CAJ | 학술논문

目的评价依那西普在中国RA及AS患者中的用药现状、依从性和不良反应.方法本研究为多中心、开放、观察性研究,对象为临床接受依那西普治疗并获得知情同意的RA及AS成年患者.研究者根据RA及AS患者的病情选择依那西普的用法及用量.药物剂量依从性评估为应用依那西普期间的实际剂量/标准剂量×100％.疗效评估包括医生对疾病状况的总体评估(PGA),患者对疾病状况的总体评估(PtGA)及患者疼痛可视模拟评分(VAS);RA患者的其他疗效评估包括28个关节的压痛数(TJC)及肿胀数(SJC)和DAS28(ESR)评分.安全性评估包括不良反应以及实验室检查的异常.每次访视的疗效和安全性评估终点均用描述性统计量来分析.结果本研究共入组159例患者,包括69例RA及90例AS.RA患者接受依那西普治疗的疗程为1～60周,疗程中位数为5周,AS患者疗程为1～60周,疗程中位数为10周,其治疗时间RA较AS短,43.5％(30/69)的RA患者及20.5％(18/88)的AS患者治疗时间小于3周.依那西普治疗的剂量依从性在RA和AS患者中分别为(67±23)％及(73±27)％.12周和24周时RA的停药率分别为68.1％(47/69)、84.1％(58/69),而在AS患者则分别为为51.1％ (46/90)、74.4％(67/90).RA、AS患者PGA,PtGA及患者对疼痛的VAS评分均随治疗时间的延长逐渐下降.在治疗第4周及12周,RA患者中达到疾病缓解[DAS28 (ESR)＜2.6]的患者比例分别为27.8％(5/18),50.0％(4/8).共4例患者因不良反应研究终止治疗,无严重不良反应或死亡.结论依那西普治疗我国RA及AS患者的用药总体依从性差,AS的平均治疗时间略长于RA,药物依从性好于RA.依那西普治疗RA及AS有效,临床安全性良好.
목적 평개의나서보재중국RA급AS환자중적용약현상、의종성화불량반응.방법 본연구위다중심、개방、관찰성연구,대상위림상접수의나서보치료병획득지정동의적RA급AS성년환자.연구자근거RA급AS환자적병정선택의나서보적용법급용량.약물제량의종성평고위응용의나서보기간적실제제량/표준제량×100％.료효평고포괄의생대질병상황적총체평고(PGA),환자대질병상황적총체평고(PtGA)급환자동통가시모의평분(VAS);RA환자적기타료효평고포괄28개관절적압통수(TJC)급종창수(SJC)화DAS28(ESR)평분.안전성평고포괄불량반응이급실험실검사적이상.매차방시적료효화안전성평고종점균용묘술성통계량래분석.결과 본연구공입조159례환자,포괄69례RA급90례AS.RA환자접수의나서보치료적료정위1～60주,료정중위수위5주,AS환자료정위1～60주,료정중위수위10주,기치료시간RA교AS단,43.5％(30/69)적RA환자급20.5％(18/88)적AS환자치료시간소우3주.의나서보치료적제량의종성재RA화AS환자중분별위(67±23)％급(73±27)％.12주화24주시RA적정약솔분별위68.1％(47/69)、84.1％(58/69),이재AS환자칙분별위위51.1％ (46/90)、74.4％(67/90).RA、AS환자PGA,PtGA급환자대동통적VAS평분균수치료시간적연장축점하강.재치료제4주급12주,RA환자중체도질병완해[DAS28 (ESR)＜2.6]적환자비례분별위27.8％(5/18),50.0％(4/8).공4례환자인불량반응연구종지치료,무엄중불량반응혹사망.결론 의나서보치료아국RA급AS환자적용약총체의종성차,AS적평균치료시간략장우RA,약물의종성호우RA.의나서보치료RA급AS유효,림상안전성량호.
Objective To evaluate the current status usage,treatment adherence and adverse effects of etaner-cept in real clinical practice in Chinese rheumatoid arthritis (RA) and ankylosing spondylitis (AS) subjects.Methods This was a 52-week open-label,multicenter,observational study,conducted in Chinese RA and AS subjects receiving etanercept.The use and dosage recommendations for etanercept were made according to the physician's decision.The current usage,treatment adherence rate and adverse effect were evaluated.Treatment adherence rate was calculated by actual dosing/expected dosing ×100％.Descriptive summary statistics or frequency tables were provided for each endpoint by visit.Results A total of 159 subjects were enrolled including 69 RA and 90 AS patients.The median treatment durations for RA and AS were 5 weeks and 10 weeks.43.5％(30/69) RA and 20.5％(18/88) AS treatmentlasted for less than 3 weeks.The mean (SD) treatment adherence was(67±23)％ and (73±27)％ in the subjects with RA and AS,respectively.At 12 weeks and 24 weeks,68.1％(47/69) and 84.1％(58/69) RA patients stopped the treatment,51.1％(46/90) and 74.4％(67/90) AS patients stopped the treatment.The PGA,PtGA and pain assessment decreased during the study.At week 4 and 12,the proportion of RA patients reaching DAS28 (ESR)＜2.6 were 27.8％(5/18) and 50％(4/8),respectively.Four subjects interrupted etanercept treatment due to AE,no SAE or death during the study.Conclusion The treatment adherence of etanercept was low in China.The treatment duration of AS is longer than RA and treatment adherence of AS is higher than RA.Etanercept has been found to be safe and well-tolerated in Chinese RA and AS subjects.