Furuzawa-Carballeda Janette, Cabral Antonio R, Zapata-Zuñiga Martín, Alcocer-Varela Jorge
Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
J Rheumatol. 2003 Feb;30(2):256-9.
To determine the efficacy, tolerance and safety of subcutaneous injections of porcine type I collagen-polyvinylpyrrolidone (PVP) in patients with rheumatoid arthritis (RA).
Eleven patients with active RA on stable therapy with methotrexate (MTX) were enrolled in a 3 month prospective and longitudinal study. Patients were treated weekly with subcutaneous injections of 0.2 ml of collagen-PVP (1.7 mg of collagen) in the 8 most painful joints. The primary endpoints included the Ritchie index (RI), swollen joint count, disease activity score (DAS), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). The secondary endpoints included morning stiffness, pain intensity on a visual analog scale (VAS), and the Spanish-Health Assessment Questionnaire Disability Index (HAQ-DI). Improvement was determined using American College of Rheumatology (ACR) response criteria.
Collagen-PVP was safe and well-tolerated and there were no adverse events. Patients had a statistically significant improvement (p < 0.05) in basal versus 3 month's treatment in morning stiffness (Delta -32.3, -68.6%), RI (Delta -10.2, -46.4%), swollen joint count (Delta -10.7, -71.8%), VAS (Delta -39.9, -63.8%), HAQ-DI (Delta -0.5, -48.5%), DAS (Delta -1.35, -70.5%) and ACR20, 50, and 70 (80.0%; 60.0% and 20.0% respectively). We found no differences in serologic or hematologic variables.
Collagen-PVP was a safe and well-tolerated drug for the short term treatment of RA. The combination of collagen-PVP plus MTX was more efficacious than MTX alone. However, double-blind placebo-controlled phase II and III clinical trials are necessary to determine whether this drug could be useful in the longterm treatment of RA.
确定皮下注射猪I型胶原-聚乙烯吡咯烷酮（PVP）治疗类风湿关节炎（RA）患者的疗效、耐受性和安全性。
11例接受甲氨蝶呤（MTX）稳定治疗的活动性RA患者参加了一项为期3个月的前瞻性纵向研究。患者每周在8个最疼痛的关节皮下注射0.2 ml胶原-PVP（1.7 mg胶原）。主要终点包括里奇指数（RI）、肿胀关节计数、疾病活动评分（DAS）、红细胞沉降率（ESR）和C反应蛋白（CRP）。次要终点包括晨僵、视觉模拟量表（VAS）疼痛强度和西班牙健康评估问卷残疾指数（HAQ-DI）。使用美国风湿病学会（ACR）反应标准确定改善情况。
胶原-PVP安全且耐受性良好，未发生不良事件。与治疗前相比，患者在治疗3个月时晨僵（差值-32.3，-68.6%）、RI（差值-10.2，-46.4%）、肿胀关节计数（差值-10.7，-71.8%）、VAS（差值-39.9，-63.8%）、HAQ-DI（差值-0.5，-48.5%）、DAS（差值-1.35，-70.5%）以及ACR20、50和70（分别为80.0%；60.0%和20.0%）方面有统计学显著改善（p < 0.05）。我们未发现血清学或血液学变量有差异。
胶原-PVP是一种用于RA短期治疗的安全且耐受性良好的药物。胶原-PVP联合MTX比单独使用MTX更有效。然而，需要进行双盲安慰剂对照的II期和III期临床试验来确定该药物是否可用于RA的长期治疗。
