塞来昔布联合双醋瑞因治疗老年退行性膝骨关节炎的有效性及安全性:随机对照临床试验方案  

Effectiveness and safety of celecoxib combined with diacerein in the treatment of senile degenerative knee osteoarthritis: study protocol for a randomized controlled trial

作　　者：王国栋[1] 杨凌云[1] 何斌[1] 王云华[1] 陈琦[1] 范磊[1] Wang Guo-dong;Yang Ling-yun;He Bin;Wang Yun-hua;Chen Qi;Fan Lei(Department of Orthopedics, the Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China)

机构地区：[1]南京医科大学第二附属医院骨科,江苏省南京市210011

出　　处：《中国组织工程研究》2017年第36期5747-5751,共5页Chinese Journal of Tissue Engineering Research

摘　　要：背景:非类固醇类抗炎药塞来昔布治疗老年退行性膝骨关节炎起效快,不良反应较少,但不能防止疾病的发生和发展,停药不久后有可能出现反跳,甚至症状加重。改善关节软骨代谢的药物——双醋瑞因可延缓老年退行性膝骨关节炎的疾病进程,但起效较慢。如联合塞来昔布与双醋瑞因治疗老年退行性膝骨关节炎,是否可以有取长补短,产生更好治疗效果的作用?目的:观察塞来昔布联合双醋瑞因治疗老年退行性膝骨关节炎的有效性及安全性。方法:研究为前瞻性、单中心、随机对照临床试验。将南京医科大学第二附属医院骨科的老年退行性膝骨关节炎患者300例,随机分为3组,单独以塞来昔布胶囊口服,200 mg/次,1次/d,为塞来昔布组;单独以双醋瑞因胶囊口服,50 mg/次,2次/d,为双醋瑞因组;塞来昔布胶囊和双醋瑞因胶囊联合口服(塞来昔布胶囊,200 mg,口服1次/d;双醋瑞因胶囊,50 mg,口服2次/d),为联合治疗组,每组100例,各组均服药治疗12周,随访36周。试验的主要结局指标为治疗前和治疗后1,4,12,24,36周患者20 m步行痛目测类比评分;试验的次要结局指标为治疗前和治疗后1,4,12,24,36周骨关节炎指数评分及膝关节X射线形态,治疗后1,4,12,24,36周不良反应发生率。试验经南京医科大学第二附属医院伦理委员会批准[审批单位:南京医科大学第二附属医院,(2017)KY第091号]。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对试验方案和过程均知情同意,并签署知情同意书。试验于2018年1月开始进行患者招募,样本及数据收集时间为2018年1月至2018年12月,结果指标分析时间为2020年1月,试验完成时间为2020年2月。文章结果将以科学会议报告,或在同行评议的期刊上发表传播。试验已在中国临床试验注册中心注册(注册号:Chi CTR-IOR-17013867)。讨论:试验结果希望能证实塞来昔布联合双�BACKGROUND:The non-steroidal anti-inflammatory drug celecoxib,used for the treatment of senile degenerative kneeosteoarthritis,has a rapid onset of action and few side effects.However,it cannot prevent the occurrence anddevelopment of knee osteoarthritis.Celecoxib withdrawal is likely to induce a rebound increase in inflammation that mayaggravate symptoms.Diacerein is a drug used to improve articular cartilage metabolism.It can delay the progression ofsenile degenerative knee osteoarthritis,but has a slow onset of action.Whether combined treatment with celecoxib anddiacerein provides complimentary actions to achieve a better therapeutic effect on senile degenerative kneeosteoarthritis remains unclear.Whether combined treatment with celecoxib and diacerein provides complimentaryactions to achieve a better therapeutic effect on senile degenerative knee osteoarthritis remains unclear.OBJECTIVE:To investigate the effectiveness and safety of celecoxib combined with diacerein in the treatment of seniledegenerative knee osteoarthritis.METHODS:This is a prospective,single-center,randomized controlled trial.Three hundred patients with seniledegenerative knee osteoarthritis who receive treatment at the Department of Orthopedics,Second Affiliated Hospital ofNanjing Medical University,China will be randomly assigned to celecoxib(200mg,once a day,orally),diacerein(50mg,twice a day,orally),and celecoxib+diacerein(celecoxib200mg,once a day,orally and diacerein50mg,twice a day,orally)groups,with100patients in each group.Patients in each group will be treated for12successive weeks,and a36-week follow-up will be performed.The primary outcome measure of this study is the20-meter walk pain visualanalogue scale score before and1,4,12,24,and36weeks after treatment.The secondary outcome measures of thisstudy include osteoarthritis index and X-ray image findings of the knee before and1,4,12,24,and36weeks aftertreatment,as well as the incidence of adverse events at1,4,12,24,and36weeks after treatment.This study wasapproved by the Ethics

关 键 词：组织构建 骨组织工程 临床试验 塞来昔布 双醋瑞因 老年 退行性膝骨关节炎 X 射线 疗效 不良反应 

分 类 号：R318[医药卫生—生物医学工程]