未经评估:我们旨在评估针对三种主要细胞因子的生物制剂的有效性和安全性,也就是说,神经生长因子(NGF),白细胞介素-1(IL-1),和肿瘤坏死因子-α(TNF-α),用于骨关节炎(OA)治疗。
UNASSIGNED:数据库(PubMed,Embase,和CochraneLibrary)和ClinicalTrials.gov从开始到2020年11月15日,系统地搜索了生物制剂的随机安慰剂对照试验(RCT)。结果是疼痛的平均变化,函数得分,和不良反应(AE)的风险。
未经评估:在28项研究中,包括29项RCT(8555名个体),生物制剂在疼痛缓解(标准化平均差[SMD]=0.28,95%置信区间[CI]=0.17~0.38,p<0.001)和功能改善(SMD=0.30,95%CI=0.18~0.43,p<0.001)方面优于安慰剂.任何AEs的发生率(风险比[RR]=1.09,95%CI=1.05-1.14,p<0.001)和因AEs引起的停药(RR=1.39,95%CI=1.05-1.83,p=0.021)在使用生物制剂治疗后较高,而在严重的AEs中没有发现显着差异。亚组分析表明,NGF抑制剂提供了更好的疼痛缓解(SMD=0.36,95%CI=0.26-0.47,p<0.001)和功能改善(SMD=0.41,95%CI=0.30-0.51,p<0.001),而IL-1抑制剂和TNF-α抑制剂没有。同时,NGF抑制剂增加了任何AE的发生率(RR=1.12,95%CI=1.07-1.17,p<0.001)和由于AE而导致的停药(RR=1.48,95%CI=1.07-2.06,p=0.018)。与安慰剂相比,IL-1抑制剂和TNF-α抑制剂的安全性没有差异。
UNASSIGNED:生物制剂的疗效和安全性因作用机制而异。NGF抑制剂可以缓解OA相关疼痛并改善功能,但涉及安全性问题。IL-1抑制剂和TNF-α抑制剂是相对安全的选择,但疗效有限。
UNASSIGNED: We aimed to evaluate the efficacy and safety of biologic agents targeting three main cytokines, that is, nerve growth factor (NGF), interleukin-1 (IL-1), and tumor necrosis factor-α (TNF-α), for osteoarthritis (OA) treatment.
UNASSIGNED: Databases (PubMed, Embase, and Cochrane Library) and ClinicalTrials.gov were systematically searched for randomized placebo-controlled trials (RCTs) of biologic agents from inception to November 15, 2020. The outcomes were the mean change in pain, function scores, and the risk of adverse effects (AEs).
UNASSIGNED: Out of the 28 studies with 29 RCTs (8555 individuals) included, biologic agents were superior to placebo in pain relief (standardized mean difference [SMD] = 0.28, 95% confidence interval [CI] = 0.17-0.38, p < 0.001) and function improvement (SMD = 0.30, 95% CI = 0.18-0.43, p < 0.001). The incidence of any AEs (risk ratio [RR] = 1.09, 95% CI = 1.05-1.14, p < 0.001) and discontinuations due to AEs (RR = 1.39, 95% CI = 1.05-1.83, p = 0.021) were higher following treatment with biologic agents while no significant difference was found in serious AEs. Subgroup analyses showed that NGF inhibitors provided superior pain relief (SMD = 0.36, 95% CI = 0.26-0.47, p < 0.001) and function improvement (SMD = 0.41, 95% CI = 0.30-0.51, p < 0.001), whereas IL-1 inhibitors and TNF-α inhibitors did not. Meanwhile, NGF inhibitors increased the incidence of any AEs (RR = 1.12, 95% CI = 1.07-1.17, p < 0.001) and discontinuations due to AEs (RR = 1.48, 95% CI = 1.07-2.06, p = 0.018). IL-1 inhibitors and TNF-α inhibitors showed no difference in safety compared with placebo.
UNASSIGNED: The efficacy and safety of biologic agents vary by mechanism of action. NGF inhibitors can relieve OA-related pain and improve function but involve safety concerns. IL-1 inhibitors and TNF-α inhibitors are relatively safe options but with limited efficacy.