Course of the Modified Rodnan Skin Thickness Score in Systemic Sclerosis Clinical Trials Analysis of Three Large Multicenter, Double-Blind, Randomized Controlled Trials
Course of the Modified Rodnan Skin Thickness Score in Systemic Sclerosis Clinical Trials Analysis of Three Large Multicenter, Double-Blind, Randomized Controlled Trials
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DOI：
10.1002/art.24681
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发表时间：
2009-08-01
影响因子：
--
通讯作者：
Khanna, Dinesh
中科院分区：
文献类型：
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作者：
Amjadi, Sogol;Maranian, Paul;Khanna, Dinesh
Objective.在3项针对不同基线病程的弥漫性皮肤系统性硬化症（dcSSc）患者的大型、多中心、双盲、随机对照试验（RCT）中评估改良Rodnan皮肤厚度评分（MRSS）的病程，从首次dcSSc症状发作之日起定义（不包括雷诺现象）或从第一次dcSsc相关症状（包括雷诺现象）发作之日起。汇总并分析了来自3项RCT的数据，这些RCT检查了dcSSc患者中高剂量与低剂量D-青霉胺（D-Pen试验）、重组人松弛素与安慰剂（松弛素试验）以及口服牛I型胶原蛋白与安慰剂（胶原蛋白试验）治疗。根据基线时的疾病持续时间将患者分为5组。相关数据的线性混合模型用于模拟MRSS的2个预测因素：研究时间（以基线后的月数表示）和基线疾病持续时间（以月数表示，从伴有和不伴有雷诺现象的dcSSc的首次症状特征发作日期计算）。进入研究时，D-Pen试验队列的平均MRSS值为21.0，Relaxin试验队列为27.3，胶原蛋白试验队列为26.1。研究时间是MRSS改善的重要预测因素，与基线时疾病持续时间无关（P < 0.0001）。病程>= 24个月的患者比病程<24个月的患者下降速度更快。
Objective. To assess the course of the modified Rodnan skin thickness score (MRSS) in 3 large, multi-center, double-blind, randomized controlled trials (RCTs) of patients with diffuse cutaneous systemic sclerosis (dcSSc) with different baseline disease durations, as defined from the date of onset of the first dcSSc symptom (excluding Raynaud's phenomenon) or from the date of onset of the first dcSSc-related symptom (including Raynaud's phenomenon).Methods. Data from 3 RCTs examining high-dose versus low-dose D-penicillamine (D-Pen Trial), recombinant human relaxin versus placebo (Relaxin Trial), and oral bovine type I collagen versus placebo (Collagen Trial) treatment in patients with dcSSc were pooled and analyzed. Patients were divided into 5 groups according to their disease duration at baseline. The linear mixed model for correlated data was used to model the 2 predictors of MRSS: time in study (expressed in months after baseline) and baseline disease duration (expressed in months, calculated from the date of onset of the first symptom characteristic of dcSSc with and without Raynaud's phenomenon).Results. At study entry, the mean MRSS value was 21.0 in the D-Pen Trial cohort, 27.3 in the Relaxin Trial cohort, and 26.1 in the Collagen Trial cohort. Time in study was a significant predictor of improvement in MRSS regardless of the disease duration at baseline (P < 0.0001). Patients with a disease duration of >= 24 months showed a greater rate of decline as compared with patients with a disease duration of