放射学阴性中轴型脊柱关节炎患者治疗模式与疾病负担研究  

Research on Treatment Pattern and Disease Burden in Patients with Non-Radiographic Axial Spondyloarthritis

作　　者：许晓洋 王蕾 贺小宁[1,2] 徐胜前[3] 王勇 程永静[5] 吴晶 XU Xiao-yang;WANG Lei;HE Xiao-ning;XU Sheng-qian;WANG Yong;CHENG Yong-jing;WU Jing(School of Pharmaceutical Science and Technology,Tianjin University;Center for Social Science Survey and Data,Tianjin University;Rheumatology Immunology Department,the First Affiliated Hospital of Anhui Medical University;Rheumatology Immunology Department,the First Affiliated Hospital of Army Medical University;Rheumatology Immunology Department,Being Hospital)

机构地区：[1]天津大学药物与科学技术学院 [2]天津大学社会科学调查与数据中心 [3]安徽医科大学第一附属医院风湿免疫科 [4]陆军军医大学第一附属医院风湿免疫科 [5]北京医院风湿免疫科

出　　处：《中国食品药品监管》2023年第10期140-149,共10页China Food & Drug Administration Magazine

基　　金：天津市科技计划项目(21JCQNJC00660)。

摘　　要：目的:探究我国放射学阴性中轴型脊柱关节炎(nr-axSpA)患者的治疗模式与疾病负担。方法:选取安徽、重庆、北京某3家三甲医院2022年6月1日~2022年11月30日期间收治的nr-axSpA成人患者为研究对象,采用问卷调查的方式收集患者基线特征、用药情况、医疗资源使用和费用、疾病活动度和健康相关生命质量信息,其中疾病活动度和健康相关生命质量分别通过Bath强直性脊柱炎疾病活动指数(BASDAI)、第2版六维健康调查简表(SF-6Dv2)进行评估,SF-6Dv2获得的数值为健康效用值。结果:共纳入患者61例,平均年龄为(29.30±7.61)岁,男性患者27例(44.3%),女性患者34例(55.7%),平均延迟诊断(16.31±24.59)个月。分别有93.4%和68.9%的患者在首次治疗时使用非甾体抗炎药(NSAIDs)和生物制剂改善病情抗风湿药物(DMARDs)。总人群月人均门诊次数为(1.19±1.14)人次,44.3%患者因nr-axSpA误工或失业。确诊时长≥1年患者(n=40)年人均门诊次数为(7.80±3.94)人次,总费用达(36550±56198)元,其中直接医疗费用为(25895±37735)元(总药品费用占71.0%)。总人群平均BASDAI得分为(2.44±1.85)分,平均健康效用值为(0.696±0.174)。结论:现阶段我国治疗nr-axSpA所用药物以NSAIDs、生物制剂DMARDs为主,其中生物制剂DMARDs为超适应症使用。患者经济负担重,健康相关生命质量差,提示我国nr-axSpA患者的诊疗情况仍有待进一步改善。Objective:This study aims to evaluate real world treatment pattern and disease burden among patients with nonradiographic axial spondyloarthritis(nr-axSpA)in China.Methods:This study focuses on adult patients diagnosed with nraxSpA and recruited from three tertiary hospitals in Anhui,Chongqing,and Beijing between June 1,2022,and November 30,2022.A questionnaire survey is conducted to gather patient's baseline characteristics,medication use,healthcare resource usage and costs,disease activity,and health-related quality of life.The Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)and the Short-Form Six-Dimension Version 2(SF-6Dv2)are used to measure disease activity and health-related quality of life,respectively.Health utility values are used to represent SF-6Dv2 scores.Results:A total of 61 patients are included,with a mean age of(29.30±7.61)years,27(44.3%)males and 34(55.7%)females,and a mean delay in diagnosis of(16.31±24.59)months.Nonsteroidal anti-inflammatory drugs(NSAIDs)are used as the initial treatment by 93.4%of patients,while 68.9%of patients receive biologic disease-modifying antirheumatic drugs(DMARDs).The average monthly outpatient visits per person for the total population are 1.19±1.14,and 44.3%of patients experienced work loss or unemployment because of nr-axSpA.The average annual outpatient visits per person are 7.80±3.94 and the total cost is¥36550±56198 for patients diagnosed for≥1 year(n=40),with direct medical costs accounting for¥25895±37735(71.0%attributed to total medication costs).The mean BASDAI score is(2.44±1.85)and the average health utility value is(0.696±0.174).Conclusion:The drugs used to treat nr-axSpA in China are primarily NSAIDs and biologic DMARDs currently,with biologic DMARDs being used off-label.The study highlights the high economic burden and poor quality of life of patients,suggesting the need for further improvement in the diagnosis and treatment of nr-axSpA in China.

关 键 词：放射学阴性中轴型脊柱关节炎 治疗模式 经济负担 健康相关生命质量 真实世界研究 

分 类 号：R681.51[医药卫生—骨科学]