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固定剂量方案下注射用特立帕肽治疗膝骨关节炎或髋骨关节炎的疗效和安全性:一项随机对照 III 期临床试验的荟萃分析。

Efficacy and safety of tanezumab administered as a fixed dosing regimen in patients with knee or hip osteoarthritis: a meta-analysis of randomized controlled phase III trials.

机构信息

Biomechanics Labs of Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050, People's Republic of China.

Tianjin Hospital, Tianjin University, Tianjin, 300211, People's Republic of China.

出版信息

Clin Rheumatol. 2021 Jun;40(6):2155-2165. doi: 10.1007/s10067-020-05488-4. Epub 2020 Nov 6.

DOI:10.1007/s10067-020-05488-4
PMID:33159281
Abstract

This study aims to evaluate the efficacy and safety of tanezumab administered as a fixed dosing regimen in patients with knee or hip osteoarthritis. Randomized controlled phase III trials (RCTs) that evaluated the efficacy and safety associated with tanezumab for knee or hip OA were systematically identified by searching electronic databases, including Cochrane Library, PubMed, and Embase, for 30 years from December 1990 up to July 2020. Ten relevant studies were included in our meta-analysis. The research was reported based on the preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to ensure the reliability and verity of results. Our study showed that the tanezumab groups were more effective than the placebo groups in terms of mean change from the baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain (P < .00001), WOMAC physical functional (P < .00001), and patient's global assessment (PGA) (P < .00001). Discontinued due to adverse events (AEs) (P < .00001), serious AEs (P = .02), abnormal peripheral sensations (both P < .00001), and peripheral neuropathy (P < .002) in tanezumab groups were significantly higher than that in control groups. Compared with placebo, tanezumab can effectively relieve pain and improve WOMAC physical function and patient's global assessment (PGA) in knee and hip osteoarthritis. Meanwhile, adverse events are transient in nature and generally well-tolerated. However, we still need large-sample, high-quality studies to investigate the long-term safety of tanezumab to give the conclusion.

摘要

本研究旨在评估固定剂量曲坦努单抗治疗膝或髋骨关节炎患者的疗效和安全性。通过检索 Cochrane 图书馆、PubMed 和 Embase 等电子数据库,从 1990 年 12 月至 2020 年 7 月,对评估曲坦努单抗治疗膝或髋骨关节炎相关疗效和安全性的随机对照 III 期试验(RCT)进行了系统检索。我们的荟萃分析纳入了 10 项相关研究。本研究报告基于系统评价和荟萃分析的首选报告项目(PRISMA)指南,以确保结果的可靠性和真实性。我们的研究表明,与安慰剂组相比,曲坦努单抗组在从基线到 Western Ontario 和 McMaster 大学骨关节炎指数(WOMAC)疼痛(P <.00001)、WOMAC 身体功能(P <.00001)和患者整体评估(PGA)(P <.00001)的平均变化方面更有效。由于不良事件(AEs)(P <.00001)、严重 AEs(P =.02)、异常周围感觉(均 P <.00001)和周围神经病变(P <.002)而停药的情况在曲坦努单抗组明显高于对照组。与安慰剂相比,曲坦努单抗可有效缓解膝和髋骨关节炎的疼痛,改善 WOMAC 身体功能和患者整体评估(PGA)。同时,不良反应是暂时的,一般耐受性良好。然而,我们仍需要大样本、高质量的研究来调查曲坦努单抗的长期安全性,以得出结论。

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Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period.皮下注射替扎尼定治疗髋或膝关节骨关节炎:一项 24 周随机 III 期研究的疗效和安全性结果及 24 周随访期。
Ann Rheum Dis. 2020 Jun;79(6):800-810. doi: 10.1136/annrheumdis-2019-216296. Epub 2020 Mar 31.
2
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Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain.替扎尼珠单抗单药或联合非甾体抗炎药治疗膝或髋骨关节炎疼痛的疗效和安全性。
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