Puente Roberto, Illnait José, Mas Rosa, Carbajal Daisy, Mendoza Sarahí, Fernández Julio César, Mesa Meilis, Gámez Rafael, Reyes Pablo
Surgical Medical Research Centre, Havana, Cuba.
Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
Korean J Intern Med. 2014 Mar;29(2):191-202. doi: 10.3904/kjim.2014.29.2.191. Epub 2014 Feb 27.
BACKGROUND/AIMS: Nonsteroidal anti-inflammatory drugs relieve osteoarthritis (OA) symptoms but cause adverse effects. D-002, a mixture of beeswax alcohols, is effective against experimental OA. A pilot study found that D-002 (50 mg/day) for 8 weeks improves OA symptoms. The aim of this study was to investigate the effects of D-002 (50 to 100 mg/day) administered for 6 weeks on OA symptoms.
Patients with OA symptoms were double-blindly randomized to D-002 (50 mg) or placebo for 6 weeks. Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the visual analog scale (VAS) scores. Patients without symptom improvement at week 3 were titrated to two daily tablets. The primary outcome was the total WOMAC score. WOMAC pain, joint stiffness and physical function scores, VAS score, and use of rescue medications were secondary outcomes.
All randomized patients (n = 60) completed the study, and 23 experienced dose titration (two in the D-002 and 21 in the placebo groups). At study completion, D-002 reduced total WOMAC (65.4%), pain (54.9%), joint stiffness (76.8%), and physical function (66.9%) WOMAC scores, and the VAS score (46.8%) versus placebo. These reductions were significant beginning in the second week, and became enhanced during the trial. The use of rescue medication by the D-002 (6/30) group was lower than that in the placebo (17/30) group. The treatment was well tolerated. Seven patients (two in the D-002 and five in the placebo group) reported adverse events.
These results indicate that D-002 (50 to 100 mg/day) for 6 weeks ameliorated arthritic symptoms and was well tolerated.
背景/目的：非甾体抗炎药可缓解骨关节炎（OA）症状，但会引起不良反应。D-002是一种蜂蜡醇混合物，对实验性OA有效。一项初步研究发现，D-002（50毫克/天）服用8周可改善OA症状。本研究的目的是调查服用D-002（50至100毫克/天）6周对OA症状的影响。
有OA症状的患者被双盲随机分为D-002（50毫克）组或安慰剂组，为期6周。症状通过西安大略和麦克马斯特大学骨关节炎指数（WOMAC）以及视觉模拟量表（VAS）评分进行评估。在第3周时症状无改善的患者增加至每日两片。主要结局是WOMAC总分。WOMAC疼痛、关节僵硬和身体功能评分、VAS评分以及急救药物的使用情况为次要结局。
所有随机分组的患者（n = 60）均完成了研究，23例患者进行了剂量调整（D-002组2例，安慰剂组21例）。研究结束时，与安慰剂相比，D-002降低了WOMAC总分（65.4%）、疼痛评分（54.9%）、关节僵硬评分（76.8%）和身体功能评分（66.9%）以及VAS评分（46.8%）。这些降低从第二周开始显著，并在试验期间增强。D-002组（6/30）急救药物的使用低于安慰剂组（17/30）。该治疗耐受性良好。7例患者报告了不良事件（D-002组2例，安慰剂组5例）。
这些结果表明，D-002（50至100毫克/天）服用6周可改善关节炎症状，且耐受性良好。
