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用于膝骨关节炎患者的他奈珠单抗:一项荟萃分析。

Tanezumab for Patients with Osteoarthritis of the Knee: A Meta-Analysis.

作者信息

Kan Shun-Li, Li Yan, Ning Guang-Zhi, Yuan Zhi-Fang, Chen Ling-Xiao, Bi Ming-Chao, Sun Jing-Cheng, Feng Shi-Qing

机构信息

Department of Orthopaedics, Tianjin Medical University General Hospital, 154 Anshan Road, Heping District, Tianjin, 300052, China.

School of Nursing, Tianjin Medical University, 22 Qixiangtai Road, Heping District, Tianjin, 300070, China.

出版信息

PLoS One. 2016 Jun 13;11(6):e0157105. doi: 10.1371/journal.pone.0157105. eCollection 2016.

Abstract

OBJECTIVE

Tanezumab is a new therapeutic intervention for patients with osteoarthritis (OA) of the knee. We performed the present meta-analysis to appraise the efficacy and safety of tanezumab for patients with knee OA.

METHODS

We systematically searched randomized controlled trials from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL). The primary outcomes were mean change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, the WOMAC physical function and patient's global assessment (PGA). Outcomes were reported as the standard mean difference (SMD) or relative risk (RR) with 95% confidence interval (CI). We assessed the pooled data using a random-effects model.

RESULTS

Of the identified studies, four were eligible and were included in this meta-analysis (N = 1839 participants). Compared with the placebo groups, tanezumab yielded a significant reduction in mean change in the WOMAC pain (SMD = 0.51, 95% CI 0.34 to 0.69, P<0.00001), the WOMAC physical function (SMD = 0.56, 95% CI 0.38 to 0.74, P<0.00001) and PGA (SMD = 0.34, 95% CI 0.22 to 0.47, P<0.00001). There was no significant difference in serious adverse events (RR = 1.06, 95% CI 0.59 to 1.92, P = 0.84) between the tanezumab and placebo groups. Tanezumab significantly increased discontinuations due to adverse events (RR = 2.89, 95% CI 1.59 to 5.26, P = 0.0005), abnormal peripheral sensations (RR = 3.14, 95% CI 2.12 to 4.66, P<0.00001), and peripheral neuropathy (RR = 6.05, 95% CI 2.32 to 15.81, P = 0.0002).

CONCLUSION

Tanezumab can alleviate pain and improve function for patients with OA of the knee. However, considering the limited number of studies, this conclusion should be interpreted cautiously and more clinical randomized controlled trials are needed to verify the efficacy and safety of tanezumab for OA of the knee.

摘要

目的

他尼珠单抗是一种针对膝骨关节炎(OA)患者的新型治疗干预措施。我们进行了本次荟萃分析,以评估他尼珠单抗对膝OA患者的疗效和安全性。

方法

我们系统检索了来自PubMed、EMBASE和Cochrane对照试验中央注册库(CENTRAL)的随机对照试验。主要结局指标为西安大略和麦克马斯特大学骨关节炎指数(WOMAC)疼痛、WOMAC身体功能及患者整体评估(PGA)的平均变化。结局指标报告为标准均数差(SMD)或相对危险度(RR)及95%置信区间(CI)。我们使用随机效应模型评估汇总数据。

结果

在纳入的研究中,有四项符合条件并纳入本次荟萃分析(N = 1839名参与者)。与安慰剂组相比,他尼珠单抗使WOMAC疼痛的平均变化显著降低(SMD = 0.51,95%CI 0.34至0.69,P<0.00001)、WOMAC身体功能(SMD = 0.56,95%CI 0.38至0.74,P<0.00001)及PGA(SMD = 0.34,95%CI 0.22至0.47,P<0.00001)。他尼珠单抗组与安慰剂组在严重不良事件方面无显著差异(RR = 1.06,95%CI 0.59至1.92,P = 0.84)。他尼珠单抗因不良事件导致的停药显著增加(RR = 2.89,95%CI 1.59至5.26,P = 0.0005)、异常外周感觉(RR = 3.14,95%CI 2.12至4.66,P<0.00001)及外周神经病变(RR = 6.05,95%CI 2.32至15.81)。

结论

他尼珠单抗可减轻膝OA患者的疼痛并改善功能。然而,考虑到研究数量有限,该结论应谨慎解读,需要更多的临床随机对照试验来验证他尼珠单抗对膝OA的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19a2/4905652/829a0087f772/pone.0157105.g001.jpg

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