Gao Yijie, Hu Zhengxu, Huang Yi, Liu Weijian, Ren Changle
Department of Joint Surgery, Dalian Municipal Central Hospital, Dalian Medical University, Dalian, China.
Department of Orthopaedic Surgery, Ansteel Group General Hospital, Anshan, China.
Orthop J Sports Med. 2022 Apr 25;10(4):23259671221088590. doi: 10.1177/23259671221088590. eCollection 2022 Apr.
The efficacy and safety of anti-nerve growth factor (NGF) antibody therapy used for osteoarthritis (OA) pain are controversial.
To evaluate the efficacy and safety of anti-NGF antibody therapy via a meta-analysis of randomized controlled trials (RCTs).
Systematic review; Level of evidence, 1.
PubMed, the Cochrane Central Register of Controlled Trials, Embase, and the Web of Science databases were searched for RCTs assessing anti-NGF antibody treatments for hip and knee OA. A total of 623 records were retrieved from the databases. A random-effects model was used to assess primary and secondary outcomes. Bias was assessed using the Cochrane Collaboration tool, funnel plots, and the Egger test. Subgroup analyses were used to assess the efficacy and safety of the independent variables. Sensitivity analysis was conducted to evaluate the effectiveness of tanezumab and the effectiveness of anti-NGF antibodies compared to active comparator drugs. We present the effects of dose, administration mode, and treatment duration on the efficacy and safety of anti-NGF antibody therapy.
There were 19 RCTs included in our meta-analysis. Anti-NGF antibody treatment showed significant improvements on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain, physical function, and stiffness as well as on a patient global assessment (PGA). The overall standardized mean differences were as follows: WOMAC pain (-0.31 [95% CI, -0.36 to -0.26]; = 11.75; < .001; = 38%), WOMAC physical function (-0.36 [95% CI, -0.41 to -0.30]; = 12.67; < .001; = 44%), WOMAC stiffness (-3.59 [95% CI, -4.87 to -2.30]; = 5.47; < .001; = 98%), and PGA (-0.28 [95% CI, -0.34 to -0.22]; = 9.39; < .001; = 50%). Anti-NGF antibody treatment resulted in a greater incidence of adverse events (risk ratio, 1.09 [95% CI, 1.06 to 1.12]; = 5.60; < .001; = 0%). The incidence of serious adverse events was similar between the treatment and control groups (risk ratio, 1.15 [95% CI, 0.98 to 1.34]; = 1.71; = .09; = 0%).
Anti-NGF antibody treatment significantly relieved pain and improved function in patients with hip and knee OA. However, no conclusion could be drawn regarding the optimal treatment plan for anti-NGF antibodies when all 3 variables (dose, administration mode, and treatment duration) were combined in the analyses.
用于骨关节炎(OA)疼痛治疗的抗神经生长因子(NGF)抗体疗法的疗效和安全性存在争议。
通过对随机对照试验(RCT)进行荟萃分析,评估抗NGF抗体疗法的疗效和安全性。
系统评价;证据等级,1级。
检索PubMed、Cochrane对照试验中心注册库、Embase和科学网数据库,查找评估抗NGF抗体治疗髋和膝OA的RCT。从数据库中检索到共623条记录。采用随机效应模型评估主要和次要结局。使用Cochrane协作工具、漏斗图和Egger检验评估偏倚。进行亚组分析以评估自变量的疗效和安全性。进行敏感性分析以评估他尼珠单抗的有效性以及与活性对照药物相比抗NGF抗体的有效性。我们呈现了剂量、给药方式和治疗持续时间对抗NGF抗体疗法疗效和安全性的影响。
我们的荟萃分析纳入了19项RCT。抗NGF抗体治疗在西安大略和麦克马斯特大学骨关节炎指数(WOMAC)的疼痛、身体功能和僵硬方面以及患者整体评估(PGA)上均显示出显著改善。总体标准化均数差如下:WOMAC疼痛(-0.31[95%CI,-0.36至-0.26];Z = 11.75;P <.001;I² = 38%),WOMAC身体功能(-0.36[95%CI,-0.41至-0.30];Z = 12.67;P <.001;I² = 44%),WOMAC僵硬(-3.59[95%CI,-4.87至-2.30];Z = 5.47;P <.001;I² = 98%),以及PGA(-0.28[95%CI,-0.34至-0.22];Z = 9.39;P <.001;I² = 50%)。抗NGF抗体治疗导致不良事件发生率更高(风险比,1.09[95%CI,1.06至1.12];Z = 5.60;P <.001;I² = 0%)。治疗组和对照组之间严重不良事件的发生率相似(风险比,1.15[95%CI,0.98至1.34];Z = 1.71;P =.09;I² = 0%)。
抗NGF抗体治疗可显著缓解髋和膝OA患者的疼痛并改善功能。然而,当在分析中综合考虑所有三个变量(剂量、给药方式和治疗持续时间)时,无法得出关于抗NGF抗体最佳治疗方案的结论。