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左甲状腺素液体制剂和软胶囊制剂随餐服用的治疗效果及患者依从性:一项系统评价

Therapeutic efficacy and patient compliance of levothyroxine liquid and softgel formulations taken with meals: a systematic review.

作者信息

Oteri Vittorio, Volpe Salvatore, Lopes Mariarita, Sceusa Giulia, Tumminia Andrea, Belfiore Antonino, Frasca Francesco, Gullo Damiano

机构信息

Endocrine Unit, Department of Clinical and Experimental Medicine, University of Catania, Garibaldi-Nesima Hospital, Catania, Italy.

出版信息

Endocrine. 2025 Jan;87(1):48-58. doi: 10.1007/s12020-024-04016-7. Epub 2024 Aug 31.

Abstract

PURPOSE

Levothyroxine (L-T4) is the drug of choice for treating primary hypothyroidism. L-T4 tablets should be taken at least 30 min before breakfast. Several studies have suggested that serum thyroid profile is not affected by concomitant intake of liquid/softgel L-T4 with meals. Our aim is to review the evidence on therapeutic efficacy and patient compliance with the liquid and softgel formulation of L-T4 taken with meals, also compared with the standard tablet therapy regimen, in hypothyroid patients.

METHODS

We performed a systematic review of literature by searching PubMed, Embase, and Cochrane Library databases. PRISMA guidelines were applied, and the risk of bias of the included studies was assessed using the RoB 2 and ROBINS tools. The methodological quality was assessed following the GRADE criteria.

RESULTS

We included 13 studies, accounting for a total of 1697 patients. The timing of liquid L-T4 intake from breakfast did not affect the therapeutic efficacy of the treatment. No significant differences in the absorption of liquid L-T4 were found when administered together with different foods, beverages, drugs, or other supplements. TSH levels are not influenced by taking softgel L-T4 at breakfast; the efficacy of softgel and liquid formulation is similar when they are taken with a meal, but superior to that of tablet formulation. Shifting from L-T4 tablets taken 30 min before breakfast to liquid/softgel formulation taken with the meal improved medication adherence and perceived quality of life of patients.

CONCLUSION

Liquid and softgel formulation of L-T4 can be taken at breakfast or close to meals, without losing therapeutic efficacy. These formulations could also improve patient compliance and quality of life compared to L-T4 tablet therapy taken 30 min before breakfast.

摘要

目的

左甲状腺素(L-T4)是治疗原发性甲状腺功能减退症的首选药物。L-T4片剂应在早餐前至少30分钟服用。多项研究表明,餐时同时服用液体/软胶囊L-T4不会影响血清甲状腺指标。我们的目的是回顾有关甲状腺功能减退患者服用L-T4液体和软胶囊制剂餐时服用的治疗效果及患者依从性的证据,并与标准片剂治疗方案进行比较。

方法

我们通过检索PubMed、Embase和Cochrane图书馆数据库对文献进行了系统评价。应用PRISMA指南,并使用RoB 2和ROBINS工具评估纳入研究的偏倚风险。根据GRADE标准评估方法学质量。

结果

我们纳入了13项研究,共1697例患者。早餐时服用液体L-T4的时间不影响治疗效果。液体L-T4与不同食物、饮料、药物或其他补充剂一起服用时,吸收无显著差异。早餐时服用软胶囊L-T4不影响促甲状腺激素(TSH)水平;软胶囊和液体制剂餐时服用时疗效相似,但优于片剂制剂。从早餐前30分钟服用L-T4片剂改为餐时服用液体/软胶囊制剂可提高患者的用药依从性和生活质量。

结论

L-T4的液体和软胶囊制剂可在早餐时或接近餐时服用,而不会丧失治疗效果。与早餐前30分钟服用L-T4片剂治疗相比,这些制剂还可提高患者依从性和生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0cd7/11739177/45d3010c7642/12020_2024_4016_Fig1_HTML.jpg

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