痛风达标治疗人群用药真实情况分析:多中心真实世界研究结果

Analysis of the real situation of medication in the population with gout achieving T2T indicators:a multicentre real-world study

目的通过真实世界方法研究,运用数据挖掘探索痛风达标治疗人群的治疗特点和规律,并评价其安全性。为临床痛风的达标、安全治疗及管理提供指导依据。方法本研究基于医院信息系统(HIS)中临床真实世界数据,收集多家医院风湿免疫科2015年1月至2021年12月以痛风为诊断的门诊治疗患者,将其在门诊治疗中产生的临床数据建立数据库。使用SPSS及Excel软件,采取频数分析、聚类分析、因子分析,总结经治疗后达标的痛风患者的治疗措施特点及规律。记录治疗过程中的不良事件(AE)发生情况。结果共纳人痛风患者3287例,随访诊次9861个。其中治疗后血清尿酸(SUA)达标诊次占比为7.01%(691/9861),关节疼痛表现视觉模拟评分(VAS)达标占比为59.81%(5898/9861)。治疗后SUA控制达标诊次691个,降尿酸药物中使用频次最高的是非布司他,其次为苯溴马隆。高频治疗措施中,使用系统聚类分析的方法进行挖掘分析,发现6组治疗方案:①中药饮片-中医技术-生活干预措施-中成药,②阿魏酸哌嗪片-NSAIDs,③别嘌醇-碳酸氢钠,④苯溴马隆,⑤激素-秋水仙碱,⑥非布司他。同时采取因子分析,提取5个公因子。关节疼痛表现VAS评分控制达标诊次共5898个,使用频次最高的控制症状药物为NSAIDs。高频治疗措施中,使用系统聚类分析的方法进行挖掘,发现5组治疗方案:①中成药-中药饮片-中医技术-生活干预措施,②NSAIDs-秋水仙碱-激素,③别嘌醇,④苯溴马隆,⑤非布司他。整体治疗过程中共有59例AE发生。结论本次研究显示痛风患者的SUA达标率很低,关节炎控制欠佳,治疗中降尿酸药物使用率偏低,降尿酸治疗和抗炎处方模式均与国际指南存在较大差异,因此需加强痛风患者规范管理。同时生活干预措施在有限的达标人群治疗方案中均占有一席之地,需要进一步深入探索。

Objective To explore the therapeutic characteristics of population with gout achieving treat-to-target(T2T)indicators through real-world research and evaluate their safety.Methods A total of 3287 patients diagnosed with gout by rheumatologists in 21 first-class tertiary hospitals in 10 provinces,municipalities,and autonomous regions in China from January 2015 to December 2021 were included in this polycentric cross-sectional study.The database included patients'general information,disease characteristics,and clinical application of traditional Chinese and Western medicine treatment measures.SPSS and Excel software were used for data analysis.Frequency analysis,cluster analysis,and factor analysis were used to summarize the characteristics and rules of treatment measures for patients with gout who achieved the target after treatment.The occurrence of adverse events(AE)was recorded during treatment.Results After treatment,691 visits(7%)achieved the serum urate(SUA)target,and the most frequent use of urate-lowering therapy(ULT)was febuxostat,followed by benzbromarone.The most common treatment options were following:Group I:traditional Chinese medicine(TCM)decoction-TCM external treatment-physical exercise-proprietary Chinese medicine;Group I:ferulic acid-nonsteroidal anti-inflammatory drugs(NSAIDs);Group II:allopurinolsodium bicarbonate-benzbromarone;Group IV:glucocorticoid-colchicine;Group V:febuxostat.A total of 5898 visits(60%)chieved manifestations of joint pain VAS scores target,and the most frequently used drug to control joint symptoms was NSAIDs.The frequency of use of drugs to control joint symptoms were 2118 times(usage rate reached 35.9%),while the frequency of ULT were 2504 times(usage rate reached 42.5%),which was higher than the joint symptom control drug.The most common treatment options were following:Group Ⅰ:proprietary Chinese medicine-TCM decoction-TCM external treatment-physical exercise;Group Ⅱ:NSAIDscolchicine hormones;Group Ⅲ:allopurinol,Group Ⅳ:benzbromarone;Group Ⅴ:febuxostat.A total of 59 adverse events occurred during treatment.Conclusion The proportions of gout patients who reach target serum urate level&good control of joint symptoms are both very low,and ULT and anti-inflammatory prescription patterns are very different from international guidelines,so it is necessary to strengthen the standardized management of gout patients.At the same time,life intervention measures account for a certain proportion of the treatment plans for the T2T population,and further exploration is needed.