中国组织工程研究

中国组织工程研究 ›› 2017, Vol. 21 ›› Issue (36): 5747-5751.doi: 10.3969/j.issn.2095-4344.2017.36.002

• 骨组织构建 bone tissue construction • 上一篇    下一篇

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

王国栋，杨凌云，何  斌，王云华，陈  琦，范  磊   

  1. 南京医科大学第二附属医院骨科，江苏省南京市  210011
  • 收稿日期:2017-11-26 出版日期:2017-12-28 发布日期:2018-01-04
  • 通讯作者: 通讯作者：何斌，副主任医师，南京医科大学第二附属医院骨科，江苏省南京市 210011 通讯作者：杨凌云，主治医师，南京医科大学第二附属医院骨科，江苏省南京市 210011
  • 作者简介:王国栋，副主任医师。

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

Wang Guo-dong, Yang Ling-yun, He Bin, Wang Yun-hua, Chen Qi, Fan Lei   

  1. Department of Orthopedics, the Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China
  • Received:2017-11-26 Online:2017-12-28 Published:2018-01-04
  • Contact: He Bin, Associate chief physician, Department of Orthopedics, the Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China Corresponding author: Yang Ling-yun, Attending physician, Department of Orthopedics, the Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China
  • About author:Wang Guo-dong, Associate chief physician, Department of Orthopedics, the Second Affiliated Hospital of Nanjing Medical University, Nanjing 210011, Jiangsu Province, China

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摘要：

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文题释义：
塞来昔布：通过选择性抑制环氧化酶2来抑制前列腺素生成，达到抗炎症、镇痛的效果，由于它不会抑制具有胃肠道保护作用的生理酶——环氧化酶1，其胃肠道不良反应风险明显低于传统非类固醇抗炎镇痛药。
双醋瑞因：可诱导软骨生成，具有止痛、抗炎及退热作用，也可显著改善骨关节炎患者的关节功能，延缓病程，减轻疼痛，提高患者的生活质量，具有较好的安全性，临床主要用于治疗骨关节炎而发挥抗菌作用。

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：ChiCTR-IOR-17013867)。
讨论：试验结果希望能证实塞来昔布联合双醋瑞因联合应用治疗老年退行性膝骨关节炎具有互补的效应，可早期止痛，又能使临床疗效更持久且安全可靠。

中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程
ORCID: 0000-0001-7055-1092(王国栋)

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

Abstract:

BACKGROUND: The non-steroidal anti-inflammatory drug celecoxib, used for the treatment of senile degenerative knee osteoarthritis, has a rapid onset of action and few side effects. However, it cannot prevent the occurrence and development of knee osteoarthritis. Celecoxib withdrawal is likely to induce a rebound increase in inflammation that may aggravate symptoms. Diacerein is a drug used to improve articular cartilage metabolism. It can delay the progression of senile degenerative knee osteoarthritis, but has a slow onset of action. Whether combined treatment with celecoxib and diacerein provides complimentary actions to achieve a better therapeutic effect on senile degenerative knee osteoarthritis remains unclear. Whether combined treatment with celecoxib and diacerein provides complimentary actions 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 senile degenerative knee osteoarthritis.
METHODS: This is a prospective, single-center, randomized controlled trial. Three hundred patients with senile degenerative knee osteoarthritis who receive treatment at the Department of Orthopedics, Second Affiliated Hospital of Nanjing Medical University, China will be randomly assigned to celecoxib (200 mg, once a day, orally), diacerein (50 mg, twice a day, orally), and celecoxib+diacerein (celecoxib 200 mg, once a day, orally and diacerein 50 mg, twice a day, orally) groups, with 100 patients in each group. Patients in each group will be treated for 12 successive weeks, and a 36-week follow-up will be performed. The primary outcome measure of this study is the 20-meter walk pain visual analogue scale score before and 1, 4, 12, 24, and 36 weeks after treatment. The secondary outcome measures of this study include osteoarthritis index and X-ray image findings of the knee before and 1, 4, 12, 24, and 36 weeks after treatment, as well as the incidence of adverse events at 1, 4, 12, 24, and 36 weeks after treatment. This study was approved by the Ethics Committee of the Second Affiliated Hospital of Nanjing Medical University, China (approval No. (2017)KY-091). The study protocol will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Written informed consent of the study protocol and procedure will be obtained from each patient. Participant recruitment will begin in January 2018. Sample and data collection will begin in January 2018 and end in December 2018. Outcome measures will be analyzed in January 2020. The trial will end in February 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. This trial was registered with the Chinese Clinical Trial Registry (registration No. ChiCTR-IOR-17013867).
DISCUSSION: Results from this study will help to determine whether celecoxib and diacerein complement each other to produce a long-acting, safe, reliable, and rapid-onset analgesic effect in patients with senile degenerative knee osteoarthritis.

中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程

Key words: Clinical Trial, Osteoarthritis, Cartilage, Articular

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