处方级结晶硫酸氨基葡萄糖作为一种附加治疗方法，用于治疗手部侵蚀性骨关节炎的常规治疗：来自 6 个月观察性回顾性研究的结果。
Prescription-grade crystalline glucosamine sulfate as an add-on therapy to conventional treatments in erosive osteoarthritis of the hand: results from a 6-month observational retrospective study.
机构信息
Clinic for the Diagnosis and Management of Hand Osteoarthritis, Rheumatology Unit, Department of Medicine, Surgery and Neuroscience, Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte, Viale Bracci 1, 53100, Siena, Italy.
Geriatric Unit, Department of Internal Medicine and Geriatrics, University of Palermo, Palermo, Italy.
出版信息
Aging Clin Exp Res. 2022 Jul;34(7):1613-1625. doi: 10.1007/s40520-022-02151-7. Epub 2022 May 30.
OBJECTIVE
To evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS) as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA).
METHODS
This 6-month retrospective case-control study included patients with concomitant knee osteoarthritis and symptomatic EHOA. Participants were stratified into two groups based on whether or not pCGS (1500 mg/day) was added to the conventional therapy (education and training in ergonomic principles, exercise and use on-demand of symptomatic drugs) for hand osteoarthritis. Patients were evaluated at baseline, after 3 and 6 months. Primary outcomes were the change from baseline to month 6 in Visual Analogue Scale (VAS) hand pain and in Functional Index for Hand Osteoarthritis (FIHOA) score. A set of secondary parameters was also evaluated.
RESULTS
123 patients were included as follows: 67 treated with pCGS in addition to conventional therapy (pCGS Group) and 56 with conventional therapy alone (Control Group). After 6 months a significant difference in VAS and in FIHOA score (p < 0.01 and p < 0.001, respectively) was observed in favor of pCGS Group. Similar results were found for morning stiffness duration (p < 0.05), health assessment questionnaire (p < 0.01) and physical and mental component score of 36-item short form (p < 0.05 and p < 0.001, respectively). A significant reduction of symptomatic drug consumption at 3 and 6 months was reported in the pCGS Group (p < 0.001). No serious adverse event was recorded in both groups.
CONCLUSIONS
Despite all the limitations inherent to an observational study, our results suggest the potential effectiveness of pCGS, when used in combination with conventional therapy in EHOA. Further randomized placebo-controlled trials are needed to confirm these positive findings.
TRIAL REGISTRATION
ClinicalTrials.gov, http://www.
CLINICALTRIALS
gov , date of registration: February 2, 2022, NCT05237596. The present trial was retrospectively registered.
目的
评估处方级结晶氨基葡萄糖硫酸盐（pCGS）作为附加治疗与单独常规治疗相比，在手（EHOA）侵蚀性骨关节炎患者中的疗效。
方法
这是一项为期 6 个月的回顾性病例对照研究，纳入了同时患有膝骨关节炎和症状性 EHOA 的患者。参与者根据是否在常规治疗（教育和培训人体工程学原则、运动和按需使用对症药物）之外添加 pCGS（1500mg/天）对手骨关节炎进行分组。患者在基线、3 个月和 6 个月时进行评估。主要结局是从基线到第 6 个月时视觉模拟量表（VAS）手部疼痛和手部骨关节炎功能指数（FIHOA）评分的变化。还评估了一组次要参数。
结果
共纳入 123 例患者，其中 67 例患者接受了 pCGS 联合常规治疗（pCGS 组），56 例患者接受了常规治疗（对照组）。6 个月后，pCGS 组在 VAS 和 FIHOA 评分方面有显著差异（p<0.01 和 p<0.001），这表明 pCGS 组有明显优势。晨僵时间（p<0.05）、健康评估问卷（p<0.01）和 36 项简短形式（SF-36）的身体和精神成分评分（p<0.05 和 p<0.001）也有类似的结果。pCGS 组在 3 个月和 6 个月时报告的对症药物消耗显著减少（p<0.001）。两组均未发生严重不良事件。
结论
尽管存在观察性研究固有的所有局限性，但我们的结果表明，pCGS 联合常规治疗在手 EHOA 中具有潜在的有效性。需要进一步的随机安慰剂对照试验来证实这些积极发现。
试验注册
ClinicalTrials.gov，http://www.clinicaltrials.gov，注册日期：2022 年 2 月 2 日，NCT05237596。本试验是回顾性注册的。
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