Impact of oral cyclophosphamide on health-related quality of life in patients with active scleroderma lung disease - Results from the scleroderma lung study
Impact of oral cyclophosphamide on health-related quality of life in patients with active scleroderma lung disease - Results from the scleroderma lung study
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DOI：
10.1002/art.22580
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发表时间：
2007-05-01
影响因子：
--
通讯作者：
Clements, Philip J.
中科院分区：
文献类型：
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作者：
Khanna, Dinesh;Yan, Xiaohong;Clements, Philip J.
Objective.评估环磷酰胺（CYC）治疗12个月后对硬皮病患者健康相关质量（HRQOL）的影响。158例受试者参加了硬皮病肺研究，其中79例随机分配至CYC组和安慰剂组。该研究评估了3项健康状况指标的结果：简明健康状况量表（SF-36）、健康评估问卷（HAQ）残疾指数（131）和马勒呼吸困难指数，以及基于偏好的SF-6D指标的结果。使用线性混合模型计算12个月时两组间HRQOL的差异。使用效应量评价反应性。评估每个治疗组中评分改善至少等于或超过HRQOL测量的最小临床重要差异（MCID）的受试者比例。调整基线评分后，CYC组与安慰剂组相比，HAQ DI、SF-36角色身体、一般健康、活力、角色情感、心理健康量表和SF-36心理健康总评（MCS）评分的差异具有统计学意义（P < 0.05）。12个月时SF-36、HAQ DI和SF-6D所有量表的效应量可忽略不计（< 0.20）。相比之下，接受CYC治疗的患者在HAQ DI评分（30.9% vs 14.8%）、过渡期呼吸困难指数评分（46.4% vs 12.7%）、SF-36 MCS评分（33.3% vs 18.5%）和SF-6D评分（21.3% vs 3.8%）方面达到MCID的比例高于安慰剂组。CYC治疗一年可改善硬皮病肺病患者的HRQOL。
Objective. To assess the impact of cyclophosphamide (CYC) on the health-related quality of (HRQOL) of patients with scleroderma after 12 months of treatment.Methods. One hundred fifty-eight subjects participated in the Scleroderma Lung Study, with 79 each randomized to CYC and placebo arms. The study evaluated the results of 3 measures of health status: the Short Form 36 (SF-36), the Health Assessment Questionnaire (HAQ) disability index (131), and Mahler's dyspnea index, and the results of I preference-based measure, the SF-6D. The differences in the HRQOL between the 2 groups at 12 months were calculated using a linear mixed model. Responsiveness was evaluated using the effect size. The proportion of subjects in each treatment group whose scores improved at least as much as or more than the minimum clinically important difference (MCID) in HRQOL measures was assessed.Results. After adjustment for baseline scores, differences in the HAQ DI, SF-36 role physical, general health, vitality, role emotional, mental health scales, and SF-36 mental component summary (MCS) score were statistically significant for CYC versus placebo (P < 0.05). Effect sizes were negligible (< 0.20) for all of the scales of the SF-36, HAQ DI, and SF-6D at 12 months. In contrast, a higher proportion of patients who received CYC achieved the MCID compared with placebo in the HAQ DI score (30.9% versus 14.8%), transitional dyspnea index score (46.4% versus 12.7%), SF-36 MCS score (33.3% versus 18.5%), and SF-6D score (21.3% versus 3.8%).Conclusion. One year of treatment with CYC leads to an improvement in HRQOL in patients with scleroderma lung disease.