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薬理と治療
- Authors: Tatsuji Takahashi1, et al.
Abstract
Proteoglycans, in addition to collagen and hyaluronic acid, are contained in large amounts in connective tissues, such as cartilage and skin, as important components of the extracellular matrix. Recently, a method using acetic acid solution for extracting proteoglycans from salmon nasal cartilage was developed, and it was shown that salmon nasal cartilage-derived proteoglycan(SPG)exerts anti-inflammatory as well as skin-beautifying effects. However, the effects of SPG on the articular cartilage have not yet been investigated. In this study, we evaluated the effects of long-term intake of SPG on arthralgia(both objective findings and subjective symptom)and the serum╱urinary levels of cartilage metabolism markers, as also its safety, in 12 subjects(3 male and 9 female, aged 40 to 74 years old; mainly Kellgren-Lawrence(K-L)grade 0-Ⅱ)suffering from mild knee pain. The study was designed as an open study, and the subjects took one test food capsule daily containing a SPG dose of 10 mg╱day for 12 weeks. For the efficacy endpoints, the parameters frequently used for efficacy evaluation in patients with arthritis were selected: the scores on the Japanese Knee Osteoarthritis Measure(JKOM), scores of arthralgia measured on a visual analogue scale(VAS)to evaluate the patientsʼ subjective symptom of knee pain, and scores on the Japanese Orthopaedic Associationʼs Knee Osteoarthritis Therapeutic Response Rating Scale (JOA), a rating scale based on objective findings. In addition, the serum╱urinary levels of C2C and CTX︱Ⅱ, both markers of cartilage type Ⅱ collagen degradation, and of CPⅡ, a marker of cartilage type Ⅱ collagen synthesis, were measured to evaluate the effect of SPG on cartilage metabolism. Furthermore, the serum type Ⅱ collagen degradation╱synthesis ratios(C2C╱CPⅡ ratio and CTX︱Ⅱ╱CPⅡ ratio)were used as indicators to evaluate the effect of SPG on type Ⅱ collagen metabolism.(UMIN000033138) The results revealed significant improvement of the scores on all subscales of the JKOM, the VAS scores for arthralgia under all three conditions examined (pain at rest, pain on walking, and pain on ascending╱descending stairs), and the scores on 3 of the 5 subscales of JOA(“pain╱walking function,”“pain╱step up and down function”and“aggregate total symptoms”)at 12 weeks as compared with the values at the baseline. Of these subscales, the score for“Ⅰ. severity of knee pain,”an subscale of the JKOM and the VAS scores for pain severity during“walking”and“stair negotiation”began to decrease significantly by 2 weeks after the start of SPG intake, while the scores for the remaining subscales showed significant improvement by 8 weeks of intake. SPG was confirmed to have a persistent rather than a transient effect in improving the pain. Furthermore, of the cartilage metabolism markers, the serum level of C2C, a marker of cartilage type Ⅱ collagen degradation, as well as that of CP Ⅱ, a marker of cartilage type Ⅱ collagen synthesis, were significantly increased at 12 weeks as compared with the values the baseline(P<0.01 for both). Furthermore, the C2C╱CPⅡ ratio, which is considered to represent the balance between type Ⅱ collagen degradation and synthesis, tended to be lower at 12 weeks as compared with that at the baseline(P=0.085), suggesting that the intake of the test food may lead to the relative suppression of cartilage degradation(or relative enhancement of cartilage synthesis). The above results confirm that SPG provides relief from mild knee pain in individuals with mainly K-L grade 0 to Ⅱ, and can be taken safely. The intake of SPG was not associated with any adverse reactions or abnormal changes of the laboratory test results during the study period.
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