Bellando-Randone S, Wilhalme H, Bruni C, Czirjak L, Distler O, Allanore Y, Cuomo G, Denton C, Del Galdo F, Gheorghiu A M, Riccieri V, Walker U, Truchetet M E, Vonk M C, Foeldvari I, Matucci-Cerinic M, Furst D E
Department of Experimental and Clinical Medicine, University of Florence, Division of Rheumatology Scleroderma Unit, AOU Careggi Hospital, Florence, Italy.
Department of Medicine, Div. of Rheum., UCLA, California, USA.
Arthritis Res Ther. 2025 Mar 27;27(1):66. doi: 10.1186/s13075-025-03476-0.
To evaluate the use of hydroxychloroquine (HCQ) and its impact on the Health Assessment Questionnaire disability index(HAQ-DI) and the Cochin Hand Function Status(CHFS) in a large Systemic Sclerosis (SSc) cohort.
SSc patients from the European Scleroderma Trials and Research (EUSTAR) database treated with HCQ for at least 6 months were evaluated and compared to a matched group of SSc patients not using HCQ. Demographic and clinical data, concomitant drugs, HAQ-DI and CHFS (at least 2 evaluations) were recorded and were the outcome variables of interest. Statistical analysis was performed using propensity score matching for age, gender, disease duration, corticosteroids, immunosuppressives, vasoactive drugs in a 3:1 control: HCQ ratio. Standard descriptive statistics and Student's t-test and Chi-square test were used to assess the propensity-matched groups.
Out of 17,805 SSc patients evaluated, 468 (2.6%) used HCQ and constituted the HCQ group. Among them, 50 (10.7%) had at least a baseline and follow-up HAQ-DI evaluation and 44 (9.4%) had at least a baseline and follow-up CHFS evaluation. Propensity matching assured that patients were matched for female gender (HCQ vs. control 92.0% vs. 85.3%), mean age (49.8 vs. 50.0 years) disease duration (8.3 vs. 9.1 years), limited disease (55.3 vs. 62.6%) as well as background medications (all P > 0.1). We did not find any significant differences among the two groups in the change of HAQ-DI or CHFS, over up to 365 days (all P > 0.05).
Results from the EUSTAR registry showed that HCQ was used by 2.6% of SSc patients. HCQ use did not improve the HAQ-DI, or CHFS when comparing HCQ users to non-HCQ users.
评估羟氯喹（HCQ）的使用情况及其对一大群系统性硬化症（SSc）患者的健康评估问卷残疾指数（HAQ-DI）和科钦手功能状态（CHFS）的影响。
对欧洲硬皮病试验与研究（EUSTAR）数据库中接受HCQ治疗至少6个月的SSc患者进行评估，并与未使用HCQ的匹配SSc患者组进行比较。记录人口统计学和临床数据、伴随用药、HAQ-DI和CHFS（至少2次评估），这些是感兴趣的结局变量。使用倾向评分匹配法，按照3:1的对照:HCQ比例，对年龄、性别、病程、皮质类固醇、免疫抑制剂、血管活性药物进行匹配。采用标准描述性统计以及Student t检验和卡方检验来评估倾向匹配组。
在评估的17805例SSc患者中，468例（2.6%）使用HCQ，构成HCQ组。其中，50例（10.7%）至少有一次基线和随访HAQ-DI评估，44例（9.4%）至少有一次基线和随访CHFS评估。倾向匹配确保患者在性别（HCQ组与对照组分别为92.0%对85.3%）、平均年龄（49.8岁对50.0岁）、病程（8.3年对9.1年）、局限性疾病（55.3%对62.6%）以及背景用药方面相匹配（所有P>0.1）。在长达365天的时间里，两组之间在HAQ-DI或CHFS的变化方面未发现任何显著差异（所有P>0.05）。
EUSTAR注册研究的结果显示，2.6%的SSc患者使用HCQ。与未使用HCQ的患者相比，使用HCQ并未改善HAQ-DI或CHFS。
