阿达木单抗注射液治疗关节病型银屑病的临床疗效和安全性的Meta分析
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摘要
目的:系统评价阿达木单抗注射液治疗关节病型银屑病的疗效及安全性。方法:通过计算机检索中文期刊全文数据库(CNKI)、万方数据库、中国生物医学文献数据库、PubMed、Medline及Embase,检索时限均从2000年1月至2018年10月,语言限中英文。纳入研究的治疗组使用阿达木单抗注射液治疗关节病型银屑病,对照组使用甲氨蝶呤治疗。根据Cochrane系统评价方法对纳入的研究进行质量评价后,用RevMan 5.1软件进行Meta分析。结果:共纳入5篇研究,555例患者,共治疗3个月。治疗组在治疗12周后银屑病皮损改善面积和严重程度指数PASI积分[SMD=1.86,95%CI(1.29,2.68),P<0.01]、关节压痛评分[SMD=4.95,95%CI(2.74,7.15),P<0.01]、关节肿胀评分[SMD=2.73,95%CI(1.65,3.80),P<0.01]的改善程度及总有效率[OR=2.90,95%CI(2.01,4.19),P<0.01]与对照组相比,差异均具有统计学意义。治疗组的不良反应率[OR=0.47,95%CI(0.20,1.09),P=0.08]低于对照组。结论:阿达木单抗注射液治疗关节病型银屑病安全有效。
Objective:To systematically evaluate the efficacy and safety of adalimumab injection for arthropathic psoriasis.Methods:Randomized controlled trials(RCTs) of adalimumab versus methotrexate for arthropathic psoriasis published in both English and Chinese were searched on the websites of CNKI,Wanfang Database,China Biomedical Literature Database,Pubmed,Medline and Embase(January 2000 to October 2018). The quality of these studies was evaluated according to the method of Cochrane systematic evaluation. Meta-analysis was performed using RevMan 5.1 software.Results:A total of 5 RCTs, including 555 patients with arthropathic psoriasis, were included in this analysis. Following 3-month treatments, adalimumab injection significantly decreased PASI scores [SMD=1.86, 95%CI(1.29,2.68), P<0.01], joint tenderness scores [SMD=4.95, 95%CI(2.74, 7.15), P<0.01] and joint swelling scores [SMD=2.73, 95%CI(1.65,3.80), P<0.01] in comparison to methotrexate treatment. The effective rate was also higher in adalimumab than in methotrexate treatment [OR=2.90, 95%CI(2.01,4.19), P<0.01]. In addition, the rate of adverse reactions was lower in adalimumab than in methotrexate treatment [OR=0.47,95%CI(0.20,1.09), P=0.08]. Conclusion: Adalimumab injection is effective and safe for arthropathic psoriasis.
Objective:To systematically evaluate the efficacy and safety of adalimumab injection for arthropathic psoriasis.Methods:Randomized controlled trials(RCTs) of adalimumab versus methotrexate for arthropathic psoriasis published in both English and Chinese were searched on the websites of CNKI,Wanfang Database,China Biomedical Literature Database,Pubmed,Medline and Embase(January 2000 to October 2018). The quality of these studies was evaluated according to the method of Cochrane systematic evaluation. Meta-analysis was performed using RevMan 5.1 software.Results:A total of 5 RCTs, including 555 patients with arthropathic psoriasis, were included in this analysis. Following 3-month treatments, adalimumab injection significantly decreased PASI scores [SMD=1.86, 95%CI(1.29,2.68), P<0.01], joint tenderness scores [SMD=4.95, 95%CI(2.74, 7.15), P<0.01] and joint swelling scores [SMD=2.73, 95%CI(1.65,3.80), P<0.01] in comparison to methotrexate treatment. The effective rate was also higher in adalimumab than in methotrexate treatment [OR=2.90, 95%CI(2.01,4.19), P<0.01]. In addition, the rate of adverse reactions was lower in adalimumab than in methotrexate treatment [OR=0.47,95%CI(0.20,1.09), P=0.08]. Conclusion: Adalimumab injection is effective and safe for arthropathic psoriasis.
引文
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[6] TYMMS K, LITTLEJOHN G,GRIFFITHS H, et al.Treatment patterns among patients with rheumatic disease (rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and undifferentiated arthritis (UnA)) treated with subcutaneous TNF inhibitors[J].Clin Rheumatol,2018,37(6):1617-1623.
[7] SANTOS H, EUSEBIO M, GONCALVES D,et al.Effectiveness of early adalimumab therapy in psoriatic arthritis patients from Reuma.pt-EARLY PsA[J].Acta Reumatol Port, 2017,42(4):287-299.
[8] SAURAT J H, STINGL G, DUBERTRET L,et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis(CHAMPION)[J].Br J Dermatol, 2008, 158(3):558-566.
[9] MENTER A,TYRING S K,GORDON K,et al.Adalimumab therapy for moderate to severe psoriasis: a randomized,controlled phase Ⅲ trial[J].J Am Acad Dermatol,2008,58(1):106-115.
[10] LANGLEY R G,ELLIS C N. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment , and Lattice System Physician’s Global Assessment[J]. J Am Acad Dermatol,2014,51(4):563-569.
[2] 薛如君,陈慧姮,梁晓冬,等.阿维A治疗儿童脓疱型银屑病的疗效及安全性观察[J].皮肤性病诊疗学杂志,2017,24(6):377-381,388.
[3] 吴敬英,李鸣九,古东,等.阿维A联合中药治疗寻常型银屑病的Meta分析[J].皮肤性病诊疗学杂志,2015,22(4):290-295.
[4] FAGERLI K M, KEARSLEY-FLEET L,WATSON K D, et al.Long-term persistence of TNF-inhibitor treatment in patients with psoriatic arthritis. Data from the British Society for Rheumatology Biologics Register[J]. RMD Open,2018,4(1):e000596.
[5] PRAPROTNIK S,et al.The persistence of golimumab compared to other tumour necrosis factor-α inhibitors in daily clinical practice for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis:observations from the Slovenian nation-wide longitudinal registry of patients treated with biologic disease-modifying antirheumatic drugs-BioRx.si[J].Clin Rheumatol,2019,38(2):297-305.
[6] TYMMS K, LITTLEJOHN G,GRIFFITHS H, et al.Treatment patterns among patients with rheumatic disease (rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and undifferentiated arthritis (UnA)) treated with subcutaneous TNF inhibitors[J].Clin Rheumatol,2018,37(6):1617-1623.
[7] SANTOS H, EUSEBIO M, GONCALVES D,et al.Effectiveness of early adalimumab therapy in psoriatic arthritis patients from Reuma.pt-EARLY PsA[J].Acta Reumatol Port, 2017,42(4):287-299.
[8] SAURAT J H, STINGL G, DUBERTRET L,et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis(CHAMPION)[J].Br J Dermatol, 2008, 158(3):558-566.
[9] MENTER A,TYRING S K,GORDON K,et al.Adalimumab therapy for moderate to severe psoriasis: a randomized,controlled phase Ⅲ trial[J].J Am Acad Dermatol,2008,58(1):106-115.
[10] LANGLEY R G,ELLIS C N. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment , and Lattice System Physician’s Global Assessment[J]. J Am Acad Dermatol,2014,51(4):563-569.