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2.5、5 和 10 mg 特耐珠单抗治疗骨关节炎的相对疗效和耐受性:基于患者停药的随机对照试验的贝叶斯网状荟萃分析。

Relative efficacy and tolerability of 2.5, 5, and 10 mg tanezumab for the treatment of osteoarthritis: A Bayesian network meta-analysis of randomized controlled trials based on patient withdrawal.

出版信息

Int J Clin Pharmacol Ther. 2021 Feb;59(2):147-155. doi: 10.5414/CP203812.

Abstract

AIMS

To assess the relative efficacy and tolerability of tanezumab (2.5, 5, and 10 mg) in osteoarthritis (OA) patients.

MATERIALS AND METHODS

Six randomized controlled trials (RCTs) including 3,813 patients and examining the efficacy and tolerability of tanezumab (2.5, 5, 10 mg), naproxen (1,000 mg), and placebo, based on the number of withdrawals among osteoarthritis patients, were included in this Bayesian random-effects network meta-analysis, which combined direct and indirect evidence.

RESULTS

Tanezumab (5, 2.5, 10 mg) and 1,000 mg naproxen were more efficacious than placebo (odds ratio (OR): 0.34, 95% credible interval (CrI): 0.26 - 0.43; OR: 0.35, 95% CrI: 0.24 - 0.48; OR: 0.364, 95% CrI: 0.28 - 0.45; and OR: 0.44, 95% CrI: 0.32 - 0.61, respectively). The number of withdrawals due to lack of efficacy were lower in the tanezumab groups than in the naproxen group, and the difference was not significant. Ranking probability based on the cumulative ranking curve (SUCRA) indicated that 5 mg tanezumab had the highest probability of being the best treatment based on the number of withdrawals due to lack of efficacy, followed by 2.5 mg tanezumab, 10 mg tanezumab, 1,000 mg naproxen, and placebo. Ranking probability based on SUCRA indicated that 2.5 mg tanezumab and placebo had the highest probability of being the most tolerable treatment, followed by 5 mg tanezumab, 1,000 mg naproxen, and 10 mg tanezumab.

CONCLUSION

Tanezumab (5 mg) had the highest probability of being the best treatment based on the number of withdrawals due to lack of efficacy among the medications, while 2.5 mg tanezumab and placebo had the highest probability of being the most tolerable treatment.

摘要

目的

评估在骨关节炎(OA)患者中使用不同剂量的托那珠单抗(2.5、5 和 10mg)的相对疗效和耐受性。

材料与方法

本贝叶斯随机效应网络荟萃分析纳入了 6 项随机对照试验(RCT),共 3813 名患者,评估了托那珠单抗(2.5、5、10mg)、萘普生(1000mg)和安慰剂的疗效和耐受性,其依据为骨关节炎患者的退出人数。该分析结合了直接和间接证据。

结果

托那珠单抗(5mg、2.5mg、10mg)和 1000mg 萘普生比安慰剂更有效(优势比(OR):0.34,95%可信区间(CrI):0.26-0.43;OR:0.35,95% CrI:0.24-0.48;OR:0.364,95% CrI:0.28-0.45;OR:0.44,95% CrI:0.32-0.61)。与萘普生组相比,托那珠单抗组因疗效不佳而退出的人数更少,但差异无统计学意义。基于累积排序曲线(SUCRA)的排序概率表明,基于因疗效不佳而退出的人数,5mg 托那珠单抗最有可能成为最佳治疗药物,其次是 2.5mg 托那珠单抗、10mg 托那珠单抗、1000mg 萘普生和安慰剂。基于 SUCRA 的排序概率表明,2.5mg 托那珠单抗和安慰剂最有可能成为最耐受的治疗药物,其次是 5mg 托那珠单抗、1000mg 萘普生和 10mg 托那珠单抗。

结论

基于因疗效不佳而退出的人数,托那珠单抗(5mg)最有可能成为最佳治疗药物,而 2.5mg 托那珠单抗和安慰剂最有可能成为最耐受的治疗药物。

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