Efficacy between high and medium doses of glucocorticoid therapy in remission induction of IgG4-related diseases: a preliminary randomized controlled trial
Efficacy between high and medium doses of glucocorticoid therapy in remission induction of IgG4-related diseases: a preliminary randomized controlled trial
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高剂量和中剂量糖皮质激素治疗诱导 IgG4 相关疾病缓解的疗效：初步随机对照试验
DOI：
10.1111/1756-185x.13088
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发表时间：
2017-05-01
影响因子：
2.5
通讯作者：
Zhang, Wen
中科院分区：
文献类型：
--
作者：
Wu, Qingjun;Chang, Jie;Zhang, Wen
目的：为评价高、中剂量糖皮质激素治疗IgG 4-RD的疗效和安全性，采用随机对照研究方法，将初诊IgG 4-RD患者随机分为高剂量泼尼松组（0.8- 1.0mg/kg/d）和中剂量泼尼松组（0.5- 0.6mg/kg/d）。在第0、4、12和24周对患者进行评估。主要结局是第24周的缓解率。次要终点包括IgG 4-RD应答指数（IgG 4-RD RI）、IgG和IgG 4水平。第24周时，高剂量组和中剂量组的总有效率分别为95%和80%。两组之间无显著差异。高剂量组IgG 4-RD RI从14.9降至3.0，中剂量组从13.1降至3.2。第24周时，两组的IgG 4平均水平分别从1576 mg/dL降至324 mg/dL和从1445 mg/dL降至684 mg/dL。复发患者的基线IgG 4-RD RI较高。结论：高、中剂量糖皮质激素组诱导缓解效果相似。然而，基线时受累器官较多和IgG 4-RD RI评分较高的患者可能在大剂量糖皮质激素诱导缓解时获得更多益处。
Aim: In order to evaluate the efficacy and safety of high versus medium doses of glucocorticoid therapy in remission induction of immunoglobulin G4-related disease (IgG4-RD), we set up a randomized controlled study.Method: Newly diagnosed IgG4-RD patients were randomly assigned to two groups: high doses of prednisone (0.8-1.0 mg/kg/day) and medium doses (0.5-0.6 mg/kg/day). Patients were assessed at weeks 0, 4, 12 and 24. The primary outcome was the remission rate at week 24. The secondary endpoints included IgG4-RD responder index (IgG4-RD RI), IgG and IgG4 levels.Results: Twenty cases in each group finished the study. At week 24, the total response rates were 95% and 80% in high and medium dose groups, respectively. There was no significant difference between the two groups. IgG4-RD RI reduced from 14.9 to 3.0 in the high dose group, while in the medium dose group it was from 13.1 to 3.2. At week 24, the average level of IgG4 reduced from 1576 to 324 mg/dL and from 1445 to 684 mg/dL in the two groups, respectively. Relapsed patients had higher baseline IgG4-RD RI. There was no severe adverse effect shown in both groups.Conclusion: The effect of remission induction was similar in high and medium glucocorticoid groups. However, patients with more organs involved and higher IgG4-RD RI score at baseline might get more benefit with high dose glucocorticoid for remission induction.