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学科主题: 临床医学
题名:
Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz
作者: Zhang, Heng1; Zhang, Ke2; Zhang, Xianlong3; Zhu, Zhenan4; Yan, Shigui5; Sun, Tiansheng6; Guo, Ai7; Jones, John8; Steen, R. Grant8; Shan, Bin9; Zhang, Jenny9; Lin, Jianhao1
刊名: ARTHRITIS RESEARCH & THERAPY
发表日期: 2015-03-10
DOI: 10.1186/s13075-015-0557-x
卷: 17
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Rheumatology
研究领域[WOS]: Rheumatology
关键词[WOS]: INTRAARTICULAR INJECTION ; CLINICAL-TRIALS ; PAIN ; METAANALYSIS ; VISCOSUPPLEMENTATION ; PARACETAMOL ; REPLACEMENT ; MANAGEMENT ; ARTHRITIS ; CRITERIA
英文摘要:

Introduction: Intra-articular injection of hyaluronic acid (HA) is often used as therapy for knee osteoarthritis because it is less expensive and less aggressive than total knee replacement. Therefore, it is important to document whether HA is safe and efficacious. We tested whether single and multiple injection viscosupplementation with HA is associated with clinically meaningful pain relief in a new randomized clinical trial (RCT). Our objective was to compare safety and efficacy of intra-articular HA in two formulations: one 3.0 ml injection of Durolane versus five 2.5 ml injections of Artz for the treatment of knee osteoarthritis pain.

Methods: Patients (N = 349) from the People′s Republic of China were randomized to treatment (Durolane = 175, Artz = 174). The Durolane group received a 3.0 ml injection at week 0 (baseline), with sham skin punctures at weeks 1, 2, 3, and 4. The Artz group received one 2.5 ml injection at each of the same time points. The primary assessment tool was the Likert-type Western Ontario and McMaster University (WOMAC) pain scale at weeks 0, 6, 10, 14, 18, and 26. Secondary assessments were WOMAC physical function, knee stiffness, and global self-assessment, at identical time points. Statistically-controlled analyses were non-inferiority of Durolane over 18, then over 26 weeks, with a priori non-inferiority defined as 8% of the relevant scale. Acetaminophen was permitted as rescue analgesia and all adverse events (AEs) were recorded.

Results: Overall study retention was excellent; 332 patients (95.1%) completed 18 weeks and 319 (91.4%) completed 26 weeks, with no significant retention difference between treatment arms. All variables met non-inferiority criteria over 18 and 26 weeks. Efficacy response in both arms was > 90%. Treatment-related AEs were 9.8% (17/174) for Artz and 13.1% (23/175) for Durolane.

Conclusions: A single injection of Durolane is non-inferior to 5 injections of Artz over 18 and 26 weeks for pain, physical function, global self-assessment, and knee stiffness. Both treatments were efficacious, safe, and well tolerated.

语种: 英语
项目资助者: Bioventus LLC
WOS记录号: WOS:000352475900001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/61913
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Peking Univ, Peoples Hosp, Arthritis Clin & Res Ctr, Beijing 100044, Peoples R China
2.Peking Univ, Hosp 3, Dept Orthoped, Beijing 100044, Peoples R China
3.Shanghai 6th Peoples Hosp, Dept Orthoped, Shanghai, Peoples R China
4.Shanghai 9th Peoples Hosp, Dept Orthoped, Shanghai, Peoples R China
5.Zhejiang Univ, Sch Med, Affiliated Hosp 2, Dept Orthoped, Hangzhou, Zhejiang, Peoples R China
6.Beijing Mil Gen Hosp, Dept Orthoped, Beijing, Peoples R China
7.Beijing Friendship Hosp, Dept Orthoped, Beijing, Peoples R China
8.Bioventus LLC, Durham, NC USA
9.TigerMed Consulting Co Ltd, Beijing, Peoples R China

Recommended Citation:
Zhang, Heng,Zhang, Ke,Zhang, Xianlong,et al. Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz[J]. ARTHRITIS RESEARCH & THERAPY,2015,17.
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