Martin Martin Luis Severino, Massafra Umberto, Bizzi Emanuele, Migliore Alberto
Department of Internal Medicine, "Regina Apostolorum" Hospital, Via S. Francesco 50, Albano Laziale, Rome, Italy.
Operative Unit of Rheumatology "S.Pietro-Fatebenefratelli" Hospital, Via Cassia 600, 00189, Rome, Italy.
BMC Musculoskelet Disord. 2016 Feb 22;17:94. doi: 10.1186/s12891-016-0948-4.
To evaluate the clinical outcomes of a group of patients affected by knee osteoarthritis (OA) treated with MD-Knee (Guna S.p.a., Milan, Italy) versus a group of patients treated with sodium hyaluronate.
This non-inferiority prospective randomized controlled trial involved 60 patients affected by knee OA, grade 2-3 of Kellgren-Lawrence scale. The MD-Knee Group, Group A (n = 29) was administered five intra-articular injections at 1 week interval; the sodium hyaluronate Group, Group B (n = 31), was administered five doses of intra-articular injection of sodium hyaluronate at 1 week interval. All patients were prospectively evaluated before and at 3 and 6 months after the treatment by the Lequesne Knee Index (LKI) as primary endpoint and the Visual Analogue Scale (VAS), Pain Killer consumption and SF-36 questionnaires as secondary endpoints.
At the 3- and 6 month follow-up, LKI and VAS improved significantly in both groups compared to baseline and no statistically significant differences were observed between Group A and Group B. There was no statistically significant difference in the SF36 questionnaire score and pain killer consumption between two groups at any time point.
This study shows that both preparations exert similar clinical effects as assessed through multiple outcome measures. MD-Knee is effective on knee OA symptoms over 6 months after a 5-weekly injection course, and it is equally effective as the reference sodium hyaluronate.
ISRCTN93862496 . Registration date: January 18th, 2016.
评估一组接受MD-Knee（意大利米兰古纳股份公司）治疗的膝骨关节炎（OA）患者与一组接受透明质酸钠治疗的患者的临床疗效。
这项非劣效性前瞻性随机对照试验纳入了60例Kellgren-Lawrence分级为2-3级的膝OA患者。MD-Knee组（A组，n = 29）每隔1周进行5次关节腔内注射；透明质酸钠组（B组，n = 31）每隔1周进行5次透明质酸钠关节腔内注射。所有患者在治疗前以及治疗后3个月和6个月进行前瞻性评估，主要终点为Lequesne膝关节指数（LKI），次要终点为视觉模拟量表（VAS）、止痛药消耗量和SF-36问卷。
在3个月和6个月的随访中，与基线相比，两组的LKI和VAS均显著改善，A组和B组之间未观察到统计学上的显著差异。在任何时间点，两组之间的SF36问卷评分和止痛药消耗量均无统计学上的显著差异。
本研究表明，通过多种结局指标评估，两种制剂均具有相似的临床效果。MD-Knee在每周注射一次、共5周的疗程后6个月内对膝OA症状有效，且与对照透明质酸钠效果相当。
ISRCTN93862496。注册日期：2016年1月18日。
