摘要
目的观察静脉激素冲击联合甲氨蝶呤(MTX)和单纯静脉冲击在治疗中重度活动期甲状腺相关眼病(TAO)中的作用,对比二者的有效性和安全性。方法前瞻性随机对照研究。入组患者随机分为两组:联合治疗组为4.5 g静脉激素冲击方案+口服MTX,单纯激素组为4.5 g静脉激素冲击方案+口服安慰剂;于第6周和第12周评价两组的眼部体征和全身情况,记录总体有效率和不良反应发生率。结果本研究纳入53例中重度活动期TAO患者,联合治疗组22例,第6周和第12周的总体有效率分别为68.2%和81.8%;单纯治疗组23例,第6周和第12周的总体有效率分别为56.5%和73.9%,两组总体有效率均无统计学差异(P=0.542,P=0.722),联合治疗组肝功能异常的比例较单纯治疗组高,差异有统计学意义。结论激素联合MTX治疗中重度活动期TAO患者有效,可更有效降低临床活动性评分(CAS),提高视力,改善突眼度,总体有效率与单纯静脉冲击无统计学差异;联合MTX可能存在更大的肝毒性。
Objective To study the efficacy and safety of these two protocols:intravenous corticosteroid combined with methotrexate(MTX)and intravenous corticosteroid alone in the treatment of moderate to severe thyroid-associated ophthalmopathy(TAO)in active phase,and to provide new clinical evidence.Methods This is a prospective randomized control study(RCT)among patients with moderate to severe active TAO.Patients were randomly divided into combined group(4.5 g intravenous corticosteroid regimen plus oral MTX)and glucocorticoid alone group(4.5 g intravenous corticosteroid regimen plus placebo).Ophthalmic evaluation was done at the end of 6th and 12th weeks.Efficacy rate and incidence of adverse reactions were recorded.Results 53 patients with moderate to severe active TAO were included in the RCT study.The combined group had 22 patients.At the end of 6th and 12th weeks,the overall efficiency were 68.2%and 81.8%,respectively.The systemic steroids alone group had 23 patients.At the end of 6th and 12thweeks,the overall efficiency were 56.5%and 73.9%,respectively.There was no statistically significant difference on the overall efficiency rate(P>0.05).At the end of the 12th weeks,the combined group had higher incidence of alanine aminotransferase(ALT)and aspartate aminotransferase(AST)increase as compared to the systemic steroids alone grou P(P<0.05).Conclusions Glucocorticoids combined with MTX is effective in the treatment of moderate and severe TAO patients,which can effectively reduce clinical activity score(CAS),and improve vision and the degree of exophthalmos,but there was no significant difference in efficiency compared to systemic steroids alone.The combination of MTX may lead to higher liver toxicity in terms of safety evaluation.
作者
钟思思
方思捷
孙静
李寅炜
周慧芳
Zhong Sisi;Fang Sijie;Sun Jing;Li Yinwei;Zhou Huifang(Department of Ophthalmology,Ninth People’s Hospital,Shanghai JiaoTong University School of Medicine,Shanghai 200011,China;Shanghai Key Laboratory of Orbital Diseases and Ocular Oncology,Shanghai 200011,China)
出处
《临床眼科杂志》
2023年第2期130-135,共6页
Journal of Clinical Ophthalmology
基金
国家自然基金重点项目(81930024)
上海市重点实验室资助(20DZ2270800)
上海交通大学医学院附属第九人民医院临床研究助推计划(临+计划)(JYLJ202120)。
