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奥曲肽和泼尼松治疗甲状腺相关性眼病的随机对照研究 被引量:15

Randomized control trial of subcutaneous octreotide and oral prednisone in treatment of thyroid eye disease
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摘要 目的 :比较奥曲肽与泼尼松治疗活动性甲状腺相关性眼病 (TED)的疗效及安全性。 方法 :18例活动性 TED患者(甲状腺功能维持正常至少 2个月 ) ,随机分成两组 ,每组 9例。两组年龄、性别、眼病病程及严重程度可比。均为非吸烟者。奥曲肽组给予奥曲肽 10 0μg,sc,8h/次 ,共 12周。泼尼松组给予泼尼松口服 12周 (6 0 mg/ d× 2周 ,4 0 mg/ d× 2周 ,30 m g/ d× 4周 ,2 0 mg/ d× 4周 )。疗效评定依据 TED分级、分度变化及临床活动性评分变化综合评定。结果 :(1)两组总有效率 (显效 +有效 )相同 ,均为 6 7%。有效者软组织炎症、突眼、眼肌运动、角膜受累及视力均有改善。泼尼松组不良反应较奥曲肽组多且严重。(2 )两组无效者在 12周试验结束时均采用两药联合 (奥曲肽 10 0μg,sc,8h/次 ;泼尼松 15 mg/ d,po)治疗 12周 ,奥曲肽组 3例中 2例有效 ,1例无效转眼眶放疗 ;泼尼松组 3例均有效。结论 :奥曲肽和泼尼松治疗 TED疗效相同 ,但奥曲肽耐受性优于泼尼松。联合治疗对单药治疗无效者有效 ,且耐受性优于单用泼尼松。 Objective: To compare the efficacy and safety of subcutaneous octreotide with those of oral prednisone in treating moderately severe thyroid eye disease (TED). Methods:Patients ( n =18) with active TED (being euthyroid for at least 8 weeks) were randomly divided into 2 groups. The 2 groups were similar in age, sex, the duration and severity of ophthalmopathy. Patients ( n =9) of octreotide group [M 5, F 4; age (38±6) yr, ranging 22 48 yr] were treated with octreotide 100 μg, sc, q 8 h for 12 weeks. The other 9 patients in prednisone group [M 5, F 4; age (38±8) yr, ranging 23 51 yr] were treated with oral predisone for 12 weeks: 60 mg for the first 2 weeks, 40 mg for 2 weeks, 30 mg for 4 weeks, and 20 mg for 4 weeks. Therapeutic outcome, assessed 12 weeks after the start of treatment, was determined by the change in the highest NOPSECS class and clinical activity score (CAS). Results: A successful outcome was observed in 6 octreotide treated and 6 prednisone treated patients (Ridit's analysis, P >0.05). Responders to treatment in both groups showed improvements in soft tissue involvement, proptosis, eye muscle motility, corneal involvement and visual acuity. Side effects were more frequent and severe in prednisone than in octreotide. Among the 3 patients who initially received octreotide, the addition of prednisone resulted in improvement in 2, the other patient showed no improvement and underwent orbital radiotherapy; among the 3 patients who received prednisone initially, all improved after the addition of prednisone. Conclusion: (1)Subcutaneous octreotide and oral prednisone appear to be equally effective as initial treatment in patients with moderately severe TED. In view of its better tolerability, octreotide should be considered the alternative treatment.(2) Combination therapy of octrotide and prednisone appears to be effective in patients that do not respond to either drug alone and is better tolerated than prednisone therapy alone. Octreotide may be a safe and effective drug in treating active TED.
出处 《第二军医大学学报》 CAS CSCD 北大核心 2002年第5期540-543,共4页 Academic Journal of Second Military Medical University
基金 国家自然科学基金资助项目 (3 9770 70 1)
关键词 奥曲肽 泼尼松 甲状腺相关性眼病 随机对照试验 用药安全 自身免疫性疾病 octreotide prednisone thyroid eye disease randomized control trial
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