生物制剂对强直性脊柱炎患者健康相关生活质量的影响：一项随机对照试验的系统评价和荟萃分析。
Impact of biologics on health-related quality of life in patients with Ankylosing spondylitis: A systematic review and meta-analysis of randomized controlled trials.
机构信息
College of Pharmacy, Western University of Health Sciences, 309 E. Second St., Pomona, CA 91766, United States.
College of Pharmacy, Western University of Health Sciences, 309 E. Second St., Pomona, CA 91766, United States.
出版信息
Semin Arthritis Rheum. 2022 Jun;54:151996. doi: 10.1016/j.semarthrit.2022.151996. Epub 2022 Mar 19.
OBJECTIVE
To examine the impact of novel biologic disease-modifying antirheumatic drugs (bDMARDs) with tumor necrosis factor (TNF) inhibitors or Interleukin-17A (IL-17A) antibody agents on health-related quality of life (HRQoL) outcomes in patients with radiographic axial spondyloarthritis (r-axSpA).
METHODS
A literature search on PubMed, Embase, and Clinicaltrials.gov databases was performed through February 2022 to identify randomized controlled trials (RCTs) reporting HRQoL outcomes of bDMARDs for treatment of r-axSpA. Approved bDMARD therapy for r-axSpA included five TNF-inhibitors (infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol) and two IL-17A antibody agents (secukinumab, and ixekizumab). Heterogeneity (I) was used to determine the variability between studies.
RESULTS
Sixteen RCTs, involving 3481 participants, were included. The placebo-controlled and treatment blinded durations ranged from 12 to 24 weeks. Compared with the placebo, bDMARD therapy was associated with significant improvement in HRQoL measures with the 36-item Short Form Survey (SF-36), European Quality of Life-5 Dimensions (EQ-5D), and Ankylosing Spondylitis Quality of Life (ASQoL). The pooled mean differences of changes from baseline for the SF-36 Physical Component Score (PCS), SF-36 Mental Component Score (MCS), EQ-5D, and ASQoL were 4.39 [95% Confidence Interval (CI): 3.24 to 5.54, P < 0.001]; 2.37 (95%-CI: 1.25 to 3.49, P = 0.003); 0.11 (95%-CI: 0.07 to 0.14, P < 0.001); and -2.45 (95%-CI: -3.21 to -1.70, P < 0.001), respectively. Heterogeneity was high (I = 79%) among studies reporting SF-36 PCS, and moderate (I = 61%, 34%, and 49%) among studies reporting SF-36 MCS, EQ-5D, and ASQoL, respectively.
CONCLUSIONS
Biologic therapy was associated with a significant improvement in quality of life in patients with r-axSpA. The results were consistent among all three measures of HRQoL outcomes.
目的
研究新型生物改善病情抗风湿药物（bDMARD）与肿瘤坏死因子（TNF）抑制剂或白细胞介素-17A（IL-17A）抗体药物联合治疗对放射学中轴型脊柱关节炎（r-axSpA）患者健康相关生活质量（HRQoL）结局的影响。
方法
通过 2022 年 2 月在 PubMed、Embase 和 Clinicaltrials.gov 数据库进行文献检索，以确定报告 bDMARD 治疗 r-axSpA 的 HRQoL 结局的随机对照试验（RCT）。r-axSpA 的批准 bDMARD 治疗包括五种 TNF 抑制剂（英夫利昔单抗、依那西普、阿达木单抗、戈利木单抗和培塞利珠单抗）和两种 IL-17A 抗体药物（司库奇尤单抗和依奇珠单抗）。异质性（I）用于确定研究之间的可变性。
结果
纳入了 16 项 RCT，涉及 3481 名参与者。安慰剂对照和治疗盲法持续时间为 12 至 24 周。与安慰剂相比，bDMARD 治疗与 36 项简明健康状况调查问卷（SF-36）、欧洲五维健康量表（EQ-5D）和强直性脊柱炎生活质量量表（ASQoL）的 HRQoL 指标显著改善相关。SF-36 生理成分评分（PCS）、SF-36 心理成分评分（MCS）、EQ-5D 和 ASQoL 从基线变化的汇总平均差异分别为 4.39 [95%置信区间（CI）：3.24 至 5.54，P<0.001]；2.37（95%CI：1.25 至 3.49，P=0.003）；0.11（95%CI：0.07 至 0.14，P<0.001）；和-2.45（95%CI：-3.21 至-1.70，P<0.001）。报告 SF-36 PCS 的研究中存在高度异质性（I=79%），报告 SF-36 MCS、EQ-5D 和 ASQoL 的研究中存在中度异质性（I=61%、34%和 49%）。
结论
生物治疗与 r-axSpA 患者生活质量的显著改善相关。所有三种 HRQoL 结局测量结果均一致。
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