对医药级硫酸软骨素的应答者特征分析：CONCEPT 试验研究。
Responder Profile to Pharmaceutical-Grade Chondroitin Sulfate: An Analysis of the CONCEPT Trial.
机构信息
Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium.
Department of Biostatistics, University of Liège, Liège, Belgium.
出版信息
Adv Ther. 2020 Nov;37(11):4641-4648. doi: 10.1007/s12325-020-01484-x. Epub 2020 Sep 21.
INTRODUCTION
The recent CONCEPT study showed that 800 mg/day of pharmaceutical-grade chondroitin sulfate (CS) was superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in patients with symptomatic knee osteoarthritis (OA). We investigate, in the present study, whether a responder profile to CS could be defined (i.e., to determine a patient's profile with the best response to treatment).
METHODS
Subjects from the CS group of the CONCEPT study were included in the present analysis. Within the CS group, various subgroups were created on the basis of different categories of age, sex, body mass index, Kellgren and Lawrence grade, age since the beginning of OA, and baseline level of pain (i.e., VAS) or function (i.e., Lequesne index). The nonparametric Kruskal-Wallis (KW) test was applied to compare the VAS pain/Lequesne index evolutions between the subgroups, and the Dwass, Steel, Critchlow, Fligner (DSCF) procedure was used to compute multiple comparisons. The impact of various covariates on the VAS pain/Lequesne index evolution was assessed by means of multiple regression.
RESULTS
Across all analyses, the probability of response to CS treatment was significantly associated with the duration between the date of diagnosis and the initiation of treatment. In other words, the shorter the interval between the diagnosis and the beginning of the treatment, the higher the response for both pain and function, particularly for patients with a duration of less than 5 years compared to patients with a duration of 10 years or more. No other criteria were found to be consistently associated with the response to CS treatment.
CONCLUSION
The treatment of OA with CS has the highest chance of success if administered in the early stage of the disease. Further research with other clinical outcomes should be carried out prior to widespread application of these findings.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03200288.
简介
最近的 CONCEPT 研究表明，每天 800 毫克的医药级硫酸软骨素（CS）在缓解疼痛和改善功能方面优于安慰剂，与塞来昔布相似，在有症状的膝骨关节炎（OA）患者中，6 个月后有效。我们在本研究中调查了是否可以定义 CS 的反应者特征（即，确定对治疗反应最佳的患者特征）。
方法
本分析纳入了 CONCEPT 研究 CS 组的受试者。在 CS 组中，根据不同类别的年龄、性别、体重指数、Kellgren 和 Lawrence 分级、OA 开始以来的年龄以及基线疼痛（即 VAS）或功能（即 Lequesne 指数），创建了各种亚组。非参数 Kruskal-Wallis（KW）检验用于比较亚组之间的 VAS 疼痛/Lequesne 指数演变，Dwass、Steel、Critchlow、Fligner（DSCF）程序用于计算多重比较。通过多元回归评估各种协变量对 VAS 疼痛/Lequesne 指数演变的影响。
结果
在所有分析中，对 CS 治疗的反应概率与从诊断到开始治疗之间的时间间隔显著相关。换句话说，从诊断到开始治疗的间隔时间越短，疼痛和功能的反应越高，尤其是与病程超过 10 年的患者相比，病程小于 5 年的患者。没有发现其他标准与 CS 治疗的反应一致。
结论
如果在疾病早期使用 CS 治疗 OA，成功的机会最大。在广泛应用这些发现之前，应该进行其他临床结局的进一步研究。
试验注册
ClinicalTrials.gov 标识符，NCT03200288。
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