Article(id=1291339079287825150, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339021272211834, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.02.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1720627200000, receivedDateStr=2024-07-11, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808828341, onlineDateStr=2026-08-04, pubDate=1737993600000, pubDateStr=2025-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808828341, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808828341, creator=13041195026, updateTime=1785808828341, updator=13041195026, issue=Issue{id=1291339021272211834, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1737993600000', pubDateStr='2025-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808814590, creator='13041195026', updateTime=1785808814590, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=164, endPage=168, ext={EN=ArticleExt(id=1291339079728227071, articleId=1291339079287825150, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of adalimumab combined with methotrexate in the treatment of patients with rheumatoid arthritis, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To observe the clinical efficacy and safety of adalimumab (ADA) injection combined with methotrexate (MTX) tablets in the treatment of patients with rheumatoid arthritis (RA), and the effects of joint function, serum rheumatoid factor (RF), anti-citrullinated peptide (CCP) antibody and tumor necrosis factor-α(TNF-α).
Methods The RA patients were divided into control group and treatment group according to cohort method. All patients were given intra-articular injection of prednisolone acetate injection at initial dose of 5 mg every time, once every week for 4 weeks, and then adjusted dose every 2 weeks according to the disease conditions. On this basis, the control group received oral MTX tablets 10 mg once a week, and the treatment group was combined with subcutaneous injection of ADA injection 40 mg twice a week. Both groups were treated continuously for 3 months. The clinical efficacy, clinical characteristics (swollen joint count, tender joint count, morning stiffness time), joint function [disease activity scale (DAS)-28 score, joint pain degree score], serum RF, anti-CCP antibody and TNF-α levels before and after treatment were compared between the two groups.
Results The treatment group and control group included 52 and 45 cases, respectively. After treatment, the total effective rates of treatment group and control group were 92.31% (48 cases/52 cases) and 75.56% (34 cases /45 cases), respectively, and the difference was statistically significant (P<0.05). After treatment, the swollen joint counts in treatment group and control group were 4.31±1.08 and 5.56±1.25; the tender joint counts were 6.19±1.68 and 7.92±1.43; the morning stiffness times were (44.47±11.06) and (58.63±12.46) min; the DAS28 scores were (2.67±0.73) and (3.35±0.86) points; the joint pain scores were (2.47±0.76) and (3.29±0.85) points; serum RF levels were (80.25±24.31) and (114.46±27.63) U·mL-1; serum anti-CCP antibody levels were (7.41±1.48) and (9.90±1.72) RU·mL-1; the levels of serum TNF-α were (24.16±6.33) and (34.92±7.98) pg·mL-1. Compared with control group, the above indexes of treatment group had statistical significance (all P<0.001). The adverse drug reactions in the treatment group mainly included loss of appetite, headache and erythema at the injection site. The adverse drug reactions in the control group included loss of appetite and nausea and vomiting. The total incidences of adverse drug reactions in the treatment group and the control group were 5.77% and 4.44%, respectively, and the difference was not statistically significant (P>0.05).
Conclusion The treatment of RA with ADA injection combined with MTX tablets is more effective than using MTX tablets alone, and the former one can more significantly improve joint function and reduce levels of inflammatory markers, and without increasing the incidences of adverse drug reactions.
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目的 观察阿达木单抗（ADA）注射液联合甲氨蝶呤（MTX）片治疗类风湿关节炎（RA）患者的临床疗效和安全性，及其对关节功能及血清类风湿因子（RF）、抗瓜氨酸肽（CCP）抗体、肿瘤坏死因子-α（TNF-α）的影响。
方法 将RA患者按照队列法分为对照组和试验组。所有患者均予以醋酸泼尼松龙注射液关节腔注射，初始每次5 mg，每周1次，持续4周，后续根据患者情况每2周调整剂量；在此基础上，对照组予以MTX片口服，每次10 mg，每周1次；试验组在对照组治疗的基础上，联合ADA注射液皮下注射，每次40 mg，每周2次。2组患者均持续治疗3个月。比较2组患者的临床疗效，临床特征[肿胀关节数、压痛关节数、晨僵时间]、关节功能[疾病活动（DAS）28评分、关节疼痛程度评分]，血清RF、抗CCP抗体和TNF-α水平，以及安全性。
结果 试验组和对照组分别入组52和45例。治疗后，试验组和对照组的总有效率分别为92.31%（48例/52例）和75.56%（34例/45例），在统计学上差异有统计学意义（P<0.05）。治疗后，试验组和对照组的肿胀关节数分别为（4.31±1.08）和（5.56±1.25）个，压痛关节数分别为（6.19±1.68）和（7.92±1.43）个，晨僵时间分别为（44.47±11.06）和（58.63±12.46）min，DAS28评分分别为（2.67±0.73）和（3.35±0.86）分，关节疼痛程度评分分别为（2.47±0.76）和（3.29±0.85）分，血清RF水平分别为（80.25±24.31）和（114.46±27.63）U·mL-1，血清抗CCP抗体水平分别为（7.41±1.48）和（9.90±1.72）RU·mL-1，血清TNF-α水平分别为（24.16±6.33）和（34.92±7.98）pg·mL-1，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.001）。试验组的药物不良反应主要有食欲缺乏、头痛、注射部位红斑，对照组的药物不良反应有食欲缺乏、恶心呕吐。试验组和对照组的总药物不良反应发生率分别为5.77%和4.44%，在统计学上差异无统计学意义（P>0.05）。
结论 ADA注射液联合MTX片治疗RA患者的临床疗效显著优于单独使用MTX片，前者可以显著改善患者的关节功能、减少炎症标志物水平，且不会增加药物不良反应的发生率。
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戴森华（1983-），男，副主任医师，主要从事风湿免疫基础研究与临床诊疗方面的工作
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