我国类风湿关节炎患者羟氯喹使用的现状调查

The investigation of hydroxychloroquine usage in patients with rheumatoid arthritis in China

目的了解我国类风湿关节炎（RA）患者羟氯喹使用的现状及特点。方法现场调查全国20家大型医院风湿科就诊的858例RA患者，记录患者的一般人口学特征、临床病情活动度、羟氯喹用药情况以及不良反应等。采用SPSS20．0软件根据不同数据特点进行Mann—WhimevU检验、x^2检验及回归分析等。结果①羟氯喹在我国RA患者中使用方案较规范，使用率为19．5％（167／858），64．7％（108／167）达到足疗程，77．8％（130／167）达到推荐剂量，94．6％（158／167）为联合用药，最常用的联合药物为甲氨蝶呤和来氟米特。②足疗程使用羟氯喹的RA患者多项疾病活动指标得到明显改善，包括晨僵时间（U=I670．5，P〈0．05）、压痛关节数（U=I380．5，P〈0．01）及肿胀关节数（U=67974．5，P〈0．01）、患者视觉模拟评分（VAS）疼痛评分（U=2086．0，P=-0．01）、患者VAS疾病活动评分（U=2181．5，P〈0．05）、医生VAS疾病活动评分（U=2086．5，P〈0．05）、28个关节疾病活动指数（DAS28）评分（U=827．5，P〈0．01）、斯坦福健康评定量表（HAQ）评分（U=I855．5，P〈0．01）、红细胞沉降率（U=1231．0，P〈0．05）。③羟氯喹总体不良反应发生率为5．4％（9／167），最常见眼部受累（包括眼底黄斑变性、眼前闪光、眼异物感）及过敏反应、发生率分别为1．8％（3／167）及1．2％（2／167）。结论在我国大型医院就诊的RA患者中有19．5％使用羟氯喹，其中94．6％为联合用药。羟氯喹足疗程使用疗效肯定；总体不良反应发生率低，无严重不良反应。

Objective To investigate the clinical usage of hydroxychloroquine （HCQ） in patients with rheumatoid arthritis （RA）. Methods Data were obtained from 858 RA patients, who were randomly selected from Department of Rheumatology in 20 university hospitals in China. Data on social status, clinical condi- tions, strategy of combination therapy, and adverse events were collected. All analysis were performed using SPSS version 20.0. Demographic data was presented by descriptive analysis. Mann-Whitney U-test was used for categorical data analysis. Chi-square was used to assess the differences between the groups. Results Among 858 RA patients enrolled in the study, 19.5%（167/858） had received HCQ therapy, the majority 64.7% （108/167） of the patients were administered continued HCQ treatment for at least 3 months, 77.8%（130/167） were administered the recommended dose of 6.5 mg·kg^-1 ·d^-1 and 94.6%（158/167） of the patients were administered HCQ combined with methotrexate （MTX） or leflunomide （LEF）. Only 9 patients received HCQ monotherapy. Adequate duration of HCQ was benefits to RA patients in the duration of morning stiffness （U=1 670.5, P〈0.05）, tender joint counts （U=1 380.5, P〈0.01） and swollen joint counts （U=67 974.5, P〈0.01 ）, VAS pain score （U=2 086.0, P=0.01 ）, patient rating VAS（U=2 181.5, P〈0.05）, physician rating VAS （U=2 086.5, P〈0.05）, DAS28 score （U=827.5, P〈0.01）, HAQ score （U=1 855.5, P〈0.01） and ESR （U=1 231.0, P〈0.05）. The incidence of adverse events of HCQ was 5.4%（9/167）. Ocular toxicity （such as maculopathy, photopsia and intraocular foreign body sensation） and allergy were the main side effects with the incidence of 1.8%（3/167） and 1.2%（2/167）, respectively. Conclusion 19.5% of RA patients in China have received HCQ treatment, 94.6% of whom have received combination therapy. Patients who have been treated for the recommended duration of HCQ are greatly improved in disease activity and maintenance of joint function. The incidence of adverse events in HCQ therapy is low, which is 5.4% among patients with RA in China.