Golini Jeff, Jones Wendy Lou
1 All American Pharmaceutical and Natural Foods Corporation , Billings, Montana, USA .
J Med Food. 2014 Sep;17(9):1022-6. doi: 10.1089/jmf.2013.0169. Epub 2014 Jun 4.
The purpose of this study was to ascertain whether an oral, non-prescription, nutritional supplement compound composed of a proprietary alkali-buffered creatine monohydrate and cetylated fatty acids mixture (Kre-Celazine(®)) was efficacious in reducing or eliminating refractory pain and inflammation, without untoward effects, in Juvenile Rheumatoid Arthritis (JRA), which is also called Juvenile Idiopathic Arthritis (JIA). JRA/JIA is a patho-physiologically complex, chronic childhood autoimmune inflammatory disease of unknown etiology. Numerous studies have unsuccessfully attempted to pinpoint a possible common initiation event. Officially considered an affliction of children below the age of 16 years, an initial diagnosis has been confirmed in infants less than 1 year old, to individuals older then 17 years. In this study, sixteen juveniles, ages 7 through 16 years, experiencing long-standing, unremitting pain and inflammation despite previous use of prescription anti-inflammatory drugs and NSAIDs, were enrolled in a 30-day, open-label clinical study and treated with Kre-Celazine. Efficacy of this nutritional supplement was determined by the juvenile's personal physician and based on observations of the following: (1) significant reduction or elimination of palpable signs of inflammation; (2) renormalization of range of motion; (3) reduction or absence of perceived pain as reported to the physician by the patient; (4) renormalization of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) values. In addition, the individual's previous steroid or non-steroidal anti-inflamatory medication(s) were reduced or eliminated in a stepwise progressive fashion during the study.
本研究的目的是确定一种口服非处方营养补充剂复合物(由专利碱缓冲一水肌酸和十六烷酸脂肪酸混合物(Kre-Celazine(®))组成)在青少年类风湿性关节炎(JRA,也称为青少年特发性关节炎(JIA))中是否能有效减轻或消除难治性疼痛和炎症,且无不良影响。JRA/JIA是一种病理生理复杂、病因不明的儿童慢性自身免疫性炎症性疾病。众多研究都未能成功找出可能的共同起始事件。官方认为这是一种16岁以下儿童的疾病,在不到1岁的婴儿到17岁以上的个体中都已确诊过初始病例。在本研究中,16名年龄在7至16岁之间的青少年,尽管之前使用过处方抗炎药和非甾体抗炎药,但仍经历着长期、持续不断的疼痛和炎症,他们参加了一项为期30天的开放标签临床研究,并接受Kre-Celazine治疗。这种营养补充剂的疗效由青少年的私人医生判定,并基于以下观察结果:(1)明显减轻或消除可触及的炎症迹象;(2)活动范围恢复正常;(3)患者向医生报告感知疼痛减轻或消失;(4)C反应蛋白(CRP)和红细胞沉降率(ESR)值恢复正常。此外,在研究过程中,个体之前使用的类固醇或非甾体抗炎药会逐步减少或停用。