两种剂量泼尼松对131I治疗后Graves’眼病的保护作用比较

Preventive effects of different dose prednisone on Graves' ophthalmopathy following 131I treatment

目的比较小剂量泼尼松(起始约0.2mg/kg/d)与标准剂量的泼尼松(起始约0.4mg/kg/d)对131I治疗后Graves’眼病(Graves’orbitopathy,GO)的保护作用。方法进行前瞻性随机对照试验纳入行131I治疗的伴轻度活动性GO的Graves’甲亢患者,试验组35例131I治疗后2d开始口服小剂量泼尼松,每2周逐渐减量5mg至2个月停药;对照组35例口服标准剂量泼尼松,其余方法同试验组。评估两组患者治疗后6个月时GO变化以及泼尼松的副作用。结果两组患者基线特征差异无显著性。治疗后6个月比较试验组与对照组CAS评分(1.6±0.7 vs 1.3±0.9)、眼球突出度(20.8±0.9mm vs 18.3±1.0mm)、睑裂宽度(11.6±1.7mm vs 9.8±1.5mm),差异均有统计学意义(P<0.05),试验组上述GO指标的改善程度均低于对照组(P<0.05)。最终,试验组GO好转8例(22.9%),稳定23例(65.7%),恶化4例(11.4%);对照组好转24例(68.4%)、稳定11例(31.6%),无1例GO新发或者恶化;两组比较差异均有统计学意义(P<0.01)。副作用都较轻,但对照组比试验组副作用更多(63.1%vs 30.5%,P<0.05),体重增加更明显(3.8±1.8kg vs 1.4±1.2kg;P<0.05),两组患者收缩压和舒张压均轻度上升(中位10mm Hg)。结论对有轻度活动性GO的GD患者使用标准剂量、2个月疗程的泼尼松有效防止了131I治疗后GO恶化并有效改善了GO,而小剂量泼尼松的作用明显不足;但需要进一步的研究来减少糖皮质激素的副作用。

Objective To evaluate the protective effect of low dose prednisone （starting dose about 0.2mg/kg/d） and standard dose prednisone （starting dose about 0.4mg/kg/d） for Graves＇ ophthalmopathy after 131I treatment. Methods This was a prospec- tive randomized controlled trial,and it included 70 consecutive patients who underwent 131I treatment with mild active GO ran- domized into： 1）experimental group （35 subjects who received low dose prednisone （starting dose,0.22~0.03mg/kg））;2）controlled group （35 subjects who received standard dose prednisone （starting dose,0.43±0.04mg/kg））. Prednisone was started 2d after 131I and withdrawn after 2 months. We assessed ocular changes ,the overall GO outcome （2,4 and 6months after 131I） and side effects of prednisone. Results Baseline characteristics of the patients indicated that no significant difference was present between the two groups. At 6 months,GO was found to be improved in 22.9% of the experimental group and 68.4% of the controlled group pa- tients. 4 patients （11.4%） with progression GO were observed in the experimental group. The remaining patients in the two groups were found to be stable （65.7% and 31.6%）. A more significant reduction in CAS （1.6±0.7 vs 1.3±0.9）,proptosis （20.8±0.9mm vs 18.3＋l.0mm） and eyelid width （11.6±1.7mm vs 9.8±1.5mm） was observed in the controlled group from the evaluation at 6 months. No significant variations in lid width or exophthalmos occurred in the experimental group. Side effects attributable to prednisone were mild and inconstant, but more frequent in controlled group （63.1% vs 30.5% ,P〈0.05 ）. There was an overall increase in bw in both groups, significantly greater in controlled group than in experimental group （2.8 vs 1.4 kg,P〈0.05）. Neither SBP nor DBP was increased after prednisone treatment in either group （mean 10mmHg）. Conclusion Standard doses of oral prednisone（about 0.4mg/ kg bw） with a shorter period （2 months） has exhibited definitive effects in preventing mild active GO progression after 131I treat- ment. However,low dose prednisone does not result in any significant preventive effect and is inadequate. Still,further studies are needed to reduce the side effects of prednisone.