口服高生物利用度姜黄素一年具有临床和软骨保护作用：一项随机、双盲、安慰剂对照的前瞻性研究。
The Oral Administration of Highly-Bioavailable Curcumin for One Year Has Clinical and Chondro-Protective Effects: A Randomized, Double-Blinded, Placebo-Controlled Prospective Study.
作者信息
Nakagawa Yasuaki, Mori Koji, Yamada Shigeru, Mukai Shogo, Hirose Akiko, Nakamura Ryota
机构信息
Department of Orthopaedic Surgery, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.
Applied Medical Engineering Science, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
出版信息
Arthrosc Sports Med Rehabil. 2022 Jan 13;4(2):e393-e402. doi: 10.1016/j.asmr.2021.10.016. eCollection 2022 Apr.
PURPOSE
The purpose of this study was to determine the clinical and chondroprotective efficacy and safety of orally administered Theracurmin in patients who underwent mosaicplasty for knee chondral or osteochondral diseases over 12 months of treatment.
METHODS
We enrolled 50 patients, older than 20 years of age, who underwent mosaicplasty for their knee joint diseases. Theracurmin at 180 mg of curcumin per day or placebo was administered orally every day for 12 months. Because 7 patients dropped out of the study, 43 patients were examined; they included 14 men and 29 women and 24 right and 19 left knees. The mean operative age was 59.5 years (range, 24-84 years). We evaluated the Japanese Orthopaedic Association knee osteoarthritis score (JOA), visual analog scale (VAS), and Japanese Knee Osteoarthritis Measure (JKOM) as clinical symptoms; T2 mapping values using magnetic resonance imaging as an indication of the chondroprotective effect; and blood concentration of curcumin at 0, 3, 6, and 12 months after the operations. We performed intraoperative acoustic evaluation of articular cartilage as a measure of chondroprotective effect during the operations and second-look arthroscopy.
RESULTS
The JOA, VAS and JKOM at 3, 6, and 12 months were significantly better than those during the preoperative period. However, the values of JOA, VAS and JKOM and T2 mapping were not significantly different between the Theracurmin and placebo groups. The blood concentration of curcumin in the Theracurmin group was significantly higher than that in the placebo group at 3, 6, and 12 months after the operations. Cartilage stiffness and surface roughness were significantly better in the Theracurmin group than in the placebo group at second-look arthroscopy.
CONCLUSIONS
The oral administration of Theracurmin for 1 year demonstrated significantly better chondroprotective effects and no worse clinical effects and adverse events than the placebo.
LEVEL OF EVIDENCE
Level I, double-blinded, placebo-controlled, prospective study.
目的
本研究旨在确定口服Theracurmin对膝关节软骨或骨软骨疾病行镶嵌成形术患者在12个月治疗期内的临床疗效、软骨保护作用及安全性。
方法
我们纳入了50例年龄超过20岁、因膝关节疾病接受镶嵌成形术的患者。每天口服含180毫克姜黄素的Theracurmin或安慰剂，持续12个月。由于7例患者退出研究，共对43例患者进行了检查；其中男性14例，女性29例，右膝24例，左膝19例。平均手术年龄为59.5岁（范围24 - 84岁）。我们评估了日本骨科协会膝关节骨关节炎评分（JOA）、视觉模拟评分（VAS）和日本膝关节骨关节炎测量指标（JKOM）作为临床症状；使用磁共振成像的T2映射值作为软骨保护作用的指标；以及术后0、3、6和12个月时姜黄素的血药浓度。我们在手术及二次关节镜检查期间对关节软骨进行术中声学评估，作为软骨保护作用的一项指标。
结果
术后3、6和12个月时的JOA、VAS和JKOM评分均显著优于术前。然而，Theracurmin组和安慰剂组之间的JOA、VAS和JKOM评分以及T2映射值并无显著差异。术后3、6和12个月时，Theracurmin组的姜黄素血药浓度显著高于安慰剂组。在二次关节镜检查中，Theracurmin组的软骨硬度和表面粗糙度显著优于安慰剂组。
结论
口服Theracurmin 1年显示出比安慰剂显著更好的软骨保护作用，临床效果和不良事件并不更差。
证据级别
I级，双盲、安慰剂对照、前瞻性研究。
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