Mithal Ambrish, Dharmalingam Mala, Tewari Neeraj
Department of Endocrinology, Medanta - The Medicity, Gurgaon, Haryana, India.
Department of Endocrinology, Bangalore Endocrinology and Diabetes Research Center, Malleshwaram Circle, Bangalore, India.
Indian J Endocrinol Metab. 2014 Jan;18(1):83-8. doi: 10.4103/2230-8210.126582.
A large proportion of patients worldwide under treatment for hypothyroidism with thyroxine show suboptimal Thyroid Stimulating Hormone (TSH) values. There is a paucity of Indian data on 'out-of-range' TSH values in patients with primary hypothyroidism receiving levothyroxine treatment.
To assess the percentage of primary hypothyroid patients with abnormal thyroid function despite being prescribed levothyroxine for at least 2 m.
A cross-sectional, single visit, observational study in adult patients with primary hypothyroidism on treatment with levothyroxine for at least 2m was undertaken across 10 cities in India. Compliance to thyroxine therapy was assessed by interviewing the subjects and their quality of life was assessed by administering the SF-36 questionnaire. A random blood sample (5ml) was drawn from the study subjects during the same visit for assessing serum TSH levels. TSH levels were correlated with the current dose of levothyroxine.
A total of 1950 subjects (mean age 41.4 ± 11.17 years; female 81.2%, male 18.8%) with primary hypothyroidism were enrolled in the study. Of the 1925 subjects in whom TSH values were available, 808 (41.97%) were under-treated (TSH > 4 mIU/L) and 243 (12.62%) were over-treated (TSH < 0.4mIU/L). The mean dose of thyroxine in this study was 1.23 μg/kg/day (±0.85). Majority of subjects (90.79%) were compliant/moderately compliant to thyroxine therapy. Age and autoimmune hypothyroidism were the factors that had significant impact on serum TSH. Subjects with abnormal TSH had significantly lower scores for role limitation due to emotional problems (P = 0.0278) and due to physical health (P = 0.0763).
This study concluded that around half (54%) of known hypothyroid subjects had out-of-range serum TSH despite being treated with levothyroxine for at least 2m. The mean daily dose of thyroxine (1.23 μg/kg ± 0.85) was less than the recommended full replacement dose.
全球范围内，接受甲状腺素治疗的甲状腺功能减退症患者中，很大一部分患者的促甲状腺激素（TSH）值未达到最佳水平。在接受左甲状腺素治疗的原发性甲状腺功能减退症患者中，关于“超出范围”的TSH值，印度的数据较少。
评估接受左甲状腺素治疗至少2个月的原发性甲状腺功能减退患者中，甲状腺功能异常的患者百分比。
在印度的10个城市，对接受左甲状腺素治疗至少2个月的成年原发性甲状腺功能减退患者进行了一项横断面、单次就诊的观察性研究。通过询问受试者评估甲状腺素治疗的依从性，并通过发放SF-36问卷评估其生活质量。在同一次就诊期间，从研究对象中抽取5ml随机血样，用于评估血清TSH水平。TSH水平与当前左甲状腺素剂量相关。
共有1950名原发性甲状腺功能减退患者（平均年龄41.4±11.17岁；女性81.2%，男性18.8%）纳入研究。在可获得TSH值的1925名受试者中，808名（41.97%）治疗不足（TSH>4mIU/L），243名（12.62%）治疗过度（TSH<0.4mIU/L）。本研究中甲状腺素的平均剂量为1.23μg/kg/天（±0.85）。大多数受试者（90.79%）对甲状腺素治疗依从/中度依从。年龄和自身免疫性甲状腺功能减退是对血清TSH有显著影响的因素。TSH异常的受试者在因情绪问题导致的角色限制（P=0.0278）和因身体健康导致的角色限制（P=0.0763）方面得分显著较低。
本研究得出结论，约一半（54%）已知的甲状腺功能减退受试者尽管接受左甲状腺素治疗至少2个月，但血清TSH仍超出范围。甲状腺素的平均每日剂量（1.23μg/kg±0.85）低于推荐的完全替代剂量。
