Suppr超能文献

醋酸甲泼尼龙与曲安奈德膝关节腔内注射治疗慢性炎症性关节炎患者的疗效:一项24周随机对照试验

Efficacy of Methylprednisolone Acetate Versus Triamcinolone Acetonide Intra-articular Knee Injection in Patients With Chronic Inflammatory Arthritis: A 24-Week Randomized Controlled Trial.

作者信息

Kumar Ashwani, Dhir Varun, Sharma Shefali, Sharma Aman, Singh Surjit

机构信息

Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Clin Ther. 2017 Jan;39(1):150-158. doi: 10.1016/j.clinthera.2016.11.023. Epub 2016 Dec 21.

Abstract

PURPOSE

Triamcinolone hexacetonide (TH), triamcinolone acetonide (TA), and methylprednisolone acetate (MPA) are commonly used intra-articular steroid preparations. Studies suggest that intra-articular TH is more efficacious than MPA and TA in chronic inflammatory arthritis. However, it is unclear which of the latter two preparations has better efficacy. Thus, we compared intra-articular knee injections of MPA and TA in patients with chronic inflammatory arthritis.

METHODS

This double-blind, randomized controlled trial included patients with rheumatoid arthritis or spondyloarthritis with an acutely swollen knee joint (≥1 week, <24 weeks). They were randomly assigned (1:1) to intra-articular knee injection with MPA or TA (80 mg, 2 mL of each). Evaluations were performed at 4, 12, and 24 weeks. Primary outcome was time to relapse (Kaplan-Meier) over 24 weeks, with relapse defined as return to baseline pain or swelling ≥1 week. Secondary outcomes were change in pain and swelling (using a numerical rating scale), range of movement, and occurrence of adverse effects. Primary analysis was intention to treat, with last observation carried forward.

FINDINGS

One hundred patients (89 with rheumatoid arthritis) were randomly assigned in equal numbers to the MPA and TA groups. Nine patients relapsed in each group over 24 weeks. The mean time to relapse was not significantly different between the MPA and TA groups (20.8 [95% CI, 18.8-22.7] weeks and 20.9 [95% CI, 19.0-22.8] weeks, respectively; P = 0.9; hazard ratio = 1.0 [95% CI, 0.4-2.5]). In both groups, there was a significant decline in pain and swelling scores at all visits (P < 0.001); however, there were no significant intergroup differences. At 24 weeks, mean change in pain in the MPA (-4.4 [3.1]) and TA groups (-3.9 [2.8]) was not significantly different (P = 0.46). No infection, hematoma or hypopigmentation occurred in any patient. In addition, no significant intergroup differences were found in joint swelling, range of movement, modified (28 joint) Disease Activity Score using 3 variables, or Health Assessment Questionnaire over 24 weeks.

IMPLICATIONS

No significant differences were found in efficacy between intra-articular knee injections with MPA and TA in these patients with chronic inflammatory arthritis. However, results need to be extrapolated cautiously because of the small sample size. Three-quarters of the patients remained relapse free at 24 weeks. Clinical Trials Registry of India (www.ctri.nic.in) identifier: CTRI/2015/09/006187.

摘要

目的

己曲安奈德(TH)、曲安奈德(TA)和醋酸甲泼尼龙(MPA)是常用的关节内注射类固醇制剂。研究表明,在慢性炎症性关节炎中,关节内注射TH比MPA和TA更有效。然而,尚不清楚后两种制剂中哪一种疗效更好。因此,我们比较了慢性炎症性关节炎患者膝关节内注射MPA和TA的效果。

方法

这项双盲、随机对照试验纳入了类风湿关节炎或脊柱关节炎且膝关节急性肿胀(≥1周,<24周)的患者。他们被随机(1:1)分配接受膝关节内注射MPA或TA(各80mg,2mL)。在4周、12周和24周进行评估。主要结局是24周内的复发时间(Kaplan-Meier法),复发定义为疼痛或肿胀恢复至基线水平≥1周。次要结局包括疼痛和肿胀的变化(使用数字评分量表)、活动范围以及不良反应的发生情况。主要分析采用意向性治疗,末次观察值结转。

结果

100例患者(89例类风湿关节炎患者)被等数随机分配至MPA组和TA组。24周内每组各有9例患者复发。MPA组和TA组的平均复发时间无显著差异(分别为20.8[95%CI,18.8 - 22.7]周和20.9[95%CI,19.0 - 22.8]周;P = 0.9;风险比 = 1.0[95%CI,0.4 - 2.5])。两组在每次随访时疼痛和肿胀评分均显著下降(P < 0.001);然而,组间无显著差异。在24周时,MPA组(-4.4[3.1])和TA组(-3.9[2.8])的疼痛平均变化无显著差异(P = 0.46)。所有患者均未发生感染、血肿或色素减退。此外,在24周内,两组在关节肿胀、活动范围、使用3个变量的改良(28个关节)疾病活动评分或健康评估问卷方面均未发现显著的组间差异。

结论

在这些慢性炎症性关节炎患者中,膝关节内注射MPA和TA的疗效无显著差异。然而,由于样本量小,结果需要谨慎外推。四分之三的患者在24周时未复发。印度临床试验注册中心(www.ctri.nic.in)标识符:CTRI/2015/09/006187。

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验