Institute of Rheumatology, Charles University Prague, Prague, Czech Republic.
Clin Rheumatol. 2010 Jun;29(6):659-70. doi: 10.1007/s10067-010-1384-8. Epub 2010 Feb 24.
To investigate that a 6-month treatment with avocado soybean unsaponifiable (Piascledine 300 mg) once daily is as effective as with chondroitin sulfate 400 mg three times daily in femorotibial gonarthrosis, and also the carry-over effect for two more months is comparable. Patients were randomized (1:1) to the treatment groups. They received for 6 months 3 capsules chondroitin sulfate per day or one capsule of avocado soybean unsaponifiable (ASU) in a double-dummy technique. A 2-month post-treatment period followed to determine the carry-over effect. Primary efficacy criterion was the change of the WOMAC-index from study begin to end of treatment. Secondary criteria were the changes in Lequesne-index, pain on active movement and at rest, global assessment of efficacy. Three hundred sixty-four patients have been taken up into the trial. Three hundred sixty one patients were eligible for evaluation. One hundred eighty three received ASU 300 mg once daily, one hundred seventy eight chondroitin sulfate three times daily. The WOMAC-index decreased in both groups for approx. 50% to the end of therapy. During the post-treatment observation there was a further slight improvement. There was no statistical significant difference between the treatment groups during the entire observation. All other observed parameters showed the same pattern. The daily intake of rescue medication was reduced continuously. Overall efficacy has been rated excellent and good in more than 80% of the patients in both groups. Both drugs were safe and well tolerated. The first direct comparison between avocado soybean unsaponifiable 300 mg once daily and chondroitin sulfate three times daily reveiled no difference in efficacy or safety aspects between 1 capsule ASU 300 mg per day and 3 capsules chondroitin sulfate per day. It can be assumed that the once daily intake of ASU will lead to a better compliance in routine therapy.
为了研究每日一次服用鳄梨大豆不皂化物（Piascledine 300mg）6 个月与每日三次服用硫酸软骨素 400mg 相比在治疗膝关节骨关节炎方面的有效性，以及为期两个月的延续治疗效果是否相当。将患者随机（1:1）分为两组。两组患者均接受为期 6 个月的治疗，一组患者每天服用 3 粒硫酸软骨素胶囊，另一组患者则采用双盲法服用 1 粒鳄梨大豆不皂化物胶囊。在治疗结束后进行为期 2 个月的随访，以确定延续治疗效果。主要疗效标准为从研究开始到治疗结束时 WOMAC 指数的变化。次要标准为 Lequesne 指数、主动运动和休息时疼痛、疗效总体评估的变化。共纳入 364 例患者参加试验。361 例患者符合评估条件。183 例患者接受每日一次 300mg 鳄梨大豆不皂化物治疗，178 例患者接受每日三次 300mg 硫酸软骨素治疗。两组患者的 WOMAC 指数在治疗结束时均下降了约 50%。在治疗后观察期间，指数进一步略有改善。在整个观察期间，两组之间没有统计学上的显著差异。所有其他观察到的参数都呈现出相同的模式。每日使用救援药物的情况持续减少。两组患者的整体疗效均有超过 80%的患者被评为优秀和良好。两种药物均安全且耐受良好。首次对每日一次服用鳄梨大豆不皂化物 300mg 与每日三次服用硫酸软骨素进行直接比较，结果显示每日 1 粒 300mg 鳄梨大豆不皂化物胶囊与每日 3 粒硫酸软骨素胶囊在疗效或安全性方面没有差异。可以假设，每日一次服用 ASU 将提高常规治疗中的依从性。
