Villar H C C E, Saconato H, Valente O, Atallah A N
Faculdade Estadual de Medicina de Marília, Departamento de Medicina Interna, Av. Cascata 123, Marília, São Paulo, Brazil, 17515-300.
Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD003419. doi: 10.1002/14651858.CD003419.pub2.
Subclinical hypothyroidism is defined as an elevated serum thyroid-stimulating hormone (TSH) level with normal free thyroid hormones values. The prevalence of subclinical hypothyroidism is 4% to 8% in the general population, and up to 15% to 18% in women who are over 60 years of age. There is considerable controversy regarding the morbidity, the clinical significance of subclinical hypothyroidism and if these patients should be treated.
To assess the effects of thyroid hormone replacement for subclinical hypothyroidism.
We searched The Cochrane Library, MEDLINE, EMBASE and LILACS. Ongoing trials databases, reference lists and abstracts of congresses were scrutinized as well.
All studies had to be randomised controlled trials comparing thyroid hormone replacement with placebo or no treatment in adults with subclinical hypothyroidism. Minimum duration of follow-up was one month.
Two authors independently assessed trial quality and extracted data. We contacted study authors for missing or additional information.
Twelve trials of six to 14 months duration involving 350 people were included. Eleven trials investigated levothyroxine replacement with placebo, one study compared levothyroxine replacement with no treatment. We did not identify any trial that assessed (cardiovascular) mortality or morbidity. Seven studies evaluated symptoms, mood and quality of life with no statistically significant improvement. One study showed a statistically significant improvement in cognitive function. Six studies assessed serum lipids, there was a trend for reduction in some parameters following levothyroxine replacement. Some echocardiographic parameters improved after levothyroxine replacement therapy, like myocardial relaxation, as indicated by a significant prolongation of the isovolumic relaxation time as well as diastolic dysfunction. Only four studies reported adverse events with no statistically significant differences between groups.
AUTHORS' CONCLUSIONS: In current RCTs, levothyroxine replacement therapy for subclinical hypothyroidism did not result in improved survival or decreased cardiovascular morbidity. Data on health-related quality of life and symptoms did not demonstrate significant differences between intervention groups. Some evidence indicates that levothyroxine replacement improves some parameters of lipid profiles and left ventricular function.
亚临床甲状腺功能减退症的定义为血清促甲状腺激素(TSH)水平升高而游离甲状腺激素值正常。亚临床甲状腺功能减退症在普通人群中的患病率为4%至8%,在60岁以上女性中高达15%至18%。关于亚临床甲状腺功能减退症的发病率、临床意义以及这些患者是否应接受治疗存在相当大的争议。
评估甲状腺激素替代治疗亚临床甲状腺功能减退症的效果。
我们检索了考克兰图书馆、医学文献数据库、荷兰医学文摘数据库和拉丁美洲及加勒比地区卫生科学数据库。还仔细查阅了正在进行的试验数据库、参考文献列表和大会摘要。
所有研究必须是随机对照试验,比较亚临床甲状腺功能减退症成人患者使用甲状腺激素替代治疗与安慰剂或不治疗的效果。最短随访期为1个月。
两位作者独立评估试验质量并提取数据。我们联系研究作者获取缺失或额外的信息。
纳入了12项为期6至14个月、涉及350人的试验。11项试验研究了左甲状腺素替代治疗与安慰剂的效果,1项研究比较了左甲状腺素替代治疗与不治疗的效果。我们未发现任何评估(心血管)死亡率或发病率的试验。7项研究评估了症状、情绪和生活质量,未发现有统计学意义的改善。1项研究显示认知功能有统计学意义的改善。6项研究评估了血脂,左甲状腺素替代治疗后一些参数有降低趋势。左甲状腺素替代治疗后一些超声心动图参数有所改善,如心肌舒张功能,等容舒张时间显著延长以及舒张功能障碍可表明这一点。只有4项研究报告了不良事件,各治疗组间无统计学意义的差异。
在当前随机对照试验中,亚临床甲状腺功能减退症的左甲状腺素替代治疗未改善生存率或降低心血管发病率。干预组之间在与健康相关的生活质量和症状方面的数据未显示出显著差异。一些证据表明左甲状腺素替代治疗可改善血脂谱和左心室功能的一些参数。