姜黄提取物治疗膝关节骨关节炎疼痛的安全性和有效性:一项随机安慰剂对照试验。

Safety and efficacy of Curcuma longa extract in the treatment of painful knee osteoarthritis: a randomized placebo-controlled trial.

机构信息

Division of Clinical Pharmacology, St. John's Medical College, Bangalore 560034, India.

出版信息

Inflammopharmacology. 2013 Apr;21(2):129-36. doi: 10.1007/s10787-012-0163-3. Epub 2012 Dec 16.

Abstract

Curcuma longa Linn. is widely used for the treatment of disorders associated with inflammation and was evaluated for its safety and efficacy in the treatment of painful knee osteoarthritis (OA). This was a randomized, single blind, placebo-controlled trial. Total of 120 patients (37 males and 83 females) with primary knee OA received either placebo (400 mg twice daily) or NR-INF-02 (500 mg twice daily) or glucosamine sulphate (GS) (750 mg twice daily) alone or combination of NR-INF-02 and GS for 42 days. The efficacy was assessed during treatment period, on day 21 and day 42. The decrease in severity of pain symptom and function of affected knee as primary efficacy outcome measure was assessed by Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale, respectively. The clinical examination of affected joint was measured by an orthopaedic specialist and using a Clinician Global Impression Change (CGIC) scale. The analysis of post-treatment scores following administration of NR-INF-02 using VAS, WOMAC, and CGIC at each clinical visit showed significant decrease (p < 0.05) compared to placebo. NR-INF-02 treated group showed a significant (p < 0.01) decrease in use of rescue medication, along with clinical and subjective improvement compared to placebo. The tolerability and acceptability profile of NR-INF-02 was better during the trial period. The study demonstrates safety and efficacy of NR-INF-02 as a useful treatment option for patients with primary painful knee OA.

摘要

姜黄广泛用于治疗与炎症相关的疾病,并已评估其在治疗膝关节骨关节炎(OA)疼痛中的安全性和疗效。这是一项随机、单盲、安慰剂对照试验。共有 120 名(37 名男性和 83 名女性)原发性膝关节 OA 患者接受安慰剂(400mg,每日 2 次)或 NR-INF-02(500mg,每日 2 次)或硫酸葡糖胺(GS)(750mg,每日 2 次)单独治疗,或 NR-INF-02 和 GS 联合治疗,共 42 天。在治疗期间、第 21 天和第 42 天评估疗效。使用视觉模拟量表(VAS)和西部安大略省和麦克马斯特大学骨关节炎指数(WOMAC)量表评估疼痛症状严重程度和受影响膝关节功能的变化,作为主要疗效指标。受影响关节的临床检查由矫形专家进行,并使用临床医生总体印象变化(CGIC)量表进行评估。与安慰剂相比,NR-INF-02 治疗组在每次临床就诊时使用 VAS、WOMAC 和 CGIC 评估治疗后的评分,均显示出显著降低(p<0.05)。与安慰剂相比,NR-INF-02 治疗组在使用救援药物、临床和主观改善方面均有显著降低(p<0.01)。NR-INF-02 在试验期间的耐受性和可接受性更好。该研究表明 NR-INF-02 作为一种治疗原发性膝关节疼痛性 OA 的有效治疗选择是安全且有效的。

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