A clinical study on 99Tc-MDP for thyroid-associated ophthalmopathy
10.3760/cma.j.issn.2095-4255.2019.11.014
- VernacularTitle: 99Tc-MDP治疗甲状腺相关眼病的临床研究
- Author:
Bingyu WANG
1
;
Jianping SUN
;
Guohua HAO
;
Bo PENG
;
Jingyao LIU
;
Wei DUAN
Author Information
1. Department of Endocrinology, the Affiliated Zhongshan Hospital of Dalian University, Dalian 116001, China
- Publication Type:Clinical Trail
- Keywords:
Thyroid-associated ophthalmopathy;
99Technetium-methylenediphosphonate injection;
Efficacy;
Safety
- From:
Chinese Journal of Endemiology
2019;38(11):922-926
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the efficacy and safety of 99Technetium-methylenediphosphonate injection (99Tc-MDP) in the treatment of thyroid associated ophthalmopathy (TAO).
Methods:The trail was conducted in Affiliated Zhongshan Hospital of Dalian University. Patients were recruited from October 2016 to October 2018. Fifty patients with active moderate to severe TAO were randomly assigned to receive 99Tc-MDP (n = 25) or methylprednisolone administered intravenously (n = 25), the final completion of treatment and follow-up were 21 and 20 cases, respectively. In 99Tc-MDP group, 30 sets of 99Tc-MDP were applied to each course of treatment for 10 d, with a course interval of 20 d, a total of 3 courses of treatment. Patients in methylprednisolone group were given a pulse regimen, once every week for a total of 12 infusions, altogether 4.5 g in 12 weeks. The clinical activity score (CAS) and exophthalmos were assessed in a patient at weeks 12 and 24, respectively. A response was defined as a reduction of 2 points or more in CAS and reduction of 2 mm or more in exophthalmos. Safety was assessed according to the incidence of adverse events at week 12.
Results:At week 12 treatment, no significant difference was observed in CAS and exophthalmos between the two groups [CAS: (2.48 ± 0.60) , (2.20 ± 0.62) points, exophthalmos: (2.57 ± 1.02), (2.20 ± 1.09) mm, P > 0.05]. Adverse events in 99Tc-MDP group was significantly lower than that in methylprednisolone group [4.8%(1/21) vs 40.0%(8/20), P < 0.05]. At week 24, the reduction in the CAS in 99Tc-MDP group was significantly greater than that in methylprednisolone group [CAS: (3.86 ± 0.67), (3.05 ± 0.59) points, P < 0.05]. The difference in exophthalmos of patients between the two groups was not statistically significant [(3.17 ± 0.60), (2.88 ± 0.57) mm, P > 0.05]. The difference in total effective rate of patients between the two groups was not statistically significant (P > 0.05).
Conclusion:99Tc-MDP regimen could provide similar benefit to methylprednisolone pulse therapy for those patients with TAO, but with longer reduction in CAS and less adverse events.
