《刊物原文》透皮治疗可能是人类甲亢的未来：高度效性和安全性的有力证据(美国2015年甲状腺年会交流)
发布时间：
2024-04-03
Transdermal treatment could be the future for hyperthyroidism in human: strong evidence from clinical study for significant higher efficacy and safety
Ling Chen, MD1*,et al
1Division of Endocrinology, Shangdong Provincial Hospital Affiliated to Shandong University, Jinan, P.R. China
*Corresponding author: 283 Jingwu Weijiu Road, Jinan, Shandong, 250021 P.R. China;
ABSTRAST
Objective: Thiourea antithyroid drugs (ATD) has exhibited slow efficacy in reducing thyroid function, certain and sometime serious adverse events (AEs), and lower remission rate. To overcome these problems, a novel transdermal compound antithyroid ointment (CATO) containing methimazole (MMI) and hydrocortisone was developed for local thyroid therapy.
Methods: A prospective, single center, open-label, self and parallel controlled study was conducted for a course of 18-months treatment and 2-years follow-up. The inclusion criteria for treatment group (T) were clinical hyperthyroidism and had stopped ATD therapy for at least 14 days due to ATD-induced adverse effects (ATDIES), or untreated due to unsuitability for ATD. The incipient hyperthyroid patients of Graves’ disease (GD) who had similar level of free triiodothyronine (FT3) and free thyroxine (FT4) as corresponding case in T group, and could be treated with MMI were enrolled as control group (C). T and C groups were respectively received CATO or MMI treatment with titration. FT3, FT4, and thyrotropin receptor antibody (TRAb) were performed at various time points after treatment.
Results: 1147 patients completed the study. In T group, 403 cases had ATDIES, including agranulocytosis, obvious neutropenia or liver damage, epispasis, gastrointestinal symptoms and others, while the other 215 cases had concomitant disorders including agranulocytosis, obvious neutropenia or liver injury, hyperthyroid vomiting and not taking medications orally. FT3 and FT4 at 2, 4, 8 weeks, TRAb at 3,6,12 months, were measured, and found significantly lower in 529 GD patients from T group compared with the C group (all P<0.0001). Remission rate in the first two years of treatment was found significantly higher in T group than that in the C group (P<0.001). During CATO treatment, only 8.9% subjects suffered skin rush or localized AEs and 0.65% early stopped study separately. No other systemic AEs were observed.
Conclusion: Our data demonstrated strong evidence that CATO had significantly higher efficacy and safety compared with ATD. The results suggested that CATO could be the first choice drug for hyperthyroidism, especially for those who could not be treated with ATD.
