Chen Junyuan, Li Jieruo, Li Ruobin, Wang Huajun, Yang Jie, Xu Jichun, Zha Zhengang
Department of Bone and Joint Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
Department of Gynaecology and Obstetrics, The First Affiliated Hospital of Jinan University, Guangzhou, China
Pain Med. 2017 Feb 1;18(2):374-385. doi: 10.1093/pm/pnw262.
To evaluate the efficacy and safety of tanezumab for management of osteoarthritis (OA) knee and hip pain.
Articles about management of OA knee and hip pains by tanezumab were systematically searched in PubMed, EBSCO, EMBASE, ScienceDirect, Web of Science, OVID, and Cochrane Library from the available date of inception until January 2016. Randomized controlled trials (RCTs) comparing the efficacy and safety of tanezumab with placebo/active comparator for management of OA knee and hip pains were included, and those with confounding conditions were excluded. Study quality was assessed using the Jadad five-point score. Finally, a meta-analysis of all eligible RCTs was performed on Review Manager 5.3 and STATA 12.0.
Nine studies with 10 RCTs that enrolled 7,665 patients were included. The reductions in pain intensity are significantly different between tanezumab-treated patients and placebo-treated patients (5,879 patients, mean difference [MD] = -0.98, 95% confidence interval [CI] = -1.18- -0.79). Both functional improvement (6,078 patients, MD = -1.10, 95% CI = -1.28- -0.92) and Patient's Global Assessment (PGA; 5,366 patients, MD = -0.27, 95% CI = -0.34- -0.20) are significantly different. There are significantly more discontinued patients due to adverse events (AEs) after treatment with tanezumab (6,537 patients, risk ratio = 1.62, 95% CI = 1.29-2.03). However, differences in serious AEs are not significant. Moreover, tanezumab-treated patients suffer from significantly more paraesthesia, arthralgia, hypoaesthesia, and peripheral edema.
Tanezumab vs placebo provides superior pain relief and improvement in physical function and PGA in knee and hip osteoarthritis patients and is generally well tolerated with acceptable AEs. Low-dose tanezumab (10 or 25 µg/kg and 2.5 mg) provides similar effectiveness in reducing pain and improving function and is associated with fewer AEs. The long-term safety of tanezumab on osteoarthritis knee and hip pain needs further investigation.
评估他尼珠单抗治疗膝骨关节炎和髋骨关节炎疼痛的疗效及安全性。
从各数据库建库起始日期至2016年1月，在PubMed、EBSCO、EMBASE、ScienceDirect、Web of Science、OVID和Cochrane图书馆系统检索有关他尼珠单抗治疗膝骨关节炎和髋骨关节炎疼痛的文章。纳入比较他尼珠单抗与安慰剂/活性对照药治疗膝骨关节炎和髋骨关节炎疼痛疗效及安全性的随机对照试验（RCT），排除存在混杂因素的研究。采用Jadad五分制评分评估研究质量。最后，使用Review Manager 5.3和STATA 12.0对所有符合条件的RCT进行荟萃分析。
纳入9项研究，共10项RCT，涉及7665例患者。他尼珠单抗治疗组患者与安慰剂治疗组患者在疼痛强度降低方面存在显著差异（5879例患者，平均差值[MD]= -0.98，95%置信区间[CI]= -1.18至-0.79）。功能改善（6078例患者，MD = -1.10，95% CI = -1.28至-0.92）和患者整体评估（PGA；5366例患者，MD = -0.27，95% CI = -0.34至-0.20）也均存在显著差异。他尼珠单抗治疗后因不良事件（AE）停药的患者明显更多（6537例患者，风险比=1.62，95% CI = 1.29至2.03）。然而，严重AE的差异不显著。此外，他尼珠单抗治疗的患者出现感觉异常、关节痛、感觉减退和外周水肿的情况明显更多。
与安慰剂相比，他尼珠单抗能为膝骨关节炎和髋骨关节炎患者提供更优的疼痛缓解、身体功能改善及PGA改善，且一般耐受性良好，AE可接受。低剂量他尼珠单抗（10或25μg/kg及2.5mg）在减轻疼痛和改善功能方面疗效相似，且AE较少。他尼珠单抗治疗膝骨关节炎和髋骨关节炎疼痛的长期安全性有待进一步研究。
