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口服葡萄糖胺对膝骨关节炎和髋骨关节炎有效性的亚组分析:来自 OA 试验库的系统评价和个体患者数据荟萃分析。

Subgroup analyses of the effectiveness of oral glucosamine for knee and hip osteoarthritis: a systematic review and individual patient data meta-analysis from the OA trial bank.

机构信息

Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.

Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

Ann Rheum Dis. 2017 Nov;76(11):1862-1869. doi: 10.1136/annrheumdis-2017-211149. Epub 2017 Jul 28.

Abstract

OBJECTIVE

To evaluate the effectiveness of oral glucosamine in subgroups of people with hip or knee osteoarthritis (OA) based on baseline pain severity, body mass index (BMI), sex, structural abnormalities and presence of inflammation using individual patient data.

METHODS

After a systematic search of the literature and clinical trial registries, all randomised controlled trials (RCTs) evaluating the effect of any oral glucosamine substance in patients with clinically or radiographically defined hip or knee OA were contacted. As a minimum, pain, age, sex and BMI at baseline and pain as an outcome measure needed to be assessed.

RESULTS

Of 21 eligible studies, six (n=1663) shared their trial data with the OA Trial Bank. Five trials (all independent of industry, n=1625) compared glucosamine with placebo, representing 55% of the total number of participants in all published placebo-controlled RCTs. Glucosamine was no better than placebo for pain or function at short (3 months) and long-term (24 months) follow-up. Glucosamine was also no better than placebo among the predefined subgroups. Stratification for knee OA and type of glucosamine did not alter these results.

CONCLUSIONS

Although proposed and debated for several years, open trial data are not widely made available for studies of glucosamine for OA, especially those sponsored by industry. Currently, there is no good evidence to support the use of glucosamine for hip or knee OA and an absence of evidence to support specific consideration of glucosamine for any clinically relevant OA subgroup according to baseline pain severity, BMI, sex, structural abnormalities or presence of inflammation.

摘要

目的

利用个体患者数据,根据基线疼痛严重程度、体重指数 (BMI)、性别、结构异常和炎症情况,评估口服氨基葡萄糖对髋或膝关节骨关节炎 (OA) 患者亚组的疗效。

方法

在系统搜索文献和临床试验注册后,联系了所有评估任何口服氨基葡萄糖物质对临床或放射学定义的髋或膝关节 OA 患者疗效的随机对照试验 (RCT)。作为最低要求,需要评估基线时的疼痛、年龄、性别和 BMI 以及疼痛作为结局指标。

结果

在 21 项合格研究中,有 6 项(n=1663)与 OA 试验库共享了其试验数据。5 项试验(均独立于行业,n=1625)比较了氨基葡萄糖与安慰剂,占所有已发表安慰剂对照 RCT 中总参与者的 55%。在短期(3 个月)和长期(24 个月)随访中,氨基葡萄糖在疼痛或功能方面均不比安慰剂好。在预先定义的亚组中,氨基葡萄糖也不比安慰剂好。根据膝关节炎和氨基葡萄糖类型进行分层并没有改变这些结果。

结论

尽管已经提出并讨论了好几年,但 OA 氨基葡萄糖研究的开放试验数据并未广泛提供,尤其是那些由行业赞助的研究。目前,没有充分证据支持使用氨基葡萄糖治疗髋或膝关节 OA,也没有证据支持根据基线疼痛严重程度、BMI、性别、结构异常或炎症情况,考虑将氨基葡萄糖用于任何有临床意义的 OA 亚组。

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