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骨关节炎髋关节腔内黏弹性补充治疗:疼痛和残疾疗效及不良事件发生的系统评价和荟萃分析。

Viscosupplementation for Hip Osteoarthritis: A Systematic Review and Meta-Analysis of the Efficacy on Pain and Disability, and the Occurrence of Adverse Events.

机构信息

Institute of Physical Medicine and Rehabilitation, Hospital das Clinicas, University of São Paulo, São Paulo, Brazil.

Spine Center, São Paulo, Brazil.

出版信息

Arch Phys Med Rehabil. 2018 Mar;99(3):574-583.e1. doi: 10.1016/j.apmr.2017.07.010. Epub 2017 Aug 11.

Abstract

OBJECTIVE

To assess the efficacy of viscosupplementation (hyaluronic acid [HA]) on the pain and disability caused by hip osteoarthritis, and to determine the occurrence of adverse events.

DATA SOURCES

PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov database, and specific journals up to March 2017.

STUDY SELECTION

Randomized controlled trials (RCTs) comparing HA with any other intra-articular injection.

DATA EXTRACTION

Performed according to Cochrane/Grades of Recommendation, Assessment, Development, and Evaluation criteria. Two authors extracted data and assessed the risk of bias and quality of evidence. A random-effects meta-analysis was conducted.

DATA SYNTHESIS

Eight RCTs were retrieved (n=807): 4 comparing HA to placebo; 3 to platelet-rich plasma (PRP); 3 to methylprednisolone; and 1 to mepivacaine. Some RCTs had 3 arms. There is very low evidence that HA is not superior to placebo for pain at 3 months (standardized mean difference [SMD]=-.06; 95% CI, -.38 to .25; P=.69), and high evidence that it is not superior in adverse events (risk ratio [RR]=1.21; 95% CI, .79-1.86; P=.38). There is low evidence that HA is not superior to PRP for pain at 1 month. There is very low evidence that HA is not superior to PRP for pain at 6 and 12 months (mean difference in visual analog scale [in cm]: -.05 [95% CI, -.81 to .71], 1.0 [95% CI, -1.5 to 3.50], and .81 [95% CI, -1.11 to 2.73], respectively). There is high evidence that HA is no different from methylprednisolone for pain at 1 month (SMD=.02; 95% CI, -.18 to .22; P=.85). There is low evidence that HA is no different from methylprednisolone for Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International Responders Index at 1 month (RR=.44; 95% CI, .10-1.95; P=.28). There is high evidence that HA is no different from methylprednisolone for adverse events (RR=1.21; 95% CI, .79-1.87; P=.38).

CONCLUSIONS

We do not recommend viscosupplementation for hip osteoarthritis. Compared with placebo, data show scarce evidence of its efficacy up to 3 months, and suggest no difference at 6 months. However, future RCTs could present HA as an alternative to methylprednisolone for short-term symptom relief.

摘要

目的

评估黏弹性补充治疗(透明质酸[HA])对髋关节骨关节炎引起的疼痛和残疾的疗效,并确定不良事件的发生情况。

资料来源

PubMed、EMBASE、Cochrane 图书馆、ClinicalTrials.gov 数据库和特定期刊,截至 2017 年 3 月。

研究选择

比较 HA 与任何其他关节内注射的随机对照试验(RCT)。

数据提取

根据 Cochrane/建议评估、制定和评估等级标准进行。两名作者提取数据并评估偏倚风险和证据质量。进行了随机效应荟萃分析。

数据综合

共检索到 8 项 RCT(n=807):4 项比较 HA 与安慰剂;3 项比较富血小板血浆(PRP);3 项比较甲泼尼龙;1 项比较甲哌卡因。一些 RCT 有 3 个组。有非常低的证据表明,HA 在 3 个月时的疼痛缓解并不优于安慰剂(标准化均数差值[SMD]=-.06;95%CI,-.38 至.25;P=.69),并且有很高的证据表明,在不良事件方面,HA 并不优于安慰剂(风险比[RR]=1.21;95%CI,.79-1.86;P=.38)。有低证据表明,HA 在 1 个月时的疼痛缓解并不优于 PRP。有非常低的证据表明,HA 在 6 个月和 12 个月时的疼痛缓解并不优于 PRP(视觉模拟评分差值的平均值[cm]:-.05[95%CI,-.81 至.71],1.0[95%CI,-1.5 至 3.50],和.81[95%CI,-1.11 至 2.73])。有很高的证据表明,HA 在 1 个月时的疼痛缓解与甲泼尼龙无差异(SMD=.02;95%CI,-.18 至.22;P=.85)。有低证据表明,HA 在 1 个月时的关节炎临床试验中的骨关节炎研究协会国际反应者指数(Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International Responders Index)方面与甲泼尼龙无差异(RR=.44;95%CI,.10-1.95;P=.28)。有很高的证据表明,HA 在不良事件方面与甲泼尼龙无差异(RR=1.21;95%CI,.79-1.87;P=.38)。

结论

我们不建议髋关节骨关节炎使用黏弹性补充治疗。与安慰剂相比,数据显示其在 3 个月内的疗效仅有少量证据,并且提示在 6 个月时无差异。然而,未来的 RCT 可能会将 HA 作为治疗短期症状的甲基泼尼松龙的替代药物。

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