【摘要】 目的多中心调查苏州地区风湿科羟氯喹(HCQ)的应用情况及长期应用的疗效与安全性。方法回顾性收集2017年6月至2018年7月就诊于苏州4家综合性医院风湿科(苏州大学第一附属医院、苏州市中医院、昆山市第一人民医院、常熟市第一人民医院)门诊及住院患者。采用专门设计的调查问卷收集一般情况、诊断、羟氯喹使用方法与疗程、用药持续性、疗效与依从性、合并用药、用药过程中眼科及各系统的不良反应、妊娠期使用情况等。结果共纳入856例,其中男性68例(7.9%),女性788例(92.1%)。疾病分类:类风湿性关节炎(RA,含RA继发干燥综合征)147例,系统性红斑狼疮(SLE)425例,抗磷脂抗体综合征(APS)12例,原发性干燥综合征(pSS)167例,其他104例,重叠综合征(RA合并SLE)1例。HCQ用药疗程:最短0.5年,最长22.75年,平均(3.59±3.08)年。用药剂量:0.2g/d 604例,0.4g/d 424例;先后使用0.4g和0.2g的共193例;其他21例。连续使用721例。出现不良反应183例,其中男7例,女176例。分布于RA 30例,SLE 105例,APS 2例,SS 31例,其他15例。眼科不良反应70例次,相关性肯定4例次。眼科检查:每年1次121例(14.1%),每2年1次68例(7.9%)。皮肤不良反应92例次,相关性肯定8例次。其他系统不良反应少且均不能做出肯定性相关判断。连续用药、合并抗风湿药物与总不良反应相关联且连续用药或合并抗风湿药物分别与眼科、皮肤不良反应显著相关联。眼科不良反应与用药疗程相关联,服药7年以上眼底不良反应增高。合并妊娠37例,妊娠期全程使用HCQ 17例,仅见非药物相关新生儿缺陷1例。结论 HCQ在苏州地区风湿科主要用于治疗SLE、SS、RA、APS,HCQ用药规范但眼科随诊监测多不规范。不良反应以皮肤和眼科为主,连续用药、合并抗风湿药物是不良反应关联因素。长期使用HCQ的安全性和耐受性较好。更多还原

【Abstract】 Objective A multicenter survey is conducted to study the application,the long-term effect and safety of hydroxychloroquine(HCQ)in the treatment of rheumatic diseases in Suzhou. Methods Retrospectively collect the data of outpatients and inpatients from Rheumatology Department of four general hospitals in Suzhou(the First Affiliated Hospital of Suzhou University, and Suzhou Hospital of Traditional Chinese Medicine, the First People’s Hospital of Kunshan, the First People’s Hospital of Changshu)from June 2017 to July 2018. A special questionnaire was used to collect data on general information, diagnosis, methods and courses in the use of hydroxychloro-quine, duration, efficacy and compliance, combined medication, adverse reactions of ophthalmology and other systems, and the use of hydroxychloroquine(HCQ)during pregnancy.Result Totally there were 856 cases, including 68 males(7.9%)and 788 females(92.1%).Classification of diseases: 147 cases of RA(including secondary SS of RA), 425 cases of SLE,12 cases of APS, 167 cases of PSS,104 cases of others, and 1 case of overlap syndrome(RA with SLE)The treatment course of HCQ: minimum 0.5 years, maximum 22.75 years, with an average of 3.59(SD=3.08)years.Dosage: 0.2 g/day in 604 cases, 0.4 g/day in 424 cases, 193 cases of using 0.4 and 0.2 successively, and 21 in other cases;721 cases used continuously. There were adverse reactions in 183 cases(7 males and 176 females), which were distributed in 30 cases of RA, 105 cases of SLE, 2 cases of APS, 31 cases of SS and 15 other cases. Ophthalmological adverse reactions occurred in 70 cases, with positive correlation in 4 cases. Ophthalmological examination: 121 cases(14.1%)every year;68 cases(7.9%)every two years. There were 92 cases of adverse skin reactions, with 8 cases of positive correlation. Other systems had few adverse reactions and there was no positive correlation. Continuous medication, combination of anti-rheumatic drugs and adverse reactions were associated, and continuous medication or combination of anti-rheumatic drugs were significantly associated with adverse reactions in ophthalmology and skin, respectively. The adverse reactions of ophthalmology were related to the course of treatment, and the adverse reactions of fundus increased after taking medicine for more than 7 years.There were 37 pregnancies and HCQ was used in 17 cases throughout pregnancy, and only 1 case had non-drug-related neonatal defects. Conclusion HCQ is mainly used in the treatment of SLE, SS, RA and APS in Rheumatology Department in Suzhou. HCQ medication is standardized, but ophthalmic follow-up monitoring is not. Adverse reactions are mainly in skin and ophthalmology. Continuous medication and combination of antirheumatic drugs are associated factors of adverse reactions.Long-term treatment with HCQ is safe and well-toleratrd.更多还原