Ha Chul-Won, Park Yong-Beom, Min Byung-Woo, Han Seung-Beom, Lee Jae Hyup, Won Ye-Yeon, Park Ye-Soo
Department of Orthopedic Surgery, Stem Cell & Regenerative Medicine Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea; Department of Health Sciences and Technology, SAIHST, Sungkyunkwan University, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea.
Department of Orthopedic Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 102 Heukseok-ro, Dongjak-gu, Seoul 06973, South Korea.
J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25.
ETHNOPHARMACOLOGICAL RELEVANCE: This prospective, randomized, double-blinded, double-dummy, multicenter study compared the efficacy and safety of PG201 (Layla®), a new product from extracts of 12 plant sources and SKI306X (Joins®) which have been well investigated and in relatively wide usage among herbal medicine, for the treatment of patients with knee osteoarthritis. AIM OF THE STUDY: To compare the efficacy and safety of PG201 and SKI306X in patients with knee osteoarthritis. MATERIALS AND METHODS: A prospective, double-blinded multicenter study was conducted in 124 patients with Kellgren and Lawrence grade 2-3 knee osteoarthritis. Patients were randomly assigned to receive 600mg of PG201 (300mg, twice daily) and 600mg of SKI306X placebo (200mg, thrice daily) or 600mg of SKI306X (200mg, thrice daily) and PG201 placebo (300mg, twice daily) for 12 weeks. The primary outcome was the improvement of pain by week 8 as assessed by the 100-mm pain visual analog scale (VAS). Secondary outcomes included pain VAS improvement level at week 12, pain VAS improvement rate at weeks 8 and 12, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) improvement level at weeks 8 and 12, the improvement of the quality of life (EQ-5D), overall symptom self-assessment score, and rescue medication consumption. RESULTS: The pain VAS improvement at 8 weeks was 14.2±16.2 in the experimental group and 11.9±13.1 in control group (p=0.557), confirming that the experimental group was not inferior to the control group as lower limit (-8.38) of 95% CI of the difference of VAS improvement between two groups was well above the allowed limit (-10 mm). There was no significant difference in all secondary outcomes including pain VAS, WOMAC, EQ-5D, overall symptom self-assessment score, and rescue medication consumption. Adverse events were low and similar between the two groups. CONCLUSIONS: The results of this study showed that PG201 significantly reduced knee pain and improved knee function and were comparable to SKI306X. PG201 can be suggested as an effective treatment of knee osteoarthritis. Trial registration ClinicalTrials.gov:NCT01768468.
民族药理学相关性：这项前瞻性、随机、双盲、双模拟、多中心研究比较了PG201（Layla®）和SKI306X（Joins®）的疗效和安全性。PG201是一种从12种植物来源提取物制成的新产品，而SKI306X已得到充分研究且在草药中使用较为广泛，二者均用于治疗膝骨关节炎患者。 研究目的：比较PG201和SKI306X在膝骨关节炎患者中的疗效和安全性。 材料与方法：对124例凯尔格伦和劳伦斯分级为2 - 3级的膝骨关节炎患者进行了一项前瞻性、双盲多中心研究。患者被随机分配接受600mg的PG201（300mg，每日两次）和600mg的SKI306X安慰剂（200mg，每日三次），或600mg的SKI306X（200mg，每日三次）和PG201安慰剂（300mg，每日两次），持续12周。主要结局是通过100mm疼痛视觉模拟量表（VAS）评估第8周时疼痛的改善情况。次要结局包括第12周时疼痛VAS改善水平、第8周和第12周时疼痛VAS改善率、第8周和第12周时西安大略和麦克马斯特大学骨关节炎指数（WOMAC）改善水平、生活质量（EQ - 5D）改善情况、总体症状自我评估评分以及急救药物消耗量。 结果：实验组第8周时疼痛VAS改善值为14.2±16.2，对照组为11.9±13.1（p = 0.557），证实实验组不劣于对照组，因为两组VAS改善差异的95%CI下限（-8.38）远高于允许限度（-10mm）。在所有次要结局方面，包括疼痛VAS、WOMAC、EQ - 5D、总体症状自我评估评分和急救药物消耗量，均无显著差异。两组不良事件发生率较低且相似。 结论：本研究结果表明，PG201能显著减轻膝关节疼痛并改善膝关节功能，与SKI306X相当。PG201可被推荐为治疗膝骨关节炎的有效药物。试验注册ClinicalTrials.gov：NCT01768468。
J Rheum Dis. 2024-4-1
Cochrane Database Syst Rev. 2019-2-25
Knee Surg Relat Res. 2017-9-1
Zotero 插件