)。

结论

每日低剂量15mg/天的OD-MMI治疗MMI在降低血清甲状腺激素水平和诱导甲状腺功能正常方面与DD-MMI同样有效。在治疗临床症状不严重的格雷夫斯甲亢时,OD-MMI方案优于DD-MMI方案。本试验已在泰国临床试验注册中心注册:TCTR20170529001。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a53/5748309/2756cfb51007/IJE2017-2619695.001.jpg

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